More than twenty million Americans including over one million teens and children take one of today's popular antidepressants, such as Paxil, Zoloft, or Effexor. Dr. Glenmullen recognizes the many benefits of antidepressants and prescribes them to his patients, but he is also committed to warning the public of the dangers associated with overprescription. Dr. Glenmullen's last book, Prozac Backlash, sounded the alarm about possible dangers. The Antidepressant Solution provides the remedy. It is the first book to call attention to the drugs' catch-22: Although many people are ready to go off these drugs, they continue to take them because either the patient or the doctor mistakes antidepressant withdrawal for depressive relapse. The Antidepressant Solution offers an easy, step-by-step guide for patients and their doctors.
Written by the premier authority in the field, The Antidepressant Solution is an invaluable book for all those concerned with going through the process from friends and family members to doctors and patients themselves.
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As I wrote this book in 2004, doctors and the public experienced an upheaval in their view of the safety of today's popular antidepressants because the Food and Drug Administration issued a pair of warnings that have been startling to many: Antidepressants may make patients suicidal. In the initial March 2004 warning, the FDA asserted that "adult and pediatric patients" on antidepressants can develop a range of side effects that may make them suicidal, including "anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, and mania." The FDA warned that patients may be vulnerable to this lethal side effect "especially at the beginning of therapy or when the dose either increases or decreases," that is, whenever the dose changes. Since decreasing the dose of an antidepressant may make patients suicidal, the warning is directly relevant to the subject of this book: how to taper off antidepressants safely and comfortably once one no longer needs them. In the second, October 2004 warning, the FDA upgraded the alert for children and adolescents to the strongest level possible: a prominent black box warning in the official information on the drugs. Said the FDA's director of the office of medical policy, Dr. Robert Temple: "I think we now all believe there is an increase in suicidal thinking and action that is consistent across all the drugs."
The FDA warning is truly historic; it is the first time the agency has acknowledged that antidepressant drugs can make some patients suicidal. Until 2004, the FDA and pharmaceutical industry insisted that suicidality was more likely to be due to a patient's underlying psychiatric condition. Now the FDA has said unequivocally that antidepressant-induced suicidality "is beyond the suicidality as a result of the disease." The FDA warnings apply to all of today's popular antidepressants: Prozac, Zoloft, Paxil, Celexa, Lexapro, Effexor, Cymbalta, Wellbutrin, Remeron, Luvox, and Serzone. Indeed, the warnings apply to all thirty-two antidepressants currently on the market, including all of the older tricyclic and monoamine oxidase inhibitor antidepressants. The complete list of antidepressants can be found in Table P.1. In light of the FDA warnings, patients and their doctors should not change the dose of antidepressants up or down without being well informed about how to do so safely and comfortably.
The FDA is following the lead taken by its British counterpart, the Medicines and Healthcare products Regulatory Agency, the MHRA. In 2003, the British issued a series of warnings and virtually banned many antidepressants for children and adolescents under the age of eighteen. The British advised against the drugs because of the evidence in pharmaceutical company studies that the antidepressants are no more effective in children than placebo (dummy) pills but can make children agitated, sleepless, hostile, aggressive, and suicidal. While the British MHRA has virtually banned many antidepressants for some age groups, the FDA warnings have not banned any of the drugs.
The American and British warnings have been accompanied by allegations that the pharmaceutical industry suppressed data on these lethal side effects for years. According to an article in the March 2004 issue of the Canadian Medical Association Journal, GlaxoSmithKline tested its drug Paxil on children and adolescents from 1993 to 1996. The article quotes a secret, internal GlaxoSmithKline report dating to October 1998 saying the studies showed Paxil "failed" to be more effective than placebo pills in depressed children. The secret memorandum urged company executives "to effectively manage the dissemination of these data in order to minimise any potential negative commercial impact" that might "undermine the profile" of Paxil. In other words, the position paper raised concerns that the damaging information might affect Paxil's global sales, which now approach $5 billion a year. How did the report propose to "effectively manage" the potentially damaging results? By selectively publishing the few "positive data" that would appear to make Paxil look good.
