10 results

• Makena Approval Officially Withdrawn by FDA After Concerns About Pregnancy Drug’s Benefits

  April 7, 2023

  Irvin Jackson

  The FDA has officially withdrawn approval for the pregnancy drug Makena, based on postmarketing studies which failed to show it provided any benefits to pregnant mothers.

• Pregnancy Drug Makena Removed From Market Amid Concerns About Lack of Benefits Preventing Premature Birth, Unnecessary Risks for Women

  March 9, 2023

  Russell Maas

  The makers of the controversial pregnancy drug, Makena, have decided to withdraw the medication from the market after health experts determined it provides no benefit to pregnant women or their children, and put them at increased risk of adverse health effects.

• Health Experts Question Why Makena is Still on the Market Despite FDA Advisors Recommendation to Recall Pregnancy Drug

  December 28, 2022

  Irvin Jackson

  Health experts say problems with the accelerated drug approval program have led to Makena and other ineffective drugs staying on the market even after its proven they do not work.

• Makena Recall Recommended By FDA Panel Due to Ineffectiveness Reducing Preterm Birth Risk

  October 20, 2022

  Russell Maas

• FDA Hearing To Determine if Makena Is Allowed Back On The Market

  June 17, 2022

  Russell Maas

  The FDA will hold a hearing later this year to determine whether Makena should be removed from the market because the pregnancy drug's risks appear to outweigh its benefits.

• Makena, Proluton Exposure Before Birth May Increase Cancer Risks Later In Life: Study

  March 29, 2021

  Russell Maas

  A new study warns that Makena and similar pregnancy drugs could increase a child's risk of cancer later in life.

• FDA Indicates Pregnancy Drug Makena Does Not Work and Should Be Removed From Market

  October 7, 2020

  Irvin Jackson

  FDA officials say they intend to remove the pregnancy drug Makena from the market, saying it is ineffective and thus puts pregnant women at risk of unnecessary drug side effects.

• Makena Problems and Uncertain Future Leads To Removal Of Pregnancy Drug Manufacturer’s CEO

  January 29, 2020

  Irvin Jackson

  Uncertainty over Makena's future and the company's revenues has led AMAG Pharmaceuticals' CEO to step down, and has resulted in the company seeking to sell off some of its drugs.

• Expert Panel Recommends FDA Remove Makena From Market, Since Pricey Pregnancy Drug is Ineffective

  November 1, 2019

  Irvin Jackson

  An FDA Advisory board says the pregnancy drug Makena should be pulled from the market after clinical trials indicated it failed to be effective at preventing premature births.

• Makena Recall Urged By Public Citizen Due To Lack of Effectiveness Preventing Preterm Births

  October 22, 2019

  Irvin Jackson

  Public Citizen is calling on the FDA to require a Makena recall after the drug failed to show it was effective in preventing preterm births in a recent clinical trial.