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FDA Denies use of blue dye in an attempt to stop opioid abuse

FDA Nixes Use of Blue Dye in Opioid Painkiller

July 31, 2017
The U.S. Food and Drug Administration (FDA) voted overwhelmingly not to approve a version of Intellipharmaceutics International’s Rexista opioid that would attempt to discourage abuse by staining potential users with a blue dye that would be released upon a tamper attempt.

The FDA rejected the measure on the grounds that it would not mitigate the abuse of the drug via injection. The agency also scolded the drugmaker for not including enough information in its application about human studies that address the potential for the abuse of Rexista.

Rexista’s maker also included in the drug an irritant that would allegedly make it less attractive to those who wished to inhale it.

Rexista is a powerful opioid medication that is equivalent to OxyContin. It is intended for the treatment of severe, constant pain.

Intellipharmaceutics responded to the advisory panel’s decision by stating that it would commence further studies on the drug.

The abuse of prescription opioids kills about 30,000 Americans every year.

If you or a loved one has suffered at the hands of opioid painkillers, you may be entitled to significant financial consideration. Contact the expert attorneys at TheLawFirm.com to learn how we can help you.

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Opioid Drug Addiction

When you’ve had surgery, and especially a major surgery like a hip transplant, the recovery is often painful. Traditionally doctors often prescribe opioids such as Oxycodone, Vicodin, and Percocet to manage their patients’ pain.  

But now a recently concluded large-scale research study from Stanford University found that very few people are able to stop taking the powerful drugs, and are becoming addicted to the opioids. This is nothing new to the attorneys at TheLawFirm.com: we have been witnessing this unfortunate result for years.   

The research study compared the medical records of about 642,000 adults under 65 who underwent a knee replacement or other type of surgery to those of just over 18 million people who didn’t. Neither group had taken opioids in the year before the study period.    

Researchers found that nearly all the surgeries were associated with a patient filling 10 or more opioid prescriptions, or receiving more than a four-months’ supply of the drugs, in a single year. These patients are defined as having a higher risk of chronic opioid use.  

After about 3 months prior to a surgical procedure it is generally viewed as highly unusual for a patient to still need opioids to relieve pain. While complications could account for a small subset of patients that experience chronic pain, it is also extremely likely that some patients are vulnerable to opioid dependence, and wind up taking the drugs long term.  

Of the 11 common procedures studied, knee surgery was most likely to lead to long-term opioid use. The study found that 1 out of every 100 patients who had a knee replacement surgery became a chronic opioid user. That is still a lot of people, an estimated 7,200 Americans a year who weren’t taking opioids before knee surgery, wind up taking the drugs for a long time afterward.     

Could you be at risk? Prescription painkillers such as Oxycontin, Percocet, or Vicodin can be as addictive as heroin. Even people who are not addicted can become physically dependent on the drugs if they take them continuously for more than two weeks. Not surprisingly, the risk for chronic opioid use was higher in people undergoing more extensive surgeries, than those having minor procedures. Other factors that increased risk included a history of substance abuse or taking an antidepressant or a medication which includes anti-anxiety drugs and sedatives such as Xanax, Klonopin, Valium and, Ativan.  

Having risk factors for opioid dependence doesn’t mean you shouldn’t have a needed surgery, or that you should do without pain medication, but you should be aware of the risks when planning your treatment with your doctor.

If you do wind up taking opioids continuously for more than a couple of weeks, stopping the drugs abruptly can trigger withdrawal symptoms such as worsening pain, severe stomach upset, anxiety, and sleeplessness.  

There are alternatives for pain relief as opposed to taking the highly addictive pharmaceutical drugs such as ice packs, local anesthetics, and over the counter medication like Tylenol, Advil, Motrin, and Aleve. Also talk with your doctor about how soon you can start moving again as physical activity is shown to speed recovery and reduce pain. 

The attorneys at TheLawFirm.com are huge advocates of educating yourself as much as possible to make sure that you don’t get taken advantage of by a medical system that may not have your best interests at heart.

Our award-winning attorneys have successfully represented victims of dangerous drugs and have the experience and resources needed to handle these complicated matters. Click here to learn more about TheLawFirm.com Difference. Call now to speak with an experienced legal professional for free. Click here to learn more about TheLawFirm.com Difference. Call now to speak with an experienced legal professional for free.

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