Bextra Side Effects Tips
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Side effects of Bextra
Bextra use has been associated with Stevens Johnson syndrome, a deadly drug reaction that devastates the skin and mucous membranes and can lead to death if not properly treated.
Side effects of Bextra
A Bextra stroke is a possible side effect of taking this popular prescription painkiller. A Bextra stroke is just one of the many serious and potentially deadly side effects that prompted the FDA to request a recall of this drug. On April 7, 2005, Pfizer took its blockbuster painkiller, Bextra, off the market because the risks associated with Bextra far outweigh the drug's intended benefits.
Side effects of Bextra
In addition to potential cardiovascular risks, there are other serious Bextra safety issues that have been well known for some time. Bextra safety is compromised in patients who are taking other medications such as aspirin, anti-convulsants, warfarin, and oral contraceptives. The most serious well established Bextra safety risk is the potential development of serious skin diseases.
The Bextra debate
One criticism of Bextra is that is was only available in 10 mg doses. Some studies suggest that this is an unnecessarily large dose. In a review article of ten large, well-controlled, randomized trials of Bextra, doses of 2.5 and 5 mg/day were significantly superior to placebo for osteoarthritis of the knee. 5 mg of Bextra was effective for osteoarthritis of the hip. Your doctor is unlikely to know any of this, because it isn't mentioned in the Bextra package insert or Physicians' Desk Reference.
The Bextra debate
The lack of variable dosages in Bextra has raised concerns about how it is used. According to the American Medical Association, the range of response to a drug can vary from one person to another by four to forty-fold. This is not surprising; people's ages, sizes, absorption and metabolism of medications, other concomitant medical disorders, innate sensitivities to medications, and other drugs being used will have an impact. Medical science supports using the lowest, safest, proven-effective doses of drugs, particularly for NSAIDs, yet such individualization was not possible with one-size-fits-all Bextra. Whether you were 25 or 95 years old, 100 or 300 pounds, your doctor prescribed 10 mg of Bextra for your osteoarthritis. This is not only bad medicine, but also defies published studies on Bextra.
The Bextra debate
Recent Bextra warning statements have prompted concerns about the cardiovascular safety of taking this COX-2 inhibitor drug. Bextra is a prescription medication that was approved by the FDA in November 2001. Bextra is used to treat patients who suffer from the severe pain associated with osteoarthritis, rheumatoid arthritis and primary dysmenorrhea. It was touted as an alternative for patients who could not tolerate the stomach upset often associated with other nonsteroidal anti-inflammatory drugs.
What prompted the recall of Bextra?
Bextra warning statements regarding cardiovascular safety follow the recent Vioxx recall that occurred on September 30, 2004. The recall was prompted by research findings indicating that patients taking Vioxx for eighteen months double their risk of suffering from a serious heart attack or stroke. Because Bextra, like Vioxx, is a COX-2 selective nonsteroidal anti-inflammatory drugs and because it is so similar to Bextra in its actions on the body, warnings were raised regarding the safety of Bextra and all other COX-2 selective NSAIDs.
Bextra and the FDA
Bextra stroke, heart attack, and fatal skin condition risks were among the most serious side effects which prompted the Bextra recall. Bextra enjoyed about a three year stay on the market before being pulled from the shelves, yet knowledge of its serious side effects began surfacing soon after its 2001 FDA approval. As early as 2002, the FDA requested that Pfizer add stronger warnings to its Bextra labeling about serious skin side effects.
Recall of Bextra
Despite this evidence of Bextra stroke and heart attack risks, Pfizer made no indication of any plans to recall their defective drug or strengthen warning labels. In response to Bextra stroke and heart attack risks, the FDA urged doctors to limit their use of Bextra and look to alternatives for prescription pain relief. The FDA and other regulatory agencies ordered a review of all Bextra clinical trials to further evaluate Bextra stroke and heart attack risks. After comprehensive investigation, the FDA determined that Bextra stroke, heart attack, and skin risks were too great to allow this drug to remain on the market.
The Bextra debate
Bextra was only sold in 10 mg dosages. However, in a large multicenter, randomized, double-blind, placebo-controlled study of people with moderate to severe osteoarthritis of the knee, 5 mg of Bextra was significantly superior to placebo over the 12-week study. In a multicenter, randomized, double-blind study of people with osteoarthritis of the hip, 5 mg of Bextra was significantly superior to placebo over 12 weeks of study.
Does Bextra come with warning information?
Bextra warning statements have already been included in Bextra labeling information. Bextra causes rare but serious skin diseases in some patients who take it. Bextra warning statements indicate that Bextra side effects may include Stevens-Johnson syndrome, a rare skin condition characterized by a severe inflammatory eruption of the skin and mucous membranes. Toxic epidermal necrolysis is also a potential side effect of taking Bextra. This skin condition causes large portions of the skin to become red and peel in the manner similar to a second degree burn. Bextra warnings also caution that Bextra can cause severe allergic reactions in some patients, including anaphylactic shock.
