Thursday, January 24, 2008

FDA Requires Drug Companies to Include Suicide Assessment in Studies

According to the New York Times today, the FDA has recently implemented “one of the most profound changes of the past 16 years to regulations governing drug development.” This change requires that manufactures of certain drugs include an assessment of suicide risks in their clinical studies.

Such assessments will be required specifically for drugs intended to treat obesity, urinary incontinence, epilepsy, smoking cessation, and depression. The FDA had sent letters, apparently months ago, to drug companies such as Merck, Eli Lilly and Sanofi-Aventis; all three of these drug companies have reportedly complied with the requirements and are now including suicide assessments in their clinical trials.

The regulation change reportedly is due to findings that antidepressants may increase thoughts of suicide in children and teenagers. After this initial finding, it was also discovered when reviewing an application for an obesity drug that the proposed drug may pose some psychiatric problems. Similar findings were discovered in at least one additional obesity drug; with such findings, worries grew regarding other drugs that may affect a person psychologically.

Advertisements for many antidepressants often list the risk of increased suicidal thoughts as a potential side effect. The fact that antidepressants are targeted at correcting a chemical imbalance in a person’s brain would seem to create worries of how the overall medicine will affect the user. However, it is hard to imagine that somebody taking obesity medication would think that similar affects would be possible. Also, the article lists other medications that one, at least I, would not think could cause potential psychological problems – such drugs include medicine for: acne; hypertension; high cholesterol; swelling; heartburn; pain; bacterial infections; and, insomnia.

The FDA has apparently approved the continued sale of many of these drugs as they have found that the benefits of the drugs outweigh the potential harm. It is understood that there is a risk of potentially harmful side effects with almost any medication. However, it is important for doctors, and especially patients, to understand that taking something that may seem innocent – such as acne medication – may cause the person, however slight the risk, to have increased suicidal thoughts. In order for patients to know this, doctors must be informed. Such information in the end must come from the FDA, who relies on clinical studies run by drug companies to determine these potential adverse side effects. As such, this new regulation by the FDA to require the consideration of increased suicidal tendencies as a side effect is one that will seem to provide necessary information to all persons involved and help to ensure that people are adequately prepared to deal with such potential side effects.

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