The dangers may be remote, but they are real.
Early in 2000, in a non-jury trial, a Connecticut judge acquitted Christopher DeAngelo, an insurance agent, of robbing a bank after his lawyer successfully argued that his client's state of mind was due to the Prozac he had been taking at the time. Listed in the manufacturer's warning as an "infrequent" adverse reaction is "akathisia," which may cause an unsuspecting victim to become mentally restless and lose all inhibitions about his actions.
In October 1999, Pfizer, makers of Zoloft, settled for an undisclosed sum with the estate of Brynn Hartman, who had shot her husband comedian Phil Hartman dead, and then killed herself. Ms Hartman had been taking Zoloft at the time of the murder/suicide. According to the lawsuit, Ms Hartman had complained to friends that she felt as if she were going to "jump out of her skin."
Until recently, Eli Lilly, makers of Prozac, had managed to settle all of its 200 or so civil claims out of court. But that changed in 2000:
In 1992, Bill Forsyth, a retiree living in Hawaii, was prescribed Prozac for his anxiety and depression. The next day, he called his doctor to say he felt 200 percent better. The day after, however, he requested to be taken to a psychiatric hospital, where doctors continued giving him the drug. Eleven days later, he returned home, stabbed to death his wife of 37 years, then impaled himself on a kitchen knife.
Eli Lilly won the case, but possibly lost a long-term war, for the company was obliged to make public incriminating internal documents dating back to 1978.
According to company minutes, Eli Lilly had full knowledge of what its top-selling drug could do to some people. In the company's own words, back in 1978: "There have been a fairly large number of reports of adverse reactions ... Another depressed patient developed psychosis ... Akathisia and restlessness were reported in some patients."
In another meeting, it was noted that, "some patients have converted from severe depression to agitation within a few days; in one case the agitation was marked and the patient had to be taken off [the] drug."
The minutes also revealed that during the approval process, Eli Lilly's trial subjects were put on tranquilizers to counter the akathisia (and presumably skew the drug trial findings in their favor), though no warning was given when the drug came on the market in the US. In Germany, however, Eli Lilly was obliged to put this caveat on its package insert:
"For his/her own safety, the patient must be sufficiently observed, until the antidepressive effect of Fluctin [Prozac] sets in. Taking an additional sedative may be necessary."
The documents also reveal that Eli Lilly excluded from scrutiny at-risk subjects in a so-called suicide study requested by the FDA, as well as 76 out of 97 suicides.
Meanwhile, in 2001, a Wyoming jury has returned a verdict in a wrongful death suit against GlaxoSmithKline (formerly SmithKline Beecham), makers of Paxil, with damages amounting to $6.4 million. On Feb 13, 1998, Donald Schell, 60, took two Paxil tablets, then shot to death his wife, daughter, and grand-daughter before killing himself. Unpublished data from SmithKline revealed that its own investigators had attributed a variety of side effects to the drug, including akathisia (turmoil), mania, psychosis, aggression, and attempted suicides. Dr David Healy, who has published studies on Prozac (but not Paxil) side effects, testified as an expert witness, along with Harvard psychiatrist Terry Maltsberger.
This is the first successful wrongful death suit in the US involving SSRIs. The plaintiffs in the Forsyth and Tobin cases were represented by the same legal team, Vickery and Waldner of Houston, Texas. Andrew Vickery told this writer what was different about taking a drug company to court this time around:
"We had additional experts in Tobin. We tried SKB on a ‘failure to test’ theory in addition to failure to warn. In Tobin we wised up and emphasized that homicide and suicide are ‘multifactorial’ and ‘biological’ phenomena.’ These and other tactical changes made a big difference."
In October 2002, BBC aired on its flagship current affairs program, Panorama, a no-holds barred documentary on Paxil (marketed as Seroxat in the UK). Right off, with reporter Shelley Joffre's allusion to the medication's "darker side," you knew this was no industry-sponsored symposium:
In quick succession, we hear from two patients, one who cannot get off the drug and the other who mutilated himself while on the drug, followed by David Healy MD who testified in a successful wrongful death suit brought against the drug's manufacturer, and attorney Andrew Vickery who brought that wrongful death suit. Then Joffre cuts to the chase:
"The Maudsley Hospital in London runs a national information service for people taking psychiatric medicines. Trouble coming off Seroxat is the number one complaint from callers. Doctors too report far more withdrawal problems from patients on Seroxat than on any other drug."
