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Thu January 9, 2014
New Research Challenges FDA Warnings On Lyrica, Other Anti-Epileptic Drugs
A scientist from San Antonio has published a study that questions Food and Drug Administration warnings about suicide behaviors from using anti-epilepsy drugs (AEDs). The study observed cases of 90,000 older veterans who were taking the drugs for one or more conditions.
Current FDA labeling for AEDs warn that the drugs may induce suicidal thoughts. But observations in a study by Dr. Mary Jo Pugh of the UT Health Science Center showed that patients had suicidal thoughts even before they received the drug.
"The point of the paper is that the FDA has classified this entire group of medications as being a problem -- a problem with suicide," Pugh said. "If you listen to some of the advertisements on TV for Lyrica, which is one of these medications used for chronic pain, it says, 'This drug may cause suicidal ideation or suicidal behavior.' It may not be true."
Pugh said fewer than 100 patients in her study had thoughts of suicide, and for those who did, suicidal ideation often dropped off after the drug was administered. Pugh said those findings led her to conclude that thoughts of suicide were more related to the original conditions for which patients received the drugs. -- conditions that could be chronic pain and headache, depression or bipolar disorder.
Pugh said the 2008 study that prompted the FDA warning could be flawed.
"I've been doing research in epilepsy for about 15 years and when this analysis was published the neurology community was up in arms," she said. "And there was particular concern for people with epilepsy that somebody might not be willing to give them the treatment that they need, which is the only treatment available."
Pugh said although her study suggests the FDA could be wrong in issuing the suicide warning for Lyrica and other AEDs, getting the agency to rescind a warning is a daunting proposition. She said more evidence would be needed, including documenting the patients’ suicidal thoughts prior to receiving the drugs, which wasn’t done back in 2008.
Pugh’s findings were published in a November, 2013, issue of "Neurology," the medical journal of the American Academy of Neurology.