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Tag Archives: opioid
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.
U.S. Attorney General Eric Holder is urging federal law enforcement agencies to identify, train and equip personnel who may interact with a victim of a heroin overdose with the drug naloxone. The potentially life-saving drug — which effectively restores breathing to a victim in the midst of a heroin or opioid overdose — is already carried by officers in some state and local law enforcement groups while on patrol.
The U.S. Department of Justice wants federal law enforcement agencies, as well as their state and local partners, to review their policies and procedures to determine whether personnel should be equipped and trained to recognize and respond to opioid overdose by various methods, including the use of naloxone, otherwise known as Narcan. Seventeen states and the District of Columbia have amended their laws to increase access to naloxone, resulting in over 10,000 overdose reversals since 2001.
According to Holder:
The shocking increase in overdose deaths illustrates that addiction to heroin and other opioids, including some prescription painkillers, represents nothing less than a public health crisis. I am confident that expanding the availability of naloxone has the potential to save the lives, families and futures of countless people across the nation.
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.
An older form of the powerful prescription painkiller OxyContin that has been banned in the United States is still showing up in some areas of the country, possibly making the journey from Canada, where it is still legal, according to this article. In 2013, the FDA banned generic versions of OxyContin, which could easily be crushed, in favor of a tamper-resistant version produced exclusively by Oxy maker Purdue Pharma under a new patent. The Canadian government has so far continued to approve generic, crushable forms of oxycodone that are highly prone to abuse — though it has recently indicated it may soon force all opioid manufacturers to render their products tamper-resistant.
The news came as a study into skyrocketing opioid deaths in Canada found that painkillers are responsible for one in eight deaths among young adults in Ontario, according to this article. Opioid overdoses killed nearly 6,000 people in Ontario between 1991 and 2010, half of them under the age of 42, the study found.
Canada is the world’s second largest per capita consumer of prescription opioids after the United States.
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.
Opposition to Zohydro, the powerful new opiate some critics are calling “heroin in a pill,” continues to build, but the U.S. Food and Drug Administration is strongly defending the agency’s approval of the drug, saying its benefits to pain patients outweigh the potential negative consequences.
Since its approval by the FDA last October, Zohydro has come under fire from members of Congress, state attorneys general, doctors and addiction specialists who have worked to block the pill from being sold in the U.S., according to this article. Critics want the agency to rescind its approval of Zohydro, citing the alleged danger of the drug as well as the growing abuse of prescription drugs nationwide, but the FDA says that instead of blocking the sale of Zohydro based on a fear of abuse and addiction, providers should screen patients before they prescribe the drug and while they are on it, the article 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.
Despite increased media coverage and efforts to crack down on abuse, overdose deaths due to prescription drugs and heroin continue to happen at alarming rates in many states.
In Massachusetts, Gov. Deval Patrick recently declared a public health emergency due to the sharp increase in heroin overdoses and opioid addiction, with many addicts shifting from more expensive and harder-to-get pills to heroin, which is cheaper and widely available. Massachusetts state police say 185 people died from suspected heroin overdoses between November and February, a figure that does not include overdose deaths in the state’s three largest cities; the number of all opioid-related deaths increased from 363 in 2000 to 642 in 2011.
In Oklahoma, unintentional prescription drug overdoses claimed the lives of 534 residents in 2012; state health authorities say about half of them had taken drugs prescribed by their own doctors, according to this article.
In Iowa, the number of heroin overdose deaths rose 700 percent from 2003 to 2012, from one death to eight, according to this article.
The U.S. Food and Drug Administration has approved a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. The hand-held device, known as Evzio, rapidly delivers a single dose of the drug naloxone and can be carried in a pocket or stored in a medicine cabinet, according to the agency. Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for such situations, but until now it has been available mostly in hospitals and other medical settings.
Evzio is injected into the muscle (intramuscular) or under the skin (subcutaneous), the FDA said. Once turned on, the device provides verbal instruction to the user describing how to deliver the medication.
Drug overdose deaths, driven largely by prescription drug overdose deaths, are now the leading cause of injury death in the United States – surpassing motor vehicle crashes. In 2013, the U.S. Centers for Disease Control and Prevention reported the number of drug overdose deaths had steadily increased for more than a decade.
The rise in heroin addiction across the nation, fueled by the prescription drug addiction epidemic, means that increasing numbers of people are in need of inpatient treatment services — but many who need help are contending with a shortage of services and constraints placed on care by insurance companies, according to this article.
Unlike withdrawal from dependencies on alcohol or benzodiazepines, heroin withdrawal isn’t life-threatening – but it is so horrific that many addicts are drawn back to the drug and overdose, the article notes. Because withdrawal is not directly deadly, most insurance companies won’t pay for inpatient rehab, either claiming that the addict does not meet the “criteria for medical necessity” — that inpatient care would be an inappropriate treatment — or requiring that the user first try outpatient rehab, the article says.
Of the 23.1 million Americans who needed treatment for drugs or alcohol in 2012, only 2.5 million people received care at a specialty facility, the article says, citing data from the Substance Abuse and Mental Health Services Administration.
The number of people reporting heroin use in the previous year increased between 2007 and 2012, from 373,000 to 669,000, while nearly 80 percent of people who had used heroin in 2011 had also previously abused prescription painkillers classified as opioids.