PHARMACY

FDA: Topiramate could pose birth defects risk

BY Alaric DeArment

SILVER SPRING, Md. — Pregnant mothers taking a common drug for treating epilepsy may be putting their babies at risk, according to a new report from the Food and Drug Administration.

The FDA said Friday that the drug topiramate could increase the risk for such birth defects as cleft palate and cleft lip when used by expectant mothers. Johnson & Johnson markets the drug under the name Topamax, and it is available in generic form.

“Healthcare professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age,” FDA Division of Neurology Products director Russell Katz said. “Alternative medications that have a lower risk of birth defects should be considered.”

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FDA lifts liver injury risk boxed warning from Gilead’s Letairis

BY Allison Cerra

FOSTER CITY, Calif. — Gilead on Friday announced that the Food and Drug Administration has removed a boxed warning about a possible liver injury risk caused by the drug maker’s hypertension treatment.

Gilead said the FDA approved a change to the prescribing information for Letairis (ambrisentan 5-mg and 10-mg tablets), the company’s once-daily treatment of pulmonary arterial hypertension.

The announcement followed the FDA’s review of post-marketing data, which found that during 12-week controlled clinical trials, the incidence of liver function abnormalities was 0% on Letairis and 2.3% on placebo among patients. In conjunction with this label update, PAH patients receiving Letairis no longer are required to obtain monthly liver function tests.

Gilead did note, however, that the drug will continue to carry a boxed warning, since it is contraindicated in pregnancy.

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Eisai’s Banzel OKed as epilepsy treatment

BY Alaric DeArment

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a drug made by Eisai to treat a rare form of epilepsy, the drug maker said Friday.

The FDA approved Banzel (rufinamide) oral suspension for the treatment of seizures in children and adults with Lennox-Gastaut syndrome. The condition, also called LGS, affects 1% to 4% of children with epilepsy.

“This new formulation provides an option for patients who may prefer a liquid or find it difficult to take the medication in tablet form,” Eisai president and CEO Lonnel Coats said.

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