Press Release : The Illinois Department of Public Health (IDPH) is investigating two additional reports of adverse events among patients in Illinois who received injections of the steroid methylprednisolone acetate produced by Main Street Family Pharmacy, LLC in Newbern, Tennessee. All seven Illinois cases received injections at the Logan Primary Care clinic in downstate Herrin, located in Williamson County.

FOR IMMEDIATE RELEASE May 31, 2013	CONTACT: Sabrina L. Miller (312) 814-8194 www.idph.state.il.us
State Public Health Department Investigating Two Additional Steroid Injection Complications Cases Associated with Tennessee Compounding Pharmacy
CHICAGO – The Illinois Department of Public Health (IDPH) is investigating two additional reports of adverse events among patients in Illinois who received injections of the steroid methylprednisolone acetate produced by Main Street Family Pharmacy, LLC in Newbern, Tennessee. All seven Illinois cases received injections at the Logan Primary Care clinic in downstate Herrin, located in Williamson County. Initially five Illinois patients were reported to have developed abscesses after receiving injections of methylprednisolone acetate (MPA), an anti-inflammatory steroid used to treat a range of conditions including asthma and allergic reactions. The two additional cases were confirmed this week following public reports of a multistate outbreak involving more than 20 patients in Florida (13), North Carolina (2) and Illinois (7) who received injections of MPA from a shipment that originated from Main Street Family Pharmacy. IDPH is conducting a joint investigation with the Food and Drug Administration, Centers for Disease Control and Prevention and officials from other states that received shipments of MPA from Main Street Family Pharmacy. “The Illinois Department of Public Health continues to work with local and federal officials investigating these adverse events,” said IDPH Director Dr. LaMar Hasbrouck. “Our priority continues to be ensuring that all patients who might have received MPA injections have been contacted, and that they see a health care provider immediately if suffering any symptoms.” The seven Illinois cases received injections between January 3 and February 21. Investigation into the cause of the adverse events is ongoing. To date, no reports of meningitis or other life-threatening infections have been reported. Main Street Family Pharmacy has voluntarily initiated a recall of all sterile products, including MPA, in cooperation with state and federal authorities. Nearly 20 states received recalled MPA from Main Street Family Pharmacy since December 1, 2012. Main Street Family Pharmacy, LLC, is currently licensed by the Illinois Department of Financial and Professional Regulation, which is also investigating.

Illinois Department of Public Health 535 West Jefferson Street Springfield, Illinois 62761 Phone 217-782-4977 Fax 217-782-3987 TTY 800-547-0466 Questions or Comments

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

By STEPHANIE GLEASON

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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Virginia HAS Enacted a compounding law which requires a current inspection report before an out-of-state compounding pharmacy can be registered!

Fox Business- DANGERS OF COMPOUNDING PHARMACIES Video

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