Today, the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.

The FDA’s decision is based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy). This decision follows a March 2017 FDA advisory committee meeting where a group of independent experts voted 18-8 that the benefits of reformulated Opana ER no longer outweigh its risks.

Opana ER was first approved in 2006 for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. In 2012, Endo replaced the original formulation of Opana ER with a new formulation intended to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting. While the product met the regulatory standards for approval, the FDA determined that the data did not show that the reformulation could be expected to meaningfully reduce abuse and declined the company’s request to include labeling describing potentially abuse-deterrent properties for Opana ER. Now, with more information about the risks of the reformulated product, the agency is taking steps to remove the reformulated Opana ER from the market.

The FDA has requested that the company voluntarily remove reformulated Opana ER from the market. Should the company choose not to remove the product, the agency intends to take steps to formally require its removal by withdrawing 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 FDA 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.

For more information, please visit: Opana ER

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Snorting Your Prescription Painkillers

Insufflation – better known as snorting – causes drugs to enter your bloodstream quickly, giving you a more intense and faster high. People with chronic pain or those who have a painkiller addiction, seek a way to chase the high they once had. As you may know, the euphoria leaves after a short while, which leaves your body with a desperate need for that high again. What people do is increase their dosage on their own in order to bring back the euphoria. Many even make the decision to crush up their tablets and snort them. They think that it’s the fastest way to reach that desired euphoria again.; however, it’s not.

If you think snorting is a behavior of street Rx drug users, think again.  There are all too many little grannies who are doing it due to the extreme and desperate need for the body to maintain a high.

Why is Snorting Drugs Bad?
Snorting painkillers is significantly more dangerous than taking them as a pill or tablet by mouth, and the decision to crush up your hydrocodone could very well cost you your life.

5 reasons why snorting painkillers could likely cause you to lose your life:

1. It’s Harder to Control the Dosage
The process of crushing and snorting painkillers makes it easier for the drugs to be absorbed into your blood stream. This, in turn, creates a faster and more unpredictable high. Though this might sound appealing when you’re craving a Vicodin (or other opiate) fix, you’ll have zero control over the end result.

Don’t wait
Get treatment before your prescription drug use becomes life-threatening. Let me tell you, it will.

Accidental overdoses are the leading cause of accidental injury deaths, and prescription painkillers are the most frequent source of the overdose. Every time you snort painkillers, you put your life at risk. One American dies every 19 minute for an accidental overdose.

2. Time is running out

Addiction begins with tolerance, which uncontrollably pushes you to use larger doses than you initially were given. At this desperate point, all to many begin to snort.
Once you become addicted to painkillers, quitting without medically supervised detox becomes impossible–and especially dangerous.

3. Respiratory and Sinus Irritation

Snorting these potent substances will cause your sinuses and respiratory system to become extremely irritated causing frequent illness and then, disease. If you’re not careful, you could even choke (to death) as you attempt to snort the drugs.

The damage ranges from mild to life-threatening, but some of the ways snorting painkillers can affect your breathing include:

  • Chronic sinus infections and congestion.
  • Changes in your voice.
  • Frequent nose bleeds.
  • Sleep apnea and snoring.
  • Awakening due to congestion at night.
  • Lung infections, pneumonia, and similar complications.
  • Sores in and around your nose and mouth.

Why not manage the damage today by getting help to get healthy again. As long as you can still breathe, t’s never too late.

4. Intensification of Other Risk Factors

The fact that snorting painkillers is dangerous doesn’t mean that taking pills by mouth is okay… even for people with a valid medical prescription. Signs that your life is headed to total darkness:

  • Depression
  • Difficulties with motivation.
  • Anxiety and Panic Attacks.
  • Trouble concentrating.
  • Sleeping too much… not enough.
  • Changes in appetite and taste.
  • Gastrointestinal distress, such as frequent unexplained vomiting.
  • Constipation / Diarrhea
  • Cardiovascular problems.
  • Increased vulnerability to infections.
  • High-risk behavior, such as doctor shopping and stealing drugs.
  • Difficulty relating to others.
  • Worsening of chronic pain due to the drugs diminishing your overall health.
  • Trouble staying awake during the day, and disruptions in sleep during the night.
  • Vivid goulish dreams.
  • Chronic Heartburn.
  • Palpitations.
  • Apathy.
  • Headache.
  • Severe Agitation
  • Hallucinations – both auditory and visual
  • Skin crawling
  • Having to take a lot of time off from work.
  • Disconnecting from family and friends who don’t use.

5. Unpredictable Effects

The effects of painkiller use are well-known when these drugs are administered orally. But because painkillers were never designed to be snorted, it’s hard to predict how snorting painkillers might affect you.

No matter how much you believe you are in control of your painkiller use, snorting these dangerous drugs robs you of control, and can yield deadly unanticipated side effects and death. These drugs can even place you in a vegetative state for the rest of your life.
Personal factors, such as your cardiovascular health and age, can alter the effects of the drugs. – An up and coming alternative method to healing addiction through God’s principles.