Page 2: Health Product InfoWatch – August 2017
New health product safety information
The following topics have been selected to raise awareness and, in some cases, to stimulate reporting of similar adverse reactions.
Product Monograph Updates
The following safety labelling updates, which were recently made to the Canadian product monograph, have been selected for your awareness. A complete list of safety labelling updates for brand name pharmaceutical drugs is available on Health Canada's Web site.
Invokana (canagliflozin) and Invokamet (canagliflozin and metformin)
The risk of bone fracture and decreased bone mineral density (BMD) has been included in the Warnings and Precautions and Adverse Reactions sections of the Canadian product monographs for Invokana (canagliflozin) and Invokamet (canagliflozin and metformin).
Key messages for healthcare professionals:Footnote 1,Footnote 2
- An increased risk of bone fractures, occurring as early as 12 weeks after the onset of treatment, was observed in patients using canagliflozin.
- In a clinical trial of 714 older adults (mean age 64 years), patients randomized to canagliflozin 100 mg and 300 mg showed placebo-corrected declines in bone mineral density at the hip and lumbar spine after 2 years of treatment.
- Prior to initiating canagliflozin, it is important to consider factors that contribute to fracture risk.
- Reference 1
Invokamet (canagliflozin and metformin) [product monograph]. Toronto (ON): Janssen Inc.; 2017.
- Reference 2
Invokana (canagliflozin) [product monograph]. Toronto (ON): Janssen Inc.; 2017
The risk of rhabdomyolysis has been included in the Adverse Reactions section of the Canadian product monograph for Revlimid (lenalidomide).
Key messages for healthcare professionals:Footnote 3
- Rare cases of rhabdomyolysis have been reported in patients treated with Revlimid.
- Patients should be observed for signs of rhabdomyolysis, such as muscle pain, weakness or swelling, and dark urine.
- Reference 3
Revlimid (lenalidomide) [product monograph]. Mississauga (ON): Celgene Inc. Canada; 2017.
The risk of herpes simplex encephalitis has been included in the Warnings and Precautions and Adverse Reactions sections of the Canadian product monograph for Temodal (temozolomide).
Key messages for healthcare professionals:Footnote 4
- Cases of herpes simplex encephalitis (HSE), including cases with fatal outcomes, were reported in patients on Temodal, mostly in association with concomitant radiotherapy.
- All patients, particularly those with previous herpes simplex infection, need to be monitored for signs and symptoms of HSE during the treatment such as fever, headache, personality change, seizures, and/or vomiting.
- Reference 4
Temodal (temozolomide) [product monograph]. Kirkland (QC): Merck Canada Inc.; 2017.
Videx EC (didanosine)
The risk of congenital malformation has been included in the Warnings and Precautions section of the Canadian product monograph for Videx EC (didanosine).
Key messages for healthcare professionals:Footnote 5
- The Antiretroviral Pregnancy Registry has reported elevation of congenital malformation rates in infants following exposure to Videx EC during pregnancy.
- Based on human experience, Videx EC can cause congenital malformations when administered during pregnancy.
- The frequency of congenital malformations in infants exposed during the first trimester is greater than in unexposed infants.
- Reference 5
Videx EC (didanosine) [product monograph]. Montreal (QC): Bristol-Myers Squibb Canada; 2017.
The risk of Dupuytren's contracture and plantar fascial fibromatosis has been included in the Warnings and Precautions and Adverse Reactions sections of the Canadian product monograph for Zelboraf (vemurafenib).
Key messages for healthcare professionals:Footnote 6
- Dupuytren's contracture and plantar fascial fibromatosis have been reported with the use of Zelboraf.
- The majority of cases were mild to moderate, but severe and disabling cases of Dupuytren's contracture have also been reported.
- These adverse reactions should be managed with dose reduction, temporary treatment interruption, or treatment discontinuation.
- Reference 6
Zelboraf (vemurafenib) [product monograph]. Mississauga (ON): Hoffmann-La Roche Limited; 2017.
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