U.S. FDA warns Pfizer over ad for antibiotic drug

WASHINGTON (Reuters) – U.S. regulators warned Pfizer Inc.
about “misleading promotion” of its antibiotic drug Zyvox in a
professional journal, according to a letter released on
Tuesday.

The advertisement does not include information about
Zyvox’s risks, implies it is superior without supporting
evidence, and claims it can treat more infections than for
which it was approved, the U.S. Food and Drug Administration
letter said.

The agency called on the drugmaker to halt the
advertisement and take the extra step of sending out new, more
accurate promotions.

“Because the violations … are serious, we request,
further, that your submission include a comprehensive plan of
action to disseminate truthful, nonmisleading and complete
corrective messages,” the letter said.

The company has until August 3 to respond to the warning,
and Pfizer spokesman Daniel Watts said the drugmaker would send
the agency a letter next week.

“Pfizer will immediately take steps to cease distribution
of the professional advertisement cited by the FDA,” he said.

Zyvox, which comes as an injection, tablet and liquid, is
used to treat skin infections. It also treats two types of
pneumonia, one caused by methicillin-resistant Staphylococcus
aureus (MRSA) and another caused by Streptococcus pneumoniae.

Patients using the drug can experience blood disorders like
anemia and a build-up of lactic acid in the cells and blood –
but those risks were not included in the ad, the FDA said.

The agency also said it “implies that Zyvox is superior”
for treating nonsocomial pneumonia, compared to vancomycin,
which Eli Lilly and Co. sells under the brand name Vancocin.

A headline in the ad — “MRSA meets its match” — also
implies the drug “is useful in all infections caused by MRSA, a
broader range of conditions than is approved,” the FDA said.

Shares of the New York-based drugmaker were off 3 cents, or
less than 1 percent, at $26.38 in midday trading on the New
York Stock Exchange.