RSS
TwitterFacebook

Opana ER Recall Urged by FDA, Due to Opioid Abuse Risk

  • Written by: Irvin Jackson
  • 9 Comments

For the first time, federal drug regulators are calling for a drug recall, due to the high risk of abuse, indicating that problems linked to Endo Pharmaceutical’s Opana ER outweigh the benefits provided by the extended release opioid. 

The FDA issued a press release on June 8, announcing that it has requested that Endo initiate a voluntary Opana ER recall, saying that the drug, which was supposed to be “abuse deterrent”, has been linked to widespread problems and has contributed to outbreaks of HIV and hepatitis C.

If Endo does not heed its request to remove Opana from the market, the FDA will take action to have the drug forcibly recalled.

Opana ER is Endo Pharmaceutical’s extended-release version of the opioid oxymorphone, and was just approved by the FDA in 2012, replacing the original version released in 2006, with a design that was supposed to prevent the pills from being crushed and inhaled. However, the FDA has determined that the drug is still widely abused, especially after the reformulation was made to deter addicts from snorting it. This pushed many addicts to begin injecting the drug instead.

The addition of needles has added another dimension to Opana ER’s abuse, resulting in an outbreak of HIV and hepatitis C. The drug has also been linked to a blood disorder known as thrombotic microangiopathy.

The FDA determined that Opana ER needs to be recalled from the market after a study of postmarketing data and recommendations by an independent advisory committee in March, which voted that the Opana ER risks outweigh its benefits.

Opana injections were the main cause of an HIV outbreak in Indiana in 2015. Addicts began injecting Opana to bypass the abuse-deterrent aspects. It also becomes 10 times more potent than morphine when injected. More than one user will share one quarter of a pill, leading to more needle sharing.

A study by the U.S. Centers for Disease Control and Prevention indicated users must inject Opana several times a day because of its short half-life, which causes withdrawal symptoms to begin much sooner. Users melt the gel coating, which creates the extended release effect. They then crush and mix the drug with a significant amount of water. The diluted solution forces the user to inject several times a day.

“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in the press release. “This action will protect the public from further potential for misuse and abuse of this product.”

Endo received $158 million in sales on Opana ER in 2015 and said it is weighing all of its options while still claiming that Opana ER is safe and effective when used as directed.

Tags: , , , , , ,

9 comments

  1. Deborah Reply

    Opana and its counterpart are highly dangerous meds. I was on 180mg/day and withdrew from it on my own against medical advice from subscriber. Initial severe withdrawal lasted for over two months. At times I felt like I would die. But I did not expect severe withdrawal episodes to intermittently occur for well over a year. To this day, I find myself feeling like I “need” the medication. Tough, tough after effects! Will it ever go away?

  2. Stacy Reply

    I was prescribed Opana ER 20 mg every 12 hours. I started having night time auditory hallucinations. These lasted 6 months. My family intervened, I had an EEG, and now have brain Encepalopathy with areas of irritated brain and risk of seizure/epilepsy. My neuropsychiatrist has changed my meds to treat my chronic pain from 5 spine surgeries and a continuing degenerative spine. I weaned off the Opana and when I was at 15 mg every 24 hours it was suddenly pulled off the market. Narcotics and Opiods have sadly been abused by young people, resulting in too many tragic deaths. BUT OPANA WAS NOT PULLED OFF THE MARKET FOR THAT REASON ALONE! If that were the case, OxyContin, Oxycodone, etc. would be gone. I took a low, extended release of Opana ER AS DIRECTED and it almost killed me! This was a bad drug!!

  3. Mary Reply

    I’ve been on Opana 30mg twice daily for at least 4 years. I’m sorry for those that had bad experiences, but I don’t believe that is the norm. It has worked better for me than any other ER pain med that I’ve been prescribed. It makes me angry that these idiots found a way to abuse it. It’s sad for those of us who experience great relief from Opana. These idiots will just find a way to abuse something else when Opana is gone.

  4. Kelly Reply

    Like Mary, I used Opana for many years and never had any problems. In fact, I found that it did not cause the same brain fogginess that many Opiods do. I only changed off of it because I switched insurances and my new insurance company did not cover it. I never had any withdrawals or adverse affects on it or as I changed off of it. It gets very annoying to hear all of the news reports of how many lives are ruined by prescription abuse without countering it with all of the patients who do not abuse their medications. Responsible people are out there. It would be nice to be acknowledged.

  5. Donna Reply

    I was given Opana ER by my doctor. After a few weeks I had to have surgery. During this surgery I had severe complications due to Opana ER and anesthesia. I suffered brain injury. Went from a college grad to a 5th grader !!!!!!
    BAD DRUG

  6. Lisa Reply

    Too much to say about this extremely dangerous drug. I’m tired of the LIES, UNINFORMED CONSUMERS SUCH AS MYSELF. THIS HAS BEEN MY WORST NIGHTMARE, (ON OPANA ER 8-10 YRS) AND ALMOST LOST MY LIFE USING IT AS DIRECTED, ONCE DIRECTLY AFTER MAJOR SURGERY. NEED AN ATTORNEY ASAP

  7. David Reply

    I understand the abuse of this narcotic, but abusers will find a replacement tomorrow! This is not a ‘bad narcotic’! It has been abused and proven to be prescribed wrongly by many doctors. The politicians have made this a political football and are in fact stealing the stable lives of thousands of people with chronic pain who have been using Opana for years. I was under the belief that being a citizen of America gave me liberty and the pursuit of happiness. Instead a group from a government authority (FDA) have chosen to make the decision of how I live my life their own. I will not be silent and want people to join me in making our voices heard.

  8. Sara Reply

    I was prescribed.opans and perocet by my doctor.due to back.problems chronic pain I become addicted to.it then. i.lost my job because I couldn’t stand up and walk very well therefore I had no.insurance it wasn’t available at my job. I lost my doctor because she called my uncle home Left message for me to be there by ,5pm he was gone on vacation didn’t know all this time I’m trying to help my ,80yr old grandmother. I live in Indiana where the H.i.v. broke out yes after I Lost everything I began abusing it then but not before.that now it’s costing me my life it has taken and killed three family members almost.killed my brother he got s little better it gave him infection around his heart paralyzing him.they out him in.medical.coma for.months with.ventilator on him.to breathe for him. Now he has cost him his life like me regardless of what you think we got.addicted by getting them from doctor’s and after.years being on them we had made a decision that wasn’t the best thing to do
    But the withdrawal was too much I withdrawal from them over 3months that’s when I made the worst mistake of my Life.
    And now I have H.i.v. it’s.going to cost me my Life when.my doctor told me that o would not get addicted to them very much and to never miss.one but on the Percocet only take when needed it’s addicting take my opana ad prescribed twice a day.dontisd it.now I should of done things differently but.i.shouldny have to give my life for the mistake I made what if it happens yo your child you wouldn’t say screw the ppl in Indiana. No it’s idiots that.are addicted to them.thsy still want them.on.market.

    Oh by the way my knee I just had major surgery on.got.lortab.from doctor ripped up.prescription.i am taking.ibuprofen only I’m clean now. Over two years clean you don’t. Need opana for chronic pain
    .

  9. Geralyn Reply

    36year old daughter died was on opana for years

  • Share Your Comments

  • Have Your Comments Reviewed by a Lawyer

    Provide additional contact information if you want an attorney to review your comments and contact you about a potential case. This information will not be published.
  • NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

  • This field is for validation purposes and should be left unchanged.