Friday, May 31, 2013

How Makena, a Controversial Drug to Prevent Preterm Birth, Made a Comeback (lot of discussion about compounding 17P)

K-V Pharmaceutical Co., KVPHQ +21.97%a small drug maker, landed in bankruptcy court last year amid disappointing sales of its flagship medicine Makena and an outcry over the drug's high price.
Today, sales of Makena, used to prevent preterm birth, are surging.
K-V slashed the price of the drug by half. But a bigger reason for the gains, say many doctors, is an aggressive K-V campaign touting Makena as a safe alternative to cheaper versions of the drug made by compounding pharmacies.
Compounders, lightly regulated pharmacies that custom-mix drugs, have long provided a less expensive version of the main ingredient in Makena. But a string of meningitis deaths late last year linked to pain medicine from a Massachusetts compounding pharmacy medicine raised concerns about the safety of such drugs. Compounded medicines aren't approved by the Food and Drug Administration.
Doctors say K-V representatives have been pressing them to switch to Makena by reminding them of the potential for malpractice lawsuits should their patients fall ill after taking a drug formulated by a compounder.
"They've been in doctors' faces a lot more about the possible harm of compounded medications," said Armando Fuentes, a maternal-fetal medicine specialist at Children's Hospital Central California. "They've really ratcheted up their marketing," he said.
K-V in a statement said the recent "tragic cases" highlighted a need for information about the differences between compounded medicines and those that carry FDA approval. The St. Louis-based company added, "K-V is taking all responsible approaches to educate health-care providers to help avoid costly and painful unintended consequences" for patients and providers.
Compounders, for their part, say the compounded version is as safe as Makena. "We cannot conclude that there is  any disparity in quality between this manufactured drug and the compounded alternative," said a representative of the International Academy of Compounding Pharmacists, David Ball, citing a June 2012 FDA analysis that tested 16 samples of the compound and found them potent and pure.

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