The Withdrawal of Palladone from the Market: Reasons and Risks
Back in 2005, Purdue Pharma suspended Palladone extended-release sales and pulled it from the market. This decision came after pending negotiations with the Food and Drug Administration (FDA) over potentially fatal adverse reactions when the drug is mixed with even the smallest amount of alcohol (one average drink). Patients taking the medication were advised by the FDA to consult with their physicians about alternative prescriptions. Considering that Palladone contained an opioid commonly found in other medications that are still on the market, our Palm Beach rehab wanted to share more about the risks.
What Is Hydromorphone (Palladone)?
Palladone is a hydromorphone brand name containing hydromorphone hydrochloride, in particular. Palladone is an opioid painkiller that was originally sold in an extended-release (ER) formulation and was indicated for the management of moderate to severe pain in patients that required round-the-clock care. Back when it was still available for prescription and use, Palladone was a long-acting formula that would be taken once daily. This meant that the medication would act in the body anywhere from 12 to 14 hours, unlike short-acting medications that need to be taken multiple times a day. This made taking the medication easier for patients who needed to take it long-term.
Palladone Side Effects
Like other opioids, Palladone works by attaching to mu-Opioid receptors in the central nervous system. Once bound to these receptors, pain signals from the body to the brain are blocked, offering the person some relief from their symptoms. However, opioids like hydromorphone (Palladone) also stimulate the reward system in the brain, which activates the activity of dopamine. Dopamine is a “feel-good” chemical associated with improved mood, euphoria, and pleasure. It’s naturally released in the brain by pleasurable stimuli, such as sex or eating. In larger doses than prescribed or when capsules are broken, dissolved, crushed, or taken with alcohol, a Palladone high can occur. Common side effects of Palladone (hydromorphone) include:
- Changes in blood pressure
- Changes in mood or mood swings
- Constipation
- Euphoria
- Impaired coordination
- Loss of appetite and weight loss
- Mental clouding or impaired judgment
- Nausea and/or vomiting
- Nervousness and anxiety
- Rash
- Relaxation
- Restlessness
- Sedation
- Slow or rapid heartbeat
- Stomach upset
As we previously mentioned, Palladone can get you high when taken in high doses or misused. Therefore, a person who abuses Palladone for long periods risks developing physical dependence, which is marked by severe withdrawal symptoms. At this point, the brain has become accustomed to the effects of the drug and is no longer able to release and manage dopamine or function normally without it.
Overdose Risks
In addition to addiction, another major risk of abusing opioids like Palladone is overdose. A Palladone overdose can occur if the individual takes higher doses than their body can manage or mixes the drug with alcohol or other depressants. Palladone overdose symptoms to look out for include:
- Cold and clammy skin
- Constricted pupils
- Lack of skeletal muscle tone
- Reduced blood pressure
- Reduced heart rate
- Severe respiratory depression
- Stupor or coma
- Death
Opioid overdoses, in general, are fatal, so you must call 9-1-1 or seek out immediate medical attention if you notice any signs of overdose.
Why Palladone Was Taken Off the Market
In July 2005, Purdue Pharma voluntarily took extended-release Palladone capsules off the market because the FDA stated that serious and potentially fatal adverse reactions can occur when the drug is mixed with even the smallest amount of alcohol. According to research collected by the FDA, alcohol damages the extended-release action of Palladone, causing what’s referred to as “dose-dumping.” This is when a drug that’s meant to be administered over several hours is released into the body all at once. This rapid release of the drug into the person’s bloodstream, even with a low dose of Palladone, like 12 mg, could lead to serious and even fatal events. While the FDA agreed to entertain a proposal from Purdue Pharma for the use of Palladone capsules in certain institutional settings – such as hospitals and in-patient hospices – no moves have yet been made to reinstate the drug into the market.
Hydromorphone Addiction Treatment
Although Palladone is off the market, hydromorphone is not. In fact, it’s the active ingredient in a medication called Exalgo ER, another extended-release painkiller. So not only is this main ingredient still available on the market in some forms but there are hundreds of other opioids out there that are being abused every day. This comes as no surprise considering the opioid crisis that has been ongoing since the late 1990s. Fortunately, support and care are available to help those addicted to drugs like Palladone get sober. Our luxury drug and alcohol rehab in South Florida offers opioid detox and addiction treatment designed to address common challenges like withdrawal symptoms, drug cravings, triggers, and more. By working with medical staff, patients will have 24-hour access to medication-assisted care and support to ensure they remain safe throughout the treatment process. Our luxury opioid addiction treatment also utilizes therapy programs like cognitive behavioral therapy (CBT) and biofeedback to help clients understand the root psychological causes of their conditions and how to best cope with stress and triggers once they’re sober. No matter how long you’ve been dealing with addiction, we’re here to help. Call Seaside Palm Beach today at 561-677-9374 or send us your contact information to learn more about our residential addiction treatment in Palm Beach. Related Reading: Percodan: Another Narcotic? How Long Does Dilaudid Stay in Your System?