To accomplish this goal, GlaxoSmithKline turned to the psychiatrists who conducted the studies for the company. Headed by Dr. Martin Keller, chairman of the Department of Psychiatry and Human Behavior at the Brown University School of Medicine, a group of more than twenty leading academic psychiatrists published the selected Paxil data in the July 2001 issue of the Journal of the American Academy of Child and Adolescent Psychiatry. In stark contrast to the 1998 secret, internal GlaxoSmithKline memo, Keller and his colleagues used highly selected pieces of positive data to glowingly conclude in 2001: "Paxil is generally well tolerated and effective for major depression in adolescents."
After the British and FDA warnings, in April 2004 the prestigious medical journal The Lancet published a damning critique of Keller's and a number of other similar antidepressant studies. In an accompanying editorial, The Lancet expressed outrage over the GlaxoSmithKline internal memo and misleading academic reports. The Lancet described the "selective reporting of favourable research" when side effects as serious as drug-induced suicide are at stake as a "catastrophe" that "should be unimaginable." The Lancet called the false reassurances of the pharmaceutical industry and the academic psychiatrists who work closely with the industry "an abuse of the trust patients place in their physicians." Calling the burgeoning antidepressant scandal "a disaster," The Lancet called for "legal powers" to force pharmaceutical companies to make unpublished data public. Indeed, a growing chorus of consumer advocates and professional organizations, including the American Medical Association, is calling for a public database that lists all pharmaceutical company data from unpublished as well as published studies.
Keller's misleading 2001 report in the Journal of the American Academy of Child and Adolescent Psychiatry was highly influential and widely used to promote prescribing antidepressants to children. Since then the use of the drugs for children has skyrocketed. But two years later, in June 2003, the British declared that the data showed Paxil is not effective for depressed children and, in fact, makes them suicidal and aggressive. Immediately following the British announcement, GlaxoSmithKline sent a "Dear Doctor" letter to physicians in England saying that Paxil should not be prescribed to children under eighteen years of age because it "failed" to work any better than placebo and frequently caused "hostility, agitation, [and] emotional lability (including crying, mood fluctuations, self-harm, suicidal thoughts and attempted suicide)." In June 2004, Eliot Spitzer, the attorney general for the State of New York, filed suit against GlaxoSmithKline charging the company with "fraud" for misrepresenting its studies of Paxil in children. The company ultimately settled the lawsuit and agreed to post both positive and negative drug research results on its website. Psychiatrists like Keller can each make millions of dollars consulting to pharmaceutical companies and have been criticized for "distorted and unbalanced" reporting of studies in "an attempt to show the drug in the most favourable light."
In many instances, pharmaceutical companies ghostwrite the favorable drug studies published in academic journals. In some instances, the psychiatrists may allow companies to put their names on the reports without even seeing all the data. This practice, too, is increasingly coming under fire.
The FDA has been heavily criticized for its handling of antidepressant-induced suicidality. In 2004, the FDA originally suppressed an analysis of the data on children taking antidepressants by their own internal reviewer, Dr. Andrew Mosholder, who concluded that the drugs made children suicidal, much as the British concluded. The Mosholder report was ultimately leaked to the media. In a controversial move, the FDA wasted valuable time and taxpayer dollars having researchers at Columbia University reanalyze the data. The researchers essentially came to the same conclusions Mosholder and the British had. Critics charge that the FDA's investigation of the antidepressant scandal is a conflict of interest since the agency's own reputation is at stake for having approved the drugs in the first place and having swept under the carpet repeated reports of their side effects, including antidepressant-induced suicidality, for over a decade. Critics also point to the revolving door of FDA officials in and out of working for pharmaceutical companies. As I finish writing this book, several congressmen have opened investigations into the FDA's mishandling of antidepressant side effects. The continuing revelations in the antidepressant scandal have shaken public confidence not only in the drugs but also in the drug companies, academic researchers, and even the FDA.
