The U.K. Medicines Control Agency (MCA) has suggested that patient information for the class of antidepressants known as SSRIs -- including Prozac -- contain information on the drug's link to suicidal behavior.

The medical community has known about the possible connection between the drugs and suicide since the early 1990s, when reports were filed on several cases of suicidal behavior by patients taking fluoxetine (Prozac). At that time, drug safety agencies like MCA said there was not enough evidence to prove the connection.

In the U.K., the Committee on Safety of Medicines (CSM) has reviewed additional adverse reaction reports and other data. Based on this data, the government agency noted that because of "anecdotal case reports of suicidal behavior associated with fluoxetine ... (p)rescribers and patients should be aware that it is general clinical experience that the risk of suicide may increase in the early stages of treatment with any antidepressant. Patients thought to be at risk should be carefully monitored."

The MCA is trying to get drug companies to update their patient information leaflets to include the words: "Occasionally, thoughts of suicide or self-harm may occur or may increase in the first few weeks of treatment with (this drug), until the antidepressant effects become apparent. Tell your doctor immediately if you have any distressing thoughts or experiences."

Not surprisingly, Eli Lilly U.K., which markets Prozac, argued there is "no credible scientific evidence that establishes a link between Prozac and suicidal behavior." Prozac is one of the most commonly prescribed medications and, in the 12-month period ending December 1998, more than $25 million was spent on print advertising alone!

Most frightening about this link to suicide is the fact that SSRIs are increasingly being prescribed to children.

According to Dr. Jerry L. Rushton, a pediatrician and Robert Wood Johnson clinical scholar at the University of North Carolina at Chapel Hill, "despite a paucity of safety and effectiveness data more than 500,000 prescriptions for SSRIs are written for children and adolescents each year." (Pediatric Academic Societies, May 1, 1999).

Dr. Rushton's research showed that 67% of doctors responding to his questions said they had written SSRI prescriptions for children and young adolescents with mild to moderate depression.

Another 57% acknowledged having prescribed an SSRI for a diagnosis other than depression in a child younger than 18 years-old. These included children diagnosed with attention deficit hyperactivity disorder (ADHD), obsessive-compulsive disorder (OCD), aggression/conduct disorder, and enuresis (bed-wetting).

SOURCES: Current Problems newsletter, U.K. Medicines Control Agency, October 2000.