Families Blame Medication for Suicides

June 21, 2011

 By RICARDO ALONSO-ZALDIVAR Associated Press (Aug. 31, 2008, 11:52PM)

WASHINGTON — 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 believe, when drugs prescribed to relieve physical symptoms upset their mental and emotional balance., Federal drug regulators are investigating 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 one for quitting smoking — medical conditions not usually associated with psychiatric disorders., Effect on the brain, 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., The Miller and Briggs families say their lives were turned upside-down without warning., Cody Miller, 15, began using Singulair for allergies in summer 2007. When the teenager became moody and anxious, his parents were surprised., 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., Some 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., Study not ‘perfect’, 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 today 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 Dr. Norman Edelman, the group’s chief medical officer., Douglas Briggs, 54, was a family doctor practicing near Charlotte, N.C. In his 30s, Briggs had injured his back in a car crash. Three surgeries over the years failed to completely resolve his problem. But Briggs stayed active, playing tennis and basketball., In February 2004, he began taking Neurontin, an epilepsy drug also prescribed for nerve-related pain and used for chronic back trouble. His wife and two sons noticed “uncharacteristic mood swings and irritability.”, On Christmas Day in 2004, his family found Briggs had hanged himself in the foyer of their home., “For a guy who was such a family man to do that in a way that would basically ensure his family would be the first to find him was completely baffling,” said his son Andrew Briggs., 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 believe 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 in a statement. “Based on an extensive review of our clinical trial data for Neurontin, we see no evidence to support the claim that Neurontin causes an increased risk of suicide-related events.”, After Douglas Briggs killed himself, the family started hearing about other Neurontin patients who had committed suicide, Andrew Briggs said. The family is suing Pfizer; their lawyer said there are about 250 such lawsuits., This summer, the FDA convened a panel of scientific advisers to evaluate the suicide risks of 11 anti-seizure drugs, including Neurontin. Crunching data from 210 clinical trials, the agency found a small increased risk: two of 1,000 patients taking the medications experienced suicidal thoughts or behavior. When millions of people are taking a drug, even such slim odds can have significant consequences., More harm than good, The advisory panel accepted the FDA’s findings but voted against imposing the government’s strongest warning on the drugs, saying that could do more harm than good. The FDA is considering how to communicate the risks to patients., “Even though a drug is identified as a drug for weight control, or smoking cessation, or asthma, these drugs often also get into the brain, so there is always the potential for having psychiatric side effects,” said Dr. Thomas Laughren, head of the FDA’s division of psychiatric products. “But we don’t have any unifying hypothesis as to why very different classes of drugs have psychiatric side effects.”
 

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