Warning Letter to Compounding Pharmacy Says Practices that Could Lead to Another Fungal Meningitis Outbreak
The United States Food and Drug Administration (FDA) last week sent a warning letter to a compounding pharmacy in South Carolina that it must clean up its act, or it could cause another fungal meningitis outbreak.
The drug company has been charged with violating the same federal provisions as the compounding pharmacy in New Jersey, which caused a massive fungal meningitis outbreak last fall after selling tainted spinal steroid injections to medical facilities across the country.
The FDA’s letter cited Medi-Fare Drug and Home Health Center for compounding batches of drugs without patient-specific prescriptions, and was acting as a drug manufacturer rather than a compounding pharmacy. The letter also cites the compounding pharmacy for distributing unapproved new drugs that do not qualify for an exception from federal drug manufacturer requirements. They were also cited for other violations, including inadequate labeling, which allowed their drugs to become adulterated, which could cause another fungal meningitis outbreak.
The same problem became apparent in October 2012, after the Tennessee Department of Health notified the CDC that some of its epidural steroid injections had caused patients to develop fungal meningitis. Soon, many other medical facilities across the country reported similar incidents, including some facilities in South Carolina, and the problem was traced back to the New England Compounding Facility.
“The agency is particularly concerned about the large-scale distribution of compounded sterile drugs to health care facilities nationwide when compliance with appropriate standards for large-scale sterile production may not have been met, potentially putting patients at risk,” FDA spokeswoman Sara Clark-Lynn said in an email.
Clark-Lynn said that the targeted effort from the FDA is being coordinated with state boards that regulate pharmacies on the local level, which might be, despite regulations, engaged in “large-scale sterile production.”
Fifty-one people died because of the national fungal meningitis outbreak last fall. South Carolina saw its first “probable” case on October 25th, and only one facility was known to have received the tainted steroid injections from the New England Compounding Facility.
Some South Carolinians Still Suffer from First Fungal Meningitis Outbreak
The importance of tracking and cracking down on compounding pharmacies can be highlighted in one case, that of Bob Ross from Mount Pleasant, SC.
Mr. Ross suffered severe back pain and received regular steroid injections to help treat his problem. Otherwise, he was in great health – Mr. Ross said that he loved all kinds of exercise, including tennis and hiking. During the October fungal meningitis outbreak, he received a letter that told him to watch out for meningitis symptoms, including neck pain and headache, within 40 days. When that time period passed, Mr. Ross thought he was fine.
A surgeon friend suggested that Ross undergo a spinal operation to fix his back problems. Because Ross did not suffer any fungal meningitis symptoms, he decided to have the surgery on December 11th.
A week after his surgery, Mr. Ross began to feel feverish, and had severe back spasms. His doctors initially thought the problem was a bacterial infection related to surgery, and after getting a second opinion, Ross had an MRI which disclosed a cyst the size of a golf ball, caused by the tainted steroid injections.
Mr. Ross has since undergone several surgeries to clear the infection out of his spine, but he still suffers painful back spasms and must walk with a walker. His case shows in stark relief how important it is to closely regulate compounding pharmacies to prevent more infection disease outbreaks, including fungal meningitis.
The Strom Law Firm Can Help with Your Fungal Meningitis Outbreak Personal Injury Claim
If you or a loved one have been injured, harmed, or killed by a medical product such as a drug or device, you may be entitled to file a personal injury lawsuit. Defective medical devices and drugs can hurt you to such a great extent that you are unable to work. You will face mounting medical bills as you seek treatment for another’s mistake. The attorneys at the Strom Law Firm can help get you the compensation you deserve, to get you through these tough times. We are licensed to practice across South Carolina, Georgia, and New York. To help you with your case, we offer free, confidential consultations. Do not hesitate to contact us. 803.252.4800.
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