Vioxx (rofecoxib) is a COX-2 inhibitor anti-inflammatory medication which was used as a pain reliever for disorders such as arthritis. Vioxx and several other COX-2 inhibitors were discontinued due to serious side effects caused by the drugs.
Drug Warning: Vioxx
|Classification||COX-2 inhibitor, non-steroidal anti-inflammatory drug|
|Manufacturer||Merck & Co.|
|Dosage form(s)||12.5mg tablet
12.5mg/5ml oral suspension
25mg/5ml oral suspension
|Normal dosage||Adults 12.5 to 25mg daily for arthritis and dysmenorrhea, 50mg may be used for up to 5 days
25 to 50mg for migraine treatment, recommended maximum of 5 treatments per month
Children dosed by weight
Vioxx is a non-steroidal anti-inflammatory drug which works by inhibiting the COX-2 enzyme, partially responsible for inflammatory diseases.
Vioxx was approved to treat:
- Rheumatoid arthritis
- Acute pain
- Painful menstruation
- Juvenile arthritis
- Migraine attacks
Due to serious side effects and after the withdrawal of Bextra, another COX-2 inhibitor, Vioxx was voluntarily discontinued from the U.S. market in 2004.
Vioxx Side Effects
Though Vioxx was developed to have fewer side effects than ibuprofen and older members of the non-steroidal anti-inflammatory drug class (NSAID), COX-2 inhibitors may cause certain adverse events or side effects, some of which may be serious.
Common side effects of Vioxx may include:
- Abdominal pain
- High blood pressure
- Lower extremity edema
More serious side effects of Celebrex may include
- Stomach or gastrointestinal bleeding
- Cardiovascular events such as stroke and heart attack
- Cardiac effects such as hypertension, changes in heart rhythm, and heart failure
- Kidney damage
- Liver damage
- Exacerbation of Aspiring-related asthma
- Serious skin condition including exfoliative dermatitis, Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN)
- Anaphylactic reaction (severe allergic reaction)
- Premature closure of Fetal Ductus Arteriosus (Birth Defect)
Symptoms of serious Vioxx side effects should be reported to a physician immediately. Symptoms of heart attack or stroke, difficulty breathing, loss of consciousness, lack of urination, signs of significant blood loss should be treated as a medical emergency.
Prior to discontinuation, Merck was required by the Food and Drug Administration (FDA) to include two “black box warnings” on all Vioxx labeling. A black box warning is the most severes warning that the FDA can give. A black box warning is also called a “boxed statement” and must be included at the top of prescribing information in a box with a thick, black border.
The black box warning for Vioxx included the link between the medication and serious cardiovascular problems and an increased risk of gastrointestinal bleeding and perforation.
In addition to the Vioxx black box warning, it was also contraindicated and should not be given to patients who:
- Have a known allergy or sensitivity to rofecoxib
- Have a history of asthma or allergy after taking aspirin or other NSAIDs
- Have recently undergone heart bypass
Vioxx is considered a Category C pregnancy medication in the first 30 weeks of pregnancy which indicates a possibility of birth defect. After 30 weeks of pregnancy, it is a Category D which indicates a high risk of birth defect.
Vioxx should be used with caution in patients who:
- Have a history of liver damage
- Have a history of kidney damage
- Have a history of cardiac illness or dysfunction
- Have a history of gastric ulcer or bleeding
Patients should discuss their medical history and medications with their health care providers.
Vioxx Heart Attack Risk & Recall
Due to its enormous popularity, the recall of Vioxx in 2004 was the largest drug recall in history at the time. It was pulled from the market after internal studies by Merck & Co. showed that patients who were prescribed Vioxx were more likely to have cardiovascular problems than patients talking a placebo.
The first (VIGOR) study indicating cardiovascular concerns was conducted to see the degree in which Vioxx was safer on the stomach than an alternative painkiller, naproxen. Results published in 2000, indicated that Vioxx patients were found to have up to five times as many heart attacks as those taking naproxen.
A second 3-year (APPROVe) study conducted to examine Vioxx effect on gastric polyps also showed a significant cardiac risk, with users experiencing cardiovascular events at twice the normal rate. Cardiovascular results were so concerning that the study was discontinued after only 18 months.
In September of 2001, the FDA sent Merck a warning letter regarding their Vioxx advertising campaign, which the FDA believed was minimizing the possible cardiovascular side effects of Vioxx. The FDA required Merck to add a warning to Vioxx concerning the cardiovascular side effects in April of 2002 based on results of the VIGOR study. A Kaiser Permanente examination of 1.4 million patient records between 1999 through 2003 showed approximately 27,785 heart attacks and sudden cardiac deaths that may not have occurred had Vioxx not been used.
In 2004, Merck & Co. voluntarily withdrew Vioxx from the U.S. market, but many patients had already been harmed.
Thousands of Vioxx lawsuits were filed against Merck for injuries caused by the medication. Hundreds of these clients were represented by Seeger Weiss who also represented union health and welfare programs in a class action suit in New Jersey for Merck’s over-charging of union welfare funds for Vioxx. Besides seeking reimbursement for their expenditures to make the arthritis and painkiller drug.
Approximately 27,000 Vioxx medical injury product-liability lawsuits were settled in 2008 when Merck agreed to pay at total of 4.85 $billion. The settlement offer came after Merck lost multiple important bellwether or early lawsuit trials for damages up to $32 million. Merck also agreed to settle a federal class action lawsuit filed by investors for $830 million.