CDC and FDA Link Injectable Steroids to Outbreak

The Food and Drug Administration (FDA) says that they have found bacteria and fungus in a batch of injectable steroids obtained from a Tennessee pharmacy last month. This is the latest development in an episode that has worrying parallel to a 2012 case where tainted steroids caused a fungal meningitis outbreak, which led to over 740 illnesses and 58 deaths.

The first signs of trouble occurred in May, when seven people in Illinois and North Carolina developed skin abscesses after being treated with an injectable steroid. The steroid involved was methylprednisolone acetate, which is used to treat a variety of ailments including respiratory problems, joint pain, and inflammation. This is the same steroid that was at the center of last year’s meningitis outbreak. The FDA has stated that they are not aware of any cases of meningitis connected with this batch of steroids, which were made by a compounding pharmacy in Newbern, Tenn. Compounding pharmacies usually make drugs for individual patients, but some produce large amounts in a factory-like setting.

The pharmacy involved, the Main Street Family Pharmacy, subsequently recalled all of its sterile products made after December 6, 2012, and a spokesman for the company, Joe Grillo, said that there would be full cooperation with the FDA. Grillo also said that the company would do all that it could to protect patients and resolve any “lingering concerns.” However, the recent track record at the Main Street Family Pharmacy is concerning. The owners were fined $25,600 in March and placed on three-year probation after inspectors found a number of violations at the facility.

An inspection in 2011 uncovered out-of-date medication being used in the manufacture of drugs, and a technician who had been working at the facility without proper documentation for four years. A follow-up inspection in November 2012 found 109 expired or deteriorating medications among a list of other issues.

The Center for Disease Control, or CDC, has now said that patients in Florida are also being infected, and that the number of people who have become sick has reached 20. The steroids were also shipped to California, Arkansas, Kentucky, Louisiana, Mississippi, New Mexico, Tennessee, Texas, and South Carolina.

Infected patients are showing skin and soft tissue symptoms, which are in line with intramuscular injections. The case of fungal meningitis that killed dozens last year was caused by epidural injections that allowed the contamination to enter the central nervous system.

Additional Reading and Sources:
FDA release May 24 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm353941.htm
Tenn. Dept of Health release https://news.tn.gov/node/10771
Compounding pharmacies legislation proposal http://www.huffingtonpost.com/2013/05/24/edward-markey-drug-compounding-fda-oversight_n_3328680.html
FDA recall notice May 28 http://www.fda.gov/Safety/Recalls/ucm354182.htm
FDA release June 7 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm353953.htm
CDC notice http://www.cdc.gov/hai/outbreaks/TN-pharmacy/map-distribution.html