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Merck pulls Vioxx from the Market Due to Serious Problems.
The world's third largest drug manufacturer, Merck and Company pulled Vioxx from the market September 30, 2004. The drug's withdrawal is possibly one of the largest in history, and was not done without realization that serious problems exist with the drug. Vioxx was approved in June 1999 as a new Non Steroidal Antiinflammatory Agent (NSAID) which was effective in blocking the COX-II enzyme. This enzyme plays a key role in inflammation and in pain, and Vioxx was used for it anti-inflammatory, analgesic and anti-pyretic properties. The drug was available as a 12.5, 25, and 50 mg tablet and as an oral suspension for the treatment of pain from osteoarthritis, rheumatoid arthritis, dysmenorrhea and other conditions. It was marketed as a safer NSAID than older less COX II specific inhibitor medications such as Ibuprofen, Naproxen or Aspirin because it carried a lesser risk profile for gastrointestinal bleeding.
Let Us Evaluate Your Vioxx Case
Heavy Marketing Boosts Vioxx Sales Merck heavily promoted Vioxx to both physicians and potential consumers, spending 160.8 million dollars for direct consumer marketing in 2000 alone.You may be familiar with advertisements featuring Dorothy Hamill heavily endorsing the product. Unsurprisingly, annual sales were breathtaking, with 91 million prescriptions written for the drug in the United States alone and worldwide sales last year totalling over 2.5 billion dollars.
Early Health Concerns Ignored Unfortunately, from the beginning there were suggestions of significant risks associated with the drug. "Red flags right from the beginning were ignored because of business issues," said Researcher Eric Topol of the Cleveland Clinic. Harvard University researcher and physician Jerry Avorn feels " ... it's taken far too long for it to be resolved. This information was out there waving in the breeze." Prior to its approval, a study done at the University of Pennsylvania may have suggested that Vioxx could increase the risk of heart attack. Subsequent studies also raised the possibilty that patients taking Vioxx were at significantly higher risk of suffering from heart attacks and other serious compications than were those not taking Vioxx. On Sept. 17, 2001,an eight-page warning letter was sent by the FDA to Merck Chief Executive Raymond Gilmartin.The FDA said that Merck engaged "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, the letter said. Merck was rumored to be arranging a study to prove that Vioxx had a safe cardiovascular profile, but this was never done.
Health Studies Begun Too Late Sadly, Merck did not acknowledge that there was an increased risk associated with Vioxx use. The company claimed that "extensive review" of Vioxx trials showed "no difference" in heart attacks and later proclaimed that Merck "stands behind the cardiovascular safety profile of Vioxx." However, a study begun by Merck in 2000 to assess the efficacy of Vioxx in preventing the recurrence of colon polyps demonstrated a significantly increased cardiovascular risk associated with Vioxx use. Although there were many warning signs along the way, a profit driven corporate culture allowed many patients to be placed in harms way.
Vioxx Side Effects
Recently a report in the Journal of the American Medical Association linked Vioxx to blood clots,
heart attacks, and strokes.
Other serious
side effects associated with Vioxx usage are:
- Serious stomach
problems, such as stomach and intestinal bleeding, can occur with or without
warning symptoms. These problems, if severe, could lead to hospitalization
or death. Although this happens rarely, you should watch for signs that you
may have this serious side effect and tell your doctor right away.
- Serious allergic
reactions including swelling of face, lips, tongue, and/or throat which may
cause difficulty breathing or swallowing occur rarely but may require treatment
right away.
- Serious kidney
problems occur rarely, including acute kidney failure and worsening of chronic
kidney failure.
- Severe liver
problems occur rarely in patients taking NSAIDs. Tell your doctor if you develop
symptoms of liver problems. These include nausea, tiredness, itching, tenderness
in the right upper abdomen, and flu-like symptoms.
More common, non
life threatening, side effects associated with VIOXX have included:
- Upper and/or lower respiratory tract infections
- Respiratory tract inflammation
- Asthma
- Headache
- Backache
- Dizziness
- Fatigue
- Diarrhea
- Abdominal pain
- Stomach pain
- Heartburn
- Nausea and/or vomiting
- Urinary tract infection.
- High blood pressure
- Irregular Heart rhythm
- Pulmonary embolus
- Meningitis
- Poor Bone Healing
- Bad Outcome Following Orthopedic Procedures
- Swelling of the legs and/or feet
If you believe that you or a loved one has been adversely affected by Vioxx, please fill out the form below. Provide as much information as possible to speed the processing of your inquiry.
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