I took Vioxx. What should I be concerned about?
An estimated 20 million Americans took Vioxx for pain. Vioxx has been linked to serious cardiovascular side effects and conditions such as heart attacks and strokes.
The approximate 2 million arthritis-sufferers who are currently taking Vioxx should contact their doctors to discuss alternate treatment options. Merck is currently in the process of notifying health care practitioners of this voluntary recall.
Acting FDA Commissioner Dr. Lester M. Crawford had the following to say about the Vioxx risk:
"Although the risk that an individual patient would have a heart attack or stroke related to Vioxx is very small, the study that was halted suggests that, overall, patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo."
Why was Vioxx recalled?
For years, researchers had been warning about Vioxx and its apparent increased risk of heart attack and stroke. Merck believed that these studies were inconclusive because they weren't conducted under clinical trial involving placebo pills. Placebo pills are "dummy" pills that deliver no treatment to a patient.
On September 30, 2004, drug giant Merck decided to pull Vioxx after a 3-year clinical trial involving placebo pills linked the arthritis drug to serious cardiovascular side effects and conditions such as heart attacks and strokes for those taking Vioxx longer than 18 months. Those study participants who took Vioxx had a 3.5% risk for suffering a heart attack or stroke compared to a 1.9% risk for those who took the placebo. The results did not find any significant risk increase during the first 18-months of Vioxx use. The cause for this risk increase is unknown at this time.
Currently, it is not known if the risk for heart attack or stroke diminish after Vioxx is discontinued. Participants who took Vioxx in the study will continue to be monitored to see when - and if - their risk level falls since dicontinuing their use of Vioxx.
What is a voluntary recall?
Merck issued a voluntary recall of its arthritis drug Vioxx. A voluntary withdrawal occurs when a company makes an independent decision to recall a product. This recall was not required by the FDA - Food & Drug Administration - as the agency did not have the opportunity to review the study in question before Merck made its decision. What are the negative effects of Vioxx? Study participants who took vioxx longer than 18 months had a 3.5% risk for suffering a heart attack or stroke compared to a 1.9% risk for those who took the placebo.
The most serious conditions that Vioxx has been linked to are:
Read more about Vioxx.
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