Regulatory Focus™ > News Articles > Following FDA, EMA Launches Review of Emergency Contraceptive Effectiveness

Following FDA, EMA Launches Review of Emergency Contraceptive Effectiveness

Posted 24 January 2014 | By Alexander Gaffney, RAC

EU regulators have announced they are initiating a review of emergency contraceptives like Teva's Plan B One-Step following reports that the drug may lose effectiveness in women who are overweight or obese.


In November 2013, Mother Jones broke the news that HRA Pharma, manufacturer of the emergency contraceptive Norlevo, was updating its packaging to reflect new evidence that the drug begins to lose effectiveness in overweight women, and may lose all effectiveness in women who are obese.

In the wake of the revelations, the US Food and Drug Administration (FDA) said it would review the evidence to determine if labeling changes were needed for levonorgestrel-based emergency contraceptives.

"The FDA is currently reviewing the available and related scientific information on this issue, including the publication upon which the Norlevo labeling change was based," FDA spokeswoman Erica Jefferson reportedly told news outlets in an email. "The agency will then determine what, if any, labeling changes to approved emergency contraceptives are warranted."

EMA Review

But even as the European Medicines Agency (EMA) approved the label change in November 2013, it had not announced any plans to review the evidence to determine if changes were needed to similar medications-until now.

On 24 January 2014, EMA said it had started its own review of emergency contraceptives to determine the effect of a woman's body mass index (BMI) on the effectiveness of the medicine on preventing unintended pregnancy.

"EMA will evaluate the impact of new data suggesting that a high bodyweight could impair the effectiveness of emergency contraceptives," it wrote in a statement. "It will assess whether any changes should be made to the product information for all emergency contraceptive medicines containing levonorgestrel or ulipristal acetate."

Medicines that will fall under the review include Norlevo, Levonelle/Postinor, and Levodonna.

EMA said another medication, ellaOne, which contains ulipristal acetate-not levonorgestrel-would also be reviewed under the plan.

The review will be run by EMA's Committee for Medicinal Products for Human Use (CHMP), which will in turn submit its recommendations to the European Commission for final approval.


EMA Statement

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