Vioxx (rofecoxib) is a prescription drug for osteoarthritis and menstrual pain, and acute pain management in adults. It belongs to non-steroidal anti-inflammatory drugs (NSAIDs). It helps in managing the symptoms of arthritis and other causes of acute pain but does not treat the causes.
Vioxx is manufactured by Merck & Co., Inc. (Merck) and was approved by the US Food and Drug Administration in May 1999.
Merck announced on September 30, 2004, that it is implementing a voluntary withdrawal of Vioxx from the worldwide market because of reports of an increase in cardiovascular problems in users of Vioxx.
How NSAIDs Work
NSAIDs are used for the reduction of inflammation in place of steroids since steroids can cause certain side effects after prolonged use. Such side effects could be any or a combination of the following:
- Blurry vision
- Fluid retention often visible in the face
- High blood pressure
- Increased body hair
- Osteoporosis (bone weakening)
- Stomach irritation
- Sudden mood swings, muscle weakness
- Weight gain
Vioxx and others like it are used to treat inflammation to avoid the side effects that steroids may bring, such as gastrointestinal bleeding and ulcers.
History of Clinical Studies on Vioxx
Vioxx has been linked to dangerous side effects as early as August 2001. In a study conducted by the Cleveland Clinic which was published in the Journal of the American Medical Association, it has been found that Vioxx may be linked to the increase in heart attacks, blood clots and strokes in patients.
Other studies and medical journal articles have supported this result and associated Vioxx with the development of heart problems. As a result, the National Stroke Association, the American Heart Association and the Arthritis Foundation have asked Merck to conduct further studies and testing on Vioxx to find out if the drug actually increases heart attack and stroke risks in patients taking it.
Merck then claimed that upon the review of their previous studies, there is no evidence to prove that Vioxx increases the risk of heart problems in patients when compared with other NSAIDs. Because of this, FDA was disappointed that Merck has been minimizing the potential risks associated with Vioxx and sent Merck a warning letter on September 17, 2001. In its letter, the FDA demanded Merck discontinue the promotion for unofficial uses of Vioxx to doctors and required the company to send letters to the medical community regarding the matter.
FDA added rheumatoid arthritis in April 2002 to the list of the approved uses for Vioxx. A new label with a warning for Vioxx was also added to reflect the results of previous studies.
Merck’s Voluntary Withdrawal of Vioxx
Merck announced the withdrawal of Vioxx on September 30, 2004, from the worldwide market. This was a voluntary withdrawal and not ordered by the FDA.
Merck Announces $4.85B Vioxx Settlement
An announcement was made by Merck on November 9, 2007, stating that the maker of Vioxx will put $4.85 billion in a fund to settle most of the lawsuits filed against the company for the injuries and deaths associated with the drug.
Vioxx – Get Legal Help
Even if most medicines are expected to have side effects, it is the duty of the manufacturer of these medicines to inform the medical community and the public of known risks associated with the drugs they produce. Failure to give adequate warning to the public and the medical community of the dangers of the drug makes the manufacturer liable for product liability for any injury that may be caused by their product.
If you or your loved one has suffered any of the dangerous symptoms or unusual reaction after taking Vioxx, go to your doctor or the hospital as soon as possible. You may also consider consulting with an experienced attorney in order to get more information regarding your rights and possible remedies for the injuries you suffered because of the use of Vioxx.