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Title: Warning Label for Acetaminophen With Codeine to Include Nursing Mothers With Ultra-Rapid Metabolisers

"Warning Label for Acetaminophen With Codeine to Include Nursing Mothers With Ultra-Rapid Metabolisers"

OTTAWA, Ontario -- Janssen-Ortho Incorporated in collaboration with Health Canada has highlighted new safety information regarding the use of acetaminophen with codeine (Tylenol with codeine No. 2, 3, 4 and Tylenol with codeine Elixir) in nursing mothers with ultra-rapid metabolisers of codeine. · Some individuals may be ultra-rapid metabolisers of codeine due to a specific CYP2D6 genotype. · Breastfed babies of women who are ultra-rapid metabolisers are potentially at risk of dangerously high serum morphine levels due to higher-than-expected levels of morphine in the mother's breast milk. · Mothers using codeine should be informed of signs and symptoms of morphine toxicity for themselves or their babies. · Codeine-containing products should be prescribed at the lowest effective dose and for the shortest period of time. The prevalence of the CYP2D6 genotype varies widely among the population and has been estimated to be at 0.5% to 1% in patients of Chinese, Japanese, and Hispanic origin, 1% to 10% in patients of Caucasian origin, 3% in patients of African American origin, and 16% to 28% in patients of North African, Ethiopian, and Arab origin. Data are not available for other ethnic groups. When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and inform patients about the risk and signs of morphine toxicity. The risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and baby. Janssen-Ortho will be updating the Warnings and Precautions section of the Canadian Product Monograph to include the new important safety information regarding the risk of morphine toxicity in ultra-rapid metaboliser nursing mothers. Any case of serious adverse reaction in mother-infant pairs or other serious or unexpected adverse reactions in patients receiving acetaminophen with codeine should be reported to Janssen-Ortho Incorporated or Health Canada at the following addresses: Canada Vigilance Program Marketed Health Products Directorate HEALTH CANADA Address Locator: 0701C Ottawa, Ontario, K1A 0K9 Telephone: 613-957-0337 or Fax: 613-957-0335 To report an Adverse Reaction, consumers and health professionals may call toll free: Telephone: 866-234-2345, Fax: 866-678-6789 CanadaVigilance@hc-sc.gc.ca SOURCE: Health Canada

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