Boehringer Ingelheim voluntarily withdraws its clobutinol containing medications
Boehringer Ingelheim has decided in accordance with the competent authorities in Germany to voluntarily withdraw its clobutinol hydrochloride containing medications (Silomat®) in all countries where these medications are available. The drug is indicated to treat irritable, non-productive cough. Patients are asked to discontinue its use.
On the basis of data from worldwide market experience since 1961 with calculated 200 million patient exposures and cumulative safety reporting until today clobutinol appeared to be well-tolerated.
New findings from a clinical study in healthy subjects performed by Boehringer Ingelheim and analysed in the last few days suggest that a potential risk of cardiac arrhythmia can not be excluded. This potential risk might be very low, but considering the indication and the availability of therapeutic alternatives, Boehringer Ingelheim has decided in the interest of patients´ safety to withdraw its Clobutinol containing products from the market as a precautionary measure.
Dr Andreas Barner, vice-chairman of the Board of Managing Directors and responsible 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 product is marketed by Boehringer Ingelheim under the brand name Silomat® as an over-the-counter medication in some countries, in other countries as a prescription-drug.
As the substance is out of patent, there are also other clobutinol containing products on the market for which Boehringer Ingelheim is not responsible.
Patients who discontinue their treatment now should ask their doctors or pharmacists for alternative options to clobutinol containing products. As the pharmacologic effects are transient, patients with previous use of clobutinol need not be concerned about potential late adverse effects.
The Boehringer Ingelheim affiliates in the individual countries, where Silomat® is on the market, will organise the recall accordingly.
Please be advised
This release is from the Corporate Headquarters of Boehringer Ingelheim and is intended for all international markets. This being the case, please be aware that there may be some differences between countries regarding specific medical information including licensed uses. Please take account of this when referring to the material.
The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 137 affiliates in 47 countries and 38,400 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2006, Boehringer Ingelheim posted net sales of 10.6 billion euro while spending one fifth of net sales in its largest business segment Prescription Medicines on research and development.
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