• Home
• Defective Drug Index
• About A Drug Recall
• Contact A Defective Drug Lawyer

We Can Help.

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.

For more information on Palladone, please contact us to speak with a lawyer.

More Palladone® Resources