FDA pulls unproven premature birth drug Makena from market.
TL;DR Summary
The FDA has ordered the immediate withdrawal of Makena, a drug intended to prevent premature births, from the US market after data showed it doesn't help pregnant women. The medication was the only drug approved in the US to help reduce the risk of early births in women with a history of preterm deliveries. The injectable drug is a synthetic version of the hormone progesterone, which can cause side effects, including blood clots, depression and allergic reactions. 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.
Reading Insights
Total Reads
0
Unique Readers
0
Time Saved
2 min
vs 3 min read
Condensed
81%
565 → 108 words
Want the full story? Read the original article
Read on ABC News