FDA will require drug companies to look at risk of suicide side effects
Given concerns about medications with potential side effects that may increase the risk of suicidal thoughts or suicidal behavior, the FDA has instituted a new policy which will require drug manufacturers to examine whether patients become suicidal during clinical studies. The new policy was developed following the discovery that several medications which were given FDA approval could carry an increased risk of suicide, which the manufacturers did not initially warn about on the label.
>>PRIOR POST (1/25/08): Chantix Suicide Warning
According to an article last week in the New York Times, the FDA has not publicly announced the new policy, but in recent months they have sent letters to the makers of certain types of medications requiring them to include a scale measuring suicide side effects in their research protocols. Previously, most pharmaceutical companies have been largely inattentive to the psychiatric side effects of their medications and often turn a blind eye towards potential increased risk of suicide.
For several years, some popular newer types of antidepressants have been associated with reports of suicidal thoughts and behavior, particularly in children and adolescents. Early on, these reports were largely discounted by the manufacturers, but independent analysis of clinical data has found evidence to support the increased risk of antidepressant suicide side effects. As a result, the FDA placed a “black box” warnings on the medications, such as Prozac, Paxil and Zoloft, warning that children and young adults could become suicidal.
More recently, there has been a growing awareness of a possible suicide risk associated with the stop-smoking medication Chantix. Since the medication was approved by the FDA in 2006, there have been an alarmingly high number of reported suicides and suicide attempts among users. Individuals with no history of depression have reported sudden onset of suicidal thoughts after taking the drug to help them stop smoking.
Pfizer, the manufacturer of Chantix, failed to fully investigate the potential psychiatric side effects of their drug. As a result, potential users were not adequately warned about the Chantix suicide risks. FDA officials are now realizing that a wide variety of medicines, not just those targeting psychiatric illnesses, may cause dangerous suicidal behavior. Drug makers will now be required to examine this potential risk among a more broad base of medications, instead of waiting until after the drug is reported to discover such risks.
The lawyers at Saiontz & Kirk, P.A. are reviewing potential Chantix suicide lawsuits for users of the anti-smoking drug who have suffered serious physical injury or death as a result of a suicide or self-inflicted injury. If you or a loved one have suffered from these suicidal behavior side effects while using Chantix, request a free claim evaluation.