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FDA Finally Taking Drug Suicide Risks Seriously

Jul 9, 2008 | Parker Waichman Alonso LLP

On Thursday, federal regulators are expected to recommended tough new safety warnings about suicide risks for 11 epilepsy drugs.  Counting the epilepsy drugs, in the past four years, the Food & Drug Administration (FDA) has added or expanded suicide warnings for about 35 medications.  In the past, the FDA had been criticized for taking too long to act on - or ignoring altogether - the potential suicide risks of some medications, but now assessing a drug's potential for such side effects seems to have become a greater priority at the agency.

Yesterday, FDA head Andrew Von Eschenbach met with top FDA officials to discuss ways of assessing and dealing with the suicide risks posed by some medications.  According to The Wall Street Journal, the officials are contemplating the possibility of working with the National Institutes of Health to more comprehensively deal with the issue.  They want to know if  new or existing research on molecular activity in the brain could better determine what chemicals are likely to stimulate suicidal ideation.  Such information, if it were available, would help drug reviewers better assess suicide risks before drugs are approved.  

The FDA almost never considered a medication's suicide risk prior to 2004.  But that year, the agency was roundly criticized for taking more than a year to address studies that indicated some antidepressants, such as Paxil, raised the chance of suicidal behavior when taken by children and teens.

Since 2004, suicide warnings - including the agency's strictest notice, the infamous "black box" - have been added to or strengthened more than 50 times, to about 35 drugs.  According to The Wall Street Journal, among the 20 best-selling drugs of 2007, six already carry warnings for suicidality.   This year, a suicide warning was strengthened for the smoking cessation medication, Chantix, and the FDA is studying reports of suicide associated with Singulair, a popular asthma medication.

The FDA is also now asking some drug makers to conduct studies aimed at detecting suicidal behavior during the approval process. Columbia University Medical Center has developed a framework for detecting such side effects during clinical trials, and it is being used by several companies.

But while consumer advocates praise the FDA's new attention to suicide risks, not everyone is happy - especially the drug makers. They complain that the agency's new focus is adding to their costs.  But critics of the industry insist that those costs are small in comparison to the effect the FDA's new efforts could have on patients' lives.