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GENERAL INFORMATION |
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FDA Public Health Advisory: Safety of Vioxx |
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| September 30, 2004
-- Merck & Co., Inc. today announced a voluntary
withdrawal of Vioxx from the U.S. market due
to safety concerns. |
| 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. It is also approved
for the relief of the signs and symptoms
of rheumatoid arthritis in adults and children. |
| The Agency was informed
by Merck & Co., Inc. on September 27, 2004,
that the Data Safety Monitoring Board for an
ongoing long-term study of Vioxx (APPROVe)
had recommended that the study be stopped early
for safety reasons. The study was being conducted
in patients at risk for developing recurrent
colon polyps. |
| The study showed an
increased risk of cardiovascular events (including
heart attack and stroke) in patients on Vioxx
compared to placebo, particularly those who
had been taking the drug for longer than 18
months. Based on this new safety information,
Merck and FDA officials met the next day, September
28, 2004, and during that meeting FDA was informed
that Merck was voluntarily withdrawing Vioxx
from the market place. |
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| The risk that an individual
patient taking Vioxx will suffer a heart attack
or stroke related to the drug is very small.
Patients who are currently taking Vioxx should
contact their physician for guidance regarding
discontinuation and alternative therapies. |
| The FDA is working
closely with Merck to coordinate the withdrawal
of this product from the U.S. market place.
Healthcare professionals are advised to contact
Merck at 1-888-368-4699 or at www.merck.com or
at the FDA’s Drug Information Office at
301-827-4573 or 1-888-463-6332. |
| Founded in 1972, Lieff
Cabraser Heimann & Bernstein, LLP is an over fifty attorney
law firm with offices in San Francisco, New York
and Nashville. For the last five years,
the National Law Journal has recognized
Lieff Cabraser as one of the top 20 plaintiffs’ law
firms in America. |
| For our personal injury
cases, we bring a team of experienced lawyers.
Each client is assigned an individual lawyer. In
addition, we have on staff multiple nurses, legal
assistants, scientific analysts and case clerks
to assist the attorneys. To learn more about our
firm, click here. |
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| Trademark
Notice: Personal Injury Lawyer America is an electronic newsletter
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represents clients in a wide range of cases, including personal
injury and wrongful
death lawsuits. Our personal injury attorneys
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and support possible for our clients. This website provides information
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defects and related lawsuits. |
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About Lieff Cabraser: We have
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represented clients in personal injury, wrongful death and
rollover crashes and product defect lawsuits across America, including
residents of Alaska, Alabama, Arkansas, Arizona, California,
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Among the cases our personal injury
attorneys are prosecuting are the Medtronic heart lead recall, the
AMO contact lens solution recall, the Peter Pan peanut butter recall, Guidant
pacemaker defects, SUV
rollover accidents, popcorn
workers lung injuries, and Ford
switch fires.
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| Copyright © 2008 Lieff Cabraser Heimann & Bernstein, LLP |
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