Oxymorphone Hydrochloride: Opioid Painkiller OPANA ER Has More Risks Than Benefits, Says FDA Panel
March 17, 2017 — The U.S. Food and Drug Administration advising panel has declared that oxymorphone hydrochloride's significant health risks eclipse its benefits. The opioid pain killer is distributed in the market as OPANA ER and is produced by Endo International Plc.
What Is Oxymorphone Hydrochloride: Use vs. Abuse
Oxymorphone hydrochloride is a long-acting opioid analgesic indicated for extreme pain management, which other treatment options are unable to address.
The FDA requested the experts to review oxymorphone hydrochloride following rising safety concerns about the drug. The federal health agency specifically alluded to the 2015 human immunodeficiency virus outbreak in rural Austin in Indiana, which was caused by opioid addicts sharing needles while intravenously injecting the drug.
Interestingly, the latest formulation of OPANA ER, which was approved in 2006 and launched in 2012, was designed to discourage drug abuse. But the FDA believes otherwise. While nasal drug abuse has decreased, the incidence of intravenous drug abuse increased, but it remains unclear whether it was directly caused by the change in formulation.
Voting 18 to 8, the FDA panel cited the serious health dangers involved in intravenous drug abuse, which include the spread of diseases and infections, such as staph infections, botulism, hepatitis C, and HIV.
Injection of OPANA ER has also been linked to the epidemic of rare but life-threatening blood disease, thrombotic thrombocytopenic purpura or TTP in East Tennessee back in 2015.
Official Statement From OPANA ER Manufacturer
"Endo remains confident that the body of evidence established through clinical research demonstrates that OPANA® ER has a favorable risk-benefit profile when used as intended in appropriate patients," said Dr. Matthew W. Davis, Senior Vice President, Research and Development, Branded Pharmaceuticals at Endo, in an official statement.
"We plan to work collaboratively with the FDA as the Agency completes its evaluation of OPANA® ER, while advocating to preserve the important benefits of the medicine for patients," Dr. Davis added.
The FDA has yet to decide whether it will adhere to the recommendations of its advising panel.
Overdose Deaths In The United States From Prescription Opioids
According to the U.S. Centers for Disease Control and Prevention, overdose deaths related to abuse of prescription opioids have multiplied four times since 1999 along with the rise in sales of these prescription drugs.
In 2015, over 15,000 people died from overdoses involving prescription opioids.
Aside from oxymorphone hydrochloride, other types of prescription opioids include methadone, oxycodone, and hydrocodone.
Taking prescription opioids come with a high risk of addiction, abuse, and overdose. Even when they're taken as directed, they also come with side effects that may range from constipation, excessive sweating, physical dependence, depression, nausea, and vomiting.