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Tag Archives: opioid
The U.S. Food and Drug Administration said Friday it will continue to allow sales of the generic version of the painkiller Opana that does not include an abuse-resistant feature.
Opana’s manufacturer, Endo Pharmaceuticals, had submitted a petition to the agency asking it to ban generic forms of the painkiller, which Endo has reformulated as “Opana ER” to make it harder to abuse. That petition was denied by the FDA, which said Endo’s reformulation was not significantly safer than the original version:
While there is an increased ability of the reformulated version of Opana ER to resist crushing relative to the original formulation, study data show that the reformulated version’s extended-release features can be compromised when subjected to other forms of manipulation, such as cutting, grinding, or chewing, followed by swallowing. Reformulated Opana ER can be readily prepared for injection, despite Endo’s claim that these tablets have “resistance to aqueous extraction (i.e., poor syringeability).” It also appears that reformulated Opana ER can be prepared for snorting using commonly available tools and methods.
Endo’s petition came after Purdue Pharma successfully asked the FDA to ban any generic versions of OxyContin based on the powerful painkiller’s original formulation, which does not include anti-abuse features designed to make it more difficult to crush, break, or dissolve.
Although prescription drug addiction is often portrayed as an issue affecting teens and young adults, America’s 78 million aging baby boomers are also experiencing the effects of the epidemic, according to this article in the New York Times. A 2011 study by the Substance Abuse and Mental Health Services Administration found that among adults aged 50 to 59, the rate of current illicit drug use increased to 6.3% in 2011 from 2.7% in 2002; opiates were among the most commonly abused drugs, the article says.
Other studies have estimated that up to 10% of the elderly misuse prescription drugs with major abuse potential, most often anti-anxiety benzodiazepines like Klonopin, sleeping aids like Ambien, and opiate painkillers such as OxyContin, the article says. In addition, women far outnumber men when it comes to nonmedical use of prescription medication: 44% of women as opposed to 23% of men, according to SAMHSA.
One major generational difference seems to be that the elderly rarely use alcohol or drugs to “get high” — rather, they turn to alcohol and drugs in response to the physical and psychological pain due to medical and psychiatric illness, the loss of loved ones, or social isolation, the article notes.
The rate of reported drug overdoses in the U.S. more than doubled between 1999 and 2010, with about half of the additional deaths falling under the pharmaceuticals category, according to this article in Popular Science. The data, which was compiled from WONDER, the CDC National Center for Health Statistics’ multiple cause of death database, showed that nearly three-quarters of the pharmaceuticals deaths were due to opioid analgesics such as OxyContin and Vicodin.
The CDC recently found that drug overdose deaths increased for the eleventh consecutive year in 2010. According to the agency, 38,329 people died from a drug overdose in the U.S. that year, up from 37,004 deaths in 2009.
Overdose deaths involving opioid analgesics have shown a similar increase, the CDC found: starting with 4,030 deaths in 1999, the number of deaths increased to 15,597 in 2009 and 16,651 in 2010.
In 2010, nearly 60% of the drug overdose deaths (22,134) involved pharmaceutical drugs. Opioid analgesics, such as oxycodone, hydrocodone, and methadone, were involved in about 3 of every 4 pharmaceutical overdose deaths (16,651), according to the CDC.
One in four teens has misused or abused a prescription drug at least once in their lifetime – a 33% increase over the past five years – up from 18% in 2008, according to a new survey, The Partnership Attitude Tracking Study (PATS), by the Partnership at Drugfree.org and MetLife Foundation. That translates to about 5 million teens.
In addition, one in eight teens reported that at least once in their lifetime, they had taken the stimulants Ritalin or Adderall when those medications weren’t prescribed for them, the survey found.
Even more disturbing was the fact that almost one in four teens (23%) said their parents didn’t care as much if they were caught using prescription drugs without a doctor’s prescription, as compared to getting caught with illegal drugs. And more than a quarter of teens (27%) mistakenly believed that misusing and abusing prescription drugs was safer than using street drugs, with 33% saying they believed it was “okay to use prescription drugs that were not prescribed to them to deal with an injury, illness or physical pain.”
Of those kids who said they abused prescription medications, one in five (20%) had done so before age 14, the survey found.
The U.S. Food and Drug Administration said Tuesday it will not approve any generic versions of OxyContin based on the powerful painkiller’s original formulation, which does not include anti-abuse features designed to make the pill harder to abuse.
According to the agency, “because original OxyContin provides the same therapeutic benefits as reformulated OxyContin, but poses an increased potential for certain types of abuse, the FDA has determined that the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety or effectiveness.”
OxyContin’s manufacturer, Purdue Pharma, reformulated the drug in 2010 to make it more difficult to crush, break, or dissolve; the reformulated pill forms a viscous hydrogel and cannot be easily prepared for injection. The FDA noted Tuesday that abuse of OxyContin by these routes, as well as the oral route, is still possible.
