Research on the safety of taking psychiatric medications during pregnancy is sparse, leaving doctors to turn to available literature on the subject.

Clinicians are frequently caught between a teratologic rock and a clinical hard place when it comes to the use of psychiatric medications during pregnancy. Unfortunately, the Food and Drug Administration's current classification system, which assigns ratings with respect to the safety of drugs during pregnancy, does not necessarily help and can be misleading.

Recognizing such limitations, the FDA is in the process of revamping the system, but for now it's incumbent on physicians to go beyond the package insert and refer to the available literature and other resources to get a better picture of the full amount of reproductive safety data available on a certain drug.

The use of certain antidepressants during pregnancy is a striking example of how category labeling does not necessarily help guide clinical care-and how it can make certain compounds with relatively less safety data appear to be "safer" than medicines for which we have far more safety data.

For example, bupropion, marketed as Wellbutrin for depression and Zyban for smoking cessation, has been classified as a category B compound based on anecdotal human data from a very small sample of women and limited animal data, which do not support adverse effects associated with prenatal exposure.

Although the manufacturer has established a bupropion pregnancy registry, the data on this drug are sparse when compared with the amount of safety data on fluoxetine (Prozac) and citalopram (Celexa). Yet both these selective serotonin reuptake inhibitors (SSRIs) are labeled category C, presumably based on adverse effects seen in studies of rats that ingested 10-18 times the maximum human recommended daily doses of these drugs. Under the current system, these types of data justify a C category almost regardless of the amount of human data available.

The category C label does not reflect human data on more than 2,300 cases of first-trimester exposure to fluoxetine or the nearly 400 cases of first-trimester exposure to citalopram; these data do not support an increased risk for major congenital malformations. But we have seen cases of women who are stabilized on citalopram or fluoxetine and then switched during pregnancy to medicines such as bupropion, because clinicians assume a category B drug is "safer" than fluoxetine or citalopram, prompting the clinician to incorrectly assume that the absence of adverse data implies safety.

In this scenario, not only is the patient put at risk of not responding to the new antidepressant and having a relapse, but she is unnecessarily taken off a medicine for which there is a relatively abundant amount of safety data.

Category labeling also fails us when we consider the SSRIs as a class. This is a particularly important issue because it is incorrect to assume that all drugs within the same class have equal reproductive safety. All the available SSRIs are labeled category C, but there's nowhere near the amount of information on first-trimester expoÂÂ ­sure to paroxetine (Paxil) and sertraline (Zoloft) as there is for fluoxetine and citalopram.

Lithium is another dramatic example of the complexity of risk assessment of psychiatric medications when considering category label assignment. Other factors come into play when considering whether an agent should be used during pregnancy.

For example, lithium is a category D drug because of clear evidence of an increased risk of a cardiovascular malformation (Ebstein's anomaly) associated with first-trimester exposure. Many women with bipolar disorder who become pregnant or want to become pregnant are counseled by their physicians to discontinue lithium, even abruptly, solely based on the category D label.

However, the absolute risk of Ebstein's anomaly is estimated at 0.05%-0.1%. Since the risk of relapse within the first 6 months of lithium discontinuation is so high-over 60%-women with bipolar disease may choose to assume the relatively small absolute risk for teratogenesis associated with first-trimester exposure, regardless of the drug's category.

These examples underscore the limitations of the category-labeling system and the need to complement this information with other data from the medical literature and elsewhere. By not relying exclusively on the labeling system, physicians and their patients can make more informed decisions when selecting psychiatric drugs.

(References on this topic are also available on the Massachusetts General Hospital Web site at www.mgh.harvard.edu/depts/ womens/index.htm.)

Dr. Lee Cohen is a psychiatrist and director of the perinatal psychiatry program at Massachusetts General Hospital, Boston. He is a consultant for and has received research support from manufacturers of several SSRIs. He is also a consultant to Astra Zeneca, Lilly and Jannsen - manufacturers of atypical antipsychotics. He originally wrote this article for ObGyn News.

Psychiatric Drugs, Pregnancy, and Lactation: Eating Disorders

from ObGynNews

Eating disorders are highly prevalent in the general population, certainly more so in women, appearing to peak during the childbearing years. While we tend not to see pregnant women with anorexia nervosa because they have secondary reproductive endocrine dysfunction, we do see those who have been successfully treated and are contemplating pregnancy or who are pregnant. Far more often, we see patients with bulimia or other binge-eating disorders on the less severe end of the spectrum.

There is very little information in the literature on the course of these disorders as women try to conceive or in pregnancy--and even less on the treatment of symptomatic women during pregnancy or the postpartum period.

The few data that are available include studies reported in the last several years suggesting that pregnancy is associated with improvements in eating disorders followed by postpartum exacerbation of symptoms. A limitation of these studies was that there were very few women included in the samples with active illness who were on medication.

The two drug classes used most frequently in patients with eating disorders are selective serotonin reuptake inhibitors (SSRIs), most commonly fluoxetine, antianxiety agents, typically lorazepam and clonazepam. In our experience, many women have a recurrence of symptoms of the eating disorder when they stop their medication while trying to conceive or while pregnant-consistent with what we see when women with mood and anxiety disorders stop their medications.

So what is the best way to manage patients? There are two avenues of treatment, group- and individual-based cognitive-behavioral therapy and pharmacologic interventions. We have found that patients who have been on pharmacologic therapy may be able to successfully switch from medication to cognitive-behavioral therapy in conjunction with state-of-the-art nutritional counseling while trying to conceive or during pregnancy.

