Invokana & Invokamet Safety Warning [Canada]


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Canada/Ottawa: InvokanaHealth Canada issues safety warning for Invokana (Canagliflozin) and Invokamet (Canagliflozin and Metformin) due to apparent increased risk of lower limb amputation. HCSC: http://ht.ly/b0sE30eYLmN

Direct link: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2017/64366a-eng.php

Additional information:
Health Canada/Santé Canada (“HCSC”) reports the following prescription drugs are subject to this safety warning:

 

  • Invokana (Canagliflozin) sold by Janssen Inc., all lots
  • Invokamet (Canagliflozin and Metformin) sold by Janssen Inc., all lots

==> No barcodes, UPCs, DINs, item numbers or other identification numbers were listed with this recall notification.

According to Health Canada, it has noted an increase in the incidence rate of lower limb amputation, primarily of the toe and midfoot, but also of the leg in the integrated CANagliflozin cardioVascular Assessment Study (“CANVAS”) Program (0.63 per 100 patient-years in patients treated with Canagliflozin versus 0.34 per 100 patient-years in patients treated with placebo).

The CANVAS Program was comprised of CANVAS and CANVAS-R, two large, long-term, randomized, placebo-controlled trials evaluating long-term cardiovascular Outcomes in 10,142 individuals with Type 2 Diabetes with established Cardiovascular disease (CVD) or at least two risk factors for CVD who were treated with Canagliflozin.

For more information on the risks and symptoms of these drugs, please consult the Heath Canada Web site listed above.

Health Canada reminds all healthcare providers in Canada to follow established Diabetes Care Practice Guidelines in patients treated with Canagliflozin, including the following:

  • Consider factors in the patient history that may increase the risk for amputation.
  • Carefully monitor patients with risk factors for amputation events, e.g., patients with previous amputations, existing peripheral vascular disease or neuropathy.
  • Counsel patients about the importance of routine preventive foot care, good hydration, and the signs and symptoms of volume depletion.
  • Monitor patients for signs and symptoms of volume depletion and ensure that hydration is sufficient to prevent volume depletion in line with recommendations in the product information. Use of diuretics may further exacerbate dehydration.
  • Advise patients to notify their healthcare provider if they develop sores, ulceration, discoloration, infection, new lower extremity pain or tenderness.
  • Initiate early treatment for foot problems for, but not limited to, ulceration, infection, new pain or tenderness.
  • Discontinue Canagliflozin treatment in patients who develop a significant complication, such as a lower-extremity skin ulcer, infection, osteomyelitis or gangrene.

If you have any questions about this safety warning notification, please contact Janssen Inc. at 1-866-825-7122. Alternatively, you can visit the company’s Web site at http://www.janssen.com/canada.

==> To see all recalls and notifications relating to Drugs, please search for “drug” using the Search Box at the top of this page.

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More information about this recall:
HCSC ID number: RA-64366
Recalls Direct RIN: 9170-2017
Want to read more about this recall?
==> Please click on the links above to visit the originating site.
Want to read more about other recalls?
==> Please click on the links below.

General information:
More recalls? Back to the main Recalls Direct page:
==> http://www.RecallsDirect.com/
About the Recalls Direct service:
==> http://wp.me/P2bVty-2
Visit the Living Safely site:
==> http://www.LivingSafely.org/
Report an unsafe food product you purchased in Canada [external: new window opens]:
==> http://www.inspection.gc.ca/food/information-for-consumers/report-a-concern/eng/1364500149016/1364500195684
Search for a recalled food on the Health Canada Web site [external: new window opens]:
==> http://healthycanadians.gc.ca/recall-alert-rappel-avis/index-eng.php

We welcome your feedback:
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E. & O. E.

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