February 9th, 2012
CBSNews.com
By: CBS News Staff
We usually view side effects as a bad thing, but sometimes they point the way to a whole new use for a drug.
“We think of drugs as being specific to a task,” says Dr. Jeremy Greene, Harvard University medical historian. In fact, he says, “drugs are very complex objects.”
As research and development costs have climbed, drug companies are more interested than ever in finding ways to repurpose their products. Often they seek to simply market an existing drug for a new condition, but in some cases they give the drug a whole new name and face. From our friends at Health.com, here are eight drugs that lead double lives…
The first on the list? Prozac, which is also sold as Sarafem.
Click here for the full report
Tags: amphetamines, Cymbalta, drug, Propecia, Proscar, Prozac, repurpose, revatio, sarafem, Thalidomide, Tofranil, Viagra, Wellbutrin, Zyban
October 12, 2011
The Huffington Post
By: Dr. Peter Breggin
My October 3, 2011 blog on The Huffington Post described a recent precedent-setting criminal case in which a Winnipeg, Manitoba judge confirmed my written opinion and courtroom testimony that Prozac adverse drug effects drove a 16-year-old boy to stab a friend to death. I have now made the judge’s opinion available online and also as a part of my more extensive report on the case on my website.
In the case of “C.J.P,” Judge Robert Heinrichs concluded, “Dr. Breggin’s explanation of the effect Prozac was having on C.J.P.’s behavior both before that day and in committing an impulsive, inexplicable violent act that day corresponds with the evidence” (p. 18). My written report in the case stated, “At the time of the assault, [C.J.P] was suffering from a Prozac-Induced Mood Disorder (292.84) with manic features (especially extreme irritability) caused by Prozac. I want to emphasize that, within a reasonable degree of medical certainty, he would not have become violent without the exposure to Prozac, and he will not become violent again.”
Judge Heinrichs also found, “There is clear medical and collateral evidence that the Prozac affected his behavior and judgment, thereby reducing his moral culpability” (p. 20). In my report I observed that C.J.P.’s adverse reactions to Prozac exactly paralleled the description of adverse drug reactions contained in the FDA-approved label for Prozac, including the “emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down” (p. 8). C.J.P. had deteriorated emotionally over a three month period on Prozac, including an increase in dosage 17 days prior to the assault.
The case of C.J.P. and its violent outcome can be compared to a similar case that I describe in “Medication Madness: The Role of Psychiatric Drugs in Cases of Violence, Suicide and Crime.” A very gentle teenage girl whom I called Emily Ashton developed a sudden urge to thrust a knife into her mother’s back during her second week of taking Prozac. Like C. J. P., she was 16 years old; but unlike him, she showed no outward signs of a worsening mental condition and displayed no anger at all until the sudden compulsive urge to stab her mother began to overtake her. At the time, there were no angry conflicts in the family. Fortunately, Emily told her mother about the bizarre and violent compulsion. As in C.J.P.’s case, Emily’s mother knew that violence was wholly out of character for her daughter and she suspected the Prozac.
Again as in C.J.P.’s case, Emily’s mother took her back to her prescribing family doctor who then referred her to a psychiatrist. There the comparison ends. Unlike C.J.P.’s tragic case, the consultant psychiatrist recognized the problem as Prozac-induced and immediately stopped the anti-depressant, after which the compulsion gradually subsided. Emily went on to live a normal, productive adult life and to raise a family. Nonetheless, she continued to feel guilty about her violent impulse that overcame her at the age of 16. She felt relieved many years later when we talked and I was able to reassure her that the impulse had been chemically-driven by the drug.
All of the newer anti-depressants carry the same warnings as Prozac concerning “anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression and suicidal ideation.” These drugs include Celexa, Lexapro, Luvox, Prozac or Serafem, Paxil, Cymbalta, Effexor, Wellbutrin or Zyban, and Pristiq.
Many tragic acts of suicide and violence could be averted by reducing or stopping the use of anti-depressant drugs, by greater professional and public awareness of the dangers associated with these drugs, by withdrawal from the drugs at the earliest sign of mental and behavioral deterioration, and by greater reliance on individual and family psychotherapy.
The effectiveness of anti-depressants has been increasingly called into question. At the same, the risk of withdrawing from them has become more obvious, and cutting back or stopping them requires experienced clinical supervision and a slow, cautious taper. Many psychotherapists successfully treat depressed patients without resort to these drugs.
