On October 15, 2004, the FDA ordered that all antidepressants must carry the government's "black box" safety alert to warn that the drugs are linked to increased suicidal thoughts and behavior among children and teens. The warning came after two days of public hearings of the FDA's Psychopharmacologic Drugs and Pediatric Advisory Committees (PDAC), where testimony by victims, parents and experts, in combination with previous testimony from the PDAC's hearing in February was presented. The committee voted 15-to-8 for a “Black Box” warning for children and adolescents after reviewing clinical-trial data that showed the drugs are twice as likely as a placebo to cause suicidal thoughts or behavior.

The FDA’s actions followed a report issued by Britain's Department of Health which said that evidence provided by GlaxoSmithKline, the manufacturer of Paxil, from nine studies based on more than 1,000 youngsters, showed there is an increase in the rate of self harm and potentially suicidal behavior in those under 18 taking Paxil. The British regulators wrote in a statement "It has become clear that the benefits of Seroxat in children for the treatment of depressive illness do not outweigh these risks."

Each day new information is being exposed regarding the pharmaceutical industry’s knowledge of the risks associated with antidepressants and children. Kahn Gauthier Swick is currently handling numerous cases involving children and adults who either attempted suicide or committed suicide after taking one of these drugs.

The actions against the drug companies claim that the companies knew--but failed to warn physicians and patients--that a small number of patients will experience a condition called akathisia, an overwhelming physical and mental restlessness, shortly after they begin taking these drugs. Other patients may, after beginning one of these medications, find themselves sufficiently energized to harm themselves, but not yet helped enough by the drug to control their destructive thoughts.

Some of the patients who have suffered an akathisia reaction have been driven to horrible deeds. Matthew Miller was a 13-year-old who committed suicide less than a week after starting to take Zoloft. Donald Schell, 60, took two Paxil tablets before experiencing hallucinations and then shooting himself, his wife, their daughter, and their granddaughter to death on Feb. 13, 1998. On March 4, 1993, two weeks after starting to take Prozac, William Forsyth stabbed his wife 15 times as she lay in bed, and then leaned on the knife to kill himself. Reginald Payne, 63, a teacher in Great Britain, suffocated his wife and threw himself off a cliff in March 1996, after having taking Prozac for just 11 days.

In July, 2001, a federal jury in Cheyenne, Wyoming ordered GlaxoSmithKline to pay $6.4 million to Donald Schell's relatives. In that case, the relatives found internal GlaxoSmithKline documents showing the company was aware that a small number of people could become agitated or violent from Paxil. Despite this knowledge, Paxil packaging does not include a warning about suicide, violence or aggression.

Documents Are Damning

The documents discovered about Prozac are particularly revealing:

1. In 1990, Eli Lilly scientists were pressured by corporate executives to alter records on physicians' experiences with Prozac, changing mentions of suicide attempts to "overdose" and suicidal thoughts to "depression."

2. Three years before Prozac received approval by the U.S. Food and Drug Administration (FDA), a similar agency in Germany had such serious reservations about Prozac's safety that it refused to approve the antidepressant. Eli Lilly's studies showed that previously nonsuicidal patients who took the drug had a five-fold higher rate of suicide and suicide attempts than those on older antidepressants, and a three-fold higher rate than those taking placebos.

3. Lilly's own figures indicate that one in 100 previously nonsuicidal patients who took the drug in early clinical trials developed akathisia, causing them to attempt or commit suicide during the studies.

It has also been discovered that the patent for a new version of Prozac, which Eli Lilly paid $90 million to acquire, states that the new formulation would reduce "the usual adverse effects" of the original Prozac, including "nervousness, anxiety, insomnia, inner restlessness (akathisia), suicidal thoughts, self-mutilation, manic behavior."

Prozac was introduced by Eli Lilly to the U.S. market in January, 1988. Zoloft and Paxil followed in December, 1991, and December, 1992, respectively. Some 45,000 reports of adverse reactions to Prozac have been filed with the FDA. These include reports of about 2500 deaths, with the large majority linked to suicide or violence.

Physicians Report Suicidal Reactions

Dr. Martin Teicher of Harvard Medical School reported in 1990 that he and his colleagues had observed suicidal thoughts in six patients who were taking Prozac. More recently, Dr. David Healy, an expert on the brain's serotonin system and the director of the North Wales Department of Psychological Medicine at the University of Wales, estimated that "probably 50,000 people have committed suicide on Prozac since its launch, over and above the number who would have done so if left untreated."

Meanwhile, the drug companies continue to rely on a 1991 finding from an FDA advisory panel that "there is no credible evidence of a causal link between the use of antidepressant drugs, including Prozac, and suicidality or violent behaviour."