In an unprecedented move, the U.S. Food and Drug Administration has requested that Endo Pharmaceuticals pull its opioid painkiller Opana ER from the market. In a press release published last Thursday, the agency said it was doing this based on concerns that the benefits of the drug no longer outweigh its risks, and the “public health consequences of abuse”. In the midst of a public health crisis, this is the first time the agency has ever made such a request.
Initially approved for use in 2006 for moderate to severe pain management, Opana ER underwent a reformulation six years later after the FDA became concerned about the opioid epidemic and the rate of overdoses. Endo Pharmaceuticals added a protective coating to the pills, which was meant to deter people from injecting or snorting the drug.
This decision by the FDA came after an evaluation of data that revealed this strategy does not appear to have been effective. As it turns out, people continued to inject the reformulated version of powerful prescription painkiller, leading to a severe outbreak of hepatitis C, HIV, a serious and possibly deadly liver infection, and a blood disorder known as thrombotic microangiopathy, which can lead to renal failure, vision loss, seizures and other serious symptoms.
As a result, the agency has determined that this reformulation has not shown a significant reduction in abuse, and has asked Endo Pharmaceuticals to voluntarily withdraw their product from the market. Failure to do so will result in the FDA’s forceful removal of the prescription medication from pharmacy shelves and revocation of its approval. “In the interim, the FDA is making health care professionals and others aware of the particularly serious risks associated with the abuse of this product,” the press release says.
Opana ER is about twice as strong as OxyContin, another highly abused opioid prescription medication. Opioid abuse and addiction are only growing stronger in the United States, with more than 33,000 people dying as a result of an opioid overdose in 2015, according to the Centers for Disease Control and Prevention. Nearly 50% of those deaths involved a prescription opioid medication.
- Approximately 80% of the world’s supply of prescription painkillers is consumed in the United States.
- On average, 91 Americans a day from an opioid overdose.
- More than 6 out of 10 overdose deaths in this country involve an opioid.
- The amount of opioid overdose deaths in the U.S. has quadrupled since 1999.
- Improving the way opioids are prescribed – both by educating providers and consumers alike about the dangers of abuse and addiction. By reducing the exposure to these medications, there may be a way to reduce the rate of abuse and stave off drug dependence.
- Expand access to effective, evidence-based treatment services for people who are addicted to opioids.
- Make overdose reversal drugs like naxolone more available to first-responders, law enforcement and the public.
- Promoting and improving the use of state prescription drug monitoring programs, which give healthcare professionals pertinent information about patients and their drug abuse history.
- Implementing and improving state and local community programs that help prevent opioid abuse, addiction and overdose.
Thursday’s announcement is unlike any other in the agency’s history, and may be a sign of what’s to come. In a statement released by Endo, the company says it is “reviewing the request and is evaluating the full range of potential options as we determine the appropriate path forward. While the benefits of opioids in treating and managing pain are widely recognized, the misuse and abuse of these products have increased greatly in the U.S. As a pharmaceutical company with a demonstrated commitment to the improvement of pain management, Endo feels a strong sense of responsibility to improve the care of pain for patients while at the same time taking comprehensive steps to minimize the potential misuse of its products. Despite the FDA’s request to withdraw Opana ER from the market, this request does not indicate uncertainty with the product’s safety or efficacy when taken as prescribed. Endo remains confident in the body of evidence established through clinical research demonstrating that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients.”
The FDA says it will continue to “examine the risk-benefit profile of all approved opioid analgesic products and take further actions as appropriate as a part of our response to this public health crisis.”