Patients who do well using this approach are on the less severe ends of the spectrum, for example, those who engage in some binge-eating behaviors, followed by some restrictive like behavior (calorie restriction), or who have intermittent bulimic symptoms when they experience anxiety. Cognitive-behavioral interventions can help these patients justify the need to consume calories and gain weight to sustain a healthy pregnancy.

SSRI doses used to treat eating disorders are frequently higher than those used to treat depression, but the risk of adverse fetal effects, including fetal malformations, is not dose-related. Patients who decide to stay on medication, therefore, should remain on the most effective dose, because reducing the dose increases the risk of relapse.

We frequently prescribe benzodiazepines during pregnancy and postpartum in combination with antidepressants to modulate the anxiety symptoms that are frequently associated with eating disorders. A benzodiazepine can often break a cycle of behavior during pregnancy but is particularly effective during the postpartum period. A recent meta-analysis on prenatal exposure to benzodiazepines suggested that if these agents are linked to an increased risk for malformations, that risk is not for overall congenital anomalies, but only for cleft lip or palate. And this risk is less than 0.5% over the normal background risk. The risk of neonatal complications with exposure to benzodiazepines is extremely small.

Postpartum worsening of psychiatric disorders is the rule. In the postpartum period, women may demonstrate reemergence of rituals practiced before pregnancy, and comorbid depression and anxiety are common. While prophylaxis with medication is not necessarily indicated, these women should be considered at high risk for postpartum psychiatric disturbance. Women who have been successfully treated with cognitive therapy and nutritional counseling during pregnancy may need to resume or start pharmacologic treatment. For example, it would not be unusual for a patient with mild to moderate symptoms before pregnancy, who managed well during pregnancy with cognitive interventions and nutritional counseling, to experience a reemergence of the eating disorder with major depression postpartum. These patients can become ill relatively quickly, so prompt reintroduction of a medication can be extremely important.

The incidence of treatment-emergent side effects in nursing babies whose mothers are taking a benzodiazepine or an SSRI is exceedingly low, and these drugs are not contraindicated during breastfeeding.

Dr. Lee Cohen is a psychiatrist and director of the perinatal psychiatry program at Massachusetts General Hospital, Boston. He is a consultant for and has received research support from manufacturers of several SSRIs. He is also a consultant to Astra Zeneca, Lilly and Jannsen - manufacturers of atypical antipsychotics.

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Early data shows that lamotrigine (Lamictal) may be safe for treating bipolar women who are pregnant.

As the use of anticonvulsants to treat bipolar illness has grown over the past decade, so has the number of women successfully treated with these medications who have questions about whether they should discontinue these drugs before they attempt to conceive, or what to do if they are already pregnant.

The anticonvulsants that have been most widely used for bipolar illness are sodium valproate and carbamazepine, and more recently, gabapentin (Neurontin), lamotrigine (Lamictal), oxcarbazepine (Trileptal), and tiagabine (Gabitril). Until recently, there have been few reproductive safety data available on the newer anticonvulsants.

Many women and their physicians are caught in a particularly vexing bind because two of the mainstays of bipolar therapy, lithium and sodium valproate (Depakote), are known teratogens, though the teratogenicity of these two compounds is particularly different. The risk associated with first-trimester exposure ranges from a relatively modest 0.05% risk of Ebstein's anomaly with lithium to an approximately 8% risk of cardiovascular malformations and neural tube defects with sodium valproate. The latter is based on recent findings from the Antiepileptic Drug Registry at Massachusetts General Hospital (Am. J. Obstet. Gynecol. 187[6 pt. 2]:s137, 2002).

But the data that are accumulating on lamotrigine, approved in June for maintenance treatment of bipolar disorder, provide some welcome news for reproductive-aged women with bipolar disorder. An interim report on cases collected by the lamotrigine pregnancy registry maintained by the manufacturer, GlaxoSmithKline, since September 1992 indicates that the drug does not appear to be teratogenic. The report does note, however, that the sample size is not large enough to make definitive conclusions.

As of March, the pregnancy registry had collected information on more than 500 first-trimester exposures in women treated with Lamictal for bipolar illness and for epilepsy, which did not demonstrate an increase in major birth defects associated with first-trimester exposure, supporting earlier reports.

The risk of teratogenicity was significantly increased with first-trimester exposure to the combination of lamotrigine and sodium valproate (more commonly used for epilepsy), but not with lamotrigine monotherapy: Among the 302 pregnancies exposed to monotherapy in the first trimester, there were 9 (3%) major birth defects, compared with 7 (10.4%) major birth defects among the 67 cases of firsttrimester exposure to both drugs. There were 5 (3.5%) major birth defects among 148 cases of first-trimester exposure to polytherapy that did not include sodium valproate.

The clinical implications of these long-awaited data on lamotrigine are relatively clear and present an opportunity to navigate the tricky course of maintaining euthymia across pregnancy and minimizing exposure to drugs that might be harmful to the fetus.

For example, sodium valproate can be deferred for a medicine such as lamotrigine in some patients, particularly those who do not respond to or who have not tolerated lithium. Although lamotrigine has not demonstrated efficacy for the treatment of acute mania, the anticonvulsant can be combined with medicines that are helpful in treating this phase of bipolar disorder. Such adjunctive medicines include high-potency typical antipsychotics like haloperidol or trifluoperazine.

