Pain Killer Duract Withdrawn From Market (6/23/98)

Duract Withdrawn From The Marketplace Reports of Serious Liver Damage and Death Associated with Use over 10 days.

With safe, tested opioid medicines available, it is a wonder that current Federal policies favor the use of potentially dangerous NSAID’s over the latest generation of pharmaceutical narcotics.  NSAID'S (nonsteroidal anti-inflammatory analgesics) are still the most commonly prescribed drugs for chronic pain because they are not monitored by the drug enforcement agencies.  Physicians, afraid of being interrogated and harassed by the DEA or their State Medical Board, routinely avoid prescribing safe opiate-derived medications in favor of NSAID’s.  The illogic of the current policing of medical decisions is that 20 years of case studies have proven that oral opioid medicines are safe and effective, whereas NSAID’s have damaging side effects.

Take, for example, the case of Duract, (bromfenac sodium capsules) manufactured for the management of acute pain.  Duract was introduced in July 1997, and approximately 2.5 million prescriptions have been dispensed.  It was approved by the FDA for the short-term treatment of inflammation. Use of the drug was limited by the FDA to no more than 10 days. In February 1998, the company and the Food and Drug Administration agreed on labeling changes to further emphasize that DURACT should be used for 10 days or less. These changes were initiated in response to earlier reports of serious events associated with longer-term use. In 12 cases, 11 patients used the medicine for more than 10 days, resulting in severe liver failure ending in four deaths and eight liver transplants.The 12th patient had significant pre-existing liver disease.

On June 22,1998, Wyeth-Ayerst Laboratories  announced the voluntary market withdrawal of Duract.  ``We believe this voluntary action is in the best interest of patients,'' says Dr. Philip de Vane, Vice President, of Wyeth-Ayerst Laboratories.  "In light of these circumstances, as well as the availability of other therapies, Wyeth-Ayerst decided to withdraw the product."

'Wyeth-Ayerst has sent letters of notification to more than 600,000 health care professionals in the United States. They are being advised to stop prescribing and dispensing Duract immediately. In addition, they have been asked to contact patients who may be using the product longer than 10 days or who have a history of liver disease, and advise these patients to discontinue treatment.

In 1997 the American Medical Association published an article warning of the great toxicity of this class of drugs. It reported 76,000 emergency room admissions from toxic reactions to the NSAID'S, at an average cost of $20,000 per incident. Opiate-derived medications have no such effect upon the liver, or any other organ of the body. They are unarguably extremely safe in the hands of experienced physicians, and are virtually never the sole substance implicated in overdoses, which require E.R. treatment. In virtually every E.R. overdose case, a combination of drugs and alcohol was responsible, the latter being the primary factor.

So the question NFTP must asks is this:  Where is the logic in prescribing dangerous NSAID’s when safe opioid medications are available?   Why are the DEA and State Medical Boards taking these chances with our bodies?