Archive – Frequently Asked Questions – Vioxx Recall By Merck

Starting date:

September 30, 2004

Posting date:

September 30, 2004

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Important Safety Information, Product withdrawal

Audience:

General Public

Identification number:

RA-11000222

Q Who announced the withdrawal of Vioxx^®?

A: Merck & Co., Inc. of Whitehouse Station, New Jersey, U.S.A., announced the worldwide voluntary withdrawal of Vioxx^® (rofecoxib) on September 30, 2004. Merck & Co. made this decision independent of Health Canada (HC).

Q What is Vioxx^®?

A: Vioxx^® is a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID). Vioxx^® is also related to the nonselective NSAIDs, such as ibuprofen and naproxen. Vioxx^® is a prescription drug used to relieve signs and symptoms of arthritis, acute pain in adults, and painful menstrual cycles.

Q Why is Vioxx^® being withdrawn?

A: Merck's decision to withdraw Vioxx^®is based on new data from a trial called APPROVe (Adenomatous Polyp Prevention on VIOXX). The purpose of the trial was to assess the effectiveness of Vioxx^®25 mg in preventing the recurrence of colon polyps (abnormal tissue growth, which may or may not be cancerous). In the APPROVe trial, Vioxx^® was compared to a placebo (sugar pill). The trial indicated an increased risk of serious cardiovascular events, such as heart attacks and strokes, after 18 months of continuous treatment. The trial was stopped early.

Q What should I do if I am taking Vioxx^®?

A: The risk that an individual patient will suffer a heart attack or a stroke related to Vioxx^® is very small. Patients should contact their physician to discuss discontinuing use and alternative treatments.

Q Can pharmacists continue to fill prescriptions for Vioxx^®?

A: No. Merck Frosst Canada & Co.. is withdrawing Vioxx^® from all distribution channels in Canada, including the pharmacy and retail levels and Vioxx^® will no longer be available.

Q What should I do with my unused Vioxx^® medications?

A:  Patients should return unused medications to their pharmacy or point of sale. Patients should not flush unused medications down the toilet or sink to avoid contaminating ground or municipal water systems.

Q What are the possible long-term health effects of taking Vioxx^®?

A The new study by Merck shows that long-term use of Vioxx^® (longer than 18 months) may cause an increased risk of cardiovascular events, such as heart attacks and stroke during chronic use.

Q What other drugs are similar to Vioxx^®?

A: Other COX-2 selective NSAIDs currently available are Celebrex (celecoxib) and Bextra (valdecoxib). Both are approved for use in Canada. Health Canada will be reviewing safety data with respect to these drugs as it becomes available and will continue to inform the public and healthcare professionals of any new safety information.

Q What is Mobicox and is it an alternative to Vioxx^®?

A: Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) approved for use in Canada since 2000, and now marketed here by numerous companies. The product marketed by Boehringer Ingelheim has the trade name Mobicox™. Meloxicam is indicated for symptomatic relief of rheumatoid arthritis and painful osteoarthritis in adults. Unlike Vioxx^®, meloxicam is not indicated for the relief of non-arthritic pain in adults.

Q What are the risks of taking alternatives to Vioxx^®?

A The results of clinical trials with one drug in a given class do not necessarily apply to other drugs in the same class. However, all of the non-steroidal anti-inflammatory drugs (NSAIDs) have risks when taken long term. These risks include stomach bleeding, and liver and kidney toxicity. Patients using these drugs for longer than two weeks should be under the care of a physician.

Q How can I report a serious side effect from Vioxx^® or any other medication to Health Canada?

A: Serious side effects can be reported either through your doctor or directly to the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada. Health professionals and consumers may report adverse reactions toll-free at: 866-234-2345, by mail or fax, by using the form found at the following website:

• Adverse Reaction Information – How To Report

Q Did Health Canada require the withdrawal?

A: No. This withdrawal is the decision of the company to no longer sell the product.

Q How do pharmaceutical companies inform pharmacy associations that they are withdrawing a drug?

A When a product is withdrawn, the pharmaceutical company will send out notices to its customers to inform them of the withdrawal and the proper disposal of the product. The company can also inform pharmacists and practitioners through a Dear Health Care Professional letter.

Q How long does it take to get the message to pharmacies?

A: Companies typically FAX or mail the information, hence the information is normally available within 24-48 hours.

Q Why did a pharmacy still have the product on September 30?

A: Recall notices had not yet been sent out to Canadian pharmacies.

Q Have recall notices been sent now?

A: Recall notices are to be sent by the company in the course of the day (September 30, 2004).

Q When was Health Canada notified about the recall of Vioxx^®?

A Health Canada received official notice of the withdrawal of Vioxx^® by letter from Merck Frosst Canada & Co., on the morning of September 30, 2004.

Q When was Vioxx^® approved for use in Canada?

A Vioxx^® was approved in October, 1999, in liquid and tablet forms for the treatment of acute and chronic signs and symptoms of osteoarthritis, relief of menstrual pain, and relief of acute pain in adults and was first marketed in November, 1999. In April 2003, the acute and chronic treatment of the signs and symptoms of rheumatoid arthritis in adults was granted approval by Health Canada.

Q Has Health Canada tracked any cardiovascular adverse events related to this drug?

A: Yes, Health Canada has been looking at cardiovascular events as they relate to Vioxx^®.

In 2002, Health Canada issued an advisory, which included preliminary information about increased risk of cardiovascular events related to the use of Vioxx^®. The advisory was prompted by the results of a study entitled VIGOR (Vioxx^® Gastrointestinal Outcomes Research). Subsequently, Health Canada implemented labelling changes to reflect the findings from the VIGOR study, specifically the inclusion of information that Vioxx^® should be used with caution in patients with a history of heart disease.

Health Canada has been looking at post-market information about cardiovascular events as they relate to Vioxx^® and other selective COX-2 inhibitor NSAIDs since 2000.

Q The FDA will now be requiring more safety data and longer studies before approving drugs in this class, will Health Canada require this also?

A: After the Vigor study for Vioxx^® and the class study for Celebrex, larger and longer trials became the norm in Health Canada for approval of drugs in this class (since 2002).

Q What is Vioxx^® used for?

A: Vioxx^® (rofecoxib) is indicated for:

• Acute and chronic treatment of the signs and symptoms of osteoarthritis; used daily in chronic treatment, typically at doses of 12.5 mg/d, sometimes 25 mg/d.
• Acute and chronic treatment of signs and symptoms of rheumatoid arthritis in adults; used daily in chronic treatment, typically at doses of 12.5 mg/d, sometimes 25 mg/d.
• Relief of pain and treatment of primary dysmenorrhea; management of acute pain for up to 5 days, initially at 50 mg/d, subsequently at 25 or 50 mg/d. Chronic use of 50 mg/d is not recommended. Off-label use had included extended use at 50 mg/d ("high") dose.
• In Canada, Vioxx^® has not been authorized for pediatric use.