Medications and Drugs

Please Note: This Drug has been voluntarily withdrawn from the market.
GENERIC NAME: rofecoxib
BRAND NAME: Vioxx
IMPORTANT NEWS ALERT -
September 30, 2004 the Food and Drug Administration (FDA) today acknowledged the voluntary withdrawal from the market of Vioxx (chemical name rofecoxib), a nonsteroidal antiinflammatory drug (NSAID) manufactured by Merck & Co. FDA today also issued a Public Health Advisory to inform patients of this action and to advise them to consult with a physician about alternative medications.
Merck is withdrawing Vioxx from the market after the data safety monitoring board overseeing a long-term study of the drug recommended that the study be halted because of an increased risk of serious cardiovascular events, including heart attacks and strokes, among study patients taking Vioxx compared to patients receiving placebo. The study was being done in patients at risk of developing recurrent colon polyps.
To view the FDA press release, please see the recall posting "Vioxx Withdrawn From Market."
DRUG CLASS AND MECHANISM: Rofecoxib is a nonsteroidal
anti-inflammatory drug (NSAID) that is used to treat pain,
particularly the pain of osteoarthritis and menstrual cramps.
Prostaglandins are chemicals that are important in promoting
inflammation and its signs--pain, fever, swelling and tenderness.
Rofecoxib blocks the enzyme that makes prostaglandins (cyclooxygenase-
2) and thereby reduces the amounts of prostaglandins. As a
consequence, inflammation and its accompanying pain, fever, swelling
and tenderness also are reduced. Rofecoxib is similar to celecoxib
(Celebrex). Both drugs differ from other NSAIDs
in that they cause less irritation and ulceration of the stomach and
intestine
(at least during short-term treatment), and they do not interfere
with the clotting
of blood.
GENERIC AVAILABLE: No
PRESCRIPTION: Yes
PREPARATIONS: Tablets: 12.5 mg, 25 mg, and 50mg. Oral
Suspension: 12.5 mg/5 mland 25mg/5ml
STORAGE: Store at room temperature, 15-30°C (59-86°F)
PRESCRIBED FOR: Rofecoxib is used for treating the pain,
swelling, and tenderness caused by osteoarthritis and rheumatoid arthritis in adults. Rofecoxib is also used for treating
acute pain such as headache and menstrual cramps.
DOSING: The lowest effective dose should be used. For the
management of
osteoarthritis, the usual dose is 12.5 mg (tablet or suspension) once
daily.
The maximum dose is 25 mg once daily. For the treatment of acute
pain and menstrual cramps the usual dose is 50 mg once daily. It may
be taken with or without food.
DRUG INTERACTIONS: Concomitant use of rofecoxib with
aspirin or other NSAIDs (e.g., ibuprofen, naproxen, etc.) may
increase the occurrence of stomach
and intestinal ulcers. Since NSAIDs may increase the concentration of
lithium in the
body, lithium levels should be monitored during and after therapy
with rofecoxib.
Rofecoxib may accentuate the effect of the anticoagulant (blood
thinner) warfarin
(Coumadin), and promote bleeding. Persons taking warfarin should have
the clotting of their blood tested, particularly during the first few
days after starting or stopping rofecoxib.
Rifampin decreases the concentration of rofecoxib in the body by 50%
and thus may reduce the effectiveness of rofecoxib.
Rofecoxib may increase the concentration of methotrexate by 23% and
may lead to increased side effects of methotrexate. Persons taking
both drugs should be closely monitored for these side effects.
Persons who drink more than three alcoholic beverages per day may be
at increased
risk of developing stomach ulcers when taking NSAIDs. This also may
be true with
rofecoxib.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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