Unfortunately, the reproductive safety data available for the newer atypical antipsychotic olanzapine (Zyprexa)--efficacious for both acute mania and for prophylaxis against recurrent mania--are exceedingly sparse. Clinicians are left with the task of trying to minimize exposure to medicines we know very little about, such as olanzapine, and to medicines we know a lot about that appear to be particularly harmful to the fetus, such as sodium valproate (Depakote).

Lamotrigine is the only one of the newer anticonvulsants for which there are enough exposed cases to allow for some reliable quantification of teratogenic risk. Manufacturers of the other anticonvulsants have not established independent registries. The Antiepileptic Drug Registry at Massachusetts General Hospital is collecting data on a spectrum of newer anticonvulsants, but to date the numbers are too small for any conclusions, except on lamotrigine (Lamictal).

One caveat with respect to use of lamotrigine lies in the very small but quantifiable risk of Stevens-Johnson syndrome associated with lamotrigine therapy. To reduce risk, the manufacturer recommends titrating patients gingerly, by no more than 25 mg weekly.

Dr. Lee Cohen is a psychiatrist and director of the perinatal psychiatry program at Massachusetts General Hospital, Boston. He is a consultant for and has received research support from manufacturers of several SSRIs. He is also a consultant to Astra Zeneca, Lilly and Jannsen - manufacturers of atypical antipsychotics. He originally wrote this article for ObGyn News.

Psychiatric Drugs, Pregnancy and Lactation: The FDA Advisory on Paxil (Paroxetine)

from ObGynNews

Multiple studies over the past decade have been supportive of the reproductive safety of the selective serotonin reuptake inhibitors (SSRIs) when used during the first trimester; these studies include one recent meta-analysis and other extensive reviews. Particularly reassuring have been the prospective data on fluoxetine (Prozac) and citalopram (Celexa). As a result, clinicians have been relatively reassured about the absence of teratogenic risk associated with the SSRIs.

New concerns were recently raised about the reproductive safety of paroxetine (Paxil) by a presentation at the Teratology Society annual meeting that reported an increased risk of omphalocele associated with first-trimester exposure. This report was based on preliminary, unpublished data from the National Birth Defects Center, which I reviewed in a recent column (OB.GYN. NEWS, Oct. 15, 2005, p. 9). A weaker association was also found between omphalocele and other SSRIs.

A Food and Drug Administration public health advisory about paroxetine followed in December, describing preliminary results of two other unpublished studies indicating that paroxetine exposure in the first trimester may increase the risk of congenital malformations, particularly cardiac malformations. At the FDA's request, paroxetine manufacturer GlaxoSmithKline has changed the pregnancy category label for paroxetine from C to D.

It is surprising that the FDA's recommendation and advisory are based on preliminary analyses from several recent, unpublished, non-peer-reviewed epidemiologic studies, as these are data that should be considered, at least at this point, inconclusive.

Using data from the Swedish National Registry, one study found a 2% rate of cardiac defects among infants exposed during the first trimester to paroxetine vs. 1% among all registry infants. But a previous study using registry data that was based on a slightly smaller number of children exposed to paroxetine did not report this association (J. Clin. Psychopharmacol. 2005;25:59‚73).

Another study, using data from a U.S. insurance claims database, found the rate of cardiovascular malformations was 1.5% among infants exposed to paroxetine during the first trimester vs. 1% among infants exposed to other antidepressants. The majority were atrial or ventricular septal defects, which are common congenital malformations.

The modest increases in relative risk of a common anomaly, when derived from a claims database with inherent methodologic limitations, make interpretation of these data problematic. Unfortunately, the language in the FDA advisory, suggesting that "the benefits of continuing paroxetine may outweigh the potential risk to the fetus," may get lost in the information patients receive.

Although there are not as many published studies on the teratogenic risk of paroxetine as for other SSRIs, it is noteworthy that prospective studies have not identified a higher rate of congenital or cardiac malformations associated with prenatal exposure to paroxetine.

How does the clinician then counsel women of reproductive age who suffer from major depression? And what is the best option for patients who are being treated with paroxetine who want to get pregnant or who have an unplanned pregnancy? Until the issue is clarified with more rigorously obtained and conclusive data, it is reasonable to avoid paroxetine in women who are actively trying to get pregnant or plan to in the future.

For those with major depression who are antidepressant-naive, it may be most prudent to prescribe an SSRI or an SNRI for which there are no unfavorable data to date, such as fluoxetine or citalopram (Celexa) /escitalopram (Lexapro), or an older tricyclic antidepressant such as nortriptyline.

What makes sense for those who have failed to respond to one of those medications previously, as in the all-too-common scenario of non-response to multiple SSRIs and response only to paroxetine? In this situation, the use of paroxetine in women who are planning to conceive or who are already pregnant should not be considered absolutely contraindicated.

If the medication is discontinued before or during pregnancy, it should be done gradually, as is consistent with standard clinical practice.

Until the data are peer-reviewed and published, decisions about use of this medicine in women who are planning a pregnancy or are pregnant will have to be made on a case-by-case basis. But we need to keep in mind that nothing is more critical than sustaining euthymia during pregnancy. Untreated depression in pregnancy is associated with compromised fetal well-being as well as increased risk for postpartum depression.

Dr. Lee Cohen is a psychiatrist and director of the perinatal psychiatry program at Massachusetts General Hospital, Boston. He is a consultant for and has received research support from manufacturers of several SSRIs. He is also a consultant to Astra Zeneca, Lilly and Jannsen - manufacturers of atypical antipsychotics.

