US health officials identified two new drugs which may have infected patients with meningitis as they investigate a widening outbreak tied to tainted products from a Massachusetts pharmacy.
The Food and Drug Administration (FDA) urged doctors to contact patients who received those and other drugs produced by the firm to warn they are at risk of developing the slow-moving but potentially deadly infection.
“At this point in FDA’s investigation, the sterility of any injectable drugs... and cardioplegic solutions” produced by the firm are “of significant concern,” the FDA said in a statement. Cardioplegia is the deliberate stopping of the heart so as to allow complex heart surgery to be carried out.
The New England Compounding Center (NECC) recalled all of its products on October 6 after dozens of people were infected with meningitis following treatment with its steroid injections.
Health officials in 23 states sought out the nearly 14,000 people who received the potentially tainted steroids in recent months to warn them of the danger.
They have identified 214 cases — and 15 deaths — so far and the numbers have been rising daily.
A long incubation period has complicated efforts — one patient did not develop symptoms until 42 days after receiving a tainted injection.
The outbreak has led to calls for tighter regulation of the loosely controlled pharmaceutical compounding industry.
Critics said drug manufacturers have found a way to sidestep costly and strict oversight by classifying themselves as pharmacies, which are given freer rein to mix drug compounds for patients.
The company had been warned by the FDA in 2006 that its practices were violating the rules and has also been under investigation by state authorities, who have the primary regulatory responsibility for pharmacies.
Several lawmakers responded with vows to introduce new legislation to tighten oversight and calls for a criminal investigation.
The FDA could not say how many more people are at risk now that two additional drugs have also been linked to meningitis.
“At this time we do not know,” spokeswoman Sarah Clark-Lynn told AFP. “FDA continues to work with NECC to get more information on the distribution of their products.”
Two transplant patients who received a solution produced by NECC to induce cardiac muscle paralysis during open heart surgery have subsequently developed the rare fungal meningitis, the FDA said.