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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 is Palladone 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.

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What are the FDA approved uses for Palladone?

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.

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What are the side effects of Palladone?

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

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Palladone 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.

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Palladone drug contradictions

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.

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Palladone FAQs

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.

Can I file a lawsuit if I have suffered damages from taking Palladone?

Possibly. While all medications have certain, anticipated side effects, a drug manufacturer has a duty to inform physicians adequately regarding the known risks associated with its drugs. If a manufacturer fails to do so, it can be held responsible to patients who are injured as the result of inadequate warnings, under a legal theory known as “product liability.” Depending upon the particular circumstances of your case, damages may include recovery for any of the following:

  • Past and future medical expenses
  • Past and future pain and suffering
  • Lost wages
  • Loss of future earning capacity
  • Emotional distress

If you or a loved one has experienced any health problems while taking Palladone, you should contact your doctor immediately. You may also wish to contact an experienced Palladone lawyer to discuss your legal options. As all legal claims are subject to time limits, however, you may risk forfeiture of your right to financial compensation if you delay.

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