| VIOXX™ (rofecoxib) - Merck™Merck & Co., Inc. announced a voluntary withdrawal of Vioxx (rofecoxib) from the U.S. and worldwide market due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients on Vioxx. Vioxx is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved by FDA in May 1999 for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of menstrual symptoms. Vioxx was later approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children. - Statement by Dr. Steven Galson, Acting Director, Center for Drug Evaluation and Research (CDER), Regarding November 18, 2004, Committee on Finance of the U.S. Senate Hearing on Drug Safety and the Worldwide Withdrawal by Merck & Co., Inc., of Vioxx. FDA Statement (11/18/2004)
- Congressional Statement on Vioxx and Drug Safety (Posted 11/18/2004)
- FDA releases a statement on Vioxx and recent allegations, and on the Agency’s continued commitment to sound science and peer review. FDA Statement (Posted 11/17/2004)
- Slide Presentation by Sandra Kweder, M.D., November 10, 2004. [HTML] [PowerPoint] (Posted 11/10/2004)
- FDA Acts to Strengthen the Safety Program for Marketed Drugs. FDA Statement (11/5/2004)
- FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product. FDA News (9/30/2004)
- FDA Public Health Advisory: Safety of Vioxx (9/30/2004)
- Vioxx (rofecoxib) Questions and Answers (9/30/2004)
SOURCE: FDA CENTER FOR DRUG EVALUATION AND RESEARCH |
VIOXX™ NEWS | A Mass of Confusion
Winston-Salem Journal, NC
... Dr. Hayes Wilson, an Atlanta rheumatologist who testified before the FDA panel, is pleased that Vioxx could go back on the market. ... |
FDA ponders future for Cox-2 drugs
American Medical News
... The FDA panel met for three days to grapple with the safety issues that surfaced when Merck voluntarily withdrew its Cox-2 selective NSAID Vioxx (rofecoxib ... |
FDA panel suggests warning labels for Vioxx
Johns Hopkins News-Letter, MD
... US FDA panelists voted to allow sales of Vioxx, Celebrex, and ... After weighing the issue of benefits versus risks, the panel concluded that the benefits ... |
Merck: Vioxx may alter incentive pay
BusinessWeek
... its 2005 performance share units granted earlier this year may be affected from the establishment of reserves for any potential liability over Vioxx litigation ... |
Idaho lawsuit filed against Vioxx
IdahoStatesman.com, ID
• That Merck refund all sums paid for Vioxx by plaintiffs in the class action suit. • That Merck pay for doctor's visits and ... |
Strong medicine
Nature.com, UK
... The US public was made painfully aware of this yawning gap last September, when drugmaker Merck abruptly withdrew Vioxx, its blockbuster painkiller, after it ... |
Side Effects of the COX-2 Controversy
American Council on Science and Health
COX-2 inhibitors such as Vioxx have become the targets of Congressional hearings and a proposed post-approval drug monitoring body, but in all the hype about ... |
How Merck Stacked The Vioxx Deck
DisInfo.com
'The same week that drug manufacturer Merck pulled its highly profitable painkiller, Vioxx, from the market last September, acknowledging that it was linked to ... |
The man who's behind Merck's Vioxx defense
Philadelphia Inquirer, PA
... Inc.'s top staff lawyer, Kenneth C. Frazier, brings an unusual resume to the job of fighting the hundreds of lawsuits filed over Vioxx, the painkiller it ... |
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