Boehringer Ingelheim Recalls Clobutinol Product

September 7, 2007
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

Boehringer Ingelheim decided to voluntarily withdraw its “Silomat” drug, which contains clobutinol hydrochloride, in all countries where it is available.

Ingelheim, Germany (Aug. 31)-Boehringer Ingelheim decided to voluntarily withdraw its “Silomat” drug, which contains clobutinol hydrochloride, in all countries where it is available. The company advised consumers to stop using the drug.

Boehringer recently analyzed new findings from a clinical study it performed in healthy subjects that suggest that clobutinol hydrochloride carries the potential risk of cardiac arrhythmia. Although the risk might be low, the company decided to recall the drug in the interest of patients’ safety. Boehringer described the recall as a precautionary measure and noted that therapeutic alternatives to the product are available.

In a company press release, Dr. Andreas Barner, vice-chairman of Boehringer’s board of managing directors, 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 Silomat drug is a cough medicine marketed as an over-the-counter medication in some countries and a prescription drug in other countries. Boehringer advised patients to discontinue their treatment and ask their doctors for alternative options to clobutinol-containing products. According to the company, clobutinol’s pharmacological effects are temporary, and patients who previously stopped using clobutinol need not be concerned about late adverse effects.

The Boehringer affiliates in each country where Silomat is sold will organize the recall independently.