Oxycontin is still a drug abuse problem in our society… The FDA approved a new version of the drug back in 2010 and the company is supposed to do a followup study to tell us how safe the new FDA approved version is…. Have you seen the study? Five years have gone by and God knows how many addictions and lives?
“The reformulated OxyContin is intended to prevent the opioid medication from being cut, broken, chewed, crushed or dissolved to release more medication. The new formulation may be an improvement that may result in less risk of overdose due to tampering, and will likely result in less abuse by snorting or injection; but it still can be abused or misused by simply ingesting larger doses than are recommended.
“Although this new formulation of OxyContin may provide only an incremental advantage over the current version of the drug, it is still a step in the right direction,” said Bob Rappaport, M.D., director of the Division of Anesthesia and Analgesia Products in the FDA’s Center for Drug Evaluation and Research.
“As with all opioids, safety is an important consideration,” he said. “Prescribers and patients need to know that its tamper-resistant properties are limited and need to carefully weigh the benefits and risks of using this medication to treat pain.”
According to the U.S. Substance Abuse and Mental Health Services Administration’s National Survey on Drug Use and Health, approximately half a million people used OxyContin non-medically for the first time in 2008.
The manufacturer of OxyContin, Purdue Pharma L.P., will be required to conduct a postmarket study to collect data on the extent to which the new formulation reduces abuse and misuse of this opioid. The FDA is also requiring a REMS (Risk Evaluation and Mitigation Strategy) that will include the issuance of a Medication Guide to patients and a requirement for prescriber education regarding the appropriate use of opioid analgesics in the treatment of pain.”
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Aslo see more via 2010 > FDA Approves New Formulation for OxyContin.
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