The FDA announced tighter rules for labeling drugs administered for epilepsy.
Wired PR News.com – The Food and Drug Administration (FDA) has announced new rules for labeling medications used to treat epilepsy. As reported by the Associated Press (AP), the FDA now requires that labels for epilepsy drugs must include warnings of the increased suicide risks associated with them. As noted in the AP report, the FDA initially reported the higher risks approximately one year ago.
The report states that one of every 500 patients taking these kinds of medications may have an increased chance of experiencing suicidal thoughts and behaviors. All medications used to control seizures are said to carry the same risks. Some medical experts have expressed concerns that the requirements might prevent some from taking needed medications, and pose greater health risks. The agency recommends patients discuss all treatment regimen decisions with their doctor.
As quoted in the AP report, the FDA released the statement “All patients who are currently taking or starting on any antiepileptic drug for any indication should be monitored for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.”
Twenty-one medications will be required to have labeling that meets the new standards including those manufactured by GlaxoSmithKline, Johnson & Johnson, and Pfizer.
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