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Tag Archives: OP
Two California counties have launched a lawsuit accusing five major pharmaceutical companies of obscuring the addictive effects of OxyContin, Percocet and other powerful opioid painkillers while reaping billions of dollars in profits from the drugs. The companies deceived tens of millions of doctors and patients about the “significant dangers and questionable benefits of prescription opioids” for the treatment of long-term non-cancer pain, according to a complaint filed today in California state court. The five opioid manufacturers — Purdue Pharma, Cephalon, Janssen Pharmaceuticals, Endo Health Solutions, and Actavis — concealed the dangerously addictive nature of the medicines while touting benefits that had no scientific support, in order to expand the market for the drugs and boost profits, the lawsuit alleges.
The complaint charges that the pharmaceutical companies marketed opioids as “rarely” addictive, misrepresented the evidence of their efficacy for treating chronic non-cancer pain, trivialized their serious side effects and falsely assured doctors and consumers that opioids were safer than over-the-counter drugs.
According to the suit:
These pharmaceutical companies have a long history of aggressively marketing these dangerous drugs through sophisticated campaigns. These campaigns employ industry-funded professional associations, patient advocacy groups, and physicians to deceive consumers and their doctors about the harms and purported benefits of opioids for treating chronic pain.
The U.S. Food and Drug Administration has approved Zogenix Inc.’s Zohydro painkiller, a new version of pure, extended-release hydrocodone that is said to be 10 times more powerful than Vicodin. The move comes amid criticism from those who say the FDA should not be approving any additional opioids given the current prescription drug addiction epidemic. An advisory panel last year voted against approving Zohydro, citing concerns about the danger of addiction posed by the opioid drug class.
Unlike other hydrocodone-containing drugs like Vicodin, Lortab and Norco, Zohydro is not buffered with acetaminophen or some other over-the-counter medication. The drug also lacks an abuse-deterrent feature such as the ones used in new formulations of drugs like OxyContin.
Hydrocodone is currently the second most-abused medicine in the U.S. behind oxycodone.
In the wake of a Los Angeles Times report describing a decade-long effort by Purdue Pharma to identify potentially problematic prescribers of OxyContin, two state lawmakers are requesting that the company turn over the names of doctors it suspects recklessly prescribed the pills to drug dealers and addicts.
Sen. Richard “Tick” Segerblom (D-Las Vegas) and California state Sen. Ted Lieu (D-Torrance) want Purdue to reveal the names of physicians contained in a database that includes some 1,800 doctors who showed signs of dangerous prescribing, according to the LA Times.
Purdue has taken the stance that the painkiller addiction epidemic was fueled largely by pharmacy robberies, doctor-shopping patients and teens raiding home medicine cabinets, but has admitted that a small number of physicians might account for a “substantial portion” of the nation’s black-market supply of prescription painkillers, the article says.
According to the article:
Beginning in 2002, Purdue trained its sales representatives to report “red flags” in doctors’ offices, such as young patients, long lines, people nodding off in waiting rooms and frequent cash transactions. Purdue attorneys review their reports, and if a doctor’s practice is deemed too risky, the company bars sales representatives from marketing to the physicians. The suspect doctors are removed from the company’s numbered sales territories and assigned to the database, known as “Region Zero.”
Overdose deaths due to prescription painkillers have been on the rise among all segments of the population, but a new analysis of federal data by the U.S. Centers for Disease Control and Prevention has found that such deaths have quintupled among women since 1999.
Although more men are still dying of prescription drug overdoses, women are catching up: in the last 14 years, the percentage increase in deaths has been greater for women, spiking by 400% as opposed to 265% for men, the CDC says.
According to the agency, 6,631 women died of opioid overdoses in 2010 — more than twice the number who die from cervical cancer — compared with 10,020 men; in addition, while younger women in their 20s and 30s tend to have the highest rates of opioid abuse, the overdose death rate was highest among women ages 45 to 54.
In 2010, there were more than 200,000 emergency room department visits for misuse of opioids among women, one every three minutes, the CDC says.
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.
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.
New York Sen. Charles Schumer is calling for added safety features to be imposed on generic forms of the prescription painkiller OxyContin that are set to hit the market in April. The lawmaker says he fears that these copycat versions, which do not include anti-abuse protections that cause them to turn into gels or chunks when crushed, could enable abusers, according to this article.
Many popularly abused prescription painkillers, including OxyContin, have been reformulated in recent years to allegedly make them abuse-resistant. But generic manufacturers are bringing their own versions of such drugs to market that don’t include tamper-proof properties.
Oxycodone prescriptions in Staten Island — which ranks third in oxycodone prescriptions per capita in the state — have remained relatively steady, with 141,022 written last year, compared to 142,059 in 2011, according to the article.
Overdose is now the leading cause of accidental death in New York, where almost 22.5 million prescriptions for all types of narcotic painkillers were written in in 2010, according to a recent report issued by the state’s attorney general.
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 D.O.P.E. 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 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.