Pfizer reaffirms safety of Vioxx alternative Celebrex

The data released by the The National Institutes of Health that warned about the cardiovascular (heart-related) complications due to naproxen (sold as Aleve) had another interesting piece of data - that there was no increased cardiovascular risk seen in elderly patients taking Celebrex (400 mg daily) for up to three years. This is slightly different from the findings of the NIH in a separate study that found that Vioxx alternative, Celebrex, increased the risk of heart attacks. (Related article: Vioxx alternative Aleve found to cause heart problems)

This is a position that Pfizer has been taking all along, though many scientists and the FDA are very concerned about the safety of Celebrex. "It would be premature to say what we are going to do with either one of these drugs, Celebrex or Aleve," Food and Drug Administration Commissioner Lester Crawford said. "We will keep all regulatory options open and make some determinations as quickly as possible based on the data." It is important to mention that since the recall of Vioxx, the FDA has been widely criticized for not doing its job, which resulted in tens of thousands of Vioxx-related deaths and injuries.

In a press release, Pfizer said, "These results are consistent with the large body of Celebrex scientific evidence that has accumulated over 10 years in more than 40,000 patients." Since release of data questioning the safety of Celebrex, Pfizer has pulled all direct-to-consumer advertising but has refused to recall Celebrex. “This is important new information that should be considered by doctors and patients as they evaluate the various treatments for arthritis and pain,” said Hank McKinnell, chairman and chief executive officer of Pfizer. “Millions of people simply can’t get through their day without pain relief. That’s why all the emerging information about arthritis medicines—prescription and over-the-counter—must be fully evaluated by the U.S. Food and Drug Administration and other regulatory authorities." (Related article: Treatment options for Vioxx patients)

“Recently, preliminary information from three major long-term clinical trials with Celebrex has become available. Because the early information from these trials is inconsistent, physicians and patients are understandably confused. That’s why the full study results must be shared with the medical, scientific and regulatory experts so that we have a more complete understanding of the risks and benefits of these medicines,” McKinnell said. (Related article: Safety concerns about Celebrex may be good news for those Vioxx victims who have joined class action lawsuits against Merck)

Pfizer recommends physicians consider alternative therapies when choosing an arthritis and pain medication for their patients. Celebrex remains one of these treatment options for osteoarthritis, rheumatoid arthritis and acute pain and, according to good medical practice, should be administered at the lowest effective dose for appropriate patients. (Related article: Acupuncture may help with pain relief and is an option for Vioxx patients)

"This is a very confusing situation," said Dr. Sandra Kweder, deputy director of the Food and Drug Administration Office of New Drugs. But the FDA stopped short of urging patients to seek alternatives to Aleve, its generic versions or its prescription forms Naprosyn and Anaprox, as the agency had done Friday with Celebrex.

Recommended article: Celebrex has been aggressively marketed since recall of Vioxx