Pregnancy does not protect the mother against depression and certain antidepressants during pregnancy may prove helpful in treating a depression relapse and depression during pregnancy.

from ObGynNews

Even today, many clinicians mistakenly believe that pregnancy is protective against the development or relapse of depression. That misperception persists despite several studies over the past 6 years demonstrating that women experience episodes of depression and relapse at the same rate during pregnancy as they do when they're not pregnant.

Likewise, if a woman on antidepressants stops treatment during pregnancy, her risk of recurrence is just as high as it would be if she weren't pregnant and she discontinued treatment. Still, it's common for women to be counseled to stop antidepressants before or after they conceive.

The confluence of depression and pregnancy puts clinicians between a rock and a hard place. During pregnancy, the goal is to avoid the use of medications for which we don't have conclusive safety data and those data concerning antidepressants during pregnancy are more or less complete depending on the medicine. At the same time, treatment cessation in women who are at risk of relapse can have an adverse effect on fetal well-being. Each patient must be managed on a case-by-case basis, weighing the risks and benefits of treatment.

What do we know? There are good data showing that first-trimester exposure to tricyclics such as imipramine (Tofranil) and amitriptyline (Elavil) doesn't increase the rate of major congenital malformations. But these drugs are not widely used.

Of the selective serotonin reuptake inhibitors (SSRIs), the most data are available on fluoxetine (Prozac). There are about 2,000 cases in the manufacturer's registry and several prospective studies describing first-trimester exposure to fluoxetine, none of which show an increased rate of major congenital malformations with first-trimester exposure. There are about 300 cases of pregnancy exposure to citalopram (Celexa) and approximately 250 for paroxetine (Paxil), sertraline (Zoloft), or fluvoxamine (Luvox) combined, accumulated from one study. Although these are in the same class as fluoxetine, conclusions that we make must be based on data for that specific medicine, not the class.

Another critical issue: We have very few good data on the risk of long-term neurobehavioral effects associated with prenatal exposure to psychiatric medications. One study of children followed through age 6 found no differences between those exposed to fluoxetine or tricyclics in utero and those not exposed to an antidepressant.

Data suggesting that the rates of perinatal toxicity or low birth weight are higher in babies exposed to fluoxetine in utero are profoundly flawed. We have a study in press that did not find this. Ultimately what we do about maintenance therapy, switching medications, or attempting to discontinue drugs should depend on the patient's severity of illness and her wishes. Interestingly, women with similar illness histories who are given the same information regarding reproductive safety of these drugs often make very different decisions about how to proceed.

A switch to a safer drug may be appropriate. For example, a woman who is on bupropion (Wellbutrin), for which we have almost no reproductive safety data, would be best served by switching to a drug like fluoxetine or even imipramine. Yet ironically, bupropion is labeled as a category B drug while the SSRIs are labeled as category C drugs, even though there's next to no information on bupropion's reproductive safety. That's why it's so important for obstetricians to go further than the Physician's Desk Reference.

We never discontinue antidepressants around the time of labor because depression during pregnancy is one of the strongest predictors of postpartum depression. The potential for antidepressant withdrawal symptoms in babies born to women on antidepressants is a theoretical concern, but there is nothing more than a rare anecdote suggesting that such symptoms are something about which we need to be concerned.

Discover how counseling, therapy and support groups work and how these different talking treatments might help you.

Why try talking treatments?
What are the different talking treatments?
Who are talking treatments for?
When are talking treatments not suitable?
Do talking treatments work?
How can I get started?
How the therapist-patient relationship works
Organizations that can help

Counseling, Therapy, Support Groups: How They Work, What They Do For You

Here's a brief guide to the different types of talking treatments that are available. It also provides information on who might benefit from them and who you should contact about getting this type of help.

Why try talking treatments?

Talking treatments (i.e. counseling, therapy, support groups) can help you to overcome emotional difficulties and free yourself from self-destructive ways of feeling, thinking and behaving. They work by providing an opportunity for you to talk in a way that assists you to understand yourself better. Having gained this understanding, you can work out ways of living your life in a more positive and constructive way.

This way of changing your life is very different from using drugs, such as tranquilizers and antidepressants, which doctors often prescribe for people who are emotionally distressed. These drugs change your mood by affecting the balance of chemicals in your body, but do not help you to deal with underlying problems.

People who use mental health services often prefer talking treatments to drugs. Research has proved that talking treatments can be just as helpful as drugs for many mental health problems and suggests they should be offered as well as, or instead of, medication, when possible. The National Institute of Mental Health (NIMH) makes recommendations to doctors about treating mental health problems. They often suggest forms of talking treatment that are brief, cost-effective and supported by clinical evidence. This does not necessarily mean that they are always the best form of talking treatment for you. Many organizations and private therapists offer treatment, although it can be more difficult to find if you can't afford to pay very much.

What are the different talking treatments?

There is a wide variety of talking treatments. Some last for several years, while others take just a few sessions. You may see someone on your own or be part of a group.

The self-help group

This is usually for people who want to overcome a problem shared by members of the group. It may be alcohol abuse, depression or being scared to go out of the house, to give some examples. Often these groups are led by people who have overcome the difficulties themselves. The people in the group are able to share their experiences, and learn from and encourage each other.

The support group

This is similar, but for people with a common background or interest. For example, it could be a group for mothers of young children, for gay men or for people doing similar, stressful jobs.

