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Vioxx and Possible Side Effects

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Vioxx is the brand-name drug of the generic drug Rofecoxib. It is a Cyclooxygenase-2 (COX-2) selective, non-steroidal anti-inflammatory drug (NSAID). Constitutive expression of COX-2 is essential in therapeutic treatment as NSAIDs may lead to renal and cardiovascular side effects in healthy patients. Rofecoxib received FDA approval for the treatment of fever, symptomatic relief of inflammation and pain from osteoarthritis, primary dysmenorrhea, fever, and acute pain.

The drug product Vioxx was originally approved in May 1999 by the FDA. In September 2004, the Vioxx manufacturer, Merck & Co., Inc., issued a voluntary withdrawal of the drug product worldwide. While FDA action was not required for the voluntary withdrawal, the company was made aware of the significant safety concerns for individuals. That same year, a public health advisory was issued by the FDA regarding the use of the drug product.

Manufacturers of defective and dangerous products must be held accountable for the harm that results from product use. Our legal team has extensive experience handling product liability cases. If you have experienced harmful effects from the use of the drug product Vioxx, contact our law firm to discuss your potential case in detail in a free consultation with an experienced attorney. We will go over the specifics of your case and determine your best options moving forward.

What are the Side Effects of Vioxx?

The significant factor behind the 2004 recall of the drug product Vioxx was the unsettling list of potential side effects that patients experienced while using the medication. These ranged in severity from mild to severe, including:

  • Diarrhea
  • Dizziness
  • Headache
  • Hypertension
  • Respiratory infections
  • Swelling of the feet or legs
  • Urinary tract infection (UTI)
  • Upset stomach, vomiting, and nausea
  • Severe stomach issues, such as intestinal bleeding
  • Serious cardiovascular events, like stroke and heart attacks
  • Severe allergic reactions, such as shock, wheezing, hives, and more
  • Serious liver problems, including liver failure, jaundice, and hepatitis
FDA Study on the Harmful Effects of Vioxx

FDA Office of Drug Safety associate director Dr. David Graham provided testimony in November 2004 regarding the findings of the study of the drug Vioxx. Merck conducted a study (090) on Vioxx before it received FDA approval. The findings in the study indicated almost a 7-fold increase in the risk of heart attack for patients taking a low dosage of the drug. During the time of FDA approval, labeling did not disclose any risk of heart attack from the use of the medication.

Merck conducted another clinical trial (VIGOR) in November 2000. The clinical findings indicated a 5-fold increase in the risk of heart attack for individuals using a high dosage of the drug product. Following the publication of the VIGOR results approximately 18 months later, the FDA issued a labeling change on the risk of heart attack from a high dosage of Vioxx. However, it was not placed in the Warnings section of the drug product.

The FDA conducted a study into Vioxx to determine the risk of sudden death and heart attack in August 2004. In comparison to Celebrex, the competitor for Vioxx, it was determined that Vioxx increased the sudden death and heart attack risk by 1.5-fold for low drug dosage and 3.7-fold for high drug dosage. The report from the study also indicated that approximately 88,000 to 139,000 individuals in the United States experienced strokes and heart attacks from the use of Vioxx.

What is a Drug Product Liability Case?

Individuals taking prescription or over-the-counter drugs typically do not expect to experience severe and unexpected side effects and harm. The unfortunate reality is that it is not always the case. Every day, unsuspecting consumers experience significant harm from dangerous medications. An individual may have grounds for a drug product liability case when they experience harmful side effects from the use of a drug product. Furthermore, manufacturers may also be held liable for the failure to adhere to FDA regulations for drug labeling and other drug product approval criteria.

If a pharmaceutical fails to uphold FDA regulations and an individual experiences significant harm from the use of the drug product, the manufacturer may be held strictly liable for damages incurred through a California drug product liability case. There must be clear and compelling evidence demonstrating intended drug use and the unforeseen dangers or hazards that directly result from taking the medication. Working with a California drug product liability lawyer with the resources, knowledge, and experience to effectively manage your case is essential for a favorable resolution.

A skilled attorney can help their client seek full compensation for adverse effects from the intended use of a drug product, such as Vioxx and other medications. A successful case may provide a plaintiff with the compensation they need to cover medical expenses, lost earnings, and other associated losses from the harmful effects of the medication. The best lawyer will go above and beyond for their client by working diligently to hold the pharmaceutical company liable for the dangers and harmful effects of the intended use of their drug products.

What an Attorney Can Do For You and Your Drug Product Liability Case

If an individual hires a lawyer to handle their drug product liability case against a manufacturer, they can depend on their attorney to use their resources, knowledge, and skills to:

  • Independently investigate the drug product
  • Review reports submitted to the FDA database (FAERS) for medication error, drug product quality, and adverse events
  • Work with experts in the field to obtain their insight into a drug product liability case
  • Calculate the fair and reasonable value of non-economic and economic damages with respect to all facts and circumstances involved in the case
  • Protect their client’s rights if the other side disputes the drug product liability case and alleges product misuse on the part of the plaintiff
  • Handle negotiations with the opposing party and take the case to court if necessary

Contact a Drug Product Liability Lawyer in California

If you or a family member has experienced harmful side effects from the use of the drug product Vioxx, it is advisable to seek the assistance of an experienced attorney. Our legal team is available to review your potential Vioxx case and provide advice that is free and friendly. Call our experienced and knowledgeable California drug product liability lawyers at (916) 921-6400 or (800) 404-5400. We are committed to assisting clients in obtaining justice and maximum compensation from negligent pharmaceutical companies and manufacturers in product liability cases.

Photo Credit: By KarolinaGrabowska on Pexels ds [cs 1092]

DISCLAIMER: This document is for informational purposes only and does not constitute a Retainer/Services Agreement. No attorney-client relationship will exist between you and our firm unless and until we enter into a signed Retainer/Services Agreement. The information you obtain at this site is not, nor is it intended to be medical or legal advice. Do not stop taking any medication without consulting your physician.