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GENERAL INFORMATION |
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Vioxx
Dangers, Vioxx Recall
and Vioxx Suit Timeline
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- May 1999: Vioxx Introduced
Merck introduces Vioxx to the market
with great fanfare. The FDA approves Vioxx
for arthritis pain as well as other kinds
of pain in adults. Vioxx is sold in over
80 countries.
- 2000: Merck Spends Millions on Vioxx
Marketing
Merck spends $161 million on Vioxx
advertising (more than Pepsi or Budweiser
spent on advertising that year).
- November 2000: Vioxx Trial Results
Published, Vioxx Dangers Reported
The New England Journal of Medicine publishes
the results of a Merck trial called Vigor.
It showed that patients taking the drug were
four times as likely -- 0.4% to 0.1% -- to
have a heart attack or stroke as patients
taking the over-the-counter pain reliever
naproxen.
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- Early 2001: FDA Meets To Discuss Findings
At a meeting of an FDA advisory panel,
Merck argues that the trial results might reflect
the protective effects of naproxen and not
danger from its drug. The committee ends up
recommending that the issue be noted on Vioxx's
label, and members call for follow-up research
to clear up the questions.
- February 2001: FDA Approves Vioxx Re-Labeling
FDA Approves Merck request to label Vioxx as safer on the stomach than
older painkillers, giving the drug a slight but important edge over
Celebrex.
- August 2001: Further Examination of
Vioxx Adverse Effects Published Doctors
at the Cleveland Clinic examine data from
several trials of Vioxx patients and publish
their findings in the Journal of the
American Medical Association, claiming
the “available data raise a cautionary
flag about the risk of cardiovascular events" with
Cox-2 inhibitors, especially Vioxx.
- September 17, 2001: FDA Letter Warns
Merck on Advertising and Vioxx Side Effects
In an eight-page letter to Merck Chief
Executive Raymond Gilmartin, the FDA warns
Merck for engaging "in a promotional campaign
for Vioxx that minimizes the potentially serious
cardiovascular findings that were observed" in
a clinical trial comparing Vioxx to naproxen,
a less-expensive painkiller. "Your promotional
campaign discounts the fact" that in the
trial, "patients on Vioxx were observed
to have a four to five-fold increase" in
heart attacks, compared with patients on naproxen,
the letter said.
- April 2002: FDA Approves New Vioxx
Labeling
The FDA, following up on the advisory
panel's advice from the year before, approves
new labeling for Vioxx that points out the
association with higher heart-attack and stroke
risk.
- 2003: High Volume of Vioxx Sales
Worldwide sales of Vioxx reach $2.5
billion.
- October 2003: Merck Study Finds Increased
Vioxx Risk
Merck-funded study finds patients taking Vioxx are at a 39% increased
risk of heart attack within the first ninety days, compared with Celebrex.
- Early 2004: Merck Faces Securities
Litigation
A securities class action complaint is filed on behalf of several Merck
investors alleging the company engaged in a marketing campaign that
included false and misleading statements concerning the safety profile
of Vioxx and that company insiders sold personally held shares of Merck
for over $175 million in proceeds.
- August 2004: Kaiser Reconsiders Vioxx
HMO Kaiser Permanente reconsiders Vioxx for its member patients after
an FDA study finds that patients who had taken more than 25 mg a
day were 3.15 times more likely to have a heart problem.
- September 30, 2004: Vioxx Pulled from
Market
Merck withdraws Vioxx from the market. The FDA issues a Public Health
Advisory to inform patients of this action and to advise them to consult
with a physician about alternative medications.
- October 6, 2004: Editorials Question
Safety of All Arthritis Drugs; Call for
Formal Investigation of Merck
The New England Journal of Medicine issues two editorials calling
for renewed scrutiny into the entire class of arthritis drugs to see
if other drugs in the category also cause heart problems. In one editorial,
Cleveland Clinic cardiologist Eric Topol, who was the first to raise
the alarm about Vioxx three years ago, calls for a formal government
investigation into how Merck and the U.S. Food and Drug Administration
left Vioxx on the market for so long after concerns about its possible
heart risks had been raised.
- November 5, 2004: A study in Britain's The
Lancet concludes Vioxx Should Have
Been Pulled from Market in 2000
The British Medical Journal The Lancet published a study that
concluded Merck and Federal officials should have withdrawn the painkiller
Vioxx from the market as early as 2000 because studies of the drug
had clearly shown that it doubled the risk of heart attack among users.
- November 2004: Vioxx Investigations
Launched
The Justice Department and the Securities & Exchange Commission
launch investigations into Merck's handling of Vioxx. U.S. Senate begins
hearings on how Merck and the FDA responded to safety concerns about
Vioxx.
- December 9, 2004: New FDA Warning Released
FDA warns that people who have recently had heart-bypass surgery shouldn't
take Bextra, after a study showed patients who had just had cardiac
surgery and were treated with Bextra were more likely to have heart
and blood clotting problems than those who didn't receive the drug.
- December 17, 2004 - Celebrex Problems
Found
Pfizer said a government-sponsored study of Celebrex in cancer prevention
found a significant risk of cardiovascular problems. A second cancer
study released simultaneously, though, showed no increased risk. Pfizer
declined to recall Celebrex and advised patients using Celebrex to
consult with their doctors.
- December 21, 2004 - Naproxen/Aleve
Problems Found
A government clinical trial showed an increased risk for heart attacks
and strokes in patients taking Naproxen, sold by Bayer under the brand
name Aleve. The FDA recommends consumers limit their use of naproxen
to the amount suggested on the label and not take the pills for longer
than ten days unless advised to do so by a doctor.
- April 7, 2005 - Bextra Withdrawn From
Market
Pfizer Inc. agrees to voluntarily recall its painkiller Bextra at the
request of the U.S. Food and Drug Administration due to the risk of
heart attack and stroke. The FDA also asks Pfizer to include a black
box warning on its painkiller Celebrex.
- August 19, 2005 - Merck Found Liable
in Vioxx Death
In the first Vioxx
product liability trial, a Texas state court
jury finds Merck liable or the death of Robert
Ernst, who took Vioxx, awarding his widow,
Carol Ernst, $253.4 million in damages.
- December 8, 2005
- Editorial Says Merck Concealed Heart
Attacks in Clinical Study
An editorial in the New England Journal of Medicine said Merck
concealed heart attacks suffered by three patients during a clinical
study of Vioxx in a report on the study published in the Journal in
2000.
- February
17, 2006 - Merck Cleared of Responsibility
in the Death of Florida Man
A federal jury clears Merck & Co.
of any responsibility in the death of a 53-year-old
Florida man who had a heart attack after taking
Vioxx for less than a month.
- April 5, 2006 - New Jersey Man
Wins $4.5 Million Verdict Against Merck
A state jury
finds Merck & Co. liable for one of two former
Vioxx users’ heart attacks and orders $4.5
million in damages in a closely-watched trial
involving two New Jersey men.
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