Individual counseling

This is an opportunity to talk about whatever is troubling you, and to be heard. It is generally face-to-face, but can also take place over the phone or via email. If you decide to see a counselor in person, it may be for one session, or you may arrange for regular appointments, perhaps an hour a week for several months. Telephone and internet counseling is also obtainable from a variety of organizations and is especially valuable in a particular crisis.

Counseling tends to focus on your current problems, with the counselor helping you to find the best ways to tackle them. The counselor's most important skill is the ability to listen. The aim is not to tell you what to do, or to offer a personal opinion, but about helping you to arrive at your own solutions.

Individual psychotherapy

The overall aim of psychotherapy is to help you to understand why you feel the way you do, and what lies behind your responses to other people and to things that happen to you. Talking about your experiences can help you to release painful feelings and find better ways of managing situations you have been finding difficult. This should enable you to reach a greater understanding of events that have shaped your life, and of self-destructive patterns of behavior. It may, therefore, enable you to overcome specific problems, such as compulsive eating and lack of confidence, or simply allow you to become happier.

Psychotherapists have many different styles of working, and the number of sessions required can vary from one to five times a week. Each session may last for 50 minutes or an hour. You may agree to a fixed term of treatment, or the therapy may be open-ended and could continue for several years.

Some therapists will want you to talk mainly about your early childhood, and others will be more interested in what can be learnt from the relationship you make with them (known as 'the transference'). The psychotherapist may want to know how you feel about yourself, as a woman, a Black person or someone with a physical disability, to give some examples. Others will be more interested in your dreams and fantasies. Some will encourage you to get rid of bad feelings by crying or getting angry, as well as talking.

There is a great deal of overlap between psychotherapy and counseling, and there are many different types of psychotherapy. If you want more detailed information, you can read "Types of Therapy" or you could consult the organizations listed under Useful Organizations.

Relationship counseling and family therapy

Relationship counseling is for couples who want to sort out problems in their relationship. They attend sessions together and the counselor helps them to express their difficulties, listen to each other, develop an understanding of each other, and find ways of making their relationship work better. They may decide to end the relationship but, with luck, having gained more understanding of why it was not working and what lessons they can learn for the future. Family therapy works in just the same way, with the entire family attending.

Group therapy

Group therapy enables people to deal with interpersonal problems and develop self-awareness. There are generally 8 to 12 people in the group, who meet together regularly, with a therapist, and talk about their concerns.

The idea of group therapy can be intimidating, but most people find it reassuring that others may be in a similar position to themselves. In a group environment, opportunities may arise to behave differently, to be more assertive or more vulnerable. It is also helpful for people to hear other points of view about their concerns, the way they appear, how their behavior comes across and in what way it affects other people.

Cognitive behavior therapy (CBT)

Behavior therapy, also known as exposure therapy or desensitization, is often practiced by psychologists. It is used to help people overcome fears or phobias, such as feeling too scared to go into a shop, or obsessive behavior, such as washing many times a day. An opportunity is usually given to discuss the problem, and then to face your fear, gradually, so that you learn to cope. Cognitive therapy helps to identify connections between your thoughts, feelings, and behavior. It is a practical treatment that focuses on specific problem-solving techniques and enables you to develop new coping mechanisms.

Behavior and cognitive therapies are often combined, and practitioners of either may refer to their approach as cognitive behavior therapy. New forms of CBT have been developed and NIMH has recommended particular types for particular problems, such as depression, anxiety, eating disorders, schizophrenia and personality disorders. They include Mindfulness, interpersonal therapy and dialectical behavior therapy.

CBT may be offered by clinical psychologists or psychiatrists.

The therapeutic community

This is a place where you can either live full time or attend regularly during the day. Usually, there is a mixture of individual and group therapy, and informal support from other members of the community.

Who is therapy for?

Prejudice about emotional distress sometimes stops people from using talking treatments they could benefit from. They may feel that it is a sign of weakness or inadequacy to seek assistance in this way. The truth is very different; it is not your fault if you experience emotional difficulties, and it takes courage to face up to them and find better ways of coping. Most people can benefit from talking treatments. They can do for the mind what exercise does for the body. They liven you up, help you to think more flexibly, make you stronger, emotionally, and help to stop more serious problems from occurring. Just like taking exercise, it is important to find what suits you best.

Unfortunately, it is also true that doctors are more likely to suggest talking treatments if you are white and middle class. Talking treatments work just as well for working class people, Black people and people from minority ethnic communities.

The only difficulty is that most counselors and psychotherapists are white and middle class, and they may not have a good understanding of what it is like to be you. It can help if they have made the effort to learn about cultures that are different from their own. People with learning disabilities, lesbians and gay men, older people and people with chronic illness are also under-represented when it comes to receiving talking treatments.

Good psychotherapists and counselors listen and learn from their clients, and don't try and impose their values on them. There are some organizations that offer talking treatments to specific sections of the community. There is now much more awareness of this issue, and more effort has been focused on tackling it.

When are talking treatments not suitable?

There are some good reasons (as well as bad ones) for not offering talking treatments. In groups, for instance, it is important that people should be prepared to listen to, and support each other, as well as to talk about themselves. If you aren't able to do this, or are abusive towards others, you may be asked to leave.

Psychotherapists and counselors may decide they can't help you. If you are abusing alcohol or other drugs, they may say you first need specialized care to help you stop. If your doctor has prescribed you psychotropic (mood-altering) drugs, such as tranquilizers, some psychotherapists and counselors will not mind, but others will say that you need to come off them for the treatment to work. They may be able to help you do this as part of the treatment.

