FDA's Codeine Advice Puts Infants at Risk

    TORONTO, Sept. 5 /CNW/ - The FDA's recent advisory endorsing the use of
codeine by breastfeeding mothers has sparked criticism from those who charge
that the FDA's advice could endanger the lives of nursing infants.
    The FDA's Public Health Advisory warns that infants nursed by mothers
with a specific genetic profile may be at an increased risk of morphine
overdose. The agency stresses, however, that codeine "has been used safely for
many years in nursing mothers", and "is generally considered the safest
narcotic pain reliever for a breastfeeding woman and her baby".
    The advisory follows the death of a healthy 12-day old breastfed infant
whose mother was prescribed Tylenol(R) with Codeine No. 3 for postpartum pain
and repeatedly assured that the drug was safe. Only after her son's death did
she discover that there is practically no safety data for mothers prescribed
more than a few doses of codeine, that the World Health Organization strongly
advises against breastfeeding women using repeated doses of the drug, and that
nursing infants are at greatest risk during their first weeks of life.
    Rani Jamieson, the bereaved mother, was shocked by the FDA's statement.
"I found out the hard way that codeine is not a safe drug," she said. "Who
knows how many other mothers have lost a child like I did because of the
effects of codeine? Or how many children survived the drug but are suffering
even now from the repeated doses of narcotics they received as babies?"
    The case has led to a class action lawsuit filed on behalf of infants who
ingested codeine and its metabolites through their mother's breast milk. As
Joel P. Rochon, a partner of Rochon Genova LLP, the law firm leading the case,
    "Millions of children have already been put at risk by this drug and more
will be threatened as long as it stays on the market. The safety of these
children must become the paramount consideration".

For further information:

For further information: Rochon Genova LLP, 121 Richmond St. W, Suite
900, Toronto, Ontario, M5H 2K1, Telephone: (416) 363-1867 or toll-free:
1-866-881-2292, Website address: www.rochongenova.com

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