As the national meningitis outbreak linked to a contaminated steroid continues to grow, health officials are now confronting the possibility that some of the more than 100,000 shipments of other drugs from the same company that made the steroid may have caused other types of infections. And they are scrambling to warn doctors and patients.
The meningitis outbreak — there have been 247 cases, including 19 deaths — is believed to have been caused by a drug, methylprednisolone, that was contaminated with a fungus. The drug, used in spinal injections for back and neck pain, was produced by the New England Compounding Center, in Framingham, Mass., which shipped more than 17,000 vials of it to 23 states.
Now, the worry has extended to other drugs made by the company. The Food and Drug Administration has given state health departments a list of more than 131,000 shipping invoices for products from the New England Center that were sent all over the United States. The products of most concern are drugs used during open-heart surgery and eye operations, and another steroid, triamcinolone, also used in spinal injections. But other products are suspect as well, and the list of drugs made by the company runs to 71 pages.
Using an invoice list, the Tennessee Health Department determined that 74 health care facilities in the state had received suspect products, according to a statement on its Web site. On Wednesday, health officials there began contacting the clinics, which are supposed to warn their patients.
Dr. William Schaffner, an infectious disease expert at Vanderbilt University, said that in a conference call on Wednesday for health officials from various states, there was serious concern about the possible contamination of all the products from the company center that were supposed to have been sterile: all injectable medicines and other products used during surgery. Some health departments were planning to investigate whether certain types of fungal infections in the past year were connected to products from the company, and would be going over death records, he said.
"Some of them are asking medical examiners and pathologists to review all cases going back to January," Dr. Schaffner said.
Representative John D. Dingell, Democrat of Michigan, has written the F.D.A. asking for an estimate of how many people are at risk of infection or meningitis from products made by the company. Mr. Dingell is calling for a Congressional investigation of the outbreak.
Michigan, with 48 cases of meningitis, including three deaths, has the second highest number in the country, after Tennessee, with 61 cases.
On Wednesday he said he was particularly concerned about reports of at least four previous complaints to the Massachusetts Board of Registration in Pharmacy regarding the sterility of the company's products. "Does Food and Drug talk to the Massachusetts regulatory agency and vice versa?" Mr. Dingell said. "There's evidence that they don't."
Mr. Dingell said he was particularly interested in learning whether the contamination could be traced to unhygienic practices at the company or to the products it used to make the drugs. "Was it a matter of slovenly manufacturing practices inside this particular compounder, or were they buying unsafe components that they were putting into this?" he said.
Representative Fred Upton, Republican of Michigan, who is chairman of the House Committee on Energy and Commerce, and other committee members wrote the F.D.A. on Wednesday requesting, among other things, copies of "all inspection reports and records" on facilities owned or operated by the New England Compounding Center and Ameridose, a drug manufacturing company with many of the same owners as the compounding center, since Jan. 1, 2004.
"We are determined to get to the bottom of how it occurred, whether it could have been prevented, and how we can ensure something like this never happens again," said Debbee Keller, press secretary for the committee.
Concern about the severity of the meningitis outbreak has grown as the numbers of cases and deaths have steadily risen. From Tuesday to Wednesday, cases climbed to 247 from 233, and deaths to 19 from 14.
This type of meningitis can damage blood vessels in the brain and cause devastating strokes; in Tennessee, 10 people among the 61 cases have suffered strokes. More cases of meningitis are expected because some patients who got injections are probably still in the incubation period, which can run longer than a month.
So far, officials have strongly advised against giving antifungal drugs to people who were exposed but did not have a clear diagnosis of meningitis, because the drugs can harm the kidneys, heart and liver, as well as cause vision problems and hallucinations, risks thought unacceptable in people who are healthy and may never become sick. But doctors do want to start treating patients as early as possible.
An expert panel met Wednesday to reconsider the idea of preventive treatment, said Dr. John Jernigan, a medical epidemiologist at the federal Centers for Disease Control and Prevention. He said health officials from Tennessee had gathered data that might make it possible to identify which patients exposed to the suspect medicine had the highest risk of being infected and might benefit from very early treatment. He said health officials realized that some patients might prefer the risk of kidney or liver problems to the risk of meningitis and stroke.
Dr. David R. Reagan, chief medical officer of the Tennessee Health Department, said experts had not yet determined a way to identify people for whom the treatment would be worthwhile. About 14,000 people have been exposed to the tainted methylprednisolone, and it is not clear how many would fall into the highest-risk category. But if the number is significant, it is not clear there would be enough antifungal drugs. Treatment will probably have to go on for months.
"We have been in active communication through the F.D.A. with the manufacturers of these drugs," Dr. Jernigan said. "At this point we haven't identified any potential for shortage, but obviously if use of the drug were to expand based upon changes in our recommendations, we would have to relook at that."
Denise Grady reported from New York, and Abby Goodnough from Boston.
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