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Another Pharmacy Linked to Potentially Contaminated Steroids
Megan BrooksDisclosuresMay 24, 2013
Healthcare providers should not administer any products labeled as sterile from Main Street Family Pharmacy, LLC, of Newbern, Tennessee, and should quarantine them until further notice, the US Food and Drug Administration (FDA) said today.
The agency said it is working closely with the Centers for Disease Control and Prevention and the Tennessee Board of Pharmacy to investigate reports of 7 adverse events associated with steroid injections compounded by the company.
"The reports of adverse events are all from patients who received preservative free methylprednisolone acetate (80 mg/mL) by injection," the FDA said.
"Clinical information about these patients is pending; at least 1 of these infections appears to be fungal in nature," the agency noted.
An investigation into the exact source of these adverse events is ongoing, "but these cases are associated with a potentially contaminated medication," the FDA said.
As part of the ongoing investigation, the FDA said it will "thoroughly review the sterile practices at Main Street."
The potential sterility problems at Main Street Family Pharmacy come on the heels of similar problems at several other compounding pharmacies in the United States.
As reported by Medscape Medical News, those companies include The Compounding Shop in St. Petersburg, Florida; ApothéCure Inc and NuVision Inc, both of Dallas, Texas; Green Valley Drugs in Henderson, Nevada; and Balanced Solutions Compounding Pharmacy of Lake Mary, Florida.
Adverse reactions or quality problems experienced with the use of any product may be reported to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
Megan BrooksDisclosuresMay 24, 2013
Healthcare providers should not administer any products labeled as sterile from Main Street Family Pharmacy, LLC, of Newbern, Tennessee, and should quarantine them until further notice, the US Food and Drug Administration (FDA) said today.
The agency said it is working closely with the Centers for Disease Control and Prevention and the Tennessee Board of Pharmacy to investigate reports of 7 adverse events associated with steroid injections compounded by the company.
"The reports of adverse events are all from patients who received preservative free methylprednisolone acetate (80 mg/mL) by injection," the FDA said.
"Clinical information about these patients is pending; at least 1 of these infections appears to be fungal in nature," the agency noted.
An investigation into the exact source of these adverse events is ongoing, "but these cases are associated with a potentially contaminated medication," the FDA said.
As part of the ongoing investigation, the FDA said it will "thoroughly review the sterile practices at Main Street."
The potential sterility problems at Main Street Family Pharmacy come on the heels of similar problems at several other compounding pharmacies in the United States.
As reported by Medscape Medical News, those companies include The Compounding Shop in St. Petersburg, Florida; ApothéCure Inc and NuVision Inc, both of Dallas, Texas; Green Valley Drugs in Henderson, Nevada; and Balanced Solutions Compounding Pharmacy of Lake Mary, Florida.
Adverse reactions or quality problems experienced with the use of any product may be reported to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
