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Makena is a synthetic form of the hormone progesterone. An earlier version first came on the market more than 50 years ago to treat other problems; it was withdrawn in the 1990s, though not for safety reasons.

The drug got a new life in 2003, when a study showed it helps prevent premature birth in women who previously delivered early. Doctors started prescribing it, and pharmacies mixed it.

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Online:

FDA statement: http://tinyurl.com/fdastatement