Product News and Recalls

Fungal infection confirmed for steroid medication

The U.S. Food and Drug Administration has confirmed that steroid medication linked to a deadly meningitis outbreak is contaminated with a fungus.

A Reuters report says the FDA made that confirmation on one of three lots of the medication, and is still testing the other two. The agency is also testing other injectable medications produced by the New England Compounding Center, the Massachusetts-based specialty pharmacy that produced the infected steroid.

The U.S. Centers for Disease Control says the outbreak is expanding since it was first reported on Sept. 21. As of Oct. 19, the CDC listed the number of people killed at 21, and the number of infected at 271. It’s also been reported in New York, bringing the number of states with confirmed infections to 16.

As many as 14,000 people may have received the medication, which is commonly used to treat back pain.

Meningitis is an inflammation of the tissue that surrounds the brain and spinal cord. Reuters reports that most of the meningitis cases have been linked to Exserohilum, which is a fungus associated with grass and rotting wood that appears to be especially aggressive in attacking tissues in the spine and brain stem.

Fungal infections, unlike the more common viral and bacterial variety, aren’t contagious. They typically only attack people with severely compromised immune systems, such as patients who have had bone marrow or organ transplants, Reuters says.

But the fungal contamination that prompted the outbreak has proved to be particularly damaging, because the steroid medication is injected directly into the spine.

The report says U.S. Senator Richard Blumenthal of Connecticut, who previously called for a criminal investigation of NECC, raised new questions on Thursday about a government contract for medications from NECC’s sister company, Ameridose.

In a letter to the U.S. Department of Defense, he cited a July purchase agreement for specialized medicines between the U.S. Army Medical Command and Ameridose. They were intended for use in the neonatal intensive care unit at the Army’s Tripler Medical Center in Honolulu.

Lopez McHugh is investigating cases related to this outbreak. If you or a loved one had an injection and were diagnosed with meningitis, you should consult with a Lopez McHugh lawyer for a free consultation.

See the story here:

http://www.reuters.com/article/2012/10/19/us-usa-health-meningitis-idUSBRE89H1DM20121019

See a patient notification letter that the FDA has issued about the outbreak here:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm323946.htm?source=govdelivery