The Food and Drug Administration has alerted medical doctors to new warnings on anti-seizure drugs about heightened risks of suicidal tendencies. This warning follows an earlier announcement by the FDA that the labels would be required. The labeling applies to more than 20 medications used to control seizures, psychiatric disorders and nerve pain. The warnings caution doctors that there is increased “risk of suicidal thoughts or behavior in patients taking these drugs for any indication.”
Regulators highlighted the new language in letters sent to doctors, according to a posting on FDA’s web site last month. The FDA announced in December that it would require the warnings. An analysis by FDA concluded that an additional two patients per 1,000 would have suicidal thoughts and behaviors when taking the drugs compared with placebo. If this is accurate, the heightened risk should be relatively small. Drugs bearing the new language include blockbuster products like GlaxoSmithKline’s Lamictal, Johnson & Johnson’s Topamax and Pfizer’s Lyrica.
The FDA is requiring companies to distribute medication pamphlets to patients explaining the risks. The medication guides and the new warning labels were approved by the agency on April 23rd. It should be noted that the FDA didn’t add its sternest warning to the medications, following the advice of its outside experts, which is rather interesting. In July, a panel of advisers said adding the so-called “black box” warning, the strongest type available, could cause undue alarm among patients and cause them to stop taking their medications.
Anti-seizure drugs are used for a variety of illnesses besides epilepsy, including migraines, certain nerve-pain disorders, and mental illnesses such as bipolar disorder. According to the industry research firm IMS Health, the drugs were the fourth-best-selling class in the country last year with total sales of $11.3 billion. If you need additional informational on this subject, contact Chad Cook at 800-898-2034 or by email at Chad.Cook@beasleyallen.com.
Source: Associated Press
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