Sanofi Manufacturing ‘Delays’ Cause Shortage of TB Drug

Manufacturing “delays” at an unidentified Sanofi-Aventis plant have caused a new shortage of a tuberculosis (TB) drug, according to the US FDA.

The delays are causing a shortage of Rifamate capsules containing 300 mg rifampin and 150 mg isoniazid. The French company estimates the next delivery of the drugs will be in June and that they will be available by July.

Sanofi did not respond to a request for comment on the delays. Per the recently signed Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, companies involved with shortages must provide a reason for the shortage but Sanofi has listed its reason as “other” without any further clarification.

Spread of TB

The shortage announcement from Sanofi comes as the WHO (World Health Organization) announced Monday – World TB Day -- that treatment-resistant strains of TB “could spread widely” and at least US$1.6b in international funding is needed for further treatment and prevention of the disease.

Dr Margaret Chan, Director-General of the WHO, said, “Despite recent success in shrinking the epidemic, the global TB burden remains enormous. In 2011, an estimated 8.7 million people developed TB, and 1.4 million died. This makes TB second only to HIV/AIDS as the greatest killer worldwide due to a single infectious agent.”