Some Bextra Users Are Suffering Severe Side Effects

Kahn Gauthier Swick is investigating claims against pharmaceutical company Pharmacia on behalf of patients who have been prescribed the painkiller Bextra (valdecoxib) and later suffered side effects such as heart attack, stroke, severe skin reaction, or other adverse effects. Bextra, a COX-2 inhibitor, was approved by the federal Food and Drug Administration (FDA) on November 16, 2001, and was marketed in March, 2002. It can be prescribed for osteoarthritis, adult rheumatoid arthritis, and primary dysmennorhea.

The FDA announced on November 15, 2002, that it had received about 20 reports of serious reactions from Bextra. Pharmacia had issued a "Dear Healthcare Professional" letter two days earlier. Previously, on October 22, the European Medicines Evaluation Agency (the European counterpart to the FDA) issued a public statement warning of skin related side effects.

The Problem With Cox-2 Inhibitors:

The family of COX-2 inhibitor drugs to which Bextra belongs seem to be associated with a new group of side effects involving the circulatory system.

Possible Side Effects of Bextra

The following side effects may be linked to Bextra use:

Cardiovascular: Aggravated hypertension, aneurysm, anginapectoris, arrhythmia, cardiomyopathy, congestive heart failure, coronary artery disorder, heart murmur, hypotension.

Central, peripheral nervous system: Cerebrovascular disorder, hypertonia, hypoesthesia, migraine, neuralgia, neuropathy, pares-thesia, tremor, twitching, vertigo.

Endocrine: Goiter.

Female reproductive: Amenorrhea, dysmenorrhea, leukorrhea, mastitis, menstrual disorder, menorrhagia, menstrual bloating, vaginal hemorrhage.

Gastrointestinal: Abnormal stools, constipation, diverticulosis, dry mouth, duodenal ulcer, duodenitis, eructation, esophagitis, fecal incontinence, gastric ulcer, gastritis, gastroenteritis, gastroesophageal reflux, hematemesis, hematochezia, hemorrhoids, hemorrhoids bleeding, hiatal hernia, melena, stomatitis, stool frequency increased, tenesmus, tooth disorder, vomiting.

General: Allergy aggravated, allergic reaction, asthenia, chest pain, chills, cyst NOS, edema generalized, face edema, fatigue, fever, hot flushes, halitosis, malaise, pain, periorbital swelling, peripheral pain Hearing and vestibular: Ear abnormality, earache, tinnitus.

Heart rate and rhythm: Bradycardia, palpitation, tachycardia.

Hemic: Anemia

Liver and biliary system: Hepatic function abnormal, hepatitis, ALT increased, AST increased.

Male reproductive: Impotence, prostatic disorder.

Metabolic and nutritional: Alkaline phosphatase increased, BUN increased, CPK increased, creatinine increased, diabetes mellitus, glycosuria, gout, hypercholesterolemia, hyperglycemia, hyperkalemia, hyperlipemia, hyperuricemia, hypocalcemia, hypokalemia, LDH increased, thirst increased, weight decrease, weight increase, xerophthalmia.

Musculoskeletal: Arthralgia, fracture accidental, neck stiffness, osteoporosis, synovitis, tendonitis.

Neoplasm: Breast neoplasm, lipoma, malignant ovarian cyst.

Platelets (bleeding or clotting): Ecchymosis, epistaxis, hematoma NOS, thrombocytopenia.

Psychiatric: Anorexia, anxiety, appetite increased, confusion, depression, depression aggravated, insomnia, nervousness, morbid dreaming, somnolence.

Resistance mechanism disorders: Herpes simplex, herpes zoster, infection fungal, infection soft tissue, infection viral, moniliasis, moniliasis genital, otitis media.

Respiratory: Abnormal breath sounds, bronchitis, bronchospasm, coughing, dyspnea, emphysema, laryngitis.

Skin Related Side Effects

The skin diseases associated with Bextra use are:

1. Erythema multiforme, which is an acute mucocutaneous hypersensitivity reaction of variable severity characterized by a symmetrically distributed skin eruption, with or without mucous membrane lesions.

2. Exfoliative dermatitis, which involves a scaling erythematous dermatitis involving 90% or more of the cutaneous surface.

3. Toxic epidermal necrolysis, which is a severe mucocutaneous exfoliative disease with an uncertain pathogenesis and a high mortality rate.

Hypersensitivity Reactions

The hypersensitivity reactions associated with Bextra use are:

1. Anaphylaxis, which is a severe allergic reaction that occurs rapidly and causes a life-threatening response involving the whole body. It is potentially fatal.

2. Angioedema, which is swelling that occurs in the tissue just below the surface of the skin. Complications range from dysphonia or dysphagia to respiratory distress, complete airway obstruction, and death.

If the side effects of Bextra have harmed you, contact us today.