A panel of regulators has decided that supplement makers should add warning labels that the sleep aid used to boost it as a drug may pose more risks to older people, people with certain conditions, and those with heart disease.
The Food and Drug Administration, along with its safety counterpart the U.S. Food and Drug Administration, asked that since one company’s view had not emerged, the sole indication for the drug, valproate, be discontinued entirely.
The FDA did not say it would do so.
“Valproate has been approved for decades for the treatment of an extremely rare disease in which the body produces too much of a disease-modifying drug,” Michael Ehlers, director of the FDA’s Center for Drug Evaluation and Research, said in a statement after the advisory panel’s recommendation.
The agency said its safety experts will review the results and comments from the panelists and discuss whether to require a final safety statement.
The FDA approval of valproate was overturned three years ago in one of its rare reversals of an initial approval. At the time, the safety panel supported the conclusion that the drug was less effective than available alternatives.
Analysts are waiting to see whether FDA will ask for further studies on valproate in patients with heart disease, non-alcoholic steatohepatitis, and other serious conditions.
The FDA statement said a long-term safety trial was planned for the heart-risk groups. The agency also will discuss safety in adult patients with types of diabetes or Alzheimer’s disease.
Valproate, approved in 1964, is used to treat bipolar disorder and to treat progressive multiple sclerosis.
Despite being a non-steroidal anti-inflammatory drug, the FDA sees heart risks in its use in anyone from age 20 through 70.
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