Page 2: Health Product InfoWatch – October 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.
Erythrocin I.V. (erythromycin lactobionate)
The concomitant use of Erythrocin I.V. with HMG-CoA reductase inhibitors that are extensively metabolized by CYP3A4 is now contraindicated. This information has been included in the Contraindications section of the Canadian product monograph for Erythrocin I.V.
Key messages for healthcare professionals:Footnote 1
- Erythrocin I.V. should not be used concomitantly with HMG-CoA reductase inhibitors that are extensively metabolized by CYP3A4 (lovastatin or simvastatin), due to the increased risk of myopathy, including rhabdomyolysis.
A checklist about the contraindications to the use of mefloquine has been added to the Contraindications section of the Canadian product monograph to support healthcare professionals when they prescribe this medication. As well, the risk of permanent dizziness, vertigo, tinnitus, and loss of balance has been clarified in the Patient Medication Information section and in the patient Information Wallet Card.
Key messages for healthcare professionals:Footnote 2
- The new checklist which is available in the Canadian product monograph for Mefloquine provides a brief guide to conditions that are contraindications to mefloquine chemoprophylaxis. It is designed to assist in determining the patient's eligibility for mefloquine chemoprophylaxis.
- Patients should be advised to consult a healthcare professional if any neurological and / or psychiatric symptoms occur during the prophylactic use of mefloquine as healthcare professionals may have to discontinue mefloquine and prescribe an alternative medicine for the prevention of malaria.
Key messages to convey to patients:Footnote 2
- Serious mental and nervous system side effects may occur at any time while taking mefloquine, and in a small number of people, may last for months or years after stopping mefloquine. In some people, dizziness, vertigo, tinnitus, and loss of balance may become permanent.
Proton Pump Inhibitors (PPIs): Dexilant (dexlansoprazole), Losec (omeprazole), Nexium (esomeprazole), Nexium 24 hr (esomeprazole), Panto IVFootnote * (pantoprazole sodium for injection), Pantoloc (pantoprazole sodium), Pariet (rabeprazole), Prevacid, Prevacid FasTab (lansoprazole), Tecta (pantoprazole magnesium), Vimovo (naproxen/esomeprazole)
Interference with laboratory tests has been updated in the Warnings and Precautions, Drug Interactions and Action and Clinical Pharmacology sections of the Canadian product monographs for PPIs.
- During treatment with antisecretory drugs (e.g., PPIs), chromogranin A (CgA) increases due to decreased gastric acidity. Increased CgA levels may interfere with investigations for neuroendocrine tumours.
- To avoid this interference, PPI treatment should be stopped 14 days before CgA measurements.
- Footnote *
The PANTO IV (pantoprazole for injection, 40 mg/vial) DIN has been cancelled as of February 27, 2017. While Takeda Canada Inc. has stopped sale of the product, other parties in the distribution chain such as wholesalers, retailers, pharmacists and medical practitioners may still sell or distribute the remaining stock until the expiry date of March 31, 2018 for the last manufactured lot (#3364321). Generic versions of this drug product and dosage form are available on the Canadian market.
- Footnote 3
Dexilant (dexlansoprazole) [product monograph]. Oakville (ON): Takeda Canada Inc.; 2017.
- Footnote 4
Losec (omeprazole) [product monograph]. Mississauga (ON): AstraZeneca Canada Inc.; 2017.
- Footnote 5
Nexium (esomeprazole) [product monograph]. Mississauga (ON): AstraZeneca Canada Inc.; 2017.
- Footnote 6
Nexium 24 hr (esomeprazole)[product monograph]. Mississauga (ON): Pfizer Canada Inc.; 2017.
- Footnote 7
Panto IV* (pantoprazole sodium for injection) [product monograph]. Oakville (ON): Takeda Canada Inc.; 2017.
- Footnote 8
Pantoloc (pantoprazole sodium) [product monograph]. Oakville (ON): Takeda Canada Inc.; 2017.
- Footnote 9
Pariet (rabeprazole) [product monograph]. Toronto (ON): Janssen Inc.; 2017.
- Footnote 10
Prevacid, Prevacid FasTab (lansoprazole) [product monograph]. Deerfield (Illinois): Takeda Pharmaceuticals America, Inc.; 2017.
- Footnote 1
Tecta (pantoprazole magnesium) [product monograph]. Oakville (ON): Takeda Canada Inc.; 2017.
- Footnote 12
Vimovo (naproxen/esomeprazole) [product monograph]. Mississauga (ON): AstraZeneca Canada Inc.; 2017
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