Why does Health Canada remove certain drugs and medications from the market?

On October 4, 2007, Health Canada retracted the market authorization for the sale of Prexige (lumiraboxib), an anti-inflammatory drug to treat the signs and symptoms of osteoarthritis in adults. So, why does Health Canada suddenly decide to withdraw certain products from the market? The answer is quite simple: to protect our health!

On October 4, 2007, Health Canada retracted the market authorization for the sale of Prexige (lumiraboxib), an anti-inflammatory drug to treat the signs and symptoms of osteoarthritis in adults. So, why does Health Canada suddenly decide to withdraw certain products from the market? The answer is quite simple: to protect our health!

Before authorizing the marketing and sale of any drug or medication, Health Canada must carefully review the information provided by the manufacturer. This information includes a description of the physical characteristics of a product such as its chemical composition and formulation. The manufacturer must also provide data on the medication’s stability to establish its longevity (expiry date), it’s efficacy and and it’s safety. Efficacy and safety are determined during the clinical trials conducted with healthy volunteers, as well as patients suffering from the disease targeted by the medication.

When a medication is first marketed, the data are still relatively limited because it has usually only been used by a few thousand patients throughout the trials leading to its approval. When it becomes accessible to the general population, a great number of patients begin using it in various contexts that were not necessarily tested during the trials. Consequently, serious adverse effects unseen during clinical trials may surface once the product becomes widely available. The severity and frequency of serious adverse effects can lead to Health Canada’s decision to remove a drug or medication from the market.

This is what happened with Prexige, a Cox-2 selective inhibitor and “cousin” of Vioxx, which was pulled from the market in 2004. Prexige has only been available for less than 12 months, but two cases of hepatitis, a serious inflammation of the liver, have already been reported. Both patients were taking Prexige at the 100 mg daily dose recommended by the manufacturer. This past August, Australia also decided to remove Prexige from the market. This decision came after reports that several patients suffered serious hepatic problems while taking doses that were higher (200 mg and 400 mg daily) than those recommended by the manufacturer. In fact, the Australian ban led Health Canada to request additional safety information from the manufacturer regarding the serious adverse effects recorded after the product was made available in Canada.

Health Canada also has the power to issue a product recall. In such cases, the manufacturing process rather than the product itself is generally the culprit. Hence, a particular lot number is recalled because the manufacturer has discovered that certain irregularities occurred during its fabrication. When a product is recalled, only the lot in question is removed from the market, and the medication is still sold to the general population.

What should you do when a product recall is issued for one of your medications? Firstly, you must stop taking it immediately and contact your physician. He or she can evaluate alternative treatment options, and replace the recalled medication by another. You should know however that it is very important not to discard any unused drugs and medications by throwing them in the garbage or flushing them down the toilet. Rather, you should bring any unused and expired drugs and medications to your pharmacy, where they will be disposed of in an environmentally safe manner. You must remember that drugs and medications can contaminate soil and water ways, jeopardizing our water resources.

Medications are important to help us heal and/or control a variety of health problems, and treatment adherence is the key to any successful treatment! It is crucial you take medication exactly as prescribed by your physician, and over-the-counter medications as recommended by the manufacturer. You should also be aware that there can be an interaction between medications, and this applies to natural remedies as well. Your health is not a game! It is therefore important you speak with your pharmacist before starting any new medication, natural remedy and/or dietary supplements.

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