FDA forces unproven premature birth drug Makena off 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.

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.

WASHINGTON — The Food and Drug Administration on Thursday ordered the immediate market withdrawal of a drug intended to prevent premature births, which has remained available for years despite data showing itThe decision follows repeated efforts by Swiss drugmaker Covis Pharma to keep Makena on the U.S. market while it conducted additional studies. The medication was the only drug approved in the U.S. to help reduce the risk of early births in women with a history of preterm deliveries.

“Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce,” the agency said in a statement.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.

AND CAN YOU PLEASE TELL ME, WHEN THEIR GOING TO STOP THE COVID-19 VACCINE, FROM PRODUCTION

Nederland Laatste Nieuws, Nederland Headlines

Similar News:Je kunt ook nieuwsberichten lezen die vergelijkbaar zijn met deze die we uit andere nieuwsbronnen hebben verzameld.

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
Bron: WOKVNews - 🏆 247. / 63 Lees verder »

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.
Bron: ksatnews - 🏆 442. / 53 Lees verder »

FDA forces unproven premature birth drug Makena off marketThe Food and Drug Administration on Thursday 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.
Bron: WashTimes - 🏆 235. / 63 Lees verder »

FDA pulls pre-term birth drug Makena and its generics from market after 12 yearsThe U.S. Food and Drug Administration said Thursday it has reached a final decision to fully withdraw approval of pre-term birth drug Makena and its... I smell some up coming big big pharma litigation.
Bron: MarketWatch - 🏆 3. / 97 Lees verder »

FDA forces unproven premature birth drug Makena off marketThe FDA orders the immediate market withdrawal of Makena, a drug intended to prevent premature births, which has remained available for years despite data showing it doesn’t help pregnant women. Classic FDA. Bought and paid for by Big Pharma since 1992. Now do the covid vax US_FDA will approve this dangerous drug for 12 years while safe and effective NurOwn for 100% fatal disease ALS is blocked by FDACBER. PALS DiedWaiting DyingWaiting MakesNoSense katiecouric USNewsHealth WSJhealth SenSusanCollins POTUS SenatorBraun lisamurkowski
Bron: NBCNews - 🏆 10. / 86 Lees verder »