Compounding pharmacies have made headlines recently, especially since the New England Compounding Center (NECC) caused an outbreak of meningitis in more than 20 states including California. While the NECC case is most well-known because it led to at least 48 deaths and 720 patients developing persistent fungal infections, this compounding center is not the only one putting patients at risk.
Unfortunately, compounding pharmacies currently fall into a regulatory gap. This is resulting in many pharmacies producing dangerous products that make hundreds or thousands of peoples ill. Our Los Angeles products liability attorneys know that lawmakers are considering changing the way that compounding centers are regulated. This is an important change that should be made, especially as yet another compounding pharmacy may have recently sent out potentially contaminated medications.
Compounding Center Releases Dangerous Products
According to USA Today, government health officials are now investigating complaints about a potentially contaminated medicine produced by a compounding center in Tennessee. At least seven reports have been made to the FDA by patients who received injections of the steroid methylprednisolone acetate. This is the same drug that was produced by NECC, which allegedly led to the deadly and widespread fungal meningitis outbreak.
The complaints made to the FDA about the Tennessee compounding pharmacy are not necessarily isolated incidents either. A separate announcement was made by the North Carolina Department of Health, which indicated that it was investigating two complaints from patients who had received injections in Greenville and who were experiencing potential skin infections as a result.
While the FDA reports that at least one of the Tennessee cases appears to involve a fungal infection, officials say there have not yet been reports of any stroke, meningitis or death. Yet, the FDA has recommended that doctors stop using any sterile drugs that were distributed by the Tennessee Compounding Pharmacy, which is called the Main Street Family Pharmacy.
Hopefully, these few reports of incidents will be the only reports and there will not be another widespread meningitis outbreak that touches patients throughout the United States.
Compounding Pharmacies Need Better Regulations
The many recent incidents with compounding pharmacies show that we need to do much better in the United States with keeping drugs safe and keeping defective products off the market.
Unfortunately, there are gaps in our regulatory framework that result in compounding pharmacies not being very well-regulated. Originally, these pharmacies were generally small local pharmacies that mixed specific medications for particular patients when a drug was not available in pre-packaged form. The pharmacies were simply regulated by local state agencies.
The compounding pharmacies, however, began to take on a broader role in part due to rising medical costs and drug shortages. Now, many compounding pharmacies essentially manufacture drugs on a large scale, mixing certain medications such as steroids for widespread distribution. Yet, the FDA does not have clear regulatory authority over these huge compounding pharmacies.
Lawmakers are currently considering proposals to make it clear that the FDA is in charge and these proposals could go a long way towards preventing outbreaks that reach from New England to California when a single pharmacy makes a dangerous product.
Contact Howard Law, PC today, if you or a loved one has been injured by a defective product or dangerous drug. Call today for a free and confidential consultation to discuss your case. 1-800-872-5925.
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