Ellen Campbell -Grizzle - PHARMACY TODAY MERCK, THE manufacturer of Vioxx (Rofecoxib) voluntarily withdrew the product used to treat arthritis and acute pain. This meant that pharmacists stopped dispensing the drug. Patients who were taking Vioxx were asked to visit their physicians for reassessment and change of therapy. There were an estimated two million consumers taking the drug at the time of its removal from the market.
Merck explained that during a study to evaluate the effectiveness of Vioxx in preventing the reoccurrence of colorectal polyps, researchers observed a comparative increased risk for heart attacks and strokes. This was after 18 months of treatment with Vioxx compared to those on placebo (sugar pill).
Vioxx is a Cyclooxygenase 2 (COX-2) selective nonsteroidal anti-inflammatory drug (NSAID). It inhibits the COX-2 enzyme which plays a central role in the production of pain and inflammation within the body. Vioxx is a prescription medicine (List 4) used to relieve the signs and symptoms of arthritis, acute pain in adults and painful menstrual cycles. There are alternatives within this class of medication. However, you should consult your doctor to determine the treatment that is right for you.
MAJOR CONCERN
There is a major concern as to the safety of the other drugs in this class. However, the results of clinical studies with one drug in a given class do not necessarily apply to other drugs in the same class. All of the NSAIDs have risks, especially of bleeding in the stomach and toxicity related to the liver and kidney, when taken for prolonged periods.
The risk of stomach bleeding is lower with COX-2 drugs. Patients who use COX-2 drugs for long periods require regular monitoring. The U.S. Food and Drug Administration (FDA) indicated that in April 2002, it instructed Merck to implement labelling changes to include information about the increase in risk of cardiovascular events including heart attack and strokes. The FDA was in the process of reviewing the most recent results when Merck withdrew the product.
All drugs have side effects. Despite rigorous testing before marketing, the extent of some of these risks does not usually show up until after a period of time during the post-marketing phase. In most countries, post- marketing surveillance is an important activity in ensuring drug safety. Patients have an important role to play by reporting untoward medication side effects to their prescribers and pharmacists.
It is advised that patients heed the advice of pharmacists about the adverse effects of any drug and further to follow the methods recommended to reduce the occurrence of these effects.
Here are some important don'ts - do not change the dose of your medication without consulting your physician; do not share your medication with others; do not use expired drugs and do not add other painkillers, including aspirin, paracetamol and ibuprofen, to your medication mix, if you are taking NSAIDS.
Persons who are prone to asthma, excessive itching and running nose should be very careful with the use of NSAIDS and elderly persons on medication should be closely monitored. As always, store your medication safely and out of the reach of children.
Ellen Campbell-Grizzle, president, Caribbean Association of Pharmacists; director, Information and Research, National Council on Drug Abuse.
