FDA Calls for Investigation of Singulair by Merck

By: Gerri L. Elder

In just the latest case of potentially defective drugs present on the U.S. market, the Food and Drug Administration announced that it would be conducting a thorough investigation of the drug Singulair made by the New-Jersey-based drug giant Merck. Singulair, a medication used to treat asthma and seasonal allergies, has been linked to reports of mood conditions, suicidal behavior and instances of suicide in patients.

Merck has been cautious about the label on Singulair, having updated its contents no less than four times over the course of the past year to include information about additional side effects, such as tremors, anxiousness, depression and suicidal behavior.

The FDA is acting on that last potential side effect by requesting more clinical studies and analysis of data to determine if so serious a condition is a real risk. It's obvious that the FDA is becoming more proactive in light of the public outcry over their slowness to move on Vioxx, also manufactured by Merck, as well as other defective drugs that have been eventually recalled over the past few years.

The FDA consumer warning stresses that they are merely making recommendations for more study, and that the results of the investigation may not be available for nine months. The FDA also clarifies that patients who are taking Singulair should talk to their doctor before stopping any treatment with it.

Merck responded by indicating that they are following the FDA's recommendations for further analysis because of the gravity of a possible link to a life-threatening problem, but that their earlier clinical trials did not suggest a link to suicide. Of the 11,000 patients involved in 40 clinical trials, none committed suicide. More common side effects included headache, flu, abdominal pain and cough.

Of course, Merck is no stranger to public backlashes over defective drugs. Within the last few months, the company settled a host of lawsuits over problems with its flagship drug Vioxx for an amazing $4.85 billion. Previously, they had vowed to fight each lawsuit individually, though a string of costly losses prompted them to reconsider that and make the massive settlement with over 25,000 plaintiffs (including 265 class-action lawsuits).

There is no indication that this Singulair problem will come to lawsuits yet, but Total Injury will have updates as they become available over the coming months.