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FDA Drug Safety Podcast for Healthcare Professionals: Modified Risk Evaluation and Mitigation Strategies (REMS) for Nplate (romiplostim) and Promacta (eltrombopag)

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Narrator: Welcome to the FDA Drug Safety Podcast for Healthcare Professionals from the Division of Drug Information. Today’s topic: Modified Risk Evaluation and Mitigation Strategies (REMS) for Nplate (romiplostim) and Promacta (eltrombopag).

Steven Jackson, a pharmacist in the Division, will provide you with additional information about this Communication.

Guest Speaker: On December 6, 2011, the Food and Drug Administration issued a Drug Safety Communication informing the public that FDA has approved modifications to the REMS, for the platelet-booster drugs Nplate injection and Promacta 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 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.

At the time of approval in 2008, experience with both Nplate and Promacta was limited, and safety concerns led to a decision to require a REMS that included restricted distribution and additional safety data collection requirements for each drug to ensure that the benefits of the drugs outweighed their risks. These risks included bone marrow changes, higher risk for blood clots, possible worsening of blood cancers, and worsening low blood platelet count after stopping the drugs. 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, post-approval studies, and post-marketing 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.

At this time, FDA recommends that Healthcare Professionals be aware that:

  1. Healthcare professionals no longer need to: Enroll in the Nplate NEXUS Program to prescribe Nplate; enroll in the Promacta CARES Program to prescribe Promacta; or complete periodic safety forms for patients receiving Nplate or Promacta.
  2. Institutions no longer need to: Enroll in the Nplate NEXUS Program; enroll in the Promacta CARES Program; or verify prescriber and patient enrollment before dispensing Nplate.
  3. Pharmacies and pharmacists no longer need to: Enroll in the Promacta CARES Program; or verify prescriber and patient enrollment before dispensing Promacta.
  4. The drug prescribing information should be referred to for the latest recommendations on prescribing Nplate and Promacta.
  5. Patients should be encouraged to read the Medication Guide that they get along with their Nplate or Promacta prescription.
  6. Adverse events involving Nplate or Promacta should be reported to the FDA MedWatch program at www.fda.gov/medwatch.

Narrator: Thank you for listening. The FDA is committed to keeping healthcare professionals informed of the latest safety information. A link to this communication can be found at www.fda.gov/DrugSafetyCommunications. If you have drug questions, you can reach us at druginfo@fda.hhs.gov.

Follow us on Twitter @FDA_Drug_Info for up to the minute important drug information. Know the moment it happens.

 

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