There is no general agreement among psychotherapists and counselors about whether they can assist people who are diagnosed as having serious mental illnesses, such as schizophrenia or manic depression (bipolar disorder). Some will say, 'Yes, but only if you stop taking the drugs'. Most will say that whether they can help depends on the person, not on the diagnosis.

Generally, successful treatment depends on the person being prepared to try and make their life better, using the support that is offered. If you blame all your difficulties on other people, or expect the counselor, psychotherapist or fellow group members to 'make you better' without putting in any effort yourself, then you will not be able to benefit.

Talking treatments can assist people to overcome many different sorts of problems, but some difficulties are better helped by other treatments as well, or instead. For example, if you find it hard to sleep, learning relaxation techniques would probably be your first priority.

Does therapy really work?

Talking treatments like therapy or counseling certainly do work, but not always. There are many people whose lives have improved beyond recognition as a result of attending a group, or seeing a counselor or psychotherapist. It may have been a struggle and taken a long time, but it has been worth it. Profound changes have taken place and they know, whatever happens, they will not experience their old problems again.

Others know that they have, at least, experienced some benefit. They may understand themselves better and have some clues about how they can lead more positive lives. The good periods may last longer and the bad times may be more manageable.

Some people are disappointed. They may have found their counselor or psychotherapist never really understood them, or felt that they did not fit into their group. A bad experience of talking treatments may have left them feeling more hopeless than before. Talking treatments vary in their quality. Some professionals are simply better at their jobs than others. They all have strengths and weaknesses. Some may be better at helping women than men. Others may have a great deal of understanding of depression but not of addiction.

Therapists use different methods, and some may be more effective than others. Or one may particularly suit you when another one does not. Your own attitude will also make a difference. Some people find that just knowing that their therapist is there and focusing on their concerns makes them feel valued.

If you go along determined to make the most of every session and to be completely honest about yourself, it is more likely to work. If, as a result of what you learn about yourself, you are prepared to face your fears and risk making changes in your life, you are much more likely to achieve good results.

It is useful if you can be clear about how you hope to benefit from the talking treatments. It will help you to make the best use of your sessions and, also, to decide if it is proving to be useful for you.

How can I get started?

Talking treatments may be available free through various support groups, an area medical school psychiatric training program, through social services or from independent organizations, such as the local women's shelter. What is available varies a great deal from place to place. Unfortunately, there is not always something suitable. What services do exist are often not well publicized, and it is worth asking about them in as many places as possible. Try your local support group, your doctor, local social services or United Way, or the other organizations listed here.

Sometimes, counseling organizations ask for a donation, based on what you can afford. If you are a student, you may find you can see a counselor at your college. Large companies sometimes employ counselors for their staff. Some therapeutic communities are free.

The cost of private counseling or psychotherapy can vary a great deal. A fee of $60-150 per session is quite common. Groups may be cheaper. Sometimes you can pay less if you are on a low income, or if you are prepared to see a student (who should be supervised by an experienced therapist).

There are many diplomas and certificates, each requiring different amounts of study and experience. (For information about the organizations mentioned see Useful Organizations.) Check whether your counselor or therapist is a member of a professional body with insurance and a complaints procedure. He or she should be working to a code of practice and should be able to give you a copy of it.

Word-of-mouth is one of the best ways of identifying good practitioners. If you know people who have seen counselors and psychotherapists, it's worth asking them if they can recommend someone.

It's usual to have an initial assessment or interview so that the group leader, psychotherapist or counselor can decide if they can help you, and you can decide if you want to see them. Don't be afraid to ask questions about their training, experience and anything else you want to know, and whether or not they are receiving supervision from someone more experienced. If you are religious, you may want to ask how the person feels about your beliefs.

If you have the choice, it may be worth seeing several people before you make up your mind. The most important question to ask yourself is, 'Can I make a good relationship with this person?' Research suggests this is one of the most important ingredients in successful treatments.

If you can't find the talking treatment you want, there may be a befriending scheme, in your area. This is not as formal as the talking treatments described here. You will be introduced to someone who will listen to you sympathetically and help you in whatever ways they can.

How should the therapist-patient relationship work?

The relationship with a psychotherapist (or indeed with counselors, psychologists and group leaders) is very different from the one you make with a friend. You will find out very little about their personal life and their own difficulties and struggles. But you will reveal a lot about yourself.

The psychotherapist will be an important figure in your life. You are likely to develop strong feelings about him or her, which could be positive or negative. Either way, it is easy to feel that the psychotherapist is stronger and more powerful than you. This need not cause any difficulties, but it can leave you vulnerable to exploitation. A psychotherapist may persuade you to carry on seeing them (and paying for your sessions) even though your best judgment is that the sessions are not working. Psychotherapists have also been guilty of sexual harassment. Remember that you are the customer, as well as a client or patient.

You may need to discuss practical arrangements, review how your sessions are going, or air a grievance. You have every right to do this, as one responsible adult to another. If a psychotherapist can only relate to you as a neurotic patient, treat them with suspicion. Remember you can always leave.

It's worth remembering that your psychotherapist or counselor is a real person, doing a challenging job. They have good days and bad days, like the rest of us. You can help them to do their job to the best of their ability by treating them respectfully, by being on time for your session and paying your bills. If you appreciate their efforts, tell them so, and give them feedback, so they know when you can see their work is producing results.

