Boehringer Ingelheim to withdraw cough medicine

Boehringer Ingelheim has announced that it is to withdraw its cough treatment Silomat (clobutinol hydrochloride) from sale, while also advising patients to discontinue their use of the drug.

This decision has been made following discussions with the relevant German authorities following the recent publication of new clinical study data.

Boehringer Ingelheim reports that clobutinol has appeared to be well-tolerated in patients since 1961, with approximately 200 million patients receiving that drug since that time.

However, recent analysis of new clinical study results have suggested a potential risk of cardiac arrhythmia that the company states cannot be excluded.

Dr Andreas Barner, vice-chairman of the board of managing directors of Boheringer Ingelheim with responsibility for research, development and medicine, said: “We see our obligation to carefully consider any new information that becomes apparent and to initiate responsible measures to minimize and avoid even potential risks for patients. Therefore we decided to voluntarily recall clobutinol.”

The company notes that the drug is marketed as an over-the-counter drug in some countries and a prescription medication in others for patients with an irritable, non-productive cough, with the compound marketed under the Silomat brand name.

In March 2007, Boehringer Ingelheim announced that it become a founding sponsor of the Massachusetts Institute of Technology Centre for Biomedical Innovation, joining firms including AstraZeneca, Eli Lilly and Novartis.