The makers of Propofol have been ordered to pay over $500 million in fines and damages. It is alleged that the companies made the vials larger than necessary to eliminate costs and increase profit. Approximately 100 patients were infected, and 20,000 patients were notified about their possible exposure. In addition 73 lots of Propofol and 85 lots of Liposyn that were distributed between July 2009 and October 2009 were recalled by the Food and Drug Administration (FDA) due to contamination by particulates which could impede blood flow, causing stroke, kidney failure, and heart attack.
5/28/2010: Teva Pharmaceutical Industries Ltd. announced on May 28, 2010 that it will stop making its sedative propofol.
Teva did not say why it is discontinuing propofol, but the company is facing almost 250 lawsuits connected to the drug. It is a sedative often used in operating rooms. Teva, which is based in Israel, said it will continue marketing doses that have already been made. The company said it believes propofol is safe and effective when it is used properly.
In 2008, propofol was connected to a hepatitis C outbreak that infected as many as 114 people. Vials of propofol were allegedly used to treat more than one patient each, spreading the liver disease. In May 2010 a Nevada court ordered Teva to pay $356 million to a man who said he contracted hepatitis C from a vial of propofol. Teva's partner, Baxter International Inc., was ordered to pay $144 million. Both companies say they plan to appeal that verdict, and Teva said that if the man contracted hepatitis C from the clinic, it was because the drug was "blatantly misused."
Propofol Linked to Hepatitis C Outbreak. Baxter and Teva Healthcare Ordered to pay $500 Million in Fines and Damages in Propofol Case.
Baxter and Teva Healthcare were ordered to pay $500 million in fines and damages in the first of over a hundred cases, following a Hepatitis C outbreak in southern Nevada. The outbreak occurred due to contamination at the Desert Shadow Endoscopy Center, where larger than necessary vials of Propofol were reused by doctors. According to the Associated Press, a Clark County District Court jury ordered Teva to pay $356 million to the plaintiffs and Baxter Healthcare Corporation was ordered to pay $144 million. These amounts do not include the $5 million already awarded to the plaintiffs by the same jury.
Propofol is an intravenous drug that reduces anxiety, and assists in achieving loss of consciousness or sleep. It is most commonly used in surgical procedures or short diagnostic tests, to induce or maintain anesthesia.
Propofol bottles contain five times the amount of drug needed for short procedures such as colonoscopies, which tempt healthcare professionals to reuse the drugs, regardless of the risk of transmission of diseases such as Hepatitis C. Teva used to sell 10 milliliter vials, which is the amount needed for one patient, but it stopped in 2007 because it was less expensive to make 50 milliliter vials.
Hepatitis C is a dangerous and often deadly disease, affecting the liver. It is often times asymptomatic, so getting tested is the only way to confirm or rule out infection. For those who do experience symptoms, they can include right upper abdominal pain, vomiting, nausea, fever, dark urine, jaundice, fatigue, and/or light colored stools. At this time, there is no cure for hepatitis C. According to GoogleHealth, the most common medications are a combination of interferon alpha and ribavirin, an antiviral medication, which is given for 24-48 weeks. Most patients receive weekly injections just under the skin. Ribavirin, which causes anemia and birth defects in most patients, is a capsule taken twice daily. Due to the side effects of Ribavirin, women should avoid getting pregnant during treatment, and up to 6 months post-treatment. In addition to anemia and birth defects, these medications can also cause thinning of hair, headache, loss of appetite, and depression. If Hepatitis C goes untreated, serious liver damage is likely to occur and lead to liver cancer or liver disease, in which the infected person would require a liver transplant. When asked to comment on the Propofol contamination, a Baxter spokeswoman stated that "this was a case of product misuse related to unsafe clinical practices as opposed to an issue with a widely used and clearly labeled product."
In Nevada where the outbreak took place, about 50,000 patients who received endoscopy procedures were urged to get tested. Of those 50,000, approximately 100 patients have tested positive, and those numbers are consistently rising as the cause of the outbreak becomes more publicized.
This isn't the first scare America has encountered with Propofol. In December of 2009, 73 lots of Propofol were recalled. The Food and Drug Administration (FDA) issued a warning letter, stating that Propofol, which is sold to hospitals and doctors, had been contaminated by particulates during the manufacturing process. The source of the particulate matter was later identified as stainless steel equipment used in the manufacturing process. Since stainless steel cannot dissolve in blood, it could easily cause mechanical damage to the body or even impede blood flow, which would lead to heart attack or stroke.
We are currently investigating claims related to Propofol contamination and recalls, and we urge you to contact us for a confidential evaluation if you or a loved one has experienced serious side effects as a result of Propofol.