The European Medicines Agency has recommended revoking the marketing authorization for medicines containing bufexamac, a non-steroidal anti-inflammatory drug, throughout the European Union, citing concerns about serious contact allergic reactions.
In a press statement April 22, EMA officials said that a scientific review by the agency’s Committee for Medicinal Products for Human Use had identified bufexamac, which is prescribed for conditions such as eczema, as causing reactions “very similar to the disease being treated, which may lead to a potential delay in the correct diagnosis and treatment of patients.”
Topical bufexamac preparations, also used for the treatment of hemorrhoids, have been used since the 1970s in European countries, though some EU member states, spurred by similar concerns over allergic reactions, had already begun to restrict their use. In December 2009 Germany’s medicines authority, following a scientific review, decided to revoke marketing authorization for bufexamac-containing products in that country. The EMA said it consulted the German data in its own review, which commenced a month after the German decision.
From Elsevier Global Medical News.
Bufexamac has been marketed as Parfenac, Bufal, Calmaderm, Fansamac, Mastu S, Parfenoide, Proctosan, and other trade names in EU countries, the agency said. The medicines may be available as creams, rectal ointments, and suppositories.
Allergic reactions to bufexamac can be serious enough to require hospitalization, the agency said, and can worsen with repeated exposure to the drug. Moreover, it said, though the drug has long been in use, it is not particularly effective. Studies from the 1970s and 1980s to establish its efficacy were of poorer quality than contemporary studies, EMA said, and “[b]ecause of this, no evidence of the effectiveness of bufexamac could be derived from them. In addition, when looking at the few more recent, controlled studies, the CHMP noted that the effectiveness of bufexamac had not been shown.”
The agency said its recommendation to revoke has been submitted to the European Commission for final approval, expected within a month. In the meantime, it said, physicians should stop prescribing medicines containing bufexamac, and patients using the drug should consult their doctors about alternatives.
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