FDA Date: 12/5/11
Nplate FDA Drug Safety Communication
Modified Risk Evaluation and Mitigation Strategies (REMS) for Nplate (romiplostim) and Promacta (eltrombopag)
FDA has approved modifications to the Risk Evaluation and Mitigation Strategies (REMS) for platelet-booster drugs Nplate (romiplostim) injection and Promacta (eltrombopag) tablets. The modifications include the removal of certain elements of the REMS, including the requirements for restricted distribution and additional safety data collection
Prescribers, healthcare institutions, pharmacies, and patients no longer have to enroll in the REMS programs in order to prescribe, dispense, or take these drugs.
Healthcare professionals and patients should be aware, however, that serious risks still exist with Nplate and Promacta. The physician labels and patient Medication Guides have been updated to reflect the current data on the risks with each therapy.
The purpose of the REMS was to promote informed risk-benefit decisions between patients and healthcare professionals prior to starting therapy and while patients remained on treatment to ensure the appropriate use of the drugs, and to establish the long-term safety and safe use of the drugs. However, the underlying medical conditions in patients with chronic immune (idiopathic) thrombocytopenia (ITP) made the safety data collected by the REMS programs difficult to interpret. FDA has determined that the REMS requirements related to safety data collection are not informative and are no longer necessary to ensure that the benefits of the drugs outweigh their risks. FDA has concluded that establishing the long-term safety of Nplate and Promacta is best achieved through ongoing clinical trials, postapproval studies, and postmarketing adverse event reports.
FDA will continue to monitor these drugs for safety risks and will update the public if it has additional information on the benefits and risks of Nplate and Promacta.