The FDA ( Food and Drug Administration ) has approved the first generic versions of Celebrex ( Celecoxib ) capsules, a treatment for rheumatoid arthritis, osteoarthritis, short-term ( acute ) pain, and other conditions.
Teva Pharmaceutical has received approval to market Celecoxib capsules in 50 milligram, 100 mg, 200 mg, and 400 mg strengths, and has 180-day exclusivity on the 100 mg, 200 mg, and 400 mg strength products. Mylan Pharmaceuticals has received approval to market 50 mg Celecoxib capsules.
Celecoxib is a non-steroidal anti-inflammatory drug ( NSAID ). All NSAIDs have a boxed warning in their prescribing information to alert health care professionals and patients about the risk of myocardial infarction or stroke that can lead to death. This chance increases for people with heart disease or risk factors for it, such as high blood pressure, or taking NSAIDs for long periods of time.
The boxed warning also highlights the risk of serious, potential life-threatening gastrointestinal ( GI ) bleeding that has been associated with use of NSAIDs.
In the clinical trials for Celebrex, the most commonly reported adverse reactions in patients taking the drug for arthritis were abdominal pain, diarrhea, dyspepsia, flatulence, swelling of the feet or legs ( peripheral edema ), accidental injury, dizziness, inflammation of the throat ( pharyngitis ), runny nose ( rhinitis ), swollen nasal passages, ( sinusitis ), upper respiratory tract infection, and rash. ( Xagena )
Fonte: FDA, 2014