Did any of you see the news about the Propulsid clinical trial?  Reuters
had a report on it yesterday.

One line that bothers me is "Janssen Pharmaceutica, the manufacturer of
Propulsid recently announced that it would stop marketing the drug in the
US in July."  Obviously, they will still import it to other countries with
the same dire outcomes.

I wonder how many other cases of "SIDS" could be traced to medications of
some kind.

Pat Gima, IBCLC
Milwaukee, Wisconsin
____________________________________________________

Friday April 28 6:28 PM ET
Propulsid May Have Caused Infant's Death
By Steve Mitchell

WASHINGTON (Reuters Health) - The coroner who initially ruled an infant's
death as due to sudden infant death syndrome (SIDS) now says that the drug
Propulsid (cisapride) may have played a role in the cause of the nine-month
old boy's demise.

The boy, who died in November, was enrolled in a clinical trial of the drug
in children at Children's Hospital in Pittsburgh, Pennsylvania.

Janssen Pharmaceutica, the manufacturer of Propulsid recently announced
that it would stop marketing the drug in the US in July. Propulsid, which
is intended as a treatment for severe nighttime heartburn experienced by
adults with gastroesophageal reflux disease that does not respond to other
therapies, has been associated with 341 reports of heart arrhythmias and 80
deaths, according to the US Food and Drug Administration (FDA).

Allegheny County coroner Dr. Cyril Wecht told Reuters Health, ``We
revisited the case. Additional medical information from the family, the
hospital, the FDA, and medical literature pertaining to the drug... led to
the conclusion... with a greater degree of likelihood that this was a
Propulsid-related death.''

Wecht noted, ``It's not uncommon to change the cause of death. It probably
happens several times a year.'' He added that a diagnosis of SIDS is not
made ``unless everything else has been ruled out.''

Based on the new information, ``we'd be quite na Jive to reject the
relation to the drug Propulsid,'' Wecht commented.

Janssen's director of public relations told Reuters Health, ''We can't draw
a definitive causal relationship between use of the drug and the child's
death.''

The parents claim that Children's Hospital had them sign a form that
incorrectly indicated that the FDA had approved Propulsid for use in
children. Panico commented, ``That study was not under (Janssen's)
auspices, so we did not devise or create those forms.'' He added, ``It's
unclear what was communicated to the parents.''




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