The possibility that a group of widely prescribed antidepressants, including Prozac and Paxil, might trigger suicide and other violence in a small percentage of users has been the subject of isolated reports in the major media since they first arrived on the market. Recently, however, the concern has been recognized by the federal government. In June, following actions taken by British drug authorities, the FDA released a statement recommending that physicians refrain from prescribing Paxil to new patients under 18.
Paxil is one of a class of drugs known as selective serotonin reuptake inhibitors (SSRIs). Studies funded by the drug’s maker, GlaxoSmithKline (GSK), showed it was no more effective than placebos for treating pediatric depression. The same studies also showed an increased occurrence of emotional disturbance in those taking it. The likelihood of a suicide attempt, for example, was about three times greater for Paxil users than for those taking placebos. In August, Wyeth pharmaceuticals drew essentially the same conclusions about its antidepressant Effexor, sending out a two-page letter to healthcare workers stating it may not be safe for pediatric use. This led to the FDA’s reanalyzing data for Effexor and several other SSRIs, and in October the FDA issued an advisory citing similar findings for Celexa, Effexor, Prozac and Zoloft. In December drug authorities in Britain banned all but one SSRI from use by children because of evidence that they can cause children to become suicidal. The consistency of these findings suggests that perhaps the FDA should be taking actions that should have been taken long ago to curb adult use of SSRIs.
Reports of a possible link between adult SSRI use and violence, including suicide, first appeared in 1990. In 1991, however, the FDA made a finding, based on a highly selective set of data put together by Eli Lilly scientists, which concluded that Prozac did not cause suicide and was safe. Since that time, SSRI makers have dismissed all allegations that the drugs cause violence and suicide by citing the FDA’s report–a report that now looks especially dubious in light of concerns over giving these drugs to children.
Meanwhile, incidents of extreme mental agitation involving SSRIs have not abated. In May 2001, for example, Australian David Hawkins strangled his wife and then attempted to kill himself after taking an overdose of Zoloft. In a similar case, a jury found that Paxil caused 60-year-old Donald Schell to shoot to death his wife, his adult daughter, his infant granddaughter and himself. He had been taking the SSRI for only two days and, like Hawkins, he had no history of violence of any kind.
These and other civil actions have given plaintiffs’ lawyers access to private company archives, where they have found a variety of unpublished studies, including many from the 1980s, confirming a link between SSRIs, agitation and violence. In one study conducted by Pfizer in the 1980s, many healthy female volunteers given either Zoloft or a placebo began complaining of problems of agitation and apprehension. Twenty-five percent of individuals–all GSK employees–experienced agitation after taking Paxil.
Instead of at least warning physicians of a risk of drug-induced agitation, SSRI makers continue to insist that the violence linked to SSRI use is the product of the “illness” the drug is said to treat. In many instances of SSRI-related violence, however, the drugs were prescribed not for clinical depression but only as an adjunct treatment for other health problems (such as back pain). Diane Cassidy, for example, was prescribed Prozac not for depression but for “off label” use as a weight-loss drug. Today, as a result, she is paralyzed on one side of her body and suffers from significant cognitive impairment.
SSRI makers, it seems, have embraced the well-tested tobacco-company tactic of denial, denial, denial. All that they have conceded to date is that whatever serious side-effects might occur in some small percentage of SSRI users, millions of others have been helped by them. But even this concession is misleading. The real question is whether SSRIs are better than non-SSRI antidepressants, including those they have come to replace, namely, tricyclics like Tofranil and Elavil. SSRIs have not been clinically proven to be more effective or safer than these older, less expensive antidepressants. Although tricyclics do have greater toxicity when taken in overdose, they do not pose the risk of severe mental agitation and violence seen with SSRIs, nor do they cause withdrawal symptoms or lowered libido.
What has become clear is that the SSRIs should not be the first line of pharmacological treatment for depression. As the London Times reported on October 20, the overprescribing of antidepressants has grown to alarming proportions since the dawn of Prozac, and as British drug authorities recently concluded, physicians should not be prescribing antidepressants for “normal problems of life.” Yes, billions of dollars in revenue are at stake in the selling of SSRIs. Zoloft, Paxil and Prozac collectively brought in more than $6 billion in gross sales in 2002. That may explain the failure of the FDA to act, but it certainly cannot justify it when the public’s health is at stake.