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  5. Drug Safety Oversight Board Meeting - January 15, 2015
  1. Center for Drug Evaluation and Research | CDER

Drug Safety Oversight Board Meeting - January 15, 2015

Public Summary

The following Drug Safety Communications (DSCs) have posted since the November 20, 2014 DSB meeting:

  • November 25, 2014: Tecfidera (dimethyl fumarate):
    FDA is warning that a patient with multiple sclerosis (MS) who was being treated with Tecfidera (dimethyl fumarate), developed progressive multifocal leukoencephalopathy (PML), and later died. As a result, information describing this case of PML is being added to the Tecfidera drug label. Patients taking Tecfidera should contact their health care professionals right away if they experience symptoms that concern them, such as new or worsening weakness; trouble using their arms or legs; or changes to thinking, eyesight, strength or balance. Health care professionals should stop Tecfidera if PML is suspected.
  • December 11, 2014: Geodon (ziprasidone):
    FDA is warning that the antipsychotic drug ziprasidone (marketed under the brand name, Geodon, and its generics) is associated with a rare but serious skin reaction that can progress to affect other parts of the body. A new warning has been added to the Geodon drug label to describe the serious condition known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Patients who have a fever with a rash and/or swollen lymph glands should seek urgent medical care. Health care professionals should immediately stop treatment with ziprasidone if DRESS is suspected. 
  • January 9, 2015: Pain medication use in pregnancy:
    FDA issued a DSC related to the concerns arising from recent reports questioning the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy. As a result of these reports, FDA evaluated research studies published in the medical literature and determined the studies are too limited to make any recommendations based on them at this time. Because of this uncertainty, the use of pain medicines during pregnancy should be carefully considered. FDA urges pregnant women to always discuss all medicines with their health care professionals before using them. http://www.fda.gov/Drugs/DrugSafety/ucm429117.htm

The Board heard two presentations:

  1. Doris Auth, PharmD, DRISK/CDER updated the Board on the status of the ER/LA opioid REMS, including the REMS-compliant prescriber training program.
  2. Cheryl Grandinetti, PharmD, Office of Medical Policy/CDER discussed the use of electronic health records data in clinical investigations.

Views expressed by non-CDER employees are those of the individual and not necessarily the opinion of his/her respective federal agency or institution.

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