For those who have time to wade, compare this report on risks involved in
topical Benzocaine (2 deaths in 132 proven/likely adverse events) vs the
vague wording in the Domperidone report (no stats, nothing out of the
ordinary to other drug information, talk of "other countries").  Both taken
from Medscape in the last 2 days - headline, snippet and link - presented as
if they are the same quality of reporting.  Which they most definitely are
not.

Is it correct to understand that the full listing of adverse events was
published in the June 14 issue of the Archives of Internal Medicine?   Can
anyone access this?

Despite what someone's friend said about the FDA's letters being serious
things (sorry, post long since buried) assassination by insinuation is a
well-known tactic, and refined to the nth degree via the Internet.   FDA
employees are humans too - also exposed to misinformation, and not
necessarily knowing much about the importance of breastfeeding.

Jacquie Nutt
*****************
Methemoglobinemia Linked to Topical Benzocaine Use  CME

News Author: Laurie Barclay, MD
CME Author: Charles Vega, MD, FAAFP

June 15, 2004 - Methemoglobinemia is an important and potentially serious
complication of topical benzocaine, according to a review of adverse events
reported to the Food and Drug Administration (FDA), published in the June 14
issue of the Archives of Internal Medicine.

"Methemoglobinemia (MHb) is characterized by abnormal levels of oxidized
hemoglobin that cannot bind and transport oxygen," write Thomas J. Moore,
from the Institute for Safe Medication Practices in Huntingdon Valley,
Pennsylvania, and colleagues. "When induced by benzocaine anesthetic spray
and other chemicals, it can result in cyanosis and life-threatening
complications."

The investigators extracted every report for use of a benzocaine product
from 818,439 adverse event reports received by the FDA from November 1997
through March 2002, and they classified each case by product type, such as
spray, gel, or solution, by whether methemoglobinemia was involved, and by
dose.

Of 198 reported adverse events of all types reported with benzocaine, 132
cases (66.7%) involved definite or probable methemoglobinemia, including 107
serious adverse events (81.1%) and two deaths (1.5%). The formulation
implicated was a spray in 123 cases (93.2%), a benzocaine-containing lozenge
in two cases (1.5%), and a gel in one case. Of the 69 cases that specified a
dose, 37 (53.6%) indicated that a single spray was applied, which is
approximately the recommended amount.

"Health professionals involved in endoscopy, intubation, bronchoscopy, or
similar invasive procedures using benzocaine-containing sprays should know
that (1) administration may cause MHb with potentially serious consequences,
(2) identifying the reaction to benzocaine usually requires cooximetry
(although it can be implied by symptoms), and (3) treatment involves
immediate intravenous administration of 1 to 2 mg/kg of methylene blue," the
authors write.

The authors note that because reports to the FDA are voluntary and
spontaneous, these data may underestimate the incidence of these adverse
events. However, the reporting of an adverse event does not in itself
establish causality.

"Correct dose ... involves much guesswork because of the difficulty of
accurately timing a 0.5-second spray, variations in the amount dispensed
depending on spray canister position, and amount of remaining contents,"
they conclude. "We believe that a metered dose and a more prominent package
warning about MHb would enhance the safety profile of benzocaine products."

The authors report no relevant financial interest in this article.

Arch Intern Med. 2004;164:1192-1195
(more detailed information then given, with CME questions afterwards.  But
you get the idea)

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

U.S. Warns Breast-Feeding Women About Drug
[No author identified]

WASHINGTON (Reuters) Jun 08 - Breast-feeding women should not take the drug
domperidone to boost milk production, because it may put them at risk of
serious heart problems and sudden death, the U.S. government warned on
Monday.

Domperidone is touted on the Internet as a safe way to stimulate milk
production, because it may increase the amount of lactin, a hormone needed
for lactation.

The drug is not approved in the United States but is sold in other countries
in intravenous and oral forms to treat stomach disorders.

The Food and Drug Administration said domperidone poses serious risks and is
not approved in any country for enhancing milk production.

Some people in other countries who were treated with the intravenous version
have experienced irregular heartbeats, cardiac arrest and sudden death, the
FDA said.

"Because of the possibility of serious adverse effects, FDA recommends that
breast-feeding women not use domperidone to increase milk production," an
FDA statement said.

In many countries, the oral form of domperidone comes with a warming that
the drug is excreted in breast milk and the risks to breast-feeding infants
are unknown, the FDA said.

The FDA said some women in the United States had obtained domperidone from
"compounding" pharmacies that prepare medicines for patients from bulk
ingredients or from foreign sources.

The agency sent warnings to six pharmacies and firms that it said were
supplying domperidone to tell them the sales were illegal.

Regulators also alerted border inspectors to watch for attempts to import
domperidone and told them to detain the drug if they find it.

Bill Swail, president of Peoples Pharmacy in Austin, Texas, said he was
unaware of any safety concerns with domperidone until he received the FDA's
warning letter. He said he would ask the FDA to provide more information
about the drug's possible risks.

"We don't want to dispense anything that could be dangerous," Swail said.

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