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Dangerous Drugs
 

Vioxx (Rofecoxib) Recall

New York Vioxx Lawyers Helping Victims Across the United States

Merck & Co., Inc. announced a voluntary withdrawal of Vioxx (rofecoxib) from the U.S. and worldwide market due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients on Vioxx.

Vioxx is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved by the FDA in May 1999 for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of menstrual symptoms. Vioxx was later approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children.

The Food and Drug Administration (FDA) issued a Public Health Advisory on Vioxx. Patients using Vioxx show an increased risk of cardiovascular events (including heart attack and stroke).

If you or a loved one was injured taking Vioxx, call us now at 1-800-621-2020 or contact us.

Common Questions About Vioxx

Vioxx Recall Attorney

What is Vioxx?

Vioxx is an anti-inflammatory medication introduced to the U.S. market in 1999, and was prescribed to relieve the pain, swelling and other symptoms of osteoarthritis. Vioxx belongs to a class of medications known as cyclooxygenase-2, or COX-2, inhibitors.

Why did Merck take Vioxx off the market?
Merck pulled Vioxx off the market based on data indicating the drug increases the risk of heart attack and stroke among users. Merck announced the immediate, voluntary worldwide withdrawal after a three-year colon cancer clinical trial with 2,600 patients revealed that 18 months after patients started taking Vioxx, test results showed an increased risk of heart attacks and other cardiovascular complications.

How can an arthritis drug lead to heart attack and stroke?
Several studies have indicated that Vioxx and other COX-2 inhibitors are known to raise blood pressure and increase the risk of heart attack. Vioxx has also been associated with several other life-threatening side effects, including blood clots, angina and nonbacterial meningitis, severe intestinal damage, ulcerations and bleeding, and kidney damage.

What are the side effects of Vioxx?
Side effects may include, but are not limited to, heartburn, nausea, diarrhea, upper respiratory tract infection, swelling of the lower extremities (legs and/or feet), high blood pressure, itching, stomach ulcers or bleeding, fatigue, vomiting, dark urine, and black stools.

Vioxx is more likely to cause severe intestinal damage, ulcerations and bleeding, blood clots and toxic epidermal necrolysis (a fatal skin disease), than other arthritis pain relievers.

Other health problems include:

  • Serious kidney problems that could lead to acute kidney failure.
  • Serious liver problems.
  • Allergic reactions, such as swelling of the face, lips, tongue, and throat which can cause difficulty breathing or swallowing.
  • The FDA reports that Vioxx has also been linked to at least five cases of a non-bacterial type of meningitis, a rare but serious side effect.

These conditions may come about suddenly with few or no symptoms. If left untreated, hospitalization or even death can occur.

Celebrex and Bextra are also COX-2 inhibitors, should I be concerned?
In light of the Vioxx study findings, several top scientists have stated that the finding of an elevated risk of heart attacks and strokes applies to all COX-2 inhibitors. Clinical trials of Celebrex and Bextra did not reveal the same problems as Vioxx because participants were allowed to take aspirin, which has proved to reduce the risk of cardiovascular problems.

What can I take instead of Vioxx or Celebrex?
Older medications like ibuprofen, naproxen or simply aspirin have been used as alternatives for Vioxx and Celebrex.

What should I do if I am currently taking Vioxx?
Contact your doctor to discuss discontinuing use of Vioxx and possible alternative medications.

What if I have leftover medication? Merck will reimburse patients for unused Vioxx. Patients seeking a refund may return any unused Vioxx tablets and oral suspension to Cellino & Barnes. Our Vioxx team will handle contacting Merck and securing your refund for you. This is a free service and your refund will be sent directly to you.

Cellino & Barnes Vioxx Refund
350 Main Street
2500 Main Place Tower
Buffalo, New York  14202

Patients must include the following information when returning any unused Vioxx tablets and oral suspension:

  1. Name, address and phone number
  2. Unused product in its original pharmacy packaging
  3. Pharmacy receipt corresponding to returned product

Merck will send a full refund of the price paid as reflected on the pharmacy receipt, plus the cost of shipping via regular U.S. mail.

Why didn't the FDA act faster? The studies required by the FDA for approving a drug don't usually run as long as the study Merck was doing on colon polyps. So an effect of a drug that doesn't show up until 18 months after you've started taking it wouldn't have been noticed in the studies the FDA requires for approval.

Why didn't Merck act faster? The voluntary withdrawal of Vioxx from the market is an unusual move for a drug company. Companies usually wait for an order to recall a drug from the FDA, even after serious side effects are found. And a recall is not always the first response to reports of serious side effects. Though each case is different, the usual scenario is for the FDA and the manufacturer to agree on a warning label listing the risks. That's what happened when the first reports of heart problems were connected to Vioxx. In extreme cases, the FDA has tried to restrict sales of some prescription drugs to certain people. In this case, Merck acted voluntarily after seeing preliminary results of a large study it was doing. It notified the FDA, but there was no intervention by the government.

Vioxx Side Effects

This information is intended to provide a brief overview of the side effects associated with Vioxx.

Vioxx (rofecoxib) belongs to a class of non-steroidal anti-inflammatory drugs (NSAIDs) called COX-2 inhibitors.

Clinical trial data concluded that Vioxx is linked to blood clots, which have caused strokes and heart attacks.  In addition, some people have died as a result of the side effects caused by Vioxx.

There are a number of side-effects associated with Vioxx, which include:

  • Abdominal pain and discomfort
  • Chest pains
  • Abscesses
  • Cysts
  • Fluid retention
  • Fever
  • Angina pectoris
  • Atrial fibrillation
  • Hematoma
  • Irregular heartbeat
  • Palpitations
  • Constipation
  • Digestive gas
  • Duodenal problems
  • Flatulence
  • Vomiting
  • Esophagus problems
  • Blurry vision
  • Conjunctivitis
  • Dry throat
  • Nasal congestion
  • Tinnitus 
  • Hypersensitivities
  • Allergies
  • Weigh gain or loss
  • Changes in appetite
  • Infections
  • Asthma
  • Persistent cough
  • Skin blisters and abrasions
  • Dermatitis
  • Herpes
  • Rash
  • Psychiatric problems (e.g. anxiety and depression)
  • Musculoskeletal problems (e.g. joint inflammation, muscular weakness, stiffness, pain)
  • Nervous system problems (e.g. insomnia, migraine, vertigo, spasms)
  • Urogenital problems (e.g. cystitis, menstrual problems, vaginitis)



 








 
 
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