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Tag Archives: hydrocodone
Hydrocodone, the nation’s most widely prescribed painkiller, will now be in the same category as other frequently abused medications such as OxyContin and fentanyl. The agency said Friday it had published a rule to reschedule hydrocodone combination products — which include Vicodin and Norco — from Schedule III to the more restrictive Schedule II of the Controlled Substances Act.
Americans consume 99% of the hydrocodone produced worldwide; because of the perception that such products are less risky than other narcotic painkillers, they are widely prescribed by general practitioners and dentists, according to this article.
Combination hydrocodone products are currently classified as Schedule III drugs, meaning that prescriptions can be written with five refills and pharmacies are not required to lock them in a safe.
Since 2007, more U.S. prescriptions were written for the combination of hydrocodone and acetaminophen than any other drug. In 2012, that was over 135 million prescriptions, or one prescription for every 2.3 men, women, and children in the U.S. that year, according to this article.
FedEx Corp. is facing charges that it delivered prescription painkillers and other controlled substances for illegal Internet pharmacies.
The charges include 15 counts of conspiracy to distribute controlled substances and misbranded drugs and drug trafficking. Prosecutors claim FedEx delivered drugs to Internet pharmacies that supplied pills to customers who filled out online questionnaires without undergoing doctors’ examinations, in violation of federal and state drug laws.
According to the indictment, FedEx knew as early as 2004 that it was delivering drugs to dealers and addicts:
FedEx’s couriers in Kentucky, Tennessee, and Virginia expressed safety concerns that were circulated to FedEx Senior management, including that FedEx trucks were stopped on the road by online pharmacy customers demanding packages of pills, that the delivery address was a parking lot, school, or vacant home where several car loads of people were waiting for the FedEx driver to arrive with their drugs, that customers were jumping on the FedEx trucks and demanding online pharmacy packages, and that FedEx drivers were threatened if they insisted on delivering packages to the addresses instead of giving the packages to customers who demanded them. In response to these concerns, FedEx adopted a procedure whereby Internet pharmacy packages from problematic shippers were held for pick up at specific stations, rather than delivered to the recipient’s address.
Heroin use skyrocketed by more than 80% nationwide from 2007 to 2012, with the number of heroin users rising from about 373,000 to 669,000 in 2012, according to this article, which cites data from the federal Substance Abuse and Mental Health Services Administration presented at the U.S. Conference of Mayors in Dallas.
Physicians in the U.S. prescribe enough painkillers to medicate everyone in the country 24 hours a day for a month, and most heroin users start with prescription drugs, the article says.
Meanwhile, new data from the CDC the number of drug poisoning deaths related to heroin jumped by 45% from 2010 to 2011. But the number of people who are dying from overdosing on prescription drugs hasn’t dropped — about half of the 41,340 people who died of drug poisoning in 2011 took prescription opiates, according to this article.
Delaware has put into place emergency prescribing regulations regarding Zohydro, a powerful new painkiller many critics fear may fuel the epidemic of painkiller abuse. Late last year, Zohydro gained FDA approval despite the fact that after its own advisory committee had voted 11-2 against allowing the drug on the market. Since then, 29 state attorneys general have urged the agency to reconsider its decision, and Massachusetts Gov. Deval Patrick even attempted to ban the drug (a federal judge later blocked that order). Delaware Secretary of State Jeffrey Bullock said the regulations were necessary “to address the imminent peril to the public health, safety and welfare of all Delawareans” caused by Zohydro. According to his statement:
The use of this new and dangerous narcotic painkiller known as Zohydro must be monitored closely because the abuse of it can be deadly. It carries even higher risks of abuse than other short-acting formulations.
Zogenix, the maker of Zohydro, recently reported that about 9,000 prescriptions were filled through June 13 since the drug hit the market in March. The company plans to target about 20,000 prescribers it describes as “high decile [extended-release/long-acting] opioid prescribers” who account for 60% of the market, and envisions Zohydro along the lines of the multibillion-dollar market for OxyContin, according to this article.
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.
