period of several months so that women taking the drug could complete their treatment. The FDA rejected that and said Thursday that the action against Makena and several generic versions should take effect immediately.
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.
Мы обобщили эту новость, чтобы вы могли ее быстро прочитать.Если новость вам интересна, вы можете прочитать полный текст здесь Прочитайте больше:
Россия Последние новости, Россия Последние новости
Similar News:Вы также можете прочитать подобные новости, которые мы собрали из других источников новостей
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
Источник: WOKVNews - 🏆 247. / 63 Прочитайте больше »
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.
Источник: ksatnews - 🏆 442. / 53 Прочитайте больше »
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.
Источник: WashTimes - 🏆 235. / 63 Прочитайте больше »
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.
Источник: MarketWatch - 🏆 3. / 97 Прочитайте больше »
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
Источник: NBCNews - 🏆 10. / 86 Прочитайте больше »