Drug Descriptions
Information About Prescription Drug LitigationBEXTRA Bextra (generic name: valdecoxib), a popular pain reliever used for the pain of arthritis and menstrual symptoms, has been associated with an increased risk of cardiovascular events in addition to the previously known risks of gastrointestinal toxicity and severe skin reactions such as Stevens Johnson syndrome. Approved in November 2001, Bextra is a Cox 2 inhibitor in the same drug class as Celebrex and Vioxx. Pfizer’s retail sales of Bextra topped $1 billion in 2004. CELEBREX Pfizer’s Celebrex (celecoxib) is the only Cox 2 inhibitor NSAID to survive the recent FDA scrutiny and remain on the market. Originally approved in December 1998 for the pain of osteoarthritis and rheumatoid arthritis, later indications included menstrual pain, ankylosing spondylitis, and reduction of adenomatous colorectal polyps. On July 29, 2005, Pfizer added a black box warning to the Celebrex label, the strongest warning that the FDA can mandate. The new black box warnings include: * increased risk of cardiovascular (CV) thrombotic events, including myocardial infarction and stroke; FOSAMAX Fosamax is a medicine in the bisphosphonates family that is prescribed widely to prevent bone loss or the decrease of bone density. It is commonly used by post menopausal women. There have been reports that persons taking Fosamax have developed a severe problem in which bone in their jaws dies. This “jaw death” (also referred to jaw necrosis or jaw decay) often appears after minor trauma such as a tooth extraction. According to press reports, the American Association of Endodontists recently released a position paper that cautions that many patients who take Fosamax may be at risk this terrible complication. Other bisphosphonates such as Actonel may also be implicated. ORTHO EVRA Although Ortho McNeil’s Ortho Evra birth control patch contains the same combination of ingredients as oral combination hormonal birth control products (estrogen and progestin), clinical trial data obtained from the FDA by the Associated Press suggests that women using the patch have a significantly increased risk of potentially fatal blood clot injuries (such as pulmonary embolism, stroke and heart attack) over those using an oral contraceptive. The Patch is touted as being more convenient than a daily pill, because it’s only applied once per week, and only three weeks per month. Unlike the oral medication which is metabolized by the body’s digestive system, the progestin and estrogen in the patch are delivered through the transdermal patch and released directly into the bloodstream. About a dozen women, mostly in their teens and early 20's, died in 2004 from blood clots believed to be related to the birth control patch. Dozens more survived strokes and other blood clot related events. Serevent is one of three inhaled bronchodilators which recently came under increased FDA scrutiny after a study showed that a significantly higher number of asthma patients suffered serious asthma episodes, including asthma related deaths, when treated with Serevent than those on placebo. In this study, 13 of 13,176 people on Serevent died as opposed to 3 deaths out of 13,179 people on placebo. The increased deaths and serious events occurred mainly in people who were not taking inhaled corticosteroids at baseline, and they occurred more frequently among African Americans than Caucasians. The FDA has mandated black box warnings for Serevent and a related drug, Advair, also manufactured by GlaxoSmithKline, advising patients and their doctors of the increased risks. Advair combines the same active ingredient as Serevent (salmeterol) with fluticasone, a corticosteroid. A third drug, Foradil, belongs to the same drug class but has not adopted the stronger warnings. Trileptal is a drug used for treatment of partial seizures in epileptic adults and children over the age of four, although on October 28, 2005, the FDA approved the use of Trileptal in children as young as two. Trileptal is often prescribed off label to treat mood disorders. Originally approved by the FDA in January 2000, Trileptal’s label was changed in April 2005, to add warnings about serious dermatological reactions, including Stevens Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) which have been reported in both adults and children using Trileptal. Additionally, the “Precautions” section of the label has been updated to include language regarding multi organ hypersensitivity reactions reported with Trileptal use. Novartis sent a “Dear Doctor” letter in April 2005, advising physicians of the increased risks. ZYPREXA Details of the $690 million settlement with Eli Lilly have been finalized. Those cases that have not been settled will continue with discovery. |
