Palladone Attorneys
FDA Asks Purdue Pharma to Withdraw Palladone for
Safety Reasons - July 13, 2005
After acquiring new information that serious and potentially fatal adverse
reactions can occur when Palladone (hydromorphone hydrochloride)
extended release capsules are taken together with alcohol, the U.S. Food
and Drug Administration has asked Purdue Pharma L.P., the makers of the
drug, to withdraw it from the market.
Palladone is a once-a-day pain management drug containing a very potent
narcotic. New data gathered from a company-sponsored study testing the
potential effects of alcohol use shows that when Palladone is taken with
alcohol the extended release mechanism is harmed which can lead to dose-dumping.
Dose-dumping is a term that describes the rapid release of the active
ingredient from an extended release product into the blood stream. The
consequences of dose dumping at the lowest marketed dose (12 mg.) of Palladone
could lead to serious, or even fatal, adverse events in some patients
and the risk is even greater for the higher strengths of the product.
As a result of this potential serious safety risk, the FDA has asked Purdue
Pharma, and they have agreed, to suspend all sales and marketing of Palladone
in the U.S. pending further discussions with the agency.
"All powerful pain management drugs have serious risks if used incorrectly,
but the current formulation of Palladone presents an unacceptably high
level of patient risk" said Dr. Steven Galson, FDA Acting Director
of the Center for Drug Evaluation and Research. "Although we have
not received reports of serious problems, this product has so far been
used in a relatively small number of patients. We are concerned that as
more patients take this drug, safety problems will arise since even having
one alcoholic drink could have fatal implications.”
The current labeling for Palladone, approved in September, 2004, already
includes the standard opioid warning against the use of alcohol and Palladone.
However, the FDA does not believe that the risk of serious, and potentially
fatal, adverse events can be effectively managed by label warnings alone
and a risk management plan.
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