Useful Organizations

American Psychiatric Association
888-35-PSYCH

Your county Psychological Association
listed in the phone book

American Psychological Association
800-964-2000

American Association for Marriage and Family Therapy
703-838-9808

National Association of Social Workers

Mental Health America
800-969-6642

National Alliance for the Mentally Ill (NAMI)
800-950-NAMI (6264)

Depression and Bipolar Support Alliance
800-826-3632

Anxiety Disorders Association of America
240-485-1001

Alcoholics Anonymous
212-870-3400

Explanation of the theory behind how support groups work and why some people find support groups very helpful.

A Boat Full of Misery

I'm not much for support groups. I never really bought into the old "I've got misery. You've got misery. Let's paddle around the same boat and talk about how miserable we are" notion.

When my mom died, I was 23. I don't know if it would have been any easier if I had been 93 (although I guess I'd have to have forgiven her for dying at 132). Some people say it was easier when their mom died than their dad. Some say the opposite. My theory is that if you're close to both your parents, the first gone is the hardest. It's an unfathomable event.

In the '80s, everyone loved to talk about "denial." "He's an alcoholic. He's just living in denial." "She knows that relationship is a dead end. She's just living in denial." I thought "living in denial" meant you saw something wrong in your life but decided you would be happier not acknowledging it. Your friends would say: "He's a loser." And you'd say: "No, he's not!" And keep on dating him.

Then my mother died and my brain turned off for a year. I left ATM cards in machines that must have been beeping. A friend asked me a while ago if I felt weird still being his friend considering we once dated. I'm sure I boosted his ego with the response every guy yearns to hear: "Dated? When did we date?"

Months later, I was able to verbalize my feelings, or maybe I should say non-feelings, in this way: Having a parent die is like having someone you completely trust tell you: "Oh, by the way, there will never be sunshine again. The sun exploded in the middle of the night while you were sleeping." You know this person would never lie to you or play such a cruel joke. You totally believe him or her. But you'd still look out the window every day for a very long time expecting to see the sun in its usual place. Every day of your entire life the sun was in the sky. How could it be gone?

Six months after Mom died, someone suggested I try a bereavement workshop. Backstroking a moment to my boat analogy: I was always a lone paddler and had no real interest in floating around with a bunch of strangers. But I went.

There was a girl my age whose mom had also had cancer. She lingered for several months, deteriorating in a convalescent home that they visited for hours each day. Another girl had lost her kid brother, part of a strict religious group in Georgia, to AIDS. A man in his fifties had lived his entire life with his mother who had recently died at 88. Now he was a lost soul.

My mother had been diagnosed with cancer in June and lived reasonably okay for another six weeks.

There's an old Yiddish saying (there are no new Yiddish sayings): If you and all your neighbors lay all of your problems on your respective front lawns, you'd look them all over, and end up taking back your own. And thus began the first support group.

Some doctors are concerned that too much emphasis is being placed on the relatively small risk of taking Prozac during pregnancy vs. the health of the mother.

In April, the National Toxicology Program's Center for the Evaluation of Risks to Human Reproduction, established by the NTP and the National Institute of Environmental Health Sciences, issued a final report on the reproductive and developmental toxicity of fluoxetine (Prozac). The report concluded that "third-trimester exposure to therapeutic doses of fluoxetine ... is associated with an increased incidence of poor neonatal adaptation," which includes jitteriness, tachypnea, poor tone, and other symptoms, "as well as increased admissions to special care nurseries."

Having reviewed the report in draft and final form and having testified at the meeting of the expert panel convened to write the report, my greatest concern is what patients and some clinicians may do with the panel's conclusions. Information in the report, while comprehensive and technically correct in most cases, might easily be misconstrued by women and their families.

The report provides a summary and review of existing data, with a thorough review of the animal and human literature on reproductive safety of fluoxetine. It does not adequately address the clinical context in which fluoxetine or other selective serotonin reuptake inhibitors (SSRIs) are used. While this may not be the aim of the project, failure to address this issue limits the report's value with respect to its ability to inform clinical care; the absence of a clinical context with which to interpret the report may lead to incorrect conclusions and clinical treatment decisions, putting women at risk for the sequelae of untreated or relapsing depressive illness.

The report criticizes much of the literature regarding reproductive safety of fluoxetine, which is understandable because controlled studies of exposures to any medication during pregnancy are not done for ethical reasons. Conclusions regarding reproductive safety of medications come from various sources, such as case series, postmarketing surveillance registries, and teratovigilance programs. These sources can sometimes provide large enough numbers of drug exposures to allow for useful conclusions regarding reproductive safety.

The panel's conclusions regarding the risk for major congenital malformations associated with prenatal exposure to fluoxetine are consistent with the literature and suggest an absence of increased risk with first-trimester exposure to the medicine. The report also addresses the risk for "perinatal toxicity," which typically includes symptoms of jitteriness and autonomic reactivity in the newborn.

Enough literature has accumulated suggesting that third-trimester exposure to SSRIs may be tied to an increased risk of transient symptoms as noted above. Most reports have not associated such exposure with adverse longer-term sequelae. Fluoxetine is the only SSRI for which we have long-term neurobehavioral data, including follow-up of exposed children through ages 4-7 years. No differences in long-term neurobehavioral outcome between exposed and un ­exposed children were noted.