A federal judge has struck down Massachusetts Gov. Deval Patrick’s ban on the controversial new form of hydrocodone, Zohydro, saying the state lacked the authority to override the FDA’s approval of the painkiller. U.S. District Court Judge Rya W. Zobel noted that the FDA approved Zohydro after a screening process, and said the federal regulatory agency has more power than the state in this case, according to this article. She also said Massachusetts lacked the authority to force Zohydro’s maker, Zogenix, to make an abuse-resistant form of the drug because that formulation has not been approved by the FDA, the article says.
Gov. Patrick issued the Zohydro ban last month, declaring a public health emergency in response to the state’s growing opioid addiction epidemic and taking a number of other steps to curb overdoses and help the addicted. In a press release, the governor said the use of oxycodone and other narcotic painkillers, often as a route to heroin addiction, has been on the rise for the last few years in Massachusetts; at least 140 people have died from suspected heroin overdoses in communities across the state in the last several months, levels previously unseen. From 2000 to 2012, the number of unintentional opiate overdoses increased by 90 percent, he added.
Massachusetts Governor Deval Patrick has declared a public health emergency in response to the state’s growing opioid addiction epidemic, issuing an order banning the controversial new form of hydrocodone, Zohydro, and taking a number of other steps to curb overdoses and help the addicted. In a press release, the governor said the use of oxycodone and other narcotic painkillers, often as a route to heroin addiction, has been on the rise for the last few years in Massachusetts; at least 140 people have died from suspected heroin overdoses in communities across the state in the last several months, levels previously unseen. From 2000 to 2012, the number of unintentional opiate overdoses increased by 90 percent, he added. The prescribing and dispensing of Zohydro, which was recently approved for sale by the FDA despite widespread protests, will be prohibited “until it is determined that adequate measures are in place to safeguard against the potential for diversion, overdose and misuse,” he said. The governor added:
The introduction of this new painkiller into the market poses a significant risk to individuals already addicted to opiates and to the public at large.
Increasing numbers of Americans are being prescribed powerful opiate painkillers during emergency room visits, a new study has found. Between 2001 and 2010, emergency departments in the United States showed a 49 percent increase in prescriptions for narcotic painkillers despite the fact that there was only a small increase in the percentage of visits for painful conditions.
The study, published in the journal Academic Emergency Medicine, found that in 2010, 31 percent of ER visits involved a narcotic painkiller prescription, up from about 21 percent in 2001.
These increases were seen for conditions including abdominal pain, back pain, headache, joint and muscle pain, and toothaches.
In addition, the study found that hydromorphone and oxycodone had the greatest increase in ER administration between 2005 and 2010, while oxycodone and hydrocodone had the greatest increases in discharge prescriptions.
About 12 million Americans abused prescription painkillers in 2010, while roughly 15,000 Americans die annually from overdosing on such drugs, according to the U.S. Centers for Disease Control and Prevention.
The U.S. Food and Drug Administration’s approval of Zogenix Inc.’s Zohydro painkiller has come under fire from critics who say the agency should not be approving any additional opioids given the current prescription drug epidemic. Forty-two public health groups are urging the FDA to withdraw its support of the painkiller, according to National Public Radio. Zogenix says it will introduce a non-crushable version of Zohydro in three years and plans to closely monitor prescription abuse, and claims that millions legitimately need the drug, NPR reports. But addiction experts say another high-potent, high-dose, long-acting opioid drug will simply add more fuel to the painkiller addiction epidemic, NPR says.
The green light for Zohydro, a new version of pure, extended-release hydrocodone that is said to be 10 times more powerful than Vicodin, came after an FDA advisory panel last year voted against approving the drug, 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.
There are many reasons why teenagers get hooked on prescription drugs, but new research conducted at the University of Michigan has found that those who are prescribed pain relievers are at “notable risk” for abusing opioid drugs.
A University of Michigan researcher found that teens may develop an increased tolerance to the medication, which can lead to continued use of the drug after the initial prescription is finished.
According to the researcher:
“Once an adolescent has been medically exposed to a potentially addictive medication, adolescents are more likely to engage in nonmedical use and diversion, including buying, selling and giving away pills.”
Earlier this year, a separate study found that 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.
Of those kids who said they abused prescription medications, one in five (20%) had done so before age 14, that survey found.