Behind the Ban: Uncovering the Mystery of Amlodipine in Canada

Canada: The Pharmaceutical Drugs Directorate (PDD) in Canada is responsible for reviewing scientific information and assessing the safety, efficacy, and quality of prescription drugs. The PDD applies the Food and Drug Regulations under the authority of the Food and Drugs Act to ensure that pharmaceutical drugs offered for sale in Canada are of high-quality, safe, and effective. The PDD is responsible for enforcing fee regulations for drugs. Before any drug can be sold in Canada, it undergoes a rigorous review process by scientists at Health Canada's Health Products and Food Branch (HPFB), as well as external experts, to evaluate its safety, effectiveness, and quality only when a drug passes this evaluation is it authorized for sale in the country.

Ensuring the safety and health of Canadians is of utmost importance throughout the drug approval process. Even after a drug is available on the market, regulatory controls remain in place. The distributor is required to promptly report any new information they receive regarding significant side effects or if the drug fails to produce its intended effect. Additionally, the distributor must inform Health Products and Food Branch (HPFB) of any new safety information discovered through studies and seek approval before implementing any significant changes to the drug's manufacturing methods, dosage, or recommended usage.

To ensure public safety, HPFB engages in comprehensive market surveillance, which includes monitoring reports of adverse reactions, investigating complaints and problems that arise, and managing recalls if necessary. Amlodipine is classified as a calcium channel blocker medication that works by relaxing the blood vessels, thus easing the workload on the heart, and lowering blood pressure. This drug also increases the blood supply to the heart, thereby controlling chest pain. However, it should be noted that taking Amlodipine regularly can help prevent chest pain but cannot stop it once it occurs.

The medication Amlodipine has multiple uses, such as treating high blood pressure in both adults and children 6 years and older. Furthermore, it can also be used to treat specific types of chest pain and coronary artery disease resulting from constricted arteries that supply blood to the heart. The patent for Amlodipine dates back to 1982, and it was approved for medical use in 1990. It has been included on the List of Essential Medicines by the World Health Organization and is available in the form of a generic medication. Notably, Amlodipine was prescribed over 75 million times in the United States in 2018, making it the fifth most prescribed medication.

Amlodipine has not been banned in Canada, despite rumors to the contrary. However, a research study revealed that women who consumed calcium-channel blockers (CCBs) such as Amlodipine (Norvasc) for more than a decade had over twice the likelihood of developing specific forms of breast cancer, including the invasive ductal breast cancer – the most common type. Although, another extensive population study concluded that CCB use does not elevate the risk of cancer. The conflicting results of these studies are causing apprehension among public health and regulatory bodies worldwide.

Amlodipine, despite the existing concerns, is not prohibited in Canada. With a valid prescription, Amlodipine can be purchased in Canada, and border health authorities permit entry with medication required for either a single course of treatment or a 90-day supply of both prescription drugs and over-the-counter medication, whichever is less.