FDA takes only drug for premature birth off the market | CNN

  • 📰 CNN
  • ⏱ Reading Time:
  • 17 sec. here
  • 2 min. at publisher
  • 📊 Quality Score:
  • News: 10%
  • Publisher: 95%

South Africa News News

South Africa South Africa Latest News,South Africa South Africa Headlines

The FDA has announced its final decision to withdraw its approval of Makena, a drug approved more than a decade ago to reduce the risk of preterm birth. The FDA says that the drug is not effective and the benefits of taking it do not outweigh the risk.

“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 – particularly in light of the fact that this serious condition has a disparate impact on communities of color, especially Black women,” FDA Commissioner Dr. Robert Califf said in a statement.

“While we stand by Makena’s favorable risk-benefit profile, including its efficacy in women at highest risk of preterm birth, we are seeking to voluntarily withdraw the product and work with the FDA to effectuate an orderly wind-down,” Covis Pharma Chief Innovation Officer Dr. Raghav Chari said in a news release at the time.

 

Thank you for your comment. Your comment will be published after being reviewed.
Please try again later.

Where the hell is your coverage of the fascism going on in Tennessee? A democratically elected law maker was just expelled for peacefully protesting gun violence with his constituents after yet another mass murder had occurred not far away. Shame on you. TenneseeThree

So ….are they confessing that they fed pregnant women placebo pills for the last 10 years or are they removing the opportunity to actually save a pregnant women and their unborn fetus from risky premature birth …please explain

We have summarized this news so that you can read it quickly. If you are interested in the news, you can read the full text here. Read more:

 /  🏆 4. in ZA

South Africa South Africa Latest News, South Africa South Africa Headlines

Similar News:You can also read news stories similar to this one that we have collected from other news sources.

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
Source: WOKVNews - 🏆 247. / 63 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.
Source: ksatnews - 🏆 442. / 53 Read more »

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.
Source: WashTimes - 🏆 235. / 63 Read more »

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.
Source: MarketWatch - 🏆 3. / 97 Read more »

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
Source: NBCNews - 🏆 10. / 86 Read more »