Arthritis drugs Vioxx, Celebrex and Bextra will stay on sale and on the shelves after the Food and Drug Administration’s (FDA) advisory panel reached a narrow consensus allowing their sale, albeit with strong warning labels and certain restrictions.
After considering various arguments, the FDA’s advisory committee left the decision to doctors and patients by stating that the three drugs, even though they could pose increased risk for heart problems, should be available to patients who benefit from them.
Most of the panellists felt that the three drugs should carry the strongest warning for prescription drugs - the ‘black box’ warning - and a guide that provides information about the risks. They also sought certain restrictions on Vioxx, such as limiting sales to the lowest dose and recommending it as a second option after other painkillers.
Advertising the drugs, direct to consumers, was also thumbed down by the panel. The onus would now be on doctors and patients to decide if they want to use the drug in spite of the concomitant complications.
Merck & Company manufactures Vioxx, while painkillers Celebrex and Bextra come from the house of Pfizer. In September 2004, Merck voluntarily withdrew Vioxx from the market after a study revealed that the drug boosted the risk of heart attacks.
The three drugs belong to a group of drugs called Cox-2 inhibitors that ease pain by restricting Cox-2 enzyme activity. Cox-2 inhibitor drugs don’t affect the stomach adversely and so are popular with those whose stomachs are sensitive to aspirin, ibuprofen and other non-steroidal antiinflammatory drugs.
The recommendations of the FDA advisory panel point towards a significant change in the mindset of the FDA, who until now adopted a strategy of withholding information about any side-effects of a drug from the public till a conclusion was reached.
Meanwhile the FDA’s decision has prompted varied and differing responses. Some have hailed the decision, while others expressed shock and displeasure. According to Dr Mark Fendrick of University of Michigan, the use of the drug should be restricted to those who have low risk of cardiac problems or have sensitive stomachs.
Critics, however, feel that the drugs are back on the shelves due to fast-track approvals based on small industry-run studies that are incapable of spotting potential dangers. Dr Sidney Wolfe, director, Public Citizen’s Health Research Group dubbed the drugs ‘weapons of mass destruction’ and said that allowing COX-2 inhibitors to stay in the market ‘defies common sense’.
