In 2002, early warnings and evidence emerged about potential harmful side effects for the drug valdecoxib, manufactured and marketed under the brand name Bextra. In 2005, the manufacturer of Bextra voluntarily recalled the drug due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients taking the drug – three years after warnings originally surfaced. If you or a loved one suffered severe side effects after taking Bextra, a personal injury attorney may be able to help you.
Bextra Side Effects
In addition to an increased risk of heart attack, stroke, and the serious skin condition Steven Johnson Syndrome, patients taking Bextra may suffer from side effects including:
- Abdominal pain, tenderness, or discomfort
- Bloody vomit
- Fatigue or lethargy
- Flu-like symptoms
- Skin rash
- Swelling or water retention
- Unexplained weight gain
- Unusual bruising or bleeding
- Yellowing of the skin or eyes
The symptoms from taking Bextra, a COX-2 non-steroidal anti-inflammatory drug, are often severe and even life-threatening. The results from these side effects may lead to:
- Angina (chest pain or discomfort caused by your heart not receiving enough oxygen-rich blood)
- Blood clots
- Gastrointestinal bleeding
- Heart attack
- Liver failure
- Other serious skin reactions
- Stevens Johnson Syndrome (a fatal skin disease)
- Toxic Epidermal Necrolysis (a life-threatening skin disorder)
Timeline of Bextra Side Effects
Marketed for the miraculous pain relief it brought to people suffering from rheumatoid arthritis, osteoarthritis, and severe menstrual pain, early warnings and evidence emerged about potential harmful side effects of Bextra:
- 2002 – Label warnings for Bextra were changed to indicate the possibility of severe skin reactions.
- 2002 – European Medicines Evaluation Agency (the European equivalent of the FDA) issues a public statement warning about Bextra side effects.
- 2002 – Pfizer announced in a Dear Doctor letter to health professionals that Bextra can cause a potentially life threatening drug reaction called Stevens-Johnson Syndrome.
- 2002 – The FDA announces that it has received about 20 reports of serious reactions to Bextra.
- 2004 (September) – The warning label was updated for the second time to reflect the death of patients from Bextra-induced Stevens Johnson Syndrome.
- 2004 (October)— Pfizer announces the results of two trials that point to an increased cardiovascular risk for patients taking Bextra. Later it is learned that Pfizer had been sitting on this information for two months.
- 2004 (October) – Six months before Pfizer recalled Bextra, the company issued a press release clearing Bextra of causing increased risks of cardiovascular thromboembolic events. Later, Pfizer acknowledged that this information was false, and the company’s own study in August 2004 linked Bextra with increased risk of heart attacks.
- 2004 (December) – The FDA orders a “black-box” warning on Bextra labels. The warning cautioned that patients undergoing heart bypass surgery should not take the drug. In addition, the FDA also strengthened warnings about the risk of serious and potentially fatal skin reactions.
- 2004 (December) – A Vanderbilt study is published indicating people taking Bextra increase their chance for a heart attack by 300%.
- 2005 (January) An American Heart Association study also associates Bextra with a 300% risk increase for a heart attack over a placebo. This is identical to the results of the Vanderbilt study.
- 2005 (April) Pfizer recalls Bextra at the request of the FDA.
Instead of immediately recalling the drug when they learned about the dangers, Pfizer chose to pursue an aggressive marketing strategy to help sales, increasing consumption of the potentially harmful drug.
Bextra Manufacturer Ordered to Pay $2.3 Billion Fine
In 2009, the United States Department of Justice (DOJ) fined Pfizer $2.3 billion after they agreed to plead guilty to one felony count to settle civil and criminal charges that it illegally marketed Bextra and other drugs, plus misbranding drugs with the intent to defraud or mislead. This fined included a $1.3 billion criminal fine to resolve claims that Pfizer promoted the drug for uses that were not approved by the FDA nor established as effective and safe. It is the largest criminal fine and largest health care fraud case in United States history.
Call 1-888-BURNETTI for More Information on Bextra
In 2005, Pfizer voluntarily recalled Bextra. Unfortunately, the drug had already been prescribed to millions. If you or someone you love took Bextra and suffered from stroke, heart attack, or Stevens Johnson Syndrome, call 1-888-BURNETTI.
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