FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs / Postmarket Safety

Review of Emergency Contraceptive Efficacy Moves to New Zealand

Feb. 28, 2014
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New Zealand regulators Thursday said they will investigate reports that emergency contraceptives such as Teva’s Plan B One-Step lose effectiveness in some women who weigh more than 165 lbs. The FDA and the European Medicines Agency have already launched a similar inquiry.

The review is being conducted by Medsafe and includes a number of levonorgestrel medicines marketed in New Zealand, including Actavis’ Next Choice and Next Choice Arrow and REX Medical’s Postinor-1, which is distributed by Bayer.

The overall benefit-risk balance of levonorgestrel drugs remains positive, the regulator assures.

The inquiries were prompted by a request from Swedish officials to update the label for HRA Pharma’s NorLevo with language warning of lower efficacy in patients weighing more than 165 pounds, and a loss of effectiveness in women 176 pounds or more.

The approval of Plan B for use in the U.S. did not include an assessment specific to weight, the FDA says. — Johnathan Rickman

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