Product News and Recalls

Meningitis outbreak prompts call for more inspections

In light of a deadly meningitis outbreak, public health watchdog group “Public Citizen” is calling on the U.S. Food and Drug Administration to re-inspect more than a dozen compounding pharmacies with prior records of violations, the Seattle Times reports.

Compounding pharmacies mix customized medications based on doctors’ instructions. One of those specialized pharmacies, the New England Compounding Center in Massachusetts, was the source of contaminated steroid medication blamed for the outbreak.

Meningitis is an inflammation of the tissue surrounding the spinal cord and the brain. The U.S. Centers for Disease Control and Prevention blame the current outbreak for 510 cases and 36 deaths in 19 states.

Public Citizen pointed out that the FDA inspected the New England Compounding Center three times before the outbreak. The FDA also issued the company a warning letter in 2006, citing several violations.

But according to Public Citizen, the agency often fails to follow up on warning letters to see if problems have been corrected.

In a letter to the FDA, Public Citizen is requesting that agency inspectors return to 16 compounding pharmacies that received similar warnings between 2003 and 2012. Five of the warning letters identified injuries or deaths allegedly associated with the pharmacies’ products, Public Citizen says.

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://seattletimes.com/html/businesstechnology/2019787434_apusmeningitisoutbreakpubliccitizen.html