-- E. J. Mundell
FRIDAY, May 30, 2014 (HealthDay News) -- The U.S. Food and Drug
Administration on Friday gave its approval to the first generic
version of the powerful pain reliever Celebrex (celecoxib).
Celecoxib is a member of the cox-2 inhibitor family of
painkillers, prescription medicines often used for arthritis and
other conditions. The drugs emerged in the early 2000s and included
once best-selling pain relievers such as Vioxx and Bextra.
However, Vioxx was pulled from the market in 2004 after studies
revealed use of the drug raised heart risks, and the withdrawal of
Bextra followed a year later. Celebrex has remained the only cox-2
inhibitor medication on drugstore shelves in the years since.
On Friday, Teva Pharmaceutical Industries got the nod from the
FDA to market cheaper generic versions of celecoxib capsules in 50
milligram, 100 mg, 200 mg, and 400 mg strengths. Mylan
Pharmaceuticals Inc. received permission to market 50 mg celecoxib
capsules, the agency said.
"It is important for patients to have access to affordable treatment options for chronic conditions," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in an agency statement. "Health care professionals and patients can be assured that these FDA-approved generic drugs have met our rigorous approval standards."
Celecoxib also falls into the category known as a non-steroidal
anti-inflammatory drug (NSAID). According to the FDA, like all
NSAID medications, generic celecoxib will "have a Boxed Warning in
their prescribing information (label) to alert health care
professionals and patients about the risk of heart attack 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 FDA noted that potential side effects of celecoxib for
people with arthritis include "abdominal pain, diarrhea,
indigestion (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
Find out more about NSAID pain relievers at the
American College of Rheumatology.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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