By Steven Reinberg and Margaret Steele
HealthDay Reporters
WEDNESDAY, Oct. 10 (HealthDay News) -- Eleven people have now died and 119 have been sickened in the national meningitis outbreak apparently linked to contaminated steroid injections, U.S. health officials reported Tuesday.
In the wake of the outbreak, members of Congress are calling for more regulatory oversight for the type of smaller, "compounding" pharmacy that distributed the steroid shots.
All of the patients were thought to be injected with methylprednisolone acetate, a steroid drug commonly used for back pain that investigators suspect was tainted with a fungus usually found in leaf mold, according to the U.S. Centers for Disease Control and Prevention.
Health officials in the 23 states that received shipments of the steroid are trying to track down patients who got the injections. As many as 13,000 people may have gotten the shots, U.S. health officials said Monday.
The steroid was manufactured by a specialty pharmacy, New England Compounding Center of Framingham, Mass., which last month voluntarily recalled three lots of the steroid. It has since shut down operations and stopped distributing its products, health officials said.
According to a report Wednesday from The New York Times, New England Compounding Center is relatively small, with 49 employees. Compounding pharmacies are not subject to the same oversight from the U.S. Food and Drug Administration as regular drug stores are, and members of Congress say the meningitis outbreak points to the need for more regulatory control.
"This incident raises serious concerns about the scope of the practice of pharmacy compounding in the United States and the current patchwork of federal and state laws," according to a statement by Rep. Henry Waxman, (D-Calif.) and two other Democrats on the House Energy and Commerce Committee, Rep. Diana DeGette of Colorado and Rep. Frank Pallone Jr. of New Jersey, the Times reported.
Republicans form the majority on the committee, but a spokeswoman for Republican committee chair Fred Upton of Michigan, told the Times that he and three other Republican members would join a request for an inquiry.
And Rep. Edward Markey, a Massachusetts Democrat who represents the district that's home to New England Compounding Center, said he would push for legislation that requires certain pharmacies that distribute products across state lines to register with the FDA.
According to the Associated Press, it is still not known how many of the steroid shots were contaminated with the fungus that causes this rare type of meningitis, so it's not clear how many people might be at risk of infection.
The 13,000 figure includes not only people who got the shots for back pain and are considered most at risk, because meningitis is inflammation of tissue surrounding the brain and spinal cord. Other patients got injections in other parts of the body, such as knees and shoulders.
There was no breakdown on the number of back injections, said Curtis Allen, a spokesman for the CDC.
On Tuesday, the CDC offered the following state-by-state breakdown of cases: Florida: 4 cases; Indiana: 12 cases; Maryland: 8 cases, including 1 death; Michigan: 25 cases, including 3 deaths; Minnesota: 3 cases; New Jersey: 1 case; North Carolina: 2 cases; Ohio: 1 case; Tennessee: 39 cases, including 6 deaths; Virginia: 24 cases, including 1 death.
The CDC last week released a list of the approximately 75 health-care facilities that received contaminated product.
U.S. health officials said they expect to see more cases of the rare type of meningitis, which is not contagious, because symptoms can take a month or more to appear.
All of the infected patients are thought to have received the medication from the Massachusetts pharmacy, said Dr. Benjamin Park, a medical officer with the CDC's National Center for Emerging and Zoonotic Infectious Diseases.
Infected patients have developed a variety of symptoms approximately one to four weeks following their injection. Symptoms include fever, new or worsening headache, nausea, and "new neurological deficit [consistent with deep brain stroke]," the CDC said in a news release. Some of these patients' symptoms were very mild in nature. Cerebrospinal fluid from these patients has shown findings consistent with meningitis, the agency said.
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