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FDA Announces Changes to Risk Strategy Requirements for Two Drugs to Treat Low Platelet Counts

Posted 7 Dec 2011 by

Includes labeling revisions for both drugs The approval of changes to the Risk Evaluation and Mitigation Strategies (REMS) for both Nplate (romiplostim) and Promacta (eltrombopag) was announced by the U.S. Food and Drug Administration. An FDA-initiated review of the current information has determined that while safety risks for both Nplate and Promacta still exist, certain restrictive requirements of the REMS programs are no longer necessary to ensure that the benefits of the drugs outweigh their risks. FDA will continue to monitor these drugs for safety risks. The agency has concluded that the long-term safety of Nplate and Promacta can be evaluated based on ongoing clinical trials, post-approval studies agreed to by both companies, and adverse event reports submitted to FDA. Major changes to the REMS for both products include: * Health care professionals, hospitals, specialty care ... Read more

Related support groups: Nplate, Promacta, Romiplostim, Eltrombopag

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