Vioxx recall makes health agencies worldwide more careful

Governments and health agencies all over the world are responding to the disturbing data about several other drugs in the Cox-2 category since the recall of Vioxx. Aleve, which is not a Cox-2 drug, but is still used for pain relief, is not being reviewed yet as agencies focus more on drugs like Celebrex.

Most governments are responding to the data released in the United States since Vioxx was withdrawn by Merck in September. The FDA is also in the process of making up its mind about Celebrex and a decision is expected any day. Most analysts expect that FDA will simply change the warning on Celebrex without actually asking for an outright recall of Celebrex. Another group of analysts believe that FDA, which has been widely criticized for failing to react fast to disturbing data, might actually recall Celebrex just to be safe this time. The FDA has been without a full-time head for years now and the agency is in complete disarray. Many experts also believe that the FDA has been hijacked by the drug industry considering the fact that industry insiders now control not only the agency but the current administration as well.

But governments in other countries, where the government agencies and drug industry do not have such cozy relationships, are moving fast to protect the health of their citizens. Victims of drugs like Vioxx are also filing class action lawsuits against Merck as well and that has put a lot of pressure on these agencies not to let another Vioxx scandal happen this time.

Pharmac (a government agency in New Zealand) yesterday accused Pfizer of continuing to aggressively promote Celebrex to doctors despite the withdrawal of Vioxx and similar concerns being raised about its own drug. The company has refused to recall Celebrex though it has discontinued its direct-to-consumer advertising at the request of the FDA. Pfizer is however aggressively promoting the drug to doctors and is continuing to stand by its safety despite conflicting data about its adverse side effects.

In the meantime, Health Canada, the equivalent of the FDA, has informed Canadians of safety concerns regarding selective COX-2 inhibitor NSAIDs (non-steroidal anti-inflammatories). These include Vioxx (rofecoxib), which has been withdrawn from the market, Celebrex (celecoxib), Bextra (valdecoxib), and Mobicox (meloxicam), which are used in the treatment of symptoms of rheumatoid arthritis, osteoarthritis and primary dysmenorrhea (menstrual pain).

Accumulating evidence indicates that the use of selective COX-2 inhibitor NSAIDs, in certain individuals, is associated with an increased risk of heart attack or stroke when compared to placebo. The risk appears to increase with the total daily dose and the length of the treatment. However, given the available data, it is not possible to identify which patients would present a higher risk of heart attack and stroke. (Related article: Aleve is also being watched carefully after recall of Vioxx and disturbing data about Celebrex)

Health Canada has requested additional safety information from the manufacturers of Celebrex, Bextra, Mobicox and generic forms of meloxicam, and will continue to review the safety profile of these drugs in order to fully consider what is presently known about the risks and benefits of these drugs when used according to their labeling.

"Until further information from long-term clinical trials becomes available, one should consider that there is a strong possibility of an increased risk of cardiovascular events, including heart attack and stroke, when using selective COX-2 inhibitor NSAIDs", Health Canada warns people.

It should be noted that alternative therapies to selective COX-2 inhibitor NSAIDs also present risks. This is particularly true after it was found that Aleve, an alternative used for Vioxx, also has serious side effects if one exceeds the recommended dosage and takes it for more than 10 days at a time. Therefore, patients should discuss with their physician all benefits and risks of selective COX-2 inhibitor NSAIDs versus alternative therapies, in order to determine the most appropriate treatment in their individual case. A recent study indicates that acupuncture may provide enormous pain relief.

The Department of Health in the UK is also asking patients who are taking Celebrex, Bextra and Arcoxia that they should make a non-urgent appointment with their doctor to review their treatment.

The Therapeutic Goods Administration (TGA), the equivalent of FDA in Australia, has now fast tracked the review of Cox-2 drugs requesting that the US research data be provided to the Australian regulator immediately and reinforcing to all other companies researching Cox-2 Inhibitors to produce their results as a matter of urgency. Australian Adverse Drug Reactions Committee (ADRAC) has advised that all drugs in the class of Cox-2 inhibitors should be regarded as having an increased cardiovascular risk until more is known.

Recommended article: What should Celebrex and Bextra patients do if they are recalled?