What do doctors and patients do when patients are ready to go off the drugs if stopping antidepressants abruptly can cause severe withdrawal reactions that include suicidality, impulsivity, aggression, dizziness, vertigo, nausea, vomiting, headaches, tremors, electric "zap" sensations in the brain, anxiety, crying spells, and insomnia? The problem is compounded by the fact that nowadays 70 percent of prescriptions for antidepressants are written by family doctors, many of whom do not know how to taper patients off the drugs. Family doctors are not responsible for the current situation; they have been pressured by HMOs and insurance companies to prescribe antidepressants rather than refer patients to specialists. In a study sponsored by the Robert Wood Johnson Foundation, 72 percent of family doctors expressed frustration over the lack of access to quality mental health services for their patients. Many family doctors are not comfortable writing so many prescriptions for anti-depressants, but feel they have little choice in the matter. Most family doctors do not feel they have the background or training to taper patients off the drugs. Even some psychiatrists are unaware of how to taper patients carefully off today's antidepressants. An estimated 20 million people are on antidepressants in this country, including one million children. With so many people using the drugs, withdrawal and dependence have become major problems.
This book is a natural outgrowth of my work as a psychiatrist and educator. I testified as an expert at the FDA hearing that resulted in the historic spring 2004 warning. My last book, Prozac Backlash: Overcoming the Dangers of Prozac, Zoloft, Paxil, and Other Antidepressants with Safe, Effective Alternatives, published in 2000, included chapters on antidepressant withdrawal reactions and antidepressant-induced suicide and violence. While Prozac Backlash called attention to these serious antidepressant side effects, no one could have predicted how large an international health problem they would become in just a few years. Physicians are increasingly concerned about malpractice lawsuits stemming from poorly managed withdrawal reactions and antidepressant-induced suicidality. Lawsuits, including class actions, involving thousands of patients who have suffered severe antidepressant withdrawal reactions, have been filed against the pharmaceutical industry so far in twenty-seven of fifty states. While my earlier book raised the withdrawal issue, which in 2000 was just coming to the attention of doctors and the public, this book provides the step-by-step solution. Since antidepressant-induced suicidality has become such a serious public health concern, a whole chapter is devoted to this topic and applies to any change in the dose, up or down.
As a clinical instructor in psychiatry at Harvard Medical School, a psychiatrist at the Harvard University Health Services, and a private practitioner in Harvard Square, I prescribe antidepressants regularly and have had countless patients report their benefits. At the same time, I have raised concerns that antidepressants are overprescribed for the stresses of everyday life and that patients are not adequately warned of their risks, including withdrawal reactions, suicide, and violence. Through my work with patients, physicians, and the media, I became aware of the need for a step-by-step guide to tapering antidepressants. Many patients and physicians have difficulty getting accurate information on antidepressant withdrawal reactions. This book is based on extensive experience tapering patients off antidepressants, input from colleagues with similar experience, and an exhaustive review of the medical literature on the subject. I also cite some pharmaceutical company documents that have become public record as a result of lawsuits.
