Makena Approval Officially Withdrawn by FDA After Concerns About Pregnancy Drug’s Benefits
FDA announced the Makena withdrawal after post-marketing studies failed to show the pregnancy drug provides any benefits in preventing preterm births
Tag Archives: Makena
-
-
Pregnancy Drug Makena Removed From Market Amid Concerns About Lack of Benefits Preventing Premature Birth, Unnecessary Risks for Women
Experts have determined the pregnancy drug Makena provides little to no benefit and puts pregnant mothers and their children at risk of adverse health events.
-
Health Experts Question Why Makena is Still on the Market Despite FDA Advisors Recommendation to Recall Pregnancy Drug
The manufacturer claims it is trying to provide help to an underserved population of black women, yet raised the price of Makena from $15 to $15,000 when it bought the rights to the drug, critics note.
-
Makena Recall Recommended By FDA Panel Due to Ineffectiveness Reducing Preterm Birth Risk
Lack of any clinical benefits from the drug reducing preterm births has resulted in calls for Makena to be removed from the market in U.S.
-
FDA Hearing To Determine if Makena Is Allowed Back On The Market
In 2019, a panel of FDA scientific advisors determined that the risk of Makena side effects outweigh any benefits for expecting mothers.
-
Makena, Proluton Exposure Before Birth May Increase Cancer Risks Later In Life: Study
-
FDA Indicates Pregnancy Drug Makena Does Not Work and Should Be Removed From Market
-
Makena Problems and Uncertain Future Leads To Removal Of Pregnancy Drug Manufacturer’s CEO
-
Expert Panel Recommends FDA Remove Makena From Market, Since Pricey Pregnancy Drug is Ineffective
-
Makena Recall Urged By Public Citizen Due To Lack of Effectiveness Preventing Preterm Births
