Five people have died and at least 35 have fallen ill after being injected with a steroid which was contaminated with fungus from a Massachusetts compounding pharmacy.
The steroid was shipped to 75 health centers in 23 states, not including Massachusetts, according to media reports. Patients treated with the steroid in six states have fallen ill and died from aspergillus meningitis. Symptoms of this rare infection include headache fever, nausea and pain at the injection site.
The steroid was produced at New England Compounding Center of Framingham, Massachusetts. The company first recalled three lots of methylprednisolone acetate last week. This week, the Food and Drug Administration (FDA) has expanded the recall to include all injectable spinal drugs made by New England Compounding Center. The FDA is further urging health care providers to discard all products from the company as a precaution.
The 35 people who were stricken ill were treated with epidural injections of methylprednisolone acetate for lower back pain between July and September. The infected patients are from Tennessee, Virginia, Maryland, Florida, North Carolina and Indiana. Patients are still being notified. No Massachusetts facilities received the defective steroid injections, but there were shipments within New England to health care providers in Connecticut, Rhode Island and New Hampshire.
Nine Massachusetts health facilities did receive methylprednisolone acetate from other lots made by New England Compounding Center, but no cases of fungus meningitis have been reported.
New England Compounding Center has voluntarily given up its state license and ceased operation. Investigators this week found a contaminated sealed vial of steroid at the company, the FDA reported, and testing is being performed to determine if it is the same fungus as the outbreak.
The Boston Globe reported a state official said the Massachusetts Board of Registration in Pharmacy received complaints about the company in 2002 and 2003. The board worked with the company to improve conditions, but the official did not share details. The board is still investigating another complaint received in March about eye medications.
In 2006, the FDA sent the company a letter stating concerns including its splitting and repacking of the injectable colorectal cancer drug Avastin.
The case shines a light on regulations regarding pharmacies which prepare custom medications, often for patients who have allergies to other medications or for treatments which are no longer commercially available.
New England Compounding Center was not accredited by the Pharmacy Compounding Accreditation Board, which conducts a site visit and review of pharmacy every three years. The accreditation is voluntary.
Hundreds seen at risk in meningitis outbreak, Associated Press.
Pharmacy Compounding Accreditation Board.
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