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FDA Approves Yet Another New Potentially Dangerous Opioid Painkiller

Hysingla ER is the name of the new opioid painkiller developed by the pharmaceutical Purdue Pharma and recently approved by the FDA for public release.

The time of release and approval could not be more controversial since cases of opioid addiction, dependence, and deaths by overdose are on the rise. In 2011, opioid painkillers were responsible for a declaration of epidemic by the Centers for Disease Control and Prevention after it was found that 40 people die every day from a painkiller-related overdose.

However, the topic of dangerous new drugs is not new. A little over a year ago, the FDA approved the release of Zohydro ER developed by the same pharmaceutical. Much controversy arose since it was found that the drug could easily be crushed for abuse purposes. However, the developers asserted that they were only providing further therapeutic options for patients with chronic pain.

Hysingla ER has been subject to similar criticism, although it does present abuse-deterrent technology that makes the pills hard to crush and therefore hard to snort. Even if the pill is crushed, the result is a thick gel that makes it difficult to inject, too.

But perhaps what has raised the most concern is the composition of the drug itself. Hysingla is an opioid painkiller with hydrocodone as its only active ingredient. The formulation has been designed to be an extended-release tablet that lasts 24 hours. The amount of hydrocodone contained in a single tablet is 24 times more than Vicodin, therefore containing a potentially lethal dose. However, when following the instructions of the medicine, the substance is released during a period of 24 hours, making it relatively safe.

The manufacturer company stated that, despite being extended-release and implementing abuse-deterrent characteristics, the drug can still be addictive and death by overdose continues to be a potential danger.

The stand of the FDA, as expressed by director of its Center for Drug Evaluation and Research, Dr. Janet Woodcock, is that of allowing access to further and appropriate treatments for pain that have been tested and with benefits that outweigh the dangers.

But with a drug as potent as Hysingla, and with the numbers of addiction and overdose through the roof, many experts fear that this might only lead to further cases of abuse with its natural consequences. On the other hand, others accept that drugs with similar potency are already on the market, and that its abuse-deterrent characteristics are a positive difference between Hysingla and its competitors.

Even with tight regulations and abuse deterrence technology giving important steps, more needs to be done to effectively cut back the cases of opioid addiction. As health experts continue to work in new and safer options for pain management, many who realize the dangers of abusing drugs are seeking for help to regain a healthier life free from addiction.

We can help you develop a plan for you or your loved one who is struggling with addiction. Recovery is possible, and there are programs available near you; from intervention services to specialized rehab facilities. By calling our toll free substance abuse helpline, you will obtain the assistance and advice you need to find the right program and start fighting back. Our services are free and our lines are open 24 hours a day.