Safety Alerts & Recalls

What does this mean?

The distribution of Nplate and Promacta is no longer restricted. Patients no longer need to be enrolled in the Nplate NEXUS (Network of Experts Understanding and Supporting Nplate and Patients) Program or the Promacta CARES Program in order to receive Nplate or Promacta. However, if you take Promacta or receive injections of Nplate, you should be aware 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. You should read the Medication Guide that you get along with your Nplate or Promacta. It explains the risks associated with the use of these drugs. Please contact your healthcare professional if you have any questions or concerns about Nplate or Promacta.

Healthcare providers and patients are encouraged to report side effects related to the use of medicines to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

FDA Makes Changes to Risk Evaluation and Mitigation Strategies (REMS) Program for Nplate (Romiplostim) and Promacta (Eltrombopag)

The U.S. Food and Drug Administration (FDA) has approved changes to the Risk Evaluation and Mitigation Strategies (REMS) for platelet-booster drugs Nplate (romiplostim) injection and Promacta (eltrombopag) tablets. The REMS for Nplate and Promacta is a program to help control the use and provide education to reduce the risks associated with these medicines. The changes include the removal of certain elements of the REMS program, 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.

For more information, please visit: more information here

Source: FDA
Publication Date: 2012-01-26
Last Updated: 2012-01-26

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