Four more people have died in an outbreak of fungal infections traced back to contaminated back pain injections, and 247 people are now confirmed infected in 15 states, federal health officials said on Wednesday.
The Centers for Disease Control and Prevention reports 19 deaths from fungal infections, in Tennessee, Virginia, Michigan, Maryland, Indiana and Florida.
Federal officials have opened an investigation into the pharmacy in Massachusetts that distributed the suspect drugs, and have asked doctors who treated any patients with any products from the pharmacy since May to check up and make sure they are well. Tens of thousands of people could eventually be affected, based on how many drugs the New England Compounding Center made and distributed.
"The signs and symptoms of meningitis include fever, headache, stiff neck, nausea and vomiting, photophobia (sensitivity to light) and altered mental status," the Food and Drug Administration said in a statement. "Symptoms for other possible infections may include fever; swelling, increasing pain, redness, warmth at injection site; visual changes, pain, redness or discharge from the eye; chest pain, or drainage from the surgical site (infection within the chest). Patients should contact their healthcare provider if they have any of these signs or symptoms."
FDA enforcers raided NECC’s Framingham, Mass., facility on Tuesday night. Earlier in the day, FDA officials said inspections of the facility made them worry about the sterility of any of the pharmacy's products.
Members of Congress said they wanted answers, although as of Wednesday they had not scheduled promised hearings. Massachusetts Rep. Ed Markey, a Democrat, noted that NECC distributed controlled substances including morphine and fentanyl without a proper license.
“The list of recalled NECC drug products appears to include nearly 1,000 formulations that contain controlled substances that fall under the jurisdiction of the Drug Enforcement Agency (DEA),” Markey said in a statement. NECC shipped more than 17,000 vials from the three suspect lots of steroid to clinics in 24 states. The pharmacy makes hundreds of more products.
Sens. Bob Corker and Lamar Alexander, both Tennessee Republicans, have written the FDA seeking explanations. The FDA had warned NECC about cleanliness and its distribution practices. FDA and Massachusetts officials have said they didn’t have enough powers to stop the pharmacy, which was not licensed to mass-produce drugs. They both asked Congress to pass legislation clarifying their powers.
Most of those sickened so far were injected with steroids from three particular lots made by NECC, and the sickest patients developed meningitis, an inflammation of the protective membranes, or meninges, covering the brain and spinal cord. The swelling is usually caused by bacteria or viruses, but meningitis can also be caused by a fungus. Most of those who died suffered strokes.
"As a result of the ongoing investigation of NECC, a patient with possible meningitis potentially associated with epidural injection of an additional NECC product, triamcinolone acetonide, has been identified through active surveillance and reported to FDA. Triamcinolone acetonide is a type of steroid injectable product made by NECC," the FDA said in a statement.
In addition, two patients who got steroids made by NECC injected into their ankles have developed infections. CDC doctors say they're still checking to see if the infections are fungal in nature. The two patients are not in danger of meningitis, CDC says.
At least one hospital system, Maryland-based Medstar, says it has begun compounding its own products when possible now to ensure their sterility. Bonnie Levin, who heads pharmacy services at Medstar, told NBC News the hospitals have rooms that are as sterile as operating rooms to do this.
So-called compounding pharmacies are frequently at the center of controversy. Under the FDA’s definition, compounding pharmacists are supposed to mix drugs to order only on an individual basis in response to a prescription from a doctor. FDA can step in if it suspects pharmacies are exceeding this authority, and if contamination is suspected.