Health Product InfoWatch - April 2017 - Page 2
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.
Information regarding cardiovascular risks associated with the use of amiodarone in pediatric populations has been added to the Warnings and Precautions section of the Canadian product monograph for intravenous amiodarone products.
Key message for healthcare professionals:Footnote 1
- Rare cases of cardiac arrest, life-threatening arrhythmias and hypotension have been reported in neonates and infants who have received amiodarone post-natally.
- Footnote 1
Amiodarone syringe, Amiodarone hydrochloride for injection (amiodarone hydrochloride) [product monograph]. Boucherville (QC): Sandoz Canada Inc.; 2016.
Primaquine (primaquine phosphate)
The risk of genotoxicity and embryo-fetal developmental toxicity with primaquine use by the mother or father has been included in the Warnings section of the Canadian product monograph.
Key messages for healthcare professionals:Footnote 2
- The use of primaquine is contraindicated during pregnancy (even if a pregnant woman is glucose-6-phosphate dehydrogenase normal, the fetus may not be).
- Preclinical data show a potential risk of genotoxicity and a potential embryo-fetal developmental toxicity.
- Patients must be informed of the potential genotoxic risk.
- Patients have to avoid pregnancy during treatment and for the following period after end of treatment:
- in treated women of childbearing potential, until completion of on-going ovulatory cycle (i.e., up to next menses),
- in treated males whose partners may become pregnant, for 3 months.
- Footnote 2
Primaquine (primaquine phosphate) [product monograph]. Laval (QC): sanofi-aventis Canada Inc.; 2017.
Seroquel (quetiapine fumarate) and Seroquel XR (quetiapine fumarate extended-release)
The risk of misuse, abuse, tolerance, and/or physical dependence has been included in the Warnings and Precautions section of the Canadian product monographs for Seroquel and Seroquel XR.
Key messages for healthcare professionals:Footnote 3,Footnote 4
- There have been reports of quetiapine misuse, abuse, tolerance, and/or physical dependence.
- These cases include adult and adolescent patients using quetiapine alone or with other substances of abuse.
- Caution is needed when prescribing quetiapine to patients with a history of alcohol or drug abuse.
- Patients should be observed closely for signs of Seroquel / Seroquel XR misuse or abuse (e.g., development of tolerance, increases in dose, drug-seeking behavior), particularly if they have a history of alcohol or drug abuse.
- Footnote 3
Seroquel (quetiapine fumarate immediate-release tablets) [product monograph]. Mississauga (ON): AstraZeneca Canada Inc.; 2017.
- Footnote 4
Seroquel XR (quetiapine fumarate extended-release tablets) [product monograph]. Mississauga (ON): AstraZeneca Canada Inc.; 2017.
Tecfidera (dimethyl fumarate)
The risk of liver injury has been included in the Warnings and Precautions and Adverse Reactions sections of the Canadian product monograph for Tecfidera (dimethyl fumarate).
Key messages for healthcare professionals:Footnote 5
- Clinically significant cases of liver injury have been reported in patients treated with Tecfidera in the postmarketing setting.
- Signs and symptoms of liver injury, including elevation of serum aminotransferases to greater than 5-fold the upper limit of normal and elevation of total bilirubin to greater than 2-fold the upper limit of normal have been observed.
- These abnormalities resolved upon treatment discontinuation.
- Some cases required hospitalization but none of the reported cases resulted in liver failure, liver transplant, or death.
- Discontinue Tecfidera if clinically significant liver injury induced by Tecfidera is suspected.
- Footnote 5
Tecfidera (dimethyl fumarate) [product monograph]. Mississauga (ON): Biogen Canada Inc.; 2017.
Valproate products (valproic acid, divalproex sodium)
Additional information regarding the risk of teratogenicity has been added to the Warnings and Precautions section (including the boxed Serious Warnings and Precautions) of the Canadian product monographs (CPMs) for Depakene (valproic acid) and Epival (divalproex sodium).
Product labelling for both Depakene and Epival already contained information on the risk of birth defects (e.g., spina bifida), as well as the risk of developmental delay, autism and/or autism spectrum disorders and decreased IQ scores for children exposed in utero. Health Canada has also previously communicated on the risks to children who were exposed to valproate products in utero.
The CPMs were updated to provide further information and raise awareness of the risk of teratogenicity when using these products during pregnancy.
Key messages for healthcare professionals:Footnote 6,Footnote 7
- Valproate products (valproic acid, divalproex sodium) should not be used in female children, in female adolescents, in women of childbearing potential and pregnant women unless alternative treatments are ineffective or not tolerated because of its high teratogenic potential and risk of developmental disorders in infants exposed in utero to valproate.
- Women of childbearing potential must use effective contraception during treatment and be informed of the risks associated with the use of valproate products during pregnancy.
- In women planning to become pregnant every effort should be made to switch to appropriate alternative treatment prior to conception.
- Footnote 6
Depakene (valproic acid) [product monograph]. Etobicoke (ON): BGP Pharma ULC; 2017.
- Footnote 7
Epival (divalproex sodium) [product monograph]. Etobicoke (ON): BGP Pharma ULC; 2017.
Did you know?
Health Canada is working with the manufacturer to update the Depakene and Epival packaging labels in order to reflect the warning for females of childbearing age, with the inclusion of a pictogram.
Warning for females of childbearing age:
This medicine can seriously harm an unborn baby. Always use an effective method of birth control during treatment. Tell your doctor right away if you become pregnant or think you might be pregnant.
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