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Palladone (Hydromorphone
Hydrochloride Extended-Release) Capsules
Questions and Answers
1. What is FDA announcing today?
FDA is announcing that it has asked Purdue Pharma
L.P. to voluntarily withdraw Palladone extended-release capsules (hydromorphone
hydrochloride) from the market. The reason for this request is that
taking Palladone with alcohol can result in rapid release of drug
from the extended-release capsules. This can result in overdose with
hydromorphone, and serious side effects, including slowed breathing
(respiratory depression), coma, and even death.
2. What is Palladone?
Palladone is a long-acting, prescription pain
medicine. Palladone contains the opioid (narcotic) pain medicine
hydromorphone. The active ingredient, hydromorphone, has been
available for pain relief for many years in other marketed drug
products. Palladone is unique because the active ingredient,
hydromorphone, is released slowly throughout the day, over 24 hours,
so that it provides pain relief with once daily dosing.
3. What is Palladone used for?
Palladone is used to treat adults (18 years of age
and older) with persistent pain that is moderate-to-severe in
intensity, which requires around the clock opioid pain relief for an
extended period of time.
4. Does the interaction of Palladone and alcohol
occur with all alcoholic beverages?
Yes. Palladone interacts with the alcohol in beer,
wine, all distilled liquors, and in prescription and
over-the-counter medications. Alcohol when taken with Palladone may
cause too much hydromorphone to be released into the blood at once,
which is called “dose-dumping.” This can result in respiratory
depression, serious injury, coma, or death. You should not drink any
beverage that contains alcohol or take any medication that contains
alcohol while you are taking Palladone.
5. What should I do if I have Palladone?
Patients being treated with Palladone should contact
their physician to discuss appropriate alternative treatments,
including immediate release hydromorphone. Any unused Palladone
capsules should be disposed of safely by flushing them down the
toilet.
6. What if I don’t drink alcohol, why do I need
to dispose of it? Why can’t I continue to take it if I don’t drink
alcohol?
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-medications that contain alcohol on
days they take Palladone.
7. If this medicine is life threatening, then why
isn’t the FDA recalling it from the distribution chain instead of
letting the supply run out?
If properly prescribed and used by fully informed
doctors and patients, the risks of this medication can be avoided.
FDA’s concern is that with time and with wider use, this drug will
not be used uniformly safely and therefore it is possible people
will be seriously harmed because they have not adhered to the vital
recommendation not to drink alcohol or take medications containing
alcohol and take Palladone at the same time.
8. Did this decision come from the Drug Safety
Oversight Board?
No, there has only been one meeting of the newly
formed Drug Safety Oversight Board and that was an organizational
meeting only.
9. Why doesn’t FDA add more warnings to the
labeling instead of asking Purdue Pharma to voluntarily withdraw
marketing of Palladone?
The labeling was approved with a standard opioid
warning that Palladone should not be taken with alcohol.
Unfortunately this warning is not enough, because the consequences
of use with alcohol can be quite serious and even fatal. FDA feels
that this action is necessary to protect public health.
10. If FDA knew that Palladone interacts with
alcohol, why was it approved?
When FDA approved Palladone, the Agency had evidence
from laboratory studies that alcohol could accelerate the release of
hydromorphone from Palladone capsules. Neither the Agency nor Purdue
Pharma anticipated that this would be life-threatening to patients
themselves.
FDA recently reviewed new evidence that dose-dumping occurs in
patients when Palladone is taken with alcohol. Purdue Pharma
completed a study in 24 healthy men that showed that, compared to
taking Palladone by itself, concentrations of hydromorphone in the
blood were 5.5 times higher when the 12 mg Palladone extended
release capsules (the lowest dose available) were taken with 8
ounces of 40% alcohol.
Lower concentrations of alcohol showed lesser, but still potentially
serious effects on the release of hydromorphone from Palladone in
some individuals. Studies showed that taking Palladone with a mixed
drink (equivalent to 20% alcohol) or beer (equivalent to 4% alcohol)
increased hydromorphone concentrations 1.9 and 1.03 times higher,
respectively, compared to taking Palladone by itself.
11. Do other pain medicines also interact with
alcohol?
FDA continues to investigate other long-acting pain
relief drug products for possible dose-dumping when taken with
alcohol.
Whether or not dose-dumping is a risk, patients should understand
that because both alcohol and narcotic pain relievers have sedative
effects, they should never be taken together.
12. What other medicines can I take for my pain?
There are many other pain relief medicines available
on the market at this time. It is important that you discuss these
medicines with your health care provider so that you can determine
which one is right for you.
13. Will Palladone come back to the market?
Palladone may return to the market if the safety
concerns are resolved.
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Date created: July 13, 2005 |
