The QMN Weekly Bulletin
Pharmaceuticals / Regulatory Affairs / Postmarket Safety

EMA’s PRAC Recommends New Label Warnings for Several Products

Aug. 11, 2017
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The European Medicine Agency’s safety committee is recommending labeling changes for several products to cover newly identified risks of adverse events and side effects.

The Pharmacovigilance Risk Assessment Committee identified safety signals for amoxicillin; ciprofloxacin and meropenem; epoetin alfa and darbepoetin alfa; fulvestrant; prednisone and prednisolone; and intravenous fluids containing electrolytes or carbohydrates.

Sponsors should submit variations in the coming months to amend the products’ labeling information, the EMA said.

For the antibiotic amoxicillin, the panel recommended sponsors include information on severe cutaneous adverse reactions reported in patients on penicillin therapy, in addition to very rare drug reactions with eosinophilia and systemic symptoms, also known as DRESS, which include flu-like symptoms.

Combinations of ciprofloxacin and meropenem co-administered intravenously may be incompatible, the PRAC said. Sponsors should make clear that the products must not be mixed with other medicines except those specifically listed.

All epoetins should include special warnings for severe cutaneous adverse reactions that can be life-threatening. The PRAC’s recommendations cover epoetin alfa, beta, theta and zeta, as well as darbepoetin alfa, also known as Amgen’s Aranesp. The committee requested that Amgen Europe lead the preparation and distribution of a direct communication for healthcare professionals.

Marketing authorization holders of fulvestrant-containing products should submit label variations to include uncommon anaphylactic reactions. Meanwhile, prednisone and prednisolone products should carry warnings for induced scleroderma renal crises.

Information for IV electrolytes and carbohydrate products should be adapted at the individual product level, but include methods of administration and monitoring, special warnings and precautions for low levels of sodium in the bloodstream, interactions with other drug products, and other undesirable effects.

The EMA also published an annual report from its Pharmacovigilance Inspectors Working Group, detailing the number and severity of findings in different categories.

EMA inspectors found two critical deficiencies — in a computerized pharmacovigilance system and a quality management system — in addition to three major and 15 minor findings in 2016.

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