According to Davis Taylor, Chief Pharmacist at the Maudsley Hospital: "If a patient is to stop taking Seroxat suddenly, then usually they would quite soon become quite anxious. They may feel very dizzy and unsteady on their feet. Often people experience electric shock sensations. They may also have a fever and feel generally unwell and they also may experience mood changes or very vivid nightmares for example."
Thanks to the wrongful death suit brought against manufacturer GlaxoSmithKline, Dr Healy gained access to some quarter million documents in the company's archives. He told Panorama that according to GSK's own studies, often on healthy volunteers, that one in four experienced mental agitation while on the drug, and in some instances up to 85 percent had withdrawal problems when they halted.
At about the same time the documentary aired, the Prescription Medicines Code of Practice Authority in the UK ruled that GSK had breached the industry's of the code of practice by playing down Paxil's side effects. Meanwhile, in the US, Paxil's most recent TV ad leaves out its previous
claim about the drug not being habit-forming.
According to the World Health Organization reported in The Guardian, Paxil tops the list for drugs in terms of difficulty to quit followed by Effexor at number two, Zoloft at number four, and Prozac at number seven. The benzodiazepines Ativan and Valium come 11th and 13th.
If you are on Paxil, please do not panic. Mental agitation or anxiety from SSRIs usually occurs in the first few days, if at all, then recedes. If the agitation or anxiety persists, it is advisable to notify your doctor or psychiatrist. If the drug is working for you, it is sensible to stay on it. If the drug is being prescribed to you for the first time, it is advisable,
as with any medication, to express any concerns to your doctor or psychiatrist. Should you no longer need to stay on the drug, following is a "reprint" from a recent Newsletter:
In December 2001, GSK changed Paxil's label, encouraging physicians to recommend "a gradual reduction in the dose rather than abrupt cessation." Paxil washes out of the system more quickly than other SSRIs when stopped. In recent clinical trials, GSK decreased the daily dose by 10 mgs a week (doses can range from 10 to 60 mg a day), then stopped treatment after reducing the dose to 20 mgs. The Washington Post reports Frederick Goodwin MD, former head of the NIMH, as in favor of an even more gradual taper, "dropping the dose every four or five days by as little as possible, even if that means cutting pills in half."
According to the manufacturer's product information, of patients who gradually weaned off Paxil 2.3 percent experienced abnormal dreams, two percent experienced a tingling sensation (paresthesia), and 7.1 percent experienced dizziness. According to GSK, the majority of cases were mild and did not require medical intervention.
Not since the tobacco lawsuits have law firms been so eagerly licking their litigious chops. A Google search turns up dozens of law firms in the US, Canada, and the UK that have already been filed on behalf of individuals or classes of individuals or are touting for business. The claims generally
allege withdrawal symptoms or suicidal gestures and the failure of GSK to issue appropriate warnings.
In (July 2003, the FDA has advised that no one under age 18 should be prescribed Paxil for depression, owing to the risk of suicide. Three studies found the drug did not help for pediatric depression, and an analysis of the data showed a three times greater risk of suicidal thoughts and attempts among mostly teens taking the drug vs those on a placebo. There were no deaths in the studies.
The warning follows similar action by the Medicines and Healthcare Products Regulatory Authority in the UK, where the drug is marketed as Seroxat.
Children and teens already on the drug should not suddenly stop the drug, the FDA cautioned, as a long tapering period is required to avoid withdrawal effects.
Prozac is the only antidepressant FDA approved to treat depression in children.
If soon after beginning antidepressant treatment you start feeling uncharacteristically hyper, call your doctor at once and stop taking the medication while you still have your wits about you. Your doctor may adjust your dose or switch medications to get you on something that works for you. If you are experiencing anxiety or agitation in the early going, the effect is usually temporary, but it won't hurt to keep your doctor informed.
