FDA Looking at Suicide Risks of Popular DrugsSep 2, 2008 | Parker Waichman LLP
It seems that some suicides might be linked to a variety of drugs that are surprising experts. In one case, the Associated Press (AP) reports a 15-year-old high school football player taking the allergy and asthma medication Singular hanged himself. In another, the AP reports that a physician taking Neurontin for an old back injury also hanged himself. The victims’ families believe the drugs, which were prescribed to relieve physical—not psychological—symptoms, upset their family members mental and emotional balance. Now, federal drug regulators are investigating, says the AP.
About two months following the teen’s suicide, Merck & Company—maker of Singulair—revised its prescribing literature to indicate that some patients experienced suicidal thinking and behavior. Merck said that the death could be a coincidence. "Singulair is a really effective drug that has been on the market 10 years and has been taken by millions of patients," said Dr. Alan Ezekowitz, an asthma expert with Merck.
Meanwhile, the 54-year-old doctor began taking Neurontin, an epilepsy drug made by Pfizer, which is also prescribed for nerve-related pain and chronic back trouble. Pfizer said that since Neurontin was first marketed in the 1990s, the prescribing literature listed "suicidal" and "suicidal gesture" as rarely reported adverse events seen in clinical trials. "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," Pfizer said. The doctor’s family is suing Pfizer and represents one of about 250 such lawsuits.
The AP reports that just this summer, the US Food and Drug Administration (FDA) “convened a panel of scientific advisers to evaluate the suicide risks of 11 anti-seizure drugs, including Neurontin.” Also, until recently, the FDA focused on psychiatric drugs, such as antidepressants prescribed to youngsters, when looking at medication-related suicide risks. Now, officials “unexpectedly broadened their concerns to include a medication for asthma, drugs for controlling seizures, and even one for quitting smoking,” the AP says. These drugs cover a spectrum of medical conditions not typically linked with psychiatric disorders.
Some independent experts are now seeing a gap in the FDA's knowledge of how drugs affect the brain, says the AP, and that “even if medications are intended for physical conditions, some drugs can have unforeseen consequences if they are able to enter the brain.” A Columbia University research group developed a method for collecting and assessing information about suicidal thinking and behavior among those enrolled in drug trials. The information is used to measure a medication’s suicide risks, possibly helping identify such risks before a drug goes to market. Although the FDA helped fund the research, it does not require drug makers to utilize the system and only requires such assessments on a case-by-case basis.
"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."