FDA orders recall of 10,000 doses of infective endocarditis drug

Taiwan's Food and Drug Administration (FDA) on Monday announced the recall of 10,000 doses of Targocid, a drug used to treat infective endocarditis.

Hung Kuo-teng (???), the head of the FDA's Medicinal Products Division, said the recall was for the antibiotic Targocid 400mg powder produced in batch 1J5721 by French multinational pharmaceutical company Sanofi.

The FDA demanded that the 10,000 doses from the specific batch in Taiwan must all be recalled by March 6, and clinics, hospitals and pharmacies have been asked to stop prescribing the drug and assist in recall efforts.

Hung said Sanofi had voluntarily notified the FDA last October that issues might have arisen in the drug's production line.

Hung said the FDA subsequently asked the company to investigate, which revealed that the batch in question was slightly contaminated with a water soluble corticosteroid known as methylprednisolone hemisuccinate (MPHS).

The corticosteroid is used to relieve a number of ailments such as severe allergic reactions, respiratory diseases, and nervous system conditions.

Approximately 120,000 doses of Targocid are prescribed under Taiwan's national health insurance program annually, according to Hung, accounting for 80 percent of the market for drugs of the same nature made with the same active ingredients and dosage.

Hung said, however, that patients who rely on the medication do not have to worry that a recall will cause a shortage of the drug because there are other brands offering the same active ingredient.

For anyone who has concerns, the FDA recommended making appointments with their doctors to discuss alternative medications.

Targocid's primary application is for the treatment of infective endocarditis brought on by staphylococcus.

Secondary applications include the treatment of osteomyelitis, pneumonia, sepsis, soft tissue infection and small intestine inflammation.

Source: Focus Taiwan News Channel