About 14,000 people who received pain-relieving steroid shots may be at risk for meningitis because of a fungal contamination that has led to the deaths of 14 people, U.S. regulators said.
The fungus strain is “new territory” that has never before caused meningitis, Todd Weber, who is overseeing the federal probe for the Centers for Disease Control and Prevention, told reporters on a conference call yesterday. He said more than 12,000 of the patients have been informed of possible exposure.
There are 184 confirmed infections traced to vials from a pharmacy in Framingham, Massachusetts, that mixed the steroid and sold it to 75 hospitals and clinics in 23 states, the CDC said today. The U.S. Food and Drug Administration said it will work with Congress on new regulations that would grant the agency greater oversight of such compounding pharmacies.
“We want to sit down with pharmacists and lawmakers and think about a scheme that recognizes that the industry and practice of pharmacy have evolved over time, and put in place a risk-based scheme,” Deborah Autor, deputy FDA commissioner for global regulatory operations and policy, said on the call.
About 7,500 compounding pharmacies now are largely exempt from FDA oversight, since they’re only supposed to prepare individual prescriptions unavailable through regular avenues, such as those with a unique dosage. The drug methylprednisolone acetate was apparently contaminated during the mixing process.
Injections of the tainted steroid -- an epidural shot used to treat neck and back pain -- were given starting May 21, the Atlanta-based CDC said on the call. Meningitis is an inflammation of the lining of the brain and spinal cord usually caused by an infection from a virus or bacteria.
The New England Compounding Center, which mixed the drug, suspended operations last week and recalled 17,676 doses. Krista Robinson of O’Neill and Associates, a Boston-based communications firm representing the center, didn’t return a request for comment.
The outbreak highlights the need to ensure product safety, the CDC’s Weber said on the conference call. “We want patients to be confident that they’re not going to get a potentially devastating disease as a result of their care,” he said.
Madeleine Biondolillo, director of the Massachusetts Department of Public Health’s Bureau of Health Care Safety and Quality, said yesterday that the Framingham company violated state regulation that forbids such pharmacies from mass- producing drugs. The U.S. House Energy and Commerce Committee is also investigating the outbreak, and yesterday requested a briefing from the compounding pharmacy by Oct. 18.
“We ask that you preserve all documents and communications that may be relevant to understanding how the product was contaminated and distributed as well as the business practices of the NECC in general,” Fred Upton, a Michigan Republican who is chairman of the House panel, and Representative Henry Waxman, a California Democrat who is the ranking minority member, wrote in a letter to the pharmacy.
The committee has requested the FDA and CDC to brief them on the outbreak by Oct. 12. Committee leaders also asked today that the Massachusetts Board of Pharmacy brief staff by Oct. 19 on any actions the board took to address potential violations.
8.9 Million Americans
New England Compounding Center was warned by the FDA in 2006 for repackaging Roche Holding AG (ROG)’s cancer drug Avastin to treat an eye disease as well as acting more like a manufacturer by promoting a triple strength anesthetic cream.
At the time, the pharmacy assured the FDA through an exchange of letters it was complying with the law, Autor said. The FDA didn’t visit the pharmacy again until the outbreak.
About 8.9 million Americans in 2010 received epidural injections for pain which take minutes to administer. Use of the shots increased 106 percent in Medicare beneficiaries from 1997 to 2006, according to a study in Pain Physician.
Since the meningitis outbreak, clinics have been left searching for a new supplier for methylprednisolone acetate, which allows physicians to treat neck and back pain without surgery or addictive pills.
While Pfizer Inc. (PFE), the world’s biggest drugmaker, offers the same steroid, the company’s product contains additives that carry greater risk when injected into the spine area, keeping it from getting U.S. approval for that use. That’s why doctors are forced to buy from the patchwork of pharmacies that compound the steroid without the preservatives, David Kloth of the American Society of Interventional Pain Physicians, said in a telephone interview earlier this week.
No Other Answers
“Pills are not the answer; surgery is definitely not the answer because surgery has its own inherent risk complications. This is sort of the next step,” Kloth said of the injections.
Pharmacies that aren’t compounding on such a large scale as the New England center are safe, said David Miller, chief executive officer of the International Academy of Compounding Pharmacists, in a telephone interview.
“Every compounding pharmacy in the country is double checking, verifying, repeating, making sure everything they’re doing is consistent with their standards,” Miller said. “This tragedy has everyone focused on making sure it never happens again.”
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