Endo Pharmaceuticals Inc. has agreed to withdraw their opioid painkiller Opana ER from the market following the Food and Drugs Administration (FDA) request. Though they still believe in their product's safety, their decision to pull the product was made after careful consideration and coordination with the agency.
Voluntary Withdrawal From The Market
In a press release, Endo Pharmaceuticals announced that they will be removing Opana ER to combat abuse and misuse of the product. As a result, Endo Pharmaceuticals Inc. is expecting to incur approximately $20 million in pre-tax impairment charge for the second quarter of 2017.
Endo stresses that their decision to voluntarily remove Opana ER from the market is not a result of any findings indicating that the product is either ineffective or unsafe even when taken as prescribed. In fact, the company remains confident in their product's safety and efficacy.
The voluntary withdrawal is a result of the FDA's early June request to Endo Pharmaceuticals Inc., asking them to remove the product based on the concern that the drug's benefits no longer outweigh the risks of addiction.
Opana ER Limitations
In the same press release, Endo also gave a wide description of the product that they are about to pull from the shelves. In it, they state that because of the high risks for addiction and overdose, Opana ER is a drug that is reserved mostly for patients in whom alternative treatments have proven ineffective or inefficient.
Going further into the risks of misuse and abuse of Opana ER, Endo acknowledges that the product may lead to addiction even among patients using the product at appropriate doses.
Further, because Opana ER is an extended-release product that contains oxymorphone, the risks are even greater for overdose and death, especially when used in a manner for which it was not intended such as snorting or injecting the crushed or dissolved product.
When discontinuing the use of Opana ER, especially since the company has decided to remove the drug from the market, Endo recommends a gradual decrease in dosage to ease in and lessen the withdrawal symptoms. A sudden discontinuation of using the product is not recommended.
The country has been battling the opioid epidemic for years, and it has been recently found to possibly have stemmed from a letter published in The New England Journal of Medicine in 1980. In it, drug specialist Dr. Hershel Jick and graduate student Jane Porter disregarded the possible addictive prospects of opioid painkillers.
Though this letter didn't directly and immediately lead to a widespread opioid abuse, it did lead to a surge in opioid prescriptions in the last 20 years and an epidemic that the country continues to face.