In , 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.
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. 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. At the time, Endo said it was reviewing the request and evaluating its options.
Opioid addiction continues to be a serious problem across the U. A report released this week from the Centers for Disease Control and Prevention found that pain-relief prescriptions in the United States vary widely from county to county , with 6 times more opioids-per-resident in regions with the highest prescribing rate compared to the lowest.
Counties in northern California, southern Nevada, and parts of Tennessee, Kentucky, and West Virginia had some of the highest per-capita rates. Contact us at letters time. Getty Images. By Amanda MacMillan. The U. Centers for Disease Control and Prevention CDC says more than 33, people died in from opioid overdoses — more than any other year on record — and nearly half of those deaths involved prescription opioids.
In new data, published in the July 7 issue of the Morbidity and Mortality Weekly Report MMWR , the CDC reported that prescriptions for opioid peaked in and have declined yearly through , although the agency says prescribing rates are still too high.
In an effort to rein in opioid use the FDA in released new prescribing guidelines for opioids. Opana ER was first approved in for the management of pain severe enough to require around-the-clock, long-term opioid treatment. The drug maker replaced the original version in with one reformulated to deter abuse, particularly by snorting. Sanjay Gupta has reported on recent research that shows today's typical heroin addict starts using at 23, is more likely to live in affluent suburbs and was likely unwittingly led to heroin through painkillers prescribed by his or her doctor.
Fentanyl — Fentanyl citrate, pictured here, is a Class II controlled substance and one of the most powerful opioids on the market. It's often administered via injection or transdermal patch, or in lozenge form for pain after surgery, for difficult-to-manage chronic pain and for people who have developed a tolerance to other opioids. The type of fentanyl usually associated with overdoses is bought on the street in powder or pill form and is often mixed with heroin in a clandestine lab to increase the high it produces.
Hydrocodone — These pills are a more powerful form of codeine, called hydrocodone, and are often mixed with acetaminophen. Hydrocodone is the most frequently prescribed opioid painkiller, according to the U. Food and Drug Administration , and the most abused. An overdose of hydrocodone can cause "cold and clammy skin, severely constricted pupils, and slow breathing that can lead to a loss of consciousness and death. Oxycodone — Oxycodone is a powerful narcotic pain reliever prescribed for moderate to high pain relief.
It's often given in an extended-release formula for patients who will need to be on pain medications for long periods of time. Patients are warned not to break, chew, crush or dissolve extended-release tablets because the rush of oxycodone into the system could cause serious health problems, including overdose and death. Though highly addictive, oxycodone is not thought to be as frequently abused as hydrocodone. OxyContin, Percocet, Percodan and Tylox are some trade-name oxycodone products.
Morphine — Morphine is another powerful opioid often administered via syringe for severe pain. It can come in pill form, usually as extended-release tablets and capsules, and is prescribed only to relieve difficult, chronic pain that cannot be controlled by the use of other pain medications.
As with most opioids, mixing medications, drinking alcohol or taking other meds that contain alcohol, or using street drugs while taking morphine, increases the risk of breathing problems or other serious, life-threatening side effects.
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