- The Washington Times - Monday, September 1, 2008

ASSOCIATED PRESS

Cody Miller was a high school football player who was allergic to ragweed. Douglas Briggs was a doctor coping with pain from an old back injury.

Both are now dead, hanging victims driven to suicide, their families think, when drugs prescribed to relieve physical symptoms upset their mental and emotional balance.

Federal drug regulators are investigating to see whether the families could be right.

Until now, the Food and Drug Administration’s attention to the suicide risks of medications has focused on psychiatric drugs, such as antidepressants prescribed to youngsters. But this year, officials unexpectedly broadened their concerns to include a medication for asthma, drugs for controlling seizures and even one for quitting smoking. Those are medical conditions not usually associated with psychiatric disorders.



Several independent experts say the safety alarms point to a gap in the FDA’s knowledge of how drugs affect the brain. Even if medications are intended for physical conditions, some drugs can have unforeseen consequences if they are able to enter the brain. A group at Columbia University has developed a method for assessing the suicide risks of drugs, possibly helping identify risks before a medication goes on the market. But the FDA only requires use of such assessments on a case-by-case basis.

Drug companies say no cause-and-effect link has been established that would tie the medications under scrutiny to suicides. Also, some doctors worry that the talk of suicide may scare patients with serious illnesses away from drugs that could help. For example, depression, a major risk factor for suicide, is associated with physical illness, they note.

Cody, 15, began using Singulair for his allergies in the summer of 2007. The teenager became moody and anxious. About two weeks after he started taking his new medication, he hanged himself in an upstairs closet of the family home in Queensbury, N.Y.

Two months later, the company that makes Singulair updated its prescribing literature to report that some patients had experienced suicidal thinking and behavior. But Merck & Co. said that only may be a coincidence because there were no such reports during controlled clinical trials with the drug.

“Singulair is a really effective drug that has been on the market 10 years and has been taken by millions of patients,” said Alan Ezekowitz, an asthma expert with Merck. “In over 40 placebo-controlled trials, no reports of suicide in Singulair-treated groups have been found.”

An independent study by the American Lung Association supports Merck’s conclusion without completely answering the question. The research looked at measures of emotional well-being in three clinical trials sponsored by the association and found a positive effect on emotional outlook in patients taking Singulair.

But the study, set to appear Monday in the Journal of Allergy and Clinical Immunology, was not designed specifically to look for suicidal thinking or actions.

“The evidence is good, but we couldn’t call it perfect,” said Norman Edelman, the group’s chief medical officer.

When he was in his 30s, Mr. Briggs had injured his back in a car crash. In February 2004, he began taking Neurontin, an epilepsy drug also prescribed for nerve-related pain and used for chronic back trouble.

“He started developing uncharacteristic mood swings and irritability,” said son Andrew Briggs.

On Christmas Day in 2004, Douglas Briggs, 54, urged his family to go see a movie. When they returned, they found he had hanged himself in the foyer of their home.

Pfizer Inc., which makes Neurontin, said that since the drug was first marketed in the 1990s, the prescribing literature had listed “suicidal” and “suicidal gesture” as rarely reported adverse events seen in clinical trials. But Pfizer does not think such reactions were connected to taking Neurontin and the company remains confident in the drug.

“Neurontin is an important medicine that has helped millions of patients with serious conditions,” Pfizer said.

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