Submit your Palladone claim details for a free, no obligation case review
Get Started:
FDA approved in September 2004 and launched in February 2005, Purdue Pharma L.P.’s extended release capsules were not even on the market for six months before the FDA ordered the company to immediately suspend all sales and marketing on July 13, 2005. The decision was made after acquiring new information that serious and potentially fatal adverse reactions that can occur when Palladone and alcohol are mixed.
Current Palladone labeling includes the standard opioid warning against the use of Palladone and alcohol, but the FDA did not believe a drug label was adequate warning considering the potentially fatal adverse events that could occur. Palladone is a once-a-day pain management drug containing a very potent narcotic. The FDA acknowledged all powerful pain management drugs carry serious adverse effect risks when improperly used, but Palladone and alcohol risks were considered so great the agency asked Purdue Pharma to withdraw it from the market.
Based on new data gathered from a company-sponsored study testing the potential effects of Palladone and alcohol use, results showed when the drug is taken with alcohol it can injure the extended release mechanism. If affected, dose-dumping can occur, a term describing the rapid release of the active ingredient from an extended release product into the blood stream. Even at the lowest marketed dose of the drug - 12 mg. – the mix of Palladone and alcohol could have fatal consequences in some patients.
Should Palladone and alcohol be mixed at even higher doses, the risks of suffering serious safety problems increase. Even though the FDA has not received any adverse event reports involving Palladone and alcohol yet, the agency notes the product has only been used in a relatively small number of patients and they do not want to run the risk of exposing a greater number of patients to such serious risks. According to FDA Acting Director of the Center for Drug Evaluation and Research, Dr. Steven Galson, “even having one alcoholic drink could have fatal implications.”
The FDA does not believe that the risk of serious, and potentially fatal, adverse events can be managed by label warnings and a risk management plan, and Purdue Pharma agreed to halt sales and implement a plan to reformulate the drug in order to reduce Palladone and alcohol interactions. The company also said it is not aware of any Palladone and alcohol injuries to date.
Approximately 11,500 patients have been prescribed Palladone, according to Purdue Pharma, and any patients taking the drug should immediately consult their doctors about alternative treatments. The drug was approved for the management of persistent, moderate-to-severe pain in patients requiring continuous pain relief. Purdue Pharma said it launched the drug with “clear and strong warnings” about Palladone and alcohol interaction.
The FDA said patients taking Palladone should consult their doctors about alternative treatments.
Contact a Palladone Lawyer today to find out more on the dangerous effects of Palladone and alcohol.
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...
Copyright © 2001 - 2009 Online Lawyer Source | Legal Marketing Site Designed by eJustice