Boehringer Told To Stop Comsat Forte Production

The FDA issued the directive after it found that certain batches of the drug contained glibenclamide, a glucose-lowering substance meant for diabetes. FDA has already ordered the company to completely withdraw all Comsat preparations from the market. The drug is prescribed mainly for patients suffering from urinary and respiratory tract infections.

A K Lakhina, commissioner, Food and Drugs Administration, Maharashtra, said, we are taking a tough stand and awaiting the final report after which we will take a legal stand.

Though Boehringer Mannheim India managing director Paul Stinson was not available for comment, other sources within the company confirmed that the production of Comsat Forte has been temporarily stopped.

 

A few weeks back, many patients in Ahmednagar, Mahar-ashtra complained of vomiting and other side effects after being administered the Comsat Forte .

An analysis of certain batches of the drug by Food and Drugs Administration labs found that the patients consuming it are likely to suffer from side effects often associated with hypoglycaemia (low blood glucose).