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FDA Calls for New Labeling for Anesthetics Used in Post-Surgery Pain Pumps

As a St. Louis defective drug attorney, I was disturbed to read about a new Food and Drug Administration warning of potential irreversible cartilage damage from certain anesthetics and medical devices. According to a Nov. 17 article from the Wall Street Journal, the FDA has called for stronger warnings on the labels of pain pumps and certain anesthetics after 35 reports that they caused permanent cartilage damage (chondrolysis) in patients who received continuous infusions after surgery. In more than half the cases, patients needed additional surgery, including joint replacements for otherwise healthy young adults. The FDA required pain pump and anesthetic makers to update their labels within 30 days to include warnings about the destruction of cartilage.
The drugs in the FDA’s announcement include bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine, all widely used local anesthetics. The FDA’s announcement noted that these drugs have been used safely for years or decades, but in smaller, short-term doses. They are not approved for continuous use or use in pain pumps, which deliver constant flows of medication over two or three days. In fact, the pain pumps themselves are not approved for use in joint (intra-articular) areas, the uses that generated the cartilage damage reports. Dr. Constance Chu, a cartilage restoration specialist the University of Pittsburgh, told the Wall Street Journal that local anesthetics are toxic to tissues at high doses and not intended for continuous use. The Canadian version of the FDA issued a warning about cartilage damage in January, following studies and reports on the issue.
Almost all (97%) of the surgeries the FDA reviewed were shoulder joint surgeries. Patients reported stiffness, loss of motion and joint pain as soon as the second month after their surgeries. About half needed additional surgeries to relieve the pain and symptoms, including joint replacements (arthroscopy). Cartilage damage and loss is not life-threatening, but it has an immense effect on the patient’s quality of life. Without cartilage, the bones in joints grind against one another, causing pain, swelling, loss of mobility and thus severe restrictions on the patient’s movement. Osteoarthritis, a common complaint among older Americans, is a form of cartilage loss with similar symptoms. A newer treatment called articular cartilage repair can mend some of the damage to cartilage, but this cannot restore cartilage. Expensive joint replacement surgery may be necessary to restore patients’ normal movements.
The Wall Street Journal noted that pain pump manufacturers are already facing hundreds of lawsuits around the United States over post-operative cartilage damage. As a southern Illinois pharmaceutical liability attorney, I expect the FDA’s warning to add to that number. If the FDA is correct, both the pain pumps and the anesthetics are apparently being widely used for off-label, unintended purposes. This report makes it explicit that the FDA does not approve of those uses, and is even taking steps to warn doctors and patients against them. In fact, medical studies turned up these problems as early as 2006, but manufacturers failed to warn patients about them — and doctors continued to prescribe pain pumps full of anesthesia.

Based in St. Louis and Belleville, Ill., the Lowe Law Firm represents people around the United States who suffered a serous injury or lost a family member to a drug or medical device with serious safety flaws. Our Missouri defective medication attorneys believe that all patients should be able to trust that the medications and devices their doctors give them are safe to use as intended. Unfortunately, an overwhelming amount of historical evidence suggests that it’s not that simple, with millions of Americans suffering serious harm from FDA-approved, properly prescribed prescription and over-the-counter drugs and defective medical devices. We help our clients hold manufacturers legally liable for the results, which can include wrongful deaths and disabling or life-threatening injuries and illnesses. In a lawsuit, patients can recover all of the financial costs of their injuries, including past and future medical bills, as well as compensation for their losses, disabilities, pain and suffering.
If your family was seriously hurt by a drug or medical device that was intended to help, there’s no need to suffer alone. To learn more about your legal options and set up a free consultation, you can call us toll-free from across the U.S. at 1-877-678-3400 or contact us through the Internet.