
EMA to Evaluate Liver Problems Linked to Zinbryta
In its June meeting, the agency’s Pharmacovigilance Risk Assessment Committee discussed medicine safety reviews.
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) discussed the safety reviews of a variety of medications during its June 2017 meeting. The medicines in review included treatments for multiple sclerosis, cancer, and products containing valproate.
The agency stated in a
PRAC also released its finding on the risk of neutropenic enterocolitis in patients treated with docetaxel. The committee determined there was no evidence of increased risk of the inflammatory condition in patients who use the cancer medication. EMA stated in the release that “the recent rise in reporting of the condition observed in France could be due to increased awareness among healthcare professionals. Reporting rates in the European Union as a whole do not provide any evidence of an increase in the incidence of neutropenic enterocolitis.”
During the meeting, PRAC announced it was scheduling the first public hearing of a drug safety review. The hearing, which was set for Sept. 26, 2017, will discuss the safety of the use of valproate-containing drugs used by pregnant women. Medicines containing valproate are used to treat epilepsy, bipolar disorders, and migraines. The committee said it will use the experiences of patients who have used the drugs in its evaluation of the drugs’ safety.
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