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FDA Public Health Advisory
Suspended Marketing of Palladone (hydromorphone hydrochloride,
extended release capsules)
| This product is not currently available for purchase in the U.S. |
FDA is issuing this public health advisory to inform
patients and health care providers that the sponsor of Palladone,
Purdue Pharma, has agreed to suspend sales and marketing of
Palladone (hydromorphone hydrochloride, extended release capsules),
a potent narcotic painkiller, because of the potential for severe
side effects if Palladone is taken with alcohol.
Purdue Pharma provided FDA data that showed that drinking alcohol
while taking Palladone may cause rapid release of hydromorphone,
leading to high drug levels in the body, with potentially fatal
effects. High drug levels of hydromorphone may depress or stop
breathing, cause coma, and even cause death.
FDA is announcing the following, effective immediately:
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At FDA's request, Purdue Pharma has agreed to
suspend sales and marketing of Palladone.
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Patients being treated with Palladone should contact
their physician to discuss appropriate alternative treatments,
including immediate release hydromorphone.
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Patients who, on the advice of their physician,
continue to take their current supply of Palladone should not drink
alcohol, including beer, wine or distilled spirits, or take other
prescription or over-the-counter-medicines that contain alcohol on
days they take Palladone.
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Any unused Palladone capsules should be disposed of
safely by flushing them down the toilet.
Palladone is a time-release formulation of
hydromorphone, a potent narcotic painkiller. Palladone is taken
once-a-day and the capsule slowly releases a steady amount of
hydromorphone into the body over that whole day. Palladone is
approved for treatment of moderate to severe chronic pain only in
opiate-tolerant patients (that is, patients who have been taking
opiate containing products for a considerable period of time).
Palladone has been sold in the U.S. only since January 2005 and has
been used only by a small number of patients. To date, FDA is not
aware of any patients who have had life-threatening side effects
from drinking alcohol while taking Palladone.
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Date created: July 13, 2005, updated: July, 2007 |
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