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drug_recall palladoneOn July 13, 2005 Purdue Pharmaceuticals announced the recall of its new potent pain reliever. The Palladone withdrawal came less than one year after the FDA approved this extended-release prescription narcotic for the management of persistent moderate to severe pain in patients who have already developed an opioid tolerance while receiving opioid therapy.
The Palladone withdrawal was prompted by Purdue-sponsored clinical findings, citing fatal drug reactions in patients who consume alcohol during Palladone therapy. Alcohol is thought to trigger dose pumping, or the rapid release of Palladone’s active substance into the blood stream. Even one drink can trigger dose dumping and cause a fatal Palladone overdose.
Prior to the Palladone withdrawal, Purdue estimates that 11,500 patients had taken Palladone. Because of the already known risks associated with Palladone, Purdue decided to limit its marketing of this powerful narcotic to only those physicians with experience prescribing drugs of this kind. Palladone belongs to a group of drugs the US government has labeled Schedule II opioid antagonists, which also includes morphine and oxycontin. This class of drugs has the highest potential for abuse and the highest risk of fatal overdose from respiratory depression.
Palladone has a high potential for abuse because of its euphoric effects when taken in larger doses. Palladone abuse is extremely dangerous because of the likelihood of a fatal overdose. Palladone is designed to be tolerated by those who have already developed a physical/chemical resistance to opioids. Palladone abuse is also incredibly dangerous because many drug abusers will crush, dissolve, chew, or break the pills to consume them. Tampering with the pill’s integrity will change Palladone’s extended release properties and can lead to a fatal Palladone overdose.
A Palladone overdose is characterized by slowed breathing, sleepiness, stupor, coma, clammy skin, constricted pupils, slowed heart rate, low blood pressure, and other signs of central nervous system overdose. A Palladone overdose is extremely life-threatening. Patients who have overdosed require a minimum of eighteen hours of consistent monitoring and treatment to stabilize their condition. Sometimes these efforts are not successful.
While the government has determined Palladone is unsafe for patient use, anyone taking this medication should speak with a doctor prior to terminating treatment. Because of the drug’s addictive properties, a sudden physical Palladone withdrawal after taking the drug for as little as five to seven days and cause uncomfortable Palladone withdrawal symptoms. Together with your physician, you can determine the best way to stop taking Palladone and search for a safer alternative.
If you would like to learn more about the recent Palladone withdrawal, please contact us to speak with a qualified and experienced attorney who can evaluate your case.
The U.S. Food and Drug Administration has asked Purdue Pharma to stop the sale and marketing of its potent new pain drug, Palladone, after just five months on the market. The decision was made after the agency acquired new information regarding the in...