(Corrects 2012 sales figure for Tygacil to $335 mln from $86
mln, paragraph 8)
Sept 27 Pfizer Inc's antibacterial drug
Tygacil increases the risk of death whether used as authorized
by the U.S. Food and Drug Administration or for unapproved
conditions, the agency warned on Friday.
Pfizer must place a warning inside a black box on the drug's
label, indicating the risk is of the most serious nature. The
FDA said the drug, which is usually given intravenously, should
only be used when alternative treatments are not suitable.
The drug is approved to treat complicated skin and abdominal
infections and community-acquired bacterial pneumonia. It is not
approved to treat diabetic foot infection or hospital-acquired
In September 2010, the FDA issued a reminder to physicians
that Tygacil carried a higher risk of death than other drugs
used to treat infection. The agency said at the time it had
analyzed pooled clinical trial data and determined that most
deaths were related to progression of the infection.
The agency said the increased risk of death was mostly seen
in patients with hospital-acquired pneumonia though it was also
seen in patients with other types of infection. The agency
updated the "Warnings and Precautions" section of the label to
Since issuing that 2010 notice, the FDA said it has analyzed
data from 10 trials of patients who took the drug only for
FDA-approved uses. This analysis also showed a higher risk of
death compared to other antibacterial drugs.
In general, the deaths resulted from worsening infections,
complications from infection or another underlying medical
condition, the agency said.
Tygacil was approved in the United States in 2005. It
generated sales in 2012 of $335 million.
Pfizer did not immediately respond to a request for comment.
The drugmaker's shares were up 42 cents, or 1.5 percent, to
$28.94 in midday trade on the New York Stock Exchange.
(Reporting by Toni Clarke in Washington; Editing by Leslie