One of the greatest failures of the NTP report is that an important confounding factor with regard to outcome of SSRI use in pregnancy is neglected: maternal mood. In the recent literature, one can find the same "toxicity," such as lower Apgar scores or obstetric complications, in children of mothers who have untreated depression during pregnancy. Failure to address this adequately in the report is a significant omission.

Fluoxetine is used to treat a serious illness; it is not a potential environmental toxin, such as those reviewed by other NTP panels. The report does not indicate that decisions about whether to use fluoxetine during pregnancy are clinical choices made by patients in the context of some risk-benefit analysis made collaboratively between the patient, her family, and the physician. My colleagues and I have described high rates of relapse in women with a history of recurrent major depression who discontinue antidepressants in pregnancy. Depression during pregnancy is associated with compromised fetal and neonatal outcomes-risks that are not reflected in the report. Discontinuation of antidepressant medication near the end of pregnancy appears to increase the risk for postpartum depression.

The panel notes in the report that it recognizes that any risks of fluoxetine need to be weighed against the risks of untreated disease. But this brief statement embedded in a lengthy document that describes fluoxetine as "a reproductive toxin" is inadequate. One has to wonder how this report will impact what actually goes on as patients make decisions about using these compounds.

Dr. Lee Cohen is a psychiatrist and director of the perinatal psychiatry program at Massachusetts General Hospital, Boston. He is a consultant for and has received research support from manufacturers of several SSRIs. He is also a consultant to Astra Zeneca, Lilly and Jannsen - manufacturers of atypical antipsychotics. He originally wrote this article for ObGyn News.

Antidepressant package inserts now warn of complications to the baby from mothers who took antidepressants during pregnancy. Is there reason for extreme concern?

Physicians and patients may be alarmed by recent changes to the product labels of the selective serotonin reuptake inhibitors (SSRIs) and the selective norepinephrine reuptake inhibitor venlafaxine (Effexor) with respect to their use during pregnancy.

The labels now describe clinical findings in newborns exposed to these drugs late in the third trimester, including respiratory distress, jitteriness, irritability, hypoglycemia, feeding difficulties, cyanosis, hypotonia, hypertonia, hyperreflexia, and constant crying. Complications requiring "prolonged hospitalization, respiratory support and tube feeding" are also mentioned.

Prompting these changes were postmarketing adverse event reports made to the Food and Drug Administration over several years, suggesting a constellation of symptoms associated with third trimester exposure. Because these spontaneous reports were uncontrolled, it is impossible to know with certainty whether they are secondary to the medicine. Some of the symptoms-such as jitteriness, irritability, and feeding difficulties-are consistent with anecdotal reports and case series in the literature, which support at least transient jitteriness and irritability associated with maternal use of these antidepressants, particularly late in the third trimester.

But more serious problems such as prolonged hospitalization and the need for respiratory support are not well supported by any objective data in the medical literature. Listing these in the label may do little but alarm patients and physicians.

One theoretical rationale for mandating the label change derives from the assumption that these symptoms are consistent with antidepressant discontinuation symptoms now well described in older patients who abruptly stop treatment with these compounds, particularly those that are shorter-acting. While the description of these symptoms as a "neonatal discontinuation syndrome" is an interesting clinical hypothesis, it is untested and not supported by data.

The label also now advises physicians to "carefully consider the potential risks and benefits of treatment" in patients and suggests that clinicians should consider tapering or discontinuing the medicine late in the third trimester before labor and delivery. One has to wonder about the wisdom of suggesting a taper or discontinuation of an antidepressant during this critical time, considering that the risk for relapse among women who discontinue antidepressants during pregnancy is high and that depression during pregnancy is one of the strongest predictors of postpartum depression.

There are no data to suggest that tapering the drug near term attenuates the risk for toxicity in the newborn. In our earlier work, we actually suggested the peripartum taper of antidepressants; the approach was intuitive as it avoided even the potential risk for neonatal toxicity. However, we then observed high relapse rates among women around labor and delivery, prompting us to shift our recommendation to continue antidepressant therapy across the peripartum period.

The labeling changes will likely create alarm about a potential clinical syndrome that has an extremely low incidence and modest clinical significance. Nonetheless, the label change has the potential to affect scores of women for whom depression remains a significant medical problem.

These changes may increase the threshold for using antidepressants during pregnancy not only during the peripartum period but also during other stages of pregnancy-despite data suggesting that depression in pregnancy has an independent adverse effect on fetal well-being and is the strongest predictor of postpartum depression. The text of the label change lacks this context and puts the clinician in the situation of prescribing counter to the new language if the decision is made to treat during at least the third trimester of pregnancy. The label change is an example of blanket, non-evidence-based recommendations that not only fail to thoughtfully inform clinical care, but also may do more harm than good.

Clinicians confused by these changes should weigh the risks and benefits of antidepressant use near delivery. No psychotropic drug is approved for use in pregnancy, so decisions about using these medicines are made on a case-by-case basis. For women who have experienced depression during pregnancy, particularly those who have had residual symptoms of depression, discontinuing antidepressant therapy may lead to significant worsening or relapse of depression. These issues should be discussed with patients in the context of the patient's individual clinical situation. Only in that context can truly thoughtful treatment decisions be made pending better controlled data.

Dr. Lee Cohen is a psychiatrist and director of the perinatal psychiatry program at Massachusetts General Hospital, Boston. He is a consultant for and has received research support from manufacturers of several SSRIs. He is also a consultant to Astra Zeneca, Lilly and Jannsen - manufacturers of atypical antipsychotics. He originally wrote this article for ObGyn News