Problems at second US firm tied to meningitis outbreak

November 12, 2012 by Mira Oberman

US federal health inspectors said Monday they have uncovered serious problems at a second Massachusetts pharmacy run by some of the same people whose tainted drugs caused a deadly meningitis outbreak.

While no Ameridose products have been associated with the nationwide outbreak of the disease or other types of infection, inspectors found similar problems as those unearthed at the New England Compounding Center (NECC).

Insects and at least one flying bird were found in the rooms where sterile drugs were packaged and stored, the 20-page inspection report said.

Inspectors also found thick orange, brown and green residues on equipment used to prepare what should be sterile drugs, along with visible rust, broken glass and plenty of "foreign material."

Drugs were not always tested to make sure they were sterile and Ameridose failed to properly investigate on at least 53 occasions in 2012 when tests did find bacteria, mold or other contaminants.

The firm also failed to test drugs to see whether they were too potent or too weak before being sent to patients, the report said.

When patients or their doctors complained of symptoms such as , postpartum hemorrhaging, and "life-threatening" reactions, Ameridose failed to properly investigate, the inspectors concluded.

Ameridose agreed to cease operations and recall all its products last month after the full extent of the problems with NECC's tainted steroids was revealed.

Some 32 people have died of the 438 who were infected with the rare fungus after receiving injections of NECC's tainted steroids, according to the latest tally by the .

The outbreak has led to calls for tighter regulation of the loosely controlled pharmaceutical compounding industry. have launched a into the case.

Critics say 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.

Some 14,000 people in 23 states are at risk after having received potentially tainted doses of the NECC steroid. It was typically injected into the spine to treat back pain but can also be used to treat joints.

Officials have said that due to the disease's long incubation period, it could be weeks before authorities have a final tally of the infections from the unprecedented outbreak.

Michigan has reported the highest number of cases—128 and eight deaths—followed by the southern state of Tennessee, which has 81 cases and the highest number of fatalities at 13.

Other badly hit states include Florida, Indiana, Maryland, New Jersey and Virginia.

Explore further: US meningitis death toll up to 23: CDC

Related Stories

US meningitis death toll up to 23: CDC

October 20, 2012

The death toll in the United States from an unprecedented outbreak of fungal meningitis linked to a contaminated drug has climbed to 23 people, health officials said Saturday.

US firm found mold long before shipping tainted drugs

October 27, 2012

A pharmacy tied to a meningitis outbreak repeatedly found bacteria and mold in its facility long before shipping tainted drugs to patients, US officials said Friday as the death toll rose to 25.

US meningitis death toll rises to 29: official

October 31, 2012

Some 29 people have died from fungal meningitis they contracted after being treated with tainted steroid injections blamed for a growing national outbreak, US health officials said Wednesday.

FDA finds contamination concerns at Ameridose

November 12, 2012

(AP)—Federal health inspectors have found more than a dozen sterility problems, including insects, at a drugmaking facility with the same founders as the specialty pharmacy linked to a deadly meningitis outbreak.

Recommended for you

Monkeys in Asia harbor virus from humans, other species

November 19, 2015

When it comes to spreading viruses, bats are thought to be among the worst. Now a new study of nearly 900 nonhuman primates in Bangladesh and Cambodia shows that macaques harbor more diverse astroviruses, which can cause ...

One-step test for hepatitis C virus infection developed

November 14, 2015

UC Irvine Health researchers have developed a cost-effective one-step test that screens, detects and confirms hepatitis C virus (HCV) infections. Dr. Ke-Qin Hu, director of hepatology services, will present findings at the ...

Computer model reveals deadly route of Ebola outbreak

November 10, 2015

Using a novel statistical model, a research team led by Columbia University's Mailman School of Public Health mapped the spread of the 2014-2015 Ebola outbreak in Sierra Leone, providing the most detailed picture to date ...


Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.