EMA Performs Risk Reviews on Several Medications

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The agency reviews hemophilia A, skin, and diabetes treatments, among others.

The European Medicines Agency (EMA) announced that it has started safety reviews of modified-release paracetamol, retinoid medications, and medicines containing factor VIII. The agency’s Pharmacovigilance Risk Assessment Committee (PRAC) discussed the reviews during a hearing held on July 4–8, 2016.

PRAC will review the benefits and risks of paracetamol modified- and prolonged-release tablets for evidence of the potential for overdose and poisoning. Modified- and prolonged-release tablets are different from the usual immediate-release tablets of paracetamol, which release API more quickly.

Measures for the prevention and/or minimization of risk of neuropsychiatric disorders in patients who use retinoid drugs during pregnancy are being evaluated by PRAC. Retinoids are used to treat a variety of skin conditions and contain APIs such as acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tazarotene, and tretinoin.

PRAC will also review drugs containing factor VIII to determine the risk of developing inhibitor proteins in patients being treated for hemophilia A. According to EMA, the review is due to “a study whose authors suggested that inhibitors develop more frequently in patients receiving factor VIII medicines made by DNA recombinant technology than in those receiving factor VIII medicines derived from blood.”


PRAC is also extending its review of diabetes drugs to include dapagliflozin and empagliflozin. Its initial review only included canagliflozin, which was initiated because of an increase in amputations observed during a clinical trial called CANVAS. EMA is extending the scope of the review because the potential risk of canagliflozin may extend to other drugs in its class.

Source: EMA