WHO warns of falsified leishmaniasis drug

Falsified copies of a drug to treat the parasitic disease leishmaniasis have been discovered in Iran and Pakistan, potentially putting patients at risk.

Both counterfeits claim to contain meglumine antimoniate, a drug that has been used since 1940s for the treatment of leishmaniasis and is on the WHO’s list of essential medicines, and falsely claim to be manufactured by Swiss pharma company Tillotts Pharma AG.

Leishmaniasis is a disease caused by single celled parasites transmitted by sandflies, and most commonly causes skin ulcers (a form known as cutaneous leishmaniasis) although more serious forms can involve lesions in the mouth and other body cavities (mucocutaneous) and organs (visceral). If patients are treated with fake or substandard drugs that don’t contain enough of the active ingredient the results can be life-threatening. In visceral leishmaniasis, drug treatment is essential or the disease is invariably fatal.

The WHO became aware of a counterfeit version of meglumine antimoniate being sold under the Gulucatime brand name in Iran in January, and another falsified version sold as in Pakistan in March. Both have been confirmed as fraudulent by Tillotts.

In a statement, the WHO said that “the results of laboratory analysis facilitated by WHO indicate that the product Gulucatime was not manufactured in accordance to good manufacturing practices,” while analysis of the Glucantime product is pending.

Circulation of the falsified products is confirmed in the WHO region of the eastern Mediterranean, says the agency. That batch numbers and other details of the fakes appear below: