September 30, 2004
Merck Announces Voluntary Worldwide
Withdrawal of VIOXX
Dear Healthcare Professional:
Merck & Co., Inc., today announced a voluntary worldwide withdrawal of
VIOXX (rofecoxib), its arthritis and acute pain medication. The Company’s
decision, which is effective immediately, is based on new, three year data from
a prospective, randomized, placebo-controlled clinical trial, the APPROVe
(Adenomatous Polyp Prevention on VIOXX) trial.
The trial, which is being stopped, was designed to evaluate the efficacy of
VIOXX 25mg in preventing recurrence of colorectal polyps in patients with a
history of colorectal adenomas. In this study, there was an increased relative
risk for confirmed cardiovascular (CV) events, such as heart attack and stroke,
beginning after 18 months of treatment in the patients taking VIOXX compared to
those taking placebo. The results for the first 18 months of the APPROVe study
did not show any increased risk of confirmed CV events on VIOXX, and in this
respect are similar to the results of two placebo-controlled studies described
in the current US labeling for VIOXX.
We are taking this action because we believe it best serves the interests of
patients. Although we believe it would have been possible to continue to market
VIOXX with labeling that would incorporate these new data, given the
availability of alternative therapies, and the questions raised by the data, we
concluded that a voluntary withdrawal is the responsible course of action.
APPROVe was a multi-center, randomized, placebo-controlled, double blind
study to determine the effect of 156 weeks (3 years) of treatment with VIOXX on
the recurrence of neoplastic polyps of the large bowel in patients with a
history of colorectal adenoma. The trial enrolled 2600 patients, and compared
VIOXX 25 mg to placebo. The trial began enrollment in 2000.
Results of the VIGOR (VIOXX GI Outcomes Research) study, released in March
2000, demonstrated that the risk of gastrointestinal (GI) toxicity with VIOXX
was less than with naproxen, but indicated an increased risk of cardiovascular
events versus naproxen. However, in other studies including our Phase III
studies that were the basis of regulatory approval of the product, there was not
an increased risk of CV events on VIOXX compared with placebo or VIOXX compared
with other non-;naproxen NSAIDS. Merck began long–term randomized clinical
trials to provide an even more comprehensive picture of the cardiovascular
safety profile of VIOXX.
Merck has always believed that prospective, randomized, controlled clinical
trials are the best way to evaluate the safety of medicines. APPROVe is
precisely this type of study––and it has provided us with new data on the
cardiovascular profile of VIOXX. While the cause of these results is uncertain
at this time, they suggest an increased risk of confirmed CV events beginning
after eighteen months of continuous therapy. While we recognize that VIOXX
benefited many patients, we believe this action is appropriate.
Merck has informed the FDA of our decision. Physicians should discontinue
VIOXX in patients currently taking VIOXX and consider possible alternative
treatments.
The results of clinical studies with one molecule in a given class are not
necessarily applicable to others in the class. Therefore, the clinical
significance of the APPROVe trial, if any, for the long term use of other drugs
in this class, consisting of COX-2 specific inhibitors and NSAIDs, is unknown.
If a patient asks you about returning unused VIOXX, please advise the patient
that Merck will reimburse them for the cost of unused product. Instructions for
patient reimbursement are attached and are posted at www.vioxx.com or can be
obtained by calling NNC directly at 1-800-805-9542.
Patients and health care professionals may obtain information from http://www.merck.com/ and
www.vioxx.com, or may call 1-888-36-VIOXX (1-888-368-4699).
The Prescribing Information for VIOXX accompanies this
letter.
Sincerely,
William F. Keane, MD
Vice President
US Medical and
Scientific Affairs
These instructions are specifically for patients. Other customers, such as
Pharmacies and Wholesalers/Distributors, will receive separate instructions on
how to return product and receive credit.
Instructions for patients on how to receive refund for
unused VIOXX
Merck will reimburse patients for unused VIOXX® (rofecoxib).
Merck is offering patients a full refund for the amount they paid
out-of-pocket for VIOXX prescriptions that remained unused as of September 30,
2004.
Patients seeking a refund for unused VIOXX should contact the National
Notification Center (NNC) at 1-800-805-9542. Patients who call that number will
receive a patient return kit directly from NNC which may be returned via UPS
(United Parcel Service). The return kit includes a shipping container and a
prepaid UPS shipping label, with complete instructions. Completed return kits
can be placed into a UPS drop or delivered to a UPS drop-off location, or the
patient can arrange for pick-up by calling UPS at 1-800-PICK-UPS. Refunds may
take four to six weeks.
- Physician Notification Letter
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PERSONAL INJURY / TORTS LAW DIRECTORY