Contact
Send comments to Erin Marie Daly at oxywatchdog@gmail.com.Follow
Oxy Watchdog’s Story
Find
Listen
Watch
Hot Topics
addiction Big Pharma Crime DEA Deaths doctors doctor shopping drug monitoring program education FDA heroin hydrocodone methadone naloxone Narcan narcotics OP Opana opiates opioid overdose overdoses oxy oxy-to-heroin oxycodone OxyContin pain clinics painkillers pain medication Percocet pharmaceutical pharmacy pill mills pills pills-to-heroin politics prescription drug abuse prescription drug monitoring program prescriptions Purdue Pharma Roxycodone Schedule II narcotics Teen deaths Vicodin XanaxBlogroll
- Addiction Journal
- An Addict In Our Son's Bedroom
- Awakening Through Love
- Breaking the Silence
- Diving Into the Mind of a Recovering Addict
- Hands Full of Tears
- Hurting Parents – Addicted Son
- Let Go Hang On
- Mom Trying To Detach With Love
- Mom vs. Heroin
- My Son is an Addict
- One Mom Talking
- OxyContin & Opiate Addiction: A Mother's Story
Resources
- Alliance of States with Prescription Monitoring Programs
- CASA Columbia
- Dispose My Meds
- Drugwatch.com
- Faces & Voices of Recovery
- Harm Reduction Coalition
- Henry's Fund
- NaloxoneInfo.org
- Narcotics Overdose Prevention and Education (NOPE Task Force)
- National Coalition Against Prescription Drug Abuse
- New Bridge Foundation's START Program
- NIDA – Commonly Abused Prescription Drugs
- No Heroin in Heaven
- Office of National Drug Control Policy – Prescription Drug Abuse
- Project J.O.S.H. (Journeying Onward Substance-Abuse Help)
- S.O.L.A.C.E. – Surviving Our Loss with Awareness, Compassion & Empathy
- SAMHSA
- Save A Star Drug Awareness Foundation
- Stop Drug Death
- TeensHealth – Prescription Drug Abuse
- The 11 Most Abused Prescription Drugs
- The D.O.P.E. Project (Drug Overdose Prevention and Education)
- The Medicine Abuse Project
- Time To Talk
- Treatment4Addiction
Categories
Archives
- February 2015
- August 2014
- July 2014
- June 2014
- May 2014
- April 2014
- March 2014
- February 2014
- January 2014
- December 2013
- November 2013
- October 2013
- September 2013
- August 2013
- July 2013
- June 2013
- May 2013
- April 2013
- March 2013
- February 2013
- January 2013
- December 2012
- November 2012
- October 2012
- September 2012
- August 2012
- July 2012
- June 2012
- May 2012
- April 2012
- March 2012
- February 2012
- January 2012
- December 2011
- November 2011
- October 2011
- September 2011
- August 2011
- July 2011
- June 2011
- May 2011
- April 2011
- March 2011
- February 2011
- January 2011
- December 2010
- November 2010
- October 2010
- September 2010
- August 2010
- July 2010
- June 2010
- May 2010
- April 2010
- March 2010
- February 2010
- January 2010
- December 2009
- November 2009
- October 2009
Tag Archives: Zohydro
Del. orders Zohydro prescribing restrictions
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.
Posted in Informational, Pharmaceutical Industry, Policy & Regulation, Trends
Tagged addiction, Big Pharma, Delaware, doctors, hydrocodone, narcotics, opiates, opioid, oxy, oxycodone, OxyContin, painkillers, pills, prescription drug abuse, prescriptions, Schedule II narcotics, Vicodin, Zogenix, Zohydro
Leave a comment
Zohydro backlash intensifies despite FDA’s defense
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.
Posted in Informational, Pharmaceutical Industry
Tagged addiction, Big Pharma, Deaths, FDA, Massachusetts, narcotics, opiates, opioid, oxy, oxycodone, OxyContin, pain medication, painkillers, pharmaceutical, politics, prescription drug abuse, prescriptions, Schedule II narcotics, Zogenix, Zohydro
Leave a comment
Judge nixes Zohydro ban in Mass.
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.
Posted in Informational, Pharmaceutical Industry, Policy & Regulation
Tagged addiction, Big Pharma, Deaths, FDA, heroin, hydrocodone, judge, Massachusetts, narcotics, opiates, overdoses, oxy, oxy-to-heroin, oxycodone, OxyContin, pain medication, painkillers, pills, pills-to-heroin, prescription drug abuse, Schedule II narcotics, Vicodin, Zogenix, Zohydro
Leave a comment
Mass. Gov. bans Zohydro amid opioid epidemic
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.
Posted in Informational, Policy & Regulation
Tagged addiction, Big Pharma, first responders, heroin, hydrocodone, Massachusetts, naloxone, Narcan, narcotics, overdoses, oxy, oxy-to-heroin, OxyContin, painkillers, PDMP, pills, pills-to-heroin, politics, prescription drug abuse, prescription drug monitoring program, Schedule II narcotics, Zohydro
Leave a comment
Ky. anti-heroin bill moves forward
A controversial bill that would boost penalties for drug dealers — particularly when the sale of drugs like heroin results in an overdose death — is gaining traction in Kentucky, where the House Judiciary Committee narrowly approved the measure. The bill needed 12 votes to advance out of committee, and only secured enough support when one lawmaker agreed to change her vote, with eight members passing and no one voting in opposition, according to this article.
