For the last three years, doctors prescribing the low-platelet drugs Promacta or Nplate were required to follow a strict regimen.
The doctor, the pharmacist and the patient had to enroll in a monitoring program for the drugs. Doctors regularly collected and reported information on any adverse drug reactions. Due to safety concerns, the U.S. Food and Drug Administration required this strict monitoring of each and every patient using the drugs.
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The FDA is now easing restrictions on GlaxoSmithKline‘s (NYSE:GSK) Promacta and Amgen‘s (NASDAQ:AMGN) Nplate. The drugs treat immune thrombocytopenia, or ITP, a condition in which platelets are destroyed by the patient’s own immune system and puts the patient at risk of bleeding.
Both drugs have been required to have Risk Evaluation and Mitigation Strategies, or REMS, since their 2008 approvals. The FDA can require REMS programs for drugs that have high safety risks. The drugs had raised concerns about risks that include bone marrow changes, higher risk of blood clots and bleeding risks shortly after discontinuing the drugs. Following a review, the FDA now says it is unlikely that the collected safety data can distinguish between adverse events related to the drugs and those related to the condition ITP itself. Therefore, the FDA and the companies concluded that some of the restrictive REMS elements could be eliminated.
With the changes, the FDA is no longer requiring doctors, patients and pharmacists to enroll in safety programs set up for Promacta and Nplate. Mandatory collection of safety data through those programs is also no longer required. But the FDA cautions that both drugs still carry serious risks and it urges healthcare providers to continue reporting any adverse events.
London-based GSK, which has its U.S. headquarters in Research Triangle Park, North Carolina, said it is implementing a plan to inform doctors and pharmacists of the REMS changes for Promacta. The easing of the REMS does not remove all precautions on the drug. Promacta will continue to be restricted to specialty pharmacies, hospital pharmacies and dispensing clinics.
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Image from Flickr user Picture Perfect Pose
