Treatment options for Vioxx patients
Since the recall of Vioxx, much of the discussion has been focused on how Merck may have hidden damaging information about the drug and how Merck's action resulted in tens of thousands of people dead worldwide. Plus, there is heated discussion about Vioxx class action lawsuits. But what has not received enough attention is what to do next if you are a Vioxx patient. This question has assumed even more importance after the problems discovered with Celebrex and earlier warnings issued about Bextra.
Dr. Mark Fendrick, Co-Editor in Chief of The American Journal of Managed Care, writes that these innovative drugs in the COX-2 family were never intended to provide pain relief superior to that of traditional nonsteroidal anti-inflammatory drugs (NSAIDs). Rather, the COX-2 selective inhibitors were meant to reduce the risk of gastrointestinal adverse events, common with NSAIDs, while affording patients symptomatic relief comparable to that of the NSAIDs. He continues, "Thus, the use of the available treatment alternatives in the "post-Vioxx" era must balance competing risks and benefits." In other words, what Dr. Fendrick is saying is that an Aspirin can do the trick, though that too has some side effects, though not as severe as those of Vioxx and others which significantly increased the risk of heart attacks.
Authorities in Europe, Canada, and Australia are reviewing the data on Cox-2 drug to determine if all drugs in this category should be withdrawn. The FDA in the United States is slated to announce its decision on Celebrex this week and on Cox-2 drugs early next year. But almost all doctors in the United States are now skeptical about the safety of Cox-2 drugs, and even more so about the risk-benefits tradeoff. This is an important point because a point very strongly being made by Pfizer is that Celebrex, despite its serious adverse side effects, is still a great drug and, therefore, there is no reason to recall Celebrex.
Dr. G A Fitzgerald writing in the New England Journal of Medicine does not seem to agree with that logic. He has said in the past that, "The burden of proof now rests with those who claim that this is a problem for rofecoxib (Vioxx) alone and does not extend to other coxibs. We must remember that the absence of evidence is not the evidence of absence."
Dr. Frendrick adds, "In light of the Vioxx withdrawal and the subsequent reassessments of COX-2 agents underway to definitively establish cardiovascular safety, clinicians should balance the benefits and risks of available agents in terms of pain relief and cardiovascular and gastrointestinal safety. Until the burden of safety is met, we should consider taking our patients "back to the future" and use older, well-studied agents to safely provide symptomatic relief." The FDA, in the meantime, has rather simple advice to former Vioxx patients: Talk to your doctor.
Recommended article: Vioxx alternatives Celebrex and Bextra may need to be recalled
