The FDA has officially withdrawn approval for the pregnancy drug Makena, based on postmarketing studies which failed to show it provided any benefits to pregnant mothers.
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…
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.
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.
A new study warns that Makena and similar pregnancy drugs could increase a child's risk of cancer later in life.
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.
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.
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.
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.
