FDA Advisory Flags Codeine Risk in Breast-Feeding: High metabolite levels
may pass to infant.


ALICIA AULT
<http://www.obgynnews.com/article/PIIS0029743707707693/fulltext#>
(Associate Editor, Practice Trends)


Article Outline


. Copyright
<http://www.obgynnews.com/article/PIIS0029743707707693/fulltext#> 

The Food and Drug Administration last month advised patients and physicians
that some women metabolize codeine so quickly that levels of morphine, a
codeine metabolite, in breast milk can threaten the lives of nursing babies.

The warning comes after the FDA analyzed a case report that was published in
the Lancet last year by Dr. Gideon Koren, a professor of pediatrics at the
University of Toronto (Lancet 2006;368:704). In that case, a 13-day-old baby
died of morphine poisoning. Dr. Koren and his colleagues determined that the
mother, who was taking codeine, had a genetic polymorphism that made her an
ultrarapid metabolizer via the enzyme cytochrome P450 2D6 (OB.GYN. NEWS,
Sept. 15, 2006, p. 10).

Ultrarapid metabolizers have increased morphine serum levels after codeine
ingestion. Side effects such as constipation or drowsiness are heightened
and, in the case of nursing mothers, higher morphine levels are passed on to
infants.

The FDA did not find any cases of serious side effects or deaths in its
adverse events database but, given Dr. Koren's findings, the prevalence of
the polymorphism in some ethnic groups, and the availability of an
FDA-approved diagnostic for the CYP2D6 enzyme, the agency decided to issue a
public health advisory, Dr. Sandra Kweder, deputy director of the FDA's
Office of New Drugs, said in a briefing with reporters.

It is estimated that 1%-10% of whites have the polymorphism.

In addition, 3% of African Americans, 1% of Asians, 1% of Hispanics, and as
many as 16%-28% of North Africans, Ethiopians, and Saudi Arabians are
ultrarapid metabolizers.

However, the FDA is not recommending that women be tested routinely. The
diagnostic "can be useful, but it is not a substitute for a doctor's
judgment," said Dr. Kweder.

Instead, the agency is asking physicians and patients to pay attention, she
said.

"When prescribing codeine for a nursing mother, doctors should prescribe the
lowest dose for the shortest period of time," she said.

Physicians also should teach women to look for signs of elevated morphine
levels, including excessive drowsiness, confusion, and severe constipation.

Babies with high morphine levels will have difficulty breast-feeding or
breathing, or will have decreased tone.

Nursing mothers have used codeine safely for many years, and codeine
generally has been considered to be the safest choice among nursing women
and their babies, the FDA said in a statement.

To raise awareness of the possible health risk to nursing women and their
babies, the FDA has asked all manufacturers of codeine products to update
the "Precautions" section of the label to include information about
potential risks of codeine use in women who are ultrarapid metabolizers.

 
Esther G

             ***********************************************

Archives: http://community.lsoft.com/archives/LACTNET.html
Mail all commands to [log in to unmask]
To temporarily stop your subscription: set lactnet nomail
To start it again: set lactnet mail (or [log in to unmask])
To unsubscribe: unsubscribe lactnet or ([log in to unmask])
To reach list owners: [log in to unmask]