Bextra And Stevens Johnson Syndrome
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In November 2001, the United States Food and Drug Administration (FDA) approved the drug Bextra, which was manufactured by the pharmaceutical company Pfizer. Classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID), Bextra was prescribed to manage chronic pain, osteoarthritis, and severe menstrual cramps. Bextra is an NSAID that is also a Cox-2 inhibitor, and therefore, according to scientific studies, much more likely to produce harmful side effects.
NSAIDs treat arthritis pain by targeting cyclooxygenase, the enzyme that increases inflammation and pain. Over-the-counter drugs like ibuprofen and naproxen are considered Cox-1 inhibitors. Cox-2 inhibitors were designed to reduce gastrointestinal bleeding, pain and inflammation associated with Cox-1 inhibitors, but instead, they have been found to increase certain risks including heart attack and stroke. While studies have concluded that the increased risks can also be associated with the dosage ingested and the length of time the drug was taken, statistically Cox-2 inhibitors are more than three times more likely to cause a heart attack than Cox-1 inhibitors.
In April 2005, Bextra was withdrawn from the market, after FDA recommendation, after being linked to high incidences of stroke, heart attacks, and the skin disease Stevens Johnson Syndrome (SJS). Canada and Europe also banned the drug at that time. Pfizer failed to place warnings about the risks and relations to side effects on the drug. Several lawsuits filed against Pfizer claimed that when it released Bextra in 2001, the company engaged in fraudulent advertising practices including "off-label" advertising. Additionally, it is believed that the company was aware of the deadly side effects related to the disease but failed to warn consumers about the risks.
In 2009, Pfizer was fined $2.3 billion after admitting that they illegally advertised and promoted Bextra. Lawsuits against the company alleged that the manufacturer knew of the potential side effects of the drug before the FDA approved the drug. Starting in 2004, when a similar drug, Vioxx, was pulled from the shelf, Bextra and other Cox-2 inhibitors were supposed to be marked with a black box that warned customers of the possibly hazardous side effects of the drugs.
According to scientific studies, the link between Bextra and SJS is thought to be an allergic reaction to the drug. It is believed that some people's bodies are unable to dispose of the sulfa, a component of Bextra, and the body's resulting allergic reaction leads to rashes and SJS.
SJS is a life-threatening skin disease that causes the epidermis to separate from the dermis. SJS causes rashes, skin peeling, and sores on the mucous membranes. Other symptoms associated with SJS include fever, cough, sores in the genital tract that cause painful urination, swelling and lesions of tongue and gums, and difficulty breathing. The disease is characterized by almost debilitating pain, misery, and the potential of death. Conjunctivitis, commonly called pink eye, is also a symptom of SJS in children. Sadly, the disease may result in permanent scarring, skin damage, and even death.
If you or a loved one have taken Bextra and experienced any painful side effects, an attorney can help you determine the extent of your injuries and help you recover compensation for your pain and suffering. After a free consultation and evaluation of your case, the attorney can refer you to a medical specialist who can diagnose your condition and begin treatment. You may be entitled to money to cover your medical treatment, lost wages, and pain and suffering.
If you believe you have experienced any of these side effects, act now because the statute of limitations has already begun to run on Bextra claims. A lawyer who specializes in medical malpractice or recalled pharmaceutical law can help you with your Bextra case.