Click here for the full report from The Huffington Post
Tags: aggressiveness, agitation, akathisia (psychomotor restlessness), anxiety, Celexa, Cymbalta, Effexor, hostility, hypomania, impulsivity, insomnia, irritability, Judge Robert Heinrichs, Lexapro, luvox, mania, panic attacks, Paxil, Pristiq, Prozac, Prozac or Serafem, suicidal ideation, Wellbutrin, worsening of depression, Zyban
July 2, 2009
New York Times
by Gardiner Harris & Duff Wilson
WASHINGTON — Federal drug regulators warned Wednesday that patients taking two popular drugs to stop smoking should be watched closely for signs of serious mental illness, as reports mount of suicides among the drugs’ users.
But officials emphasized that fear should not stop patients from taking the smoking-cessation medicines, Chantix, made by Pfizer, and Zyban, made by GlaxoSmithKline, which also sells it under the brand name Wellbutrin, for depression.
“Stopping smoking is a goal we should all be working towards,” said Dr. Curtis J. Rosebraugh, director of a drug evaluation office at the Food and Drug Administration. “We don’t want to scare people off from trying a medication that could help them achieve this goal. You should just be careful.”
Pfizer will add a so-called black box warning — the F.D.A.’s most serious caution — to the packaging information for Chantix.
The Pfizer drug, introduced in 2006, has about 90 percent of the market for prescription smoking-cessation drugs, according to IMS Health, a health care information company. Even so, Chantix sales — $846 million in 2008 — had been less than Pfizer had hoped because of previous warnings of its side effects.
Glaxo will expand its existing black box warning on Wellbutrin, citing suicidal thoughts by patients who use it for depression, to include Zyban, which has had only modest sales in the smoking cessation market.
Both companies will also be required to conduct clinical trials to assess the mental health risks associated with the drugs’ uses. Pfizer is already enrolling schizophrenia patients in a trial.
Because smokers and people trying to quit are statistically more likely to be depressed and suicidal, officials for both companies said it was difficult to identify the specific impact of the drugs on those risks. “Nicotine withdrawal itself can be very difficult for people to endure,” Dr. Steve Romano, a Pfizer vice president, said Wednesday.
Analysts said the F.D.A. action would have little effect on sales because of previous indications of the drugs’ psychiatric risks.
“I think the market and physicians have already been sensitized to this,” said Catherine J. Arnold, an analyst for Credit Suisse.
“I’m not panicking,” said Jami Rubin, an analyst for Goldman Sachs, “Sales are already down a lot. It is and will remain a small niche product.”
Chantix had already experienced a slight sales decline last year from the $883 million achieved in 2007. And this year’s first-quarter sales of $177 million were 36 percent below the corresponding period last year.
Ms. Arnold predicted that sales would probably continue falling to around $740 million for all of 2009, but that demand for smoking-cessation treatments would enable it to grow modestly after that — to perhaps half of the $2 billion in annual sales Pfizer had originally hoped for the drug.
European officials first alerted the F.D.A. in 2007 to problems associated with Chantix. In September of that year, Jeffrey Carter Albrecht, a keyboard player from the pop-music group Edie Brickell and New Bohemians, was killed by a neighbor who had complained that Mr. Albrecht was banging on his door, ranting. Mr. Albrecht’s girlfriend blamed Chantix, which she said had made him hostile.
The widely publicized event led to a cascade of similar reports and scrutiny by F.D.A. safety officials, who have now received 98 reports of suicides and 188 reports of suicide attempts among those taking Chantix.
As officials looked more closely, they found to their surprise that Zyban has similar associated risks. The agency received 14 reports of suicides and 17 reports of suicide attempts among those taking Zyban.
No one knows why the drugs are associated with mental problems. In some cases, patients could be experiencing nicotine withdrawal, but some of the reports involved patients who had yet to stop smoking. And many of the events happened just as patients began or stopped therapy, officials said.
“If this is nicotine withdrawal, it really doesn’t matter,” said Dr. Robert Temple, an F.D.A. official. “You need to pay attention to them.”
The agency’s action requires the drugs’ makers to mention the risk of suicide in advertising, and it prevents the companies from using “reminder” ads, during which consumers are encouraged to talk to their doctors about a health issue but the product’s name is not mentioned.
Click here for the full report from the New York Times.
Tags: black box warning, Chantix, clinical trials, Credit Suisse, depression, FDA, Food and Drug Administration, GlaxoSmithKline, Goldman Sachs, IMS Health, mental health, mental illness, Nicotine withdrawal, patients, Pfizer, psychiatric risks, schizophrenia, smoking, smoking cessation, suicidal thoughts, Wellbutrin, Zyban