The legislation would allow the prosecution of homicide when the sale of heroin or some other Schedule I controlled substance results in an overdose death; classify the controversial new painkiller Zohydro as a Schedule I drug; require the state Medicaid program to cover several inpatient and outpatient treatment options for people addicted to opiates, including heroin and prescription painkillers; and divert state funds to expand treatment programs, according to this article.
Prescription painkillers are the primary cause of overdose deaths in Kentucky, while heroin contributed to 129 Kentucky resident drug overdose deaths in 2012 — a 207 percent increase from the 42 heroin-involved deaths recorded in 2011.
Zohydro critics fear new wave of addiction
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.
Posted in Informational, Pharmaceutical Industry, Policy & Regulation
Tagged addiction, Big Pharma, FDA, hydrocodone, narcotics, NPR, opiates, opioid, oxy, oxycodone, OxyContin, pain medication, painkillers, pharmaceutical, pills, prescription drug abuse, prescriptions, Schedule II narcotics, Vicodin, Zogenix, Zohydro
Leave a comment
FDA OKs controversial form of Vicodin
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.
Posted in Informational, Pharmaceutical Industry, Policy & Regulation
Tagged addiction, Big Pharma, FDA, hydrocodone, Lortab, narcotics, Norco, OP, opiates, opioid, oxy, oxycodone, OxyContin, pain medication, painkillers, pharmaceutical, pills, politics, prescription drug abuse, prescriptions, Purdue Pharma, Schedule II narcotics, Vicodin, Zogenix, Zohydro
Leave a comment
FDA panel says no to pumped-up Vicodin
A U.S. Food and Drug Administration panel has voted against the agency approving Zogenix Inc.’s Zohydro painkiller, a new version of pure, extended-release hydrocodone that is said to be 10 times more powerful than Vicodin. In an 11-2 vote, the advisory panel said Zogenix had met FDA standards for safety and efficacy, but cited concerns about the danger of addiction posed by the opioid drug class, according to this article.
The FDA could still approve the drug for sale in the United States by imposing restrictions to protect public safety, though it usually follows the advice of its advisory panels when deciding whether to approve new medicines. Agency officials will consider the committee’s recommendation in deciding by March 1 whether to give Zohydro the green light, the article says.
San Diego-based Zogenix Inc.’s bid for FDA approval to begin marketing Zohydro has prompted some activists to appeal to the agency not to rubber-stamp more opioid drugs in the midst of an out-of-control epidemic. Proponents of extended-release versions of opioids – such as Purdue Pharma’s recently reformulated OxyContin, OP – claim the drugs are safer because they are “abuse-resistant,” but others point out that many opioid-addicted people simply swallow the pills whole. (Addicts are also already finding their way around allegedly tamper-proof versions.)
Posted in Informational, Pharmaceutical Industry, Policy & Regulation
Tagged addiction, Big Pharma, FDA, hydrocodone, narcotics, opiates, opioid, oxy, oxycodone, OxyContin, pain medication, painkillers, pharmaceutical, pills, politics, prescription drug abuse, prescriptions, Schedule II narcotics, Vicodin, Zogenix, Zohydro
Leave a comment
New Vicodin draws activist fire amid opioid abuse epidemic
San Diego-based Zogenix Inc.’s bid for FDA approval to begin marketing Zohydro – a new version of pure, extended-release hydrocodone that is said to be 10 times more powerful than Vicodin – has prompted some activists to appeal to the agency not to rubber-stamp more opioid drugs in the midst of an out-of-control epidemic. Proponents of extended-release versions of opioids – such as Purdue Pharma’s recently reformulated OxyContin, OP – claim the drugs are safer because they are “abuse-resistant,” but others point out that many opioid-addicted people simply swallow the pills whole. (Addicts are also already finding their way around allegedly tamper-proof versions.)
One group, Advocates for the Reform of Prescription Opioids, has launched a letter-writing campaign urging the FDA not to sign off on more opioids. According to ARPO president Pete Jackson, the approval of extended-release hydrocodone will only exacerbate the opioid addiction epidemic, which killed nearly 15,000 Americans in 2008, surpassing the number of deaths due to car accidents. “It boggles the mind that, with the steadily rising toll of death and addiction from prescription opioids that has gone on unabated for more than ten years, we could be facing the approval of still more potent narcotic pain relievers in the form of pure, extended-release hydrocodone,” Jackson says. “It makes NO sense for the FDA to approve more deadly opioids at a time when they have not figured out how to stop the carnage from the opioids already on the market. This will add thousands to the annual death toll.”
Posted in Informational, Pharmaceutical Industry, Policy & Regulation, Trends
Tagged addiction, ARPO, Big Pharma, FDA, hydrocodone, OP, opiates, opioid, oxy, oxycodone, OxyContin, pain medication, painkillers, pills, prescription drug abuse, Purdue Pharma, Schedule II narcotics, Zogenix, Zohydro
3 Comments