The FDA’s decision came on the same day that Purdue’s patent on the original OxyContin expired, which normally opens the door for generic drug makers to launch their own cheaper versions of a product. Now, these generic companies will have to develop their own abuse-deterrent designs, preserving Purdue’s monopoly on the OxyContin market for the time being.
Tighter controls on the popularly abused painkiller OxyContin in Canada have had positive results, but experts say the country’s massive pill addiction problem is still spiraling out of control: in 2010, for the first time, Canada surpassed the United States to become the highest opioid-consuming country, per capita, in the world, according to this article.
Moreover, in 2011, twice as many Ontarians were killed by opioid overdoses as drivers killed in car accidents, and addiction treatment programs are overflowing with people addicted to publicly funded drugs, the article adds.
As you may remember, OxyContin manufacturer Purdue Pharma replaced the painkiller last March in Canada with OxyNEO, an alternative billed as “tamper-resistant” because it is harder to crush. Today, Ontario’s OxyNEO prescriptions are about 60% what OxyContin prescriptions were a year ago; in Newfoundland, they’re 22%; in B.C., 67%, according to the article.
But other long-acting opioids such as fentanyl and hydromorphone — including Hydromorph Contin, also made by Purdue — are now among the fastest-growing causes of Ontario’s opioid overdose deaths, the article says.
Although opiate overdoses are skyrocketing in the U.S., many people still don’t know about naloxone, which literally reverses the dangerous effects of taking too much OxyContin or heroin by counteracting the depression of the central nervous system and respiratory system. (This always amazes me, but I myself didn’t know about naloxone until well after my brother’s heroin overdose death in 2009. It took less than 10 minutes for me to get trained in Narcan use by the wonderful folks at the DOPE Project, a nonprofit whose mission is to reduce fatal overdose deaths by providing overdose prevention education and naloxone to drug users and their loved ones — and if you live in the Bay Area, I highly suggest contacting them to get trained.)
In Canada — which is second only to the U.S. in per-capita consumption of prescription opiates — naloxone costs less than $12, but isn’t widely distributed or acknowledged, according to the Waterloo Region Crime Prevention Council. In a powerful new short film, the WRCPC explains how naloxone can help save lives and highlights the need for expanding overdose prevention.
Distributing the life-saving opioid overdose reverser naloxone can save one life for every 227 naloxone kits distributed, a study found earlier this year.
The Toledo Blade has a new story on Ohio’s recent spike in heroin-related overdose deaths following the prevalence of prescription painkiller abuse throughout the state. As we are seeing elsewhere in the nation, the trend has resulted in a shocking uptick in heroin deaths: in 2010, the paper reports, 14 such deaths occurred in the region, increasing to 31 in 2011, and to 55 last year. As of early February, 14 heroin-related deaths had already been tracked this year by the Lucas County coroner’s office, the paper adds.
Furthermore, the paper reports that the overdose deaths can be connected to an influx of “China white” heroin, which is more potent than the brown kind traditionally more prevalent in the region. Toledo police seized about 1,454 grams of heroin in 2011, but only 5.3 grams were the white type; last year, however, of the 3,371 total grams seized, about 68% was white, and so far this year, white heroin accounts for about 80% of the heroin seized, according to the paper.
Statewide, heroin overdose deaths rose from an average of 100 per year between 2000 and 2005 to about 224 per year between 2006 and 2010, the latter accounting for 15% of all overdose deaths, the paper says.
The numbers are staggering: in the United States, the number of overdose deaths from prescription opioids has more than tripled in the past decade, resulting in nearly 15,000 fatalities in 2008 alone and now accounting for more than 40 deaths every single day – not to mention the fact that estimated annual health care costs from this epidemic are as high as $72.5 billion.
How did we get here?
In the latest issue of Emergency Medicine News, Dr. Leon Gussow, a physician and editor of The Poison Review blog, examines how opioid analgesics – once feared as dangerous medications with high risk for addiction and overdose – became the drug class most frequently prescribed in the U.S., with four million patients a year receiving scripts for these powerful medications.
The recent overdose death of a 24-year-old law student at George Washington University in Washington, D.C. underscores the dangers of speedballing – the combination of stimulant and depressant drugs. In this case, the student died after mixing heroin and the prescription drug Adderall, which is meant to treat attention deficit hyperactivity disorder, according to this article. Substance abusers also commonly use it to counteract the effects of heroin so they can take more of the opiate.
Obviously, the practice of speedballing is nothing new. But the widespread abuse of prescription drugs has brought things to a whole new level. Nearly 60% of drug-related deaths in 2010 involved prescription drugs, and three-quarters of those deaths involved opioids such as oxycodone and morphine, according the the Centers for Disease Control and Prevention.
Here is a list of common drug cocktails – including medicines as seemingly innocuous as Tylenol – that can be deadly when mixed together.