Oops they did it again. Merck’s asthma drug Singulair under investigation for suicide link by FDA.

Merck is at it again. In March 2008, the FDA opened an investigation into a link between suicidal behavior and mood swings in some users of Merck’s product Singulair. Merck is currently fighting more than 4,200 state and federal Vioxx related lawsuits pending across the country and is appealing a $253.4 verdict jurors awarded to Robert Ernst’s widow, Carol which takes into account her husband’s lost pay as a Wal-Mart produce manager, their mental anguish, her loss of companionship and punitive damages.

Fifteen-year old Cody Miller was prescribed Singulair by his doctor to relieve his allergy symptoms and immediately suffered from severe mood swings and after only 2 weeks of treatment, took his own life. Cody’s parents, Kate and David Miller met with FDA officials earlier this week to share their story and recommend that the drug maker Merck post stronger warnings on Singulair labels.

In just over a year Merck has updated Singulair’s warning labels to include: tremors in March 2007, depression in April 2007, suicidal tendencies in October 2007, and anxiousness in February 2008. Given that Singulair is one of its top selling products, with sales of $4.3 billion dollars in 2007, it’s no wonder Merck is dragging their feet.

The FDA is tasking Merck to evaluate their existing clinical data for any signs of suicidal behavior. Isn’t that kind of like asking the fox to guard the hen house? Additionally the FDA plans to review reports it has received which could take up to nine months. I find it difficult to believe the FDA is even considering the data provided by Merck as reliable after it was revealed that Merck had ghostwritten clinical studies for Vioxx.

In addition, the FDA is investigating Accolate, Zyflo, and Zyflo CR for incidents of behavior or mood changes and suicide and will assess whether further action is necessary.

You may report side effects from the use of Singulair, Accolate, Zyflo, and Zyflo CR by using the FDA’s MedWatch Adverse Event Reporting program. See the following options:
1. On-line at www.fda.gov/medwatch/report.htm
2. By returning the postage-paid FDA form 3500 (available in PDF format at: www.fda.gov/medwatch/getforms.htm) to 5600 Fishers Lane, Rockville, MD 20852-9787
3. Fax the form to 1-800-FDA-0178
4. By phone at 1-800-332-1088