Health Product InfoWatch - April 2017 - Page 2

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.

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.

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.

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.

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.

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.