Those who suffer from chronic pain often turn to steroid shots to help ease their discomfort. Normally, this is treatment that is seen as safe and effective. Sadly, that perception has now changed due to the 105 people sickened across nine states and the eight who have died from fungal meningitis. Now, reports indicate that as many as 13,000 patients may have been exposed to fungal meningitis – a fungus that attacks the brain and central nervous system – from tainted spinal steroid injections.
It appears that all of the victims who have been infected were given steroids that had been produced by one Massachusetts pharmacy that issued a recall of the drug and has since closed. The pharmacy that issued the recall is the New England Compounding Center. Given the outcry since the recall was announced some lawmakers have called for bringing certain specialized pharmacies such as the one at the center of this case under greater regulatory scrutiny.
Three lots of potentially contaminated steroid injections were sent by New England Compounding Center to 75 health facilities in 23 states from July to September, according to officials. Despite the wide reach of the facility, oversight falls under the powers of the state, not the FDA. This is because NECC is considered a pharmacy and not a manufacturer.
There are about 3,000 compounding pharmacies nationwide, and drugs made by the facilities represent as much as 3% of the roughly $300 billion in prescription drugs sold in the U.S. each year, according to the International Academy of Compounding Pharmacists.
The FDA has pushed to increase its regulatory authority over compounding pharmacies. Thus far it has been prevented by court rulings and a lack of legislative interest. The FDA issued a warning back in 2007 noting that compounded drugs “are not FDA-approved.” The warning went on to say that there had been “devastating repercussions” from such drugs, including three patients dying of infections from a drug used to paralyze the heart during surgery and two patients at a veterans hospital who were blinded by a compounded product used in cataract surgery.
Authorities from across the country fear there may be many more infections as previous instances are reported or new cases develop. The virus has an incubation period of as little as two days or as many as 28 days. Fortunately, this type of meningitis is not contagious like the viral and bacterial types, but it is obviously still dangerous and potentially deadly.
If you or someone you know have been injured by a defective product and you would like to discuss your case with an attorney, please call contact the Georgia product liability litigation attorneys at Pope McGlamry P.C. today to schedule a free consultation.
Source: “As Outbreak Spreads, Calls for Tighter Controls on Specialized Pharmacies,” by Timothy Martin, published at WSJ.com.