Meningitis outbreak affects production of other critical medicines
By Bloomberg News
Published: Friday, Nov. 2, 2012, 7:46 p.m.
The recall of hundreds of drugs by Ameridose LLC, a compounding pharmacy associated with the meningitis outbreak, may be exacerbating shortages of medicines used for surgery and heart failure, regulators said.
The Food and Drug Administration is working with other manufacturers to increase production and may consider foreign suppliers, Commissioner Margaret Hamburg said in a Web posting Friday. The drugs Westborough, Mass.-based Ameridose made were already in short supply and include local anesthesias, muscle relaxers to prevent movement during surgery and diuretics to remove fluids during congestive heart failure.
Ameridose said Oct. 31 it recalled all its products after tainted drugs from New England Compounding Pharmacy Inc., a company controlled by the same people as Ameridose, were linked to meningitis infections that have killed 29 patients. Six Ameridose drugs were on the FDA's drug shortages list, according to an FDA statement yesterday. No infections have been traced to Ameridose, which suspended operations Oct. 10.
“We have doubled the number of staff members who work in drug shortage prevention and response,” Hamburg said. “We at FDA are committed to doing everything we can, using all available tools, to prevent or mitigate drug shortages and help keep critically needed products on the market.”
The FDA received additional powers in June from Congress to help mitigate shortages after a short supply of cancer drugs created an opening for dangerous unapproved versions to make it onto the market.
In 2011, total drugs in short supply hit 251, Hamburg said. This year through September, the agency worked with drug manufacturers to help avert 145 shortages.
President Barack Obama directed the FDA a year ago to gather information from drugmakers about potential shortages so the government can respond before patients' lives are threatened. The agency's drug shortage office at the time staffed five employees. Congress passed legislation in June requiring drug manufacturers to notify FDA they may discontinue a product.
The meningitis outbreak became known in late September, and regulators have linked the infections to contaminated steroids that were injected into about 14,000 patients to relieve neck and back pain. As of today, 404 infections in 19 states had been reported, including the 29 deaths, according to the Centers for Disease Control and Prevention.
Show commenting policy
TribLive commenting policy
You are solely responsible for your comments and by using TribLive.com you agree to our Terms of Service.
We moderate comments. Our goal is to provide substantive commentary for a general readership. By screening submissions, we provide a space where readers can share intelligent and informed commentary that enhances the quality of our news and information.
While most comments will be posted if they are on-topic and not abusive, moderating decisions are subjective. We will make them as carefully and consistently as we can. Because of the volume of reader comments, we cannot review individual moderation decisions with readers.
We value thoughtful comments representing a range of views that make their point quickly and politely. We make an effort to protect discussions from repeated comments either by the same reader or different readers.
We follow the same standards for taste as the daily newspaper. A few things we won't tolerate: personal attacks, obscenity, vulgarity, profanity (including expletives and letters followed by dashes), commercial promotion, impersonations, incoherence, proselytizing and SHOUTING. Don't include URLs to Web sites.
We do not edit comments. They are either approved or deleted. We reserve the right to edit a comment that is quoted or excerpted in an article. In this case, we may fix spelling and punctuation.
We welcome strong opinions and criticism of our work, but we don't want comments to become bogged down with discussions of our policies and we will moderate accordingly.
We appreciate it when readers and people quoted in articles or blog posts point out errors of fact or emphasis and will investigate all assertions. But these suggestions should be sent via e-mail. To avoid distracting other readers, we won't publish comments that suggest a correction. Instead, corrections will be made in a blog post or in an article.