Health Canada has published new drug safety information to raise awareness to health care professionals and public about the below safety concern which recently made safety labelling changes for the product monograph. –Health Product Info Watch –June 2020. The safety topics discussed below in brief.

Pulmonary edema risk with amlodipine

Risks of artery dissection and aneurysm with VEGFR TKI class of products


Pulmonary edema risk with amlodipine

Amlodipine is a calcium channel blocking agent which is used in treatment of high blood pressure in adults and children 6 years and older. It also used in treating certain types of angina (chest pain) and coronary artery disease. It acts by lowering the blood pressure by relaxing the blood vessels. Pulmonary edema is a condition of excessive accumulation of fluids in the lung tissue which causes difficult to breath. It can be caused by various reasons and the treatment for it varies depending on the type of cause and which generally includes supplemental oxygen and medications.

Health Canada says “In an amlodipine long-term, placebo-controlled study in patients with severe heart failure (NYHA class III and IV), the incidence of pulmonary edema adverse reaction was reported higher for patients in the amlodipine treated group than patients in the placebo group.”

Owing to the safety finding- pulmonary edema, Health Canada has restricted the use of amlodipine product to the below category of patients.

  1. Patients with obstruction of the outflow tract of the left ventricle. For example, patients having condition of high-grade aortic stenosis.
  2. Patients with haemodynamically unstable heart failure after acute myocardial infarction.

The benefit-risk profile of amlodipine might vary to ‘unfavorable’ for the above category of patients with the anticipated risk of pulmonary edema. The product monograph of amlodipine medicines has updated for the sections of contraindications, Warnings and Precautions, and Consumer Information with this new safety information.

Risks of artery dissection and aneurysm with VEGFR TKI class of products

Vascular endothelial growth factor (VEGF)/ vascular endothelial growth factor receptor (VEGFR) inhibitors are the agents which inhibit the activity of VEGF and VEGFR.

VEGF and VEGFR are tyrosine kinase class of receptors which are crucial in angiogenesis process (formation of new blood vessels from the existing ones). Inhibition of angiogenesis would lead to inhibited growth of tumor cells. Hence, VEGFR Tyrosine kinase inhibitors (TKI) are used in the treatment various types of cancers.

Some of the most commonly used medicines which are coming under the VEGFR TKI class are listed here- Cabometyx (cabozantinib), Caprelsa (vandetanib), Iclusig (ponatinib), Inlyta (axitinib), Lenvima (lenvatinib), Nexavar (sorafenib), Ofev (nintedanib), Stivarga (regorafenib), Sutent (sunitinib) and Votrient (pazopanib).

Health Canada has received case reports of artery dissection (serious adverse drug reaction) in association with various VEGFR TKIs with or without hypertension. Artery aneurysm (including rupture) is another serious adverse reaction which has been reported for VEGFR TKI class of medicinal products.

Health Canada has included these adverse drug reactions- “risks of artery dissection and aneurysm” under the section of Warnings and Precautions, Post-Market Adverse Drug Reactions, and Consumer Information sections of the Canadian product monographs for the VEGFR TKI class of medicinal products.

Voluntary ADR reporting:

Every medicine has its own benefits and risks (known & unknown). The medicine is prescribed to patient considering the positive benefit risk (known) profile with respect to individual patient (considering ongoing concurrent illness/disease). If any unanticipated adverse events (both expected and unexpected) are experienced by patient. It is advisable to report the same to health regulatory bodies of that nation.

Health care professionals and consumers are advised to report these new safety observations to Canada’s post-market surveillance program by submitting the voluntary reporting form online under drug health products.

For more information on other product safety updates- Product monograph brand safety updates

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