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Health National Pain Report — 25 September 2012

A drug increasingly being used in the United States to treat opioid addiction is being taken off the market in tablet form because of the risk it poses to children. Reckitt Benckiser, a British pharmaceutical company, said new data showed that Suboxone pills were significantly more likely to be swallowed accidentally by children than other formulations of the medication.

The company said it would voluntarily stop distribution of Suboxone tablets over the next six months. Reckittt says it made the decision after learning from the U.S. Poison Control Center that “accidental unsupervised pediatric exposure” to Suboxone pills was over eight times more likely than the film version of the drug.

Suboxone film contains the same active ingredients as the tablet, but is designed to dissolve under the tongue. Reckitt believes the film is more child resistant because each dose is individually wrapped – as opposed to the tablets, which come in a standard medication vial containing up to 30 tablets. Although the vials have child-proof tops, recovering addicts may forget to put the tops back on.

“We recognize many patients have relied on Suboxone Tablets to manage opioid dependence over the years and understand there may be concerns about this discontinuation, and we are committed to helping all patients and providers to ensure that managing this serious, chronic disease is not interrupted,” said Richard Simkin, President of Reckitt Benckiser.

Suboxone is currently the only oral drug available on the U.S. market to treat opioid addiction. It contains the opioid buprenorphine, which is combined with naloxone to prevent abuse. The opioid effects of Suboxone are limited and the drug is used to wean addicts from more powerful narcotics such as Vicodin, OxyContin, oxycodone, and hydrocodone. Naloxone is added to Suboxone to block opioid receptors in the brain and central nervous system.

Suboxone film strips are believed to be more child resistant.

Suboxone sales reached $1.3 billion in the U.S. in 2011 and are growing by about 10% annually.

Cynics were quick to note there may be other factors involved in the decision to take Suboxone tablets off the market. Reckitt’s tablet formulation went off patent in 2009 and the company faces increasing competition from competitors. The film version is still patent protected and accounts for a growing share of Suboxone sales.  Reckitt warned shareholders in its annual report that “up to 80% of the revenue and profit from the suboxone tablet business in the U.S. might be lost” to generic competition.

Opioid abuse is a growing problem in the U.S. and a new report this week estimated that 1.4 million Americans are addicted to painkillers. Since Suboxone was introduced in the U.S. in 2003, over three million Americans with opioid dependence have been treated with Suboxone.

In a recent report published in the Journal of Addictive Diseases, the Center for Substance Abuse Research at the University of Maryland warned “there may be an epidemic of buprenorphine misuse emerging across the U.S.” because Suboxone was being so widely prescribed to treat addicts. Researchers said addicts were smuggling buprenorphine into jails and the drug’s street value was growing because it doesn’t show up in drug tests.

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About Author

Pat Anson, Editor

Pat is Editor in Chief of American News Report. He is a veteran journalist and a former correspondent and producer for HealthWeek (PBS), Nightly Business Report (PBS) and other nationally syndicated shows. Pat has won numerous journalism awards, including a Golden Mike award for investigative reporting.

(5) Readers Comments

  1. This really makes me me so mad,the film’s do not work like tablets,they do not under any circumstances have the same affect. All of sub patients also will have higher relapse percentages cause of the lack of for formula in these welfare sub strips…..I feel this is just cheap and it allows the manufacture to save millions…..

  2. It has been a business for many Addicts they keep what they need and sell the rest. Addicts abuse the pill by crushing and snorting it they can make one pill last several days. Glad to see it discontinued and hope the film can not be abused. Like the pill is. I also spent 2 days with a step grandchild who was born with a Subutex addiction. I have been mothering for 28 years and I have never experienced a child like our newest grandchild before. It should be a crime to prescribe this drug to pregnant addicts. It is no way to start life out as an addict. It was horrible to know there was nothing I could do as a Mother to help a 3 month old baby and the sounds of her cry were unlike any cry I have ever heard in my life. They need to place a warning on this drug. DO NOT TAKE WHILE PREGNANT. We have it on other medication.

  3. I disagree. I believe this is absolutely a lie. This is a way for the suboxone maker to still keeping getting BIG money for this medication. I have seen the films.. These FILMS are much easier for a child swallow because they look exactally like those film breath mints. They dissolve very quickly, even faster than the tablet forms.
    I believe this not true at all. Those recovering are not so out of it that would not return the cap to the bottle. That is completely rediculous!! So.. I feel that people addicted deserve a cheaper medication than name brand suboxone. This is very expensive.. Those KIDS will love to get orange flavored films to eat!! So watch out America?? This will the be the next BIG MISTAKE from our government!! The DEA is the FIRST BIG MISTAKE this country has ever made when it comes to pain and health!!

  4. This happens with almost all medicines with expired or soon to be expired patents. Look at Opana and Oxycontin. As soon as the original patent was expired, the pharmaceutical companies released name brand “abuse proof,” formulations. Pharmaceutical companies are all about profit. The profit motivation is good and bad for consumers. Unfortunately, this is one of the bad effects of that motivation. Does not matter really. The generic pharmaceutical companies will probably manufacture and sell the tablet form anyways.

  5. And this has nothing to do with patents ending, and money? Let me guess…..the film is name-brand, right?