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Palladone Class Action Lawsuits Information
The FDA asked Purdue Pharma to immediately discontinue sales
and marketing of its new potent pain drug Palladone because of concerns it could
have serious, even fatal, consequences if taken with alcohol. Doctors in the
United States had looked forward to the use of Palladone after the success of a
similar drug in Canada, but the agency acquired information from a
company-sponsored study showing the drug's extended release mechanism is harmed
if taken with alcohol, which can lead to dose-dumping.
Dose-dumping means people were receiving a full dose of Palladone all at once
because alcohol injures the extended release mechanism, allowing the active
ingredient n Palladone to get into the bloodstream. Palladone's active
ingredient, hydromorphone, is a Scheduled II controlled substance, or the
highest level of control for drugs with a recognized medical use. Based on the
risks associated with Palladone, the FDA worked with Purdue Pharma to develop a
comprehensive risk management program before its drug approval, but later
concluded in light of what the study revealed that it was not sufficient.
According to Purdue Pharma's statement following the recall announcement, the
company believed the warnings and modifications to its risk management program
appropriately addressed the risks regarding alcohol interaction. Palladone
entered the market in February 2005, and before it was even on the market six
months, the agency asked Purdue Pharma to withdraw the drug on July 13, 2005.
The FDA was concerned that as more patients were prescribed Palladone reports of
safety problems would arise since the drug was only used in a relatively small
number of patients.
Palladone labeling already included the standard opioid warning against the use
of alcohol and Palladone, but because even one alcoholic drink could have fatal
implications, the FDA did not believe Palladone's significant risk factors could
be effectively managed by label warnings alone and a risk management plan.
Purdue said the FDA did agree to "entertain a proposal for use of Palladone
Capsules in certain institutional settings, such as hospitals and in-patient
hospices."
Approximately 11,500 patients were prescribed Palladone during its short stay on
the market, according to Purdue Pharma, and while the FDA said it had not
received reports of serious problems because of alcohol interactions, the agency
believed Palladone had an "unacceptably high level of patient risk." Palladone
came in 12, 16, 24 and 32-milligram capsules, but the FDA said even with a low
12 mg. dose of Palladone some patients could suffer potentially fatal adverse
events. When drug dose increased, Palladone patients were at an even higher risk
for suffering serious adverse events.
Doctors say Palladone was not on the market long enough to be missed, but the
withdrawal was disappointing to Purdue Pharma who had just lost its patent
protection on another powerful drug OxyContin. Palladone was one of a couple new
drugs on Purdue's portfolio, but at the time of the withdrawal announcement, the
company said it implemented a plan to reformulate the drug capsules to reduce
the risk of an alcohol interaction.
Palladone Side Effects
The Food and Drug Administration approved Palladone (hydromorphone
hydrochloride) capsules in September 2004 for the management of persistent
moderate to severe pain in patients requiring continuous around-the-clock opioid
pain relief for an extended period of time. Launched in February 2005, the drug
was not even on the market for six months when the FDA asked maker Purdue Pharma
to immediately discontinue all sales and marketing after discovering "serious
and potentially fatal" Palladone side effects when the drug is taken together
with alcohol.
Even though the labeling for Palladone included the standard opioid warning
against the use of alcohol with the drug, FDA officials believed the Palladone
side effects risks were so serious that it could not be effectively managed by
label warnings alone and a risk management plan. The agency's decision was based
on acquired information from a company-sponsored study testing potential effects
of alcohol use with the drug.
The study showed potentially fatal Palladone side effects could be suffered
because of the effect alcohol has on the extended release mechanism in the drug.
Dose-dumping, a term describing the rapid release of the active ingredient from
an extended release product into the blood stream, was a serious consequence of
ingesting even one alcoholic drink with the drug, and Palladone side effects
were considered unacceptably high, according to the FDA.
The active ingredient in Palladone is hydromorphone, a Scheduled II controlled
substance, which is the highest level of control for drugs with a recognized
medical use. Potential Palladone side effects, as a result of dose-dumping,
could be fatal at even the lowest marketed dose (12 mg.). Patients taking a
higher dose of the drug could be at an even greater risk for potentially deadly
Palladone side effects if alcohol harms the extended release mechanism, the FDA
warned.
Symptoms of a hydromorphone overdose include slow breathing, seizures,
dizziness, weakness, loss of consciousness, confusion, coma, tiredness, cold and
clammy hands and small pupils. According to the FDA, all powerful pain
management drugs carry serious risks if used incorrectly, but the potential
Palladone side effects risks exceeded what they considered acceptable.
By asking Purdue Pharma to withdraw Palladone the FDA hoped it could prevent a
greater number of patients from being exposed to the serious Palladone side
effects before any serious adverse event reports were made. Since the drug was
on the market for such a short time, the FDA said it was only used in a
relatively small number of patients, approximately 11,500 patients were
prescribed the drug, but they were concerned safety problems would arise as more
patients took Palladone.
The FDA said it had not received any reports of serious Palladone side effects
at the time of the withdrawal, and Purdue Pharma said it was also unaware of any
alcohol related Palladone side effects. Even before Palladone received FDA
approval, some officials were concerned about the potential for intentionally
abusing the drug due to its extremely potent morphine- based effects.
All patients prescribed Palladone are advised to consult with their physicians
for alternative treatments.
More Palladone Information
Palladone drug abuse poses a serious threat to the health and
lives of those who take this powerful narcotic medication. Palladone drug abuse
is a bigger risk than drug abuse of virtually any other prescription medication.
The risk of Palladone drug abuse is so great because the drug is addictive,
prompts tolerance in users, and produces heroin-like euphoric effects that drug
abusers seek from their drug of choice.
Palladone drug abuse is extremely dangerous because this drug is associated with
a high risk of fatal overdose. Palladone is designed to provide consistent pain
management for people who have already built a tolerance to opioid drugs. An
appropriate dose in the appropriate patient may be a lethal overdose in the
context of Palladone drug abuse where the abuser has not developed an opioid
tolerance.
Palladone drug abuse is also a life-threatening risk because of the method of
drug consumption chosen by many drug abusers. Palladone was designed to provide
patients with a slow steady supply of medication throughout a 24 hour period. In
order to achieve their desired effects, drug abusers will often manipulate drugs
like Palladone to receive a higher dose. When Palladone is broken, chewed,
crushed, or dissolved before consumption, as is common in a Palladone drug abuse
situation, the consumer has a great chance of suffering a fatal overdose.
A Palladone overdose causes a person's central nervous system to become
dangerously depressed. Symptoms of a Palladone overdose can include: slowed
heart rate, slow or difficult breathing, constricted pupils, low blood pressure,
cold clammy skin, extreme sleepiness, stupor, coma, and even death. The nature
of a Palladone overdose is so serious that a patient must be monitored and
treated for an extended period of time in hopes of stabilization and prevention
of deadly respiratory depression.
Less than one year after this drug was approved for use in the United States,
researchers discovered that Palladone death is a serious risk even in those
cases that do not involve Palladone drug abuse. In a clinical trial sponsored by
the makers of Palladone (Purdue), people who consumed even one alcoholic
beverage during Palladone treatment faced a high risk of a deadly Palladone
overdose.
This study concluded that alcohol acts as a dose-dumper when combined with
Palladone. Dose dumping is the rapid release of the active ingredient from a
drug that is designed for slow extended release into the body. Because of the
serious effects of a Palladone overdose, patients risk death when combining
Palladone with alcohol. Because drug abusers often mix substances, particularly
alcohol and other drugs, the deadly risks of Palladone drug abuse are even
greater.
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