Drug Makers Warn Of Potential Contamination of Alcohol Pads
25 Janvier 2011 - 9:53PM
Dow Jones News
Several drug makers, including Pfizer Inc. (PFE) and Merck &
Co. (MRK), are warning users of certain injectable drugs not to use
the disinfecting pads or swabs that came with the drugs, citing
possible contamination.
The alcohol prep pads and swabs, which are used to disinfect the
skin prior to an injection, were recalled earlier this month by the
supplier, Triad Group, due to concerns about potential
contamination by an organism that can cause life-threatening
infections. Triad, of Hartland, Wis., said it had received one
report of a non-life-threatening skin infection "out of hundreds of
millions of products sold."
Since Triad's recall notice, several drug makers have issued
separate alerts about the recall. Pfizer and its partner Progenics
Pharmaceuticals Inc. (PGNX) said Tuesday they have suspended
shipments of injectable formulations of anti-constipation drug
Relistor until the Triad-supplied alcohol pads can be replaced. The
companies said they would resume shipments as soon as possible.
A Pfizer spokesman said the suspended shipments would have no
significant financial impact, and that single vials of Relistor
continue to be sold.
Merck said Triad pads were distributed with Pegintron, a
treatment for hepatitis C, and a related drug, Intron A, outside
the U.S. Merck said drugs distributed in the U.S. aren't affected.
Merck said it will begin packaging orders for the drugs without
alcohol prep pads until a suitable alternative has been
identified.
GlaxoSmithKline PLC (GSK) said some of the Triad pads may have
been included in U.S. packaging for starter kits for the
blood-thinning drug Arixtra.
Roche Holding AG (RHHBY) said Triad pads are distributed with
several drugs including the Boniva bone-building drug and hepatitis
C treatment Pegasys. Bayer AG (BAYRY) said the Triad pads are
packaged for use in the U.S. with multiple-sclerosis drug
Betaseron.
In addition, Health Canada said Teva Pharmaceutical Industries
Ltd. (TEVA) is advising patients taking the Copaxone MS drug not to
use any Triad pads.
The drug companies said their medicines weren't contaminated,
and that they can continue to be used as directed, except that any
Triad pads or swabs should be discarded.
Triad said in early January the recalled products were
distributed in the U.S., Canada and Europe. Some were made for
third parties including drug distributor Cardinal Health Inc. (CAH)
and pharmacy chains Walgreen Co. (WAG) and CVS Caremark Corp.
(CVS).
As alternatives, patients are advised to use pads or swabs
supplied by other manufacturers, or use a gauze pad or cotton ball
to administer 70% isopropyl alcohol to the injection site.
More information about the Triad recall can be found on the Food
and Drug Administration's website
(http://www.fda.gov/Safety/Recalls/ucm239219.htm) and Triad's
website (http://www.triad-group.net/media/pdf/Recal_Facts.pdf).
A Triad spokesman couldn't immediately be reached.
-Peter Loftus, Dow Jones Newswires; +1-215-656-8289;
peter.loftus@dowjones.com