CHMP advises withdrawal of clobutinol-based cough drugs

The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has advised the withdrawal of marketing authorization from cough medicines containing clobutinol, due to the potential for cardiac side effects. The Agency said that the products in question, most of which are marketed by German privately-owned drugmaker Boehringer Ingelheim under the tradename Silomat, were associated with a prolongation of the heartbeat's QT interval.

The CHMP said that, following the suspension of these products by German authorities earlier in the year (Marketletters passim), it conducted a review of all clobutinol-containing medications. The committee concluded that the dangers of QT interval extension following use of such drugs outweighed the benefits, particularly because alternative non-clobutinol-based cough medicines are available.

However, the EMEA's expected adoption of the CHMP guidance will come after Boehringer Ingelheim's removal of the majority of clobutinol-based products from the shelves, which followed the initial German suspension.