If, after reading this, you feel you are ready to flush your pills down the toilet - hold on. If you have been taking antidepressants for some time, then you will need to be gradually weaned off of them under a doctor's supervision over a period of weeks or months.
If an antidepressant has harmed you or your family, you may have cause for a legal action, but this is something you would need to take up with a lawyer who specializes in these kinds of cases.
Updated Feb 11, 2008
A leading psychiatrist contends that much of what we call depression is the creation of product marketing.
Knowledge is Necessity
Copyright 2010 John McManamy Contact
You're in the right place. Check out your video guide to McMan's Web.
"Be warned! These musings are addictive." - Kimberly Read, About.com - Bipolar.
"We are who we pretend to be. You can’t go wrong pretending to be JFK or Martin Luther King." Plus more words of wisdom from the newly-anointed family patriarch and elder.
"God has a funny way of treating people He loves most. Just ask Joan of Arc." Plus more stuff I wish I knew when I was two days old.
Schizophrenia in a seven-year-old? Impossible, you say? An eye-opening account from the family.
When a college student with Aspergers is found beaten to death in his dorm room, one can't help but ask the obvious questions.
My normal can be very unpredictable, but at least I know I won't embarrass myself when I feel out-of-it and depressed.
Think you can't be manipulated? The people who signed a petition to ban dihydrogen monoxide (another name for water) didn't think so, either.
This five-part series (and counting) looks at the brief history of diagnostic psychiatry and the man responsible for how we (and our clinicians) view ourselves.
A speedy traverse of my life (in three parts) as the surprise recipient of a major award and why it didn't change my life but sure helped in my recovery.
How a conversation with my daughter triggered a long-suppressed happy memory and offered a healing moment.
How two five-second Zen moments 30 years apart changed my life.
"Nicely produced and edited. I'd love to see more frequent updates." - Sandra Kiume, journalist
The world's oldest wind instrument brings out the playful and spiritual side in me.
We forget. The present is where life is happening - here, right now.
Don't just sit there. Build yourself a tree.
Don't be fooled. There's always a somewhere.
Nature heals. So do our brains.
No koalas were harmed making this movie.
The Buddha was on to something ...
Do people with bipolar cycle in and out of time? Call me bichronic.
In the Spotlight
Lincoln and Darwin were born on the same day, 200 years ago in 1809. These two articles discuss how their actions and ideas apply to you:
His unremitting despair and constant failures steeled his character.
Is there a selective advantage to depression and bipolar?
A Random Sampling
Now that you're familiar with the DSM-IV, forget everything you've read.
A leading anthropologist explains the birds and the bees.
We're depressed way more than we are manic. Now if psychiatry only knew how to treat us.
What is arguably the most effective recovery tool requires a highly disciplined mind.
A smart dopamine med may do wonders for your depression or bipolar or mental acuity. The problem is one doesn't exist.
No, it's not normal kid behavior.
An innovative researcher discovers that patients know best.
Living Well With Depression and Bipolar Disorder by John McManamy (HarperCollins 2006)
"I doubt there is a person in the world who knows these conditions better, inside and out, than John McManamy ... He weaves together the science and the inner experiences of depression and bipolar disorder in a way that is quite rare. This book is full of studies and personal insights, in about equal measure, leavened with the practical conclusions of its even-handed and often humorous author. It breaks new ground." - Nassir Ghaemi MD, Tufts University
Sample Amazon Reviews
"John McManamy has an outstanding ability to describe his and other's experience of having bipolar disorder in all its complexity. He never tries to take the place of the patiet's psychiatrist. He refers his readers to other sources of excellent more detailed clinical information. He tells the human side of the story. He teaches patients how to be better informed consumer's of psychiatric care. He encourages patients to be active participants in their recovery." - Raymond
"This is one of the best books I've read on the subject of Bipolar Disorder or Depression. Filled with real world examples, and crammed with information this book will empower you to take charge of your illness." - Eileen