Johnson & Johnson (NYSE:JNJ) has won approval from the U.S. Food & Drug Administration for its anti-tuberculosis drug, Sirturo, also known as bedaquiline.
The FDA approved the drug, the first new treatment for the disease in four decades, on Monday, but noted that it raised the risk of dangerous heart complications and required strict physician supervision, the Associated Press noted.
Sirturo containers will be labeled with warnings that the drug can disrupt electrical activity in the heart, possibly resulting in fatal conditions. Some patients taking the drug during clinical trials died, leading critics to raise alarms about its safety.
While uncommon in the U.S., tuberculosis is responsible for 1.4 million deaths around the world each year. The FDA recommended Sirturo for use in patients who could not use other medications.
Most of the four main drugs currently used to treat tuberculosis were developed in the 1950s and 1960s, but some disease strains are now resistant to some of the drugs. Tuberculosis cases are concentrated in India, China, Russia and parts of Eastern Europe.
Shares of Johnson & Johnson rose fractionally in Wednesday morning trading.