This book presents a 5-Step Antidepressant Tapering Program developed over the years as I worked with many patients weaning off the drugs. The same guidelines apply when patients decrease the dose of their antidepressant in midtreatment. It is intended for anyone interested in or affected by antidepressant withdrawal and dependence:
- Patients on antidepressants who are ready to go off the drugs
- Patients who are considering going on antidepressants and are looking for more information on their potential side effects before making a decision
- Family doctors who are often unfamiliar with how to carefully taper the drugs
- Pediatricians who prescribe antidepressants to children and adolescents
- Psychiatric nurses (who now do much of the prescribing in the mental health departments of HMOs)
- Psychotherapists, including social workers and psychologists, supporting patients through antidepressant withdrawal reactions
- Emergency room doctors and nurses who are frequently the first to see patients in the throes of antidepressant withdrawal
- Pharmacists whom patients often turn to with questions about their medications
- Family and friends who need support and accurate information because they often bear the brunt when patients in withdrawal become quite ill, irritable, or impulsive and behave in baffling, out-of-character ways
This book is intended to be helpful to doctors and patients alike. For this reason, I shift back and forth quite readily between addressing doctors and patients. In every instance, it is clear who is being addressed. Technical jargon has been minimized in order to provide a practical, straightforward approach to weaning patients off antidepressants. In some instances, I repeat important concepts and terms for readers who lack medical training. I trust readers with more medical knowledge will be understanding of my effort to make the information as accessible to as many people as possible. For those interested in more technical information, notes (which can be found at the back of the book) cite the extensive published medical reports and scientific research on antidepressant withdrawal and dependence.
Tapering antidepressants by following the guidelines of the 5-Step Antidepressant Tapering Program reduces both the incidence and severity of withdrawal reactions. Research has shown that when patients stop antidepressants cold turkey they can have high rates of withdrawal reactions, which vary depending on the particular drug. In studies involving hundreds of patients, 66 percent of patients stopping Paxil, 60 percent of patients stopping Zoloft, and 78 percent of patients stopping Effexor have withdrawal reactions. Unfortunately, most doctors and patients have not been adequately informed about the problem of antidepressant withdrawal reactions. Under these circumstances, not surprisingly patients suffer high rates of withdrawal symptoms, including severe reactions. However, following the guidelines of the tapering program, in my experience most patients have no withdrawal reaction at all or mild withdrawal reactions that they tolerate comfortably.
The concern with withdrawal reactions should not overshadow the beneficial effects many patients report with antidepressants. Medications are not "bad" because they cause withdrawal symptoms when stopped too quickly. Other important classes of medications that can cause withdrawal reactions are blood pressure medications and anticonvulsants. With these drugs, doctors are familiar with how to taper them. While the magnitude of the problem of withdrawal and dependence with today's antidepressants has caught doctors and patients largely by surprise and is one the pharmaceutical industry has sought to minimize or deny, it is a problem that has to be confronted honestly and directly. The good news is that with proper information, doctors and patients can almost always safely and effectively overcome antidepressant withdrawal and dependence. Indeed, once patients are ready to go off antidepressants, tapering them over time provides a wonderful opportunity for collaboration, joint decision making, and strengthening the doctor-patient relationship that is at the heart of good medicine.
Copyright © 2005 by Joseph Glenmullen
Table of Contents
1. Antidepressant Withdrawal and Dependence: Defining the Problem
2. Resolving the Controversy over "Addiction" to Antidepressants: The BBC Exposé
3. The Withdrawal Spectrum: Mild, Moderate, and Severe Withdrawal Reactions
4. How Changing the Dose of Antidepressants Up or Down May Make Patients Suicidal
5. Worst Offenders: The Antidepressants that Cause the Most Frequent Withdrawal Reactions
6. The 5-Step Antidepressant Tapering Program: How to Avoid Uncomfortable or Dangerous
7. Step 1. Evaluating Whether You Are Ready to Try Tapering Off Your Antidepressant
8. Step 2. Making the Initial Dosage Reduction
9. Step 3. Monitoring Withdrawal Symptoms After a Dosage Reduction
10. Step 4. Making Additional Dosage Reductions
11. Step 5. The End-of-Taper Evaluation
12. Tapering Children Off Antidepressants
Appendix 1: Daily Checklist of Antidepressant Withdrawal Symptoms
Appendix 2: Graph of an Antidepressant Withdrawal Reaction
Appendix 3: Tapering Older Tricyclic and Heterocyclic Antidepressants
Appendix 4: Tapering Monoamine Oxidase Inhibitor Antidepressants