Palladone (hydromorphone)

Palladone (hydromorphone) is a strong narcotic pain reliever similar to morphine. This medication is used to treat moderate to severe pain that is expected to last for a long period of time (weeks to months). Palladone capsules contain the potent Schedule II opioid agonist, hydromorphone.

Why Prescribed

Palladone is prescribed to treat moderate-to-severe chronic pain (e.g., cancer pain). Palladone acts on certain centers in the brain to give long-acting narcotic pain relief.

FDA Approved Uses

Palladone was approved by the FDA in 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.

Side Effects

Side effects associated with Palladone include nausea, vomiting, constipation, headache, mild itching, drowsiness, dry mouth, lightheadedness, and weakness.

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Warnings and Alerts

In 2005, the FDA stopped the sale of Palladone, just five months after it made its entrance to the U.S. market. The FDA issued a public health advisory to notify health care professionals and consumers that the sponsor of Palladone, Purdue Pharma, has agreed to suspend sales and marketing of the drug because of the potential for severe side effects if Palladone is taken with alcohol. Drinking alcohol while taking Palladone may cause rapid release of hydromorphone, leading to high drug levels in the body. High drug levels of hydromorphone may depress or stop breathing, cause coma, and even cause death.

Drug Contraindications

Palladone is contraindicated for use on an as needed basis, in situations of significant respiratory depression--especially in unmonitored settings where there is a lack of resuscitative equipment, in patients who have acute or severe bronchial asthma, in patients who drink alcohol, in patients who have or are suspected of having paralytic ileus, and in patients with known hypersensitivity to any of its components or the active ingredient, hydromorphone.

FAQ's

What are Opioids?

Opioids are any medication which binds to opioid receptors in the central nervous system or gastointestinal tract. There are four broad classes of opioids:

• Endogenous opioid peptides (produced in the body: endorphins, dynorphins, enkephalins)
• Opium alkaloids (morphine, codeine, thebaine)
• Semi-synthetic opioids (heroin, oxycodone, hydrocodone, dihydrocodeine, hydromorphone, oxymorphone, nicomorphine)
• Fully synthetic opioids (pethidine or Demerol, methadone, fentanyl, propoxyphene, pentazocine, buprenorphine, butorphanol, tramadol)

Opioids are used as strong analgesics for relief of severe or chronic pain. There is no upper limit for the dosage of opioids used to achieve pain relief, but the dose must be increased gradually to allow for the development of tolerance to adverse effects (e.g., respiratory depression). What are symptoms of a Palladone overdose? Symptoms of a Palladone overdose can include slowed breathing, slowed heartbeat, persistent dizziness/fainting, cold/clammy skin, limp/weak muscles, excessive drowsiness, or loss of consciousness.

What is “dose-dumping?”

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.

Are there other risks associated with using Palladone?

Palladone must be swallowed whole, and not chewed, dissolved or crushed. If not swallowed whole, the contents of the capsule are rapidly absorbed at a potentially fatal dose.

Should I contact an attorney if I have experienced severe side effects from using Palladone?

If you have experienced health complications from using Palladone, it may be important to contact an experienced defective drug litigation attorney who can help you protect your legal rights. Only a licensed attorney can evaluate whether you have a case that is worth pursuing. Keep in mind however that there may be time limits, known as statute of limitations, which impact on your ability to sue and receive financial compensation.