The Food and Drug Administration is ordering an unproven drug intended to prevent premature births off the market.
FILE - This image provided by Covis Pharma shows packaging for the company's Makena medication. The Food and Drug Administration on Thursday, April 6, 2023 ordered the immediate market withdrawal of a drug intended to prevent premature births, which has remained available for years despite data showing it doesn't help pregnant women. The decision follows repeated efforts by Swiss drugmaker Covis Pharma to keep Makena on the U.S. market while it conducted additional studies.
The injectable drug is a synthetic version of the hormone progesterone, which helps the uterus sustain pregnancy. It can cause side effects, including blood clots, depression and allergic reactions. Given those risks, FDA staffers previously concluded there was no upside to keeping the drug available, given its lack of confirmed benefit.
The FDA expedited Makena's approval in 2011 based on a small study suggesting it reduced rates of premature birth in women who had previously had trouble bringing a pregnancy to term. But results from a 1,700-participant study completed in late 2018 showed the drug neither reduced premature births — as originally thought — nor resulted in healthier outcomes for babies.
“It is tragic that the scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes," Califf said in a statement Thursday. Women who have a current prescription for the drug should direct any questions to their doctor, the agency said.
United States Latest News, United States Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
FDA to require prescriptions for livestock antibioticsRight now, farmers in Alabama can purchase antibiotics like penicillin over the counter. Once the new FDA requirement is put in place, a prescription will be required for those purchases.
Read more »
Sinaloa drug cartel member extradited to US on international drug trafficking, firearms chargesA high-ranking member of the Sinaloa Cartel who worked closely with El Chapo was extradited to the U.S. Saturday to face international drug trafficking charges.
Read more »
FDA forces unproven premature birth drug Makena off marketThe Food and Drug Administration is ordering an unproven drug intended to prevent premature births off the market
Read more »
Where exactly each dollar you spend on food goes: farmers get 14 cents and 4 cents pays for packagingA new report examines what each food dollar pays for, from food processing to packaging.
Read more »
The evolution of antibiotic resistance is associated with collateral drug phenotypes in Mycobacterium tuberculosis - Nature CommunicationsHere using drug susceptibility profiling, genomics and evolutionary studies the authors provide strategies to exploit collateral drug responses in Mycobacterium tuberculosis to prevent the emergence of drug resistance.
Read more »
Eyedrops maker couldn't ensure factory was sterile, FDA saysThe Food and Drug Administration says it found a host of problems at an Indian manufacturing plant recently linked to contaminated eyedrops
Read more »