Posted Oct 26, 2013, 9:17 PM [ updated Oct 26, 2013, 9:26 PM ]
A new extended-release hydrocodone medication has been approved by the FDA. Zohydro ER has become the first medication containing only hydrocodone to be marketed in the U.S. and will be available in dosages of up to 50 mg of hydrocodone. Hydrocodone is an opioid that is often found in combination with acetaminophen in painkillers such as Vicodin, Lortab, and Norco. Zohydro ER will offer prescribers an additional therapeutic option to treat around-the-clock chronic pain in patients who can't tolerate other extended-release opioid preparations. As a pure hydrocodone product, Zohydro ER has a high potential of being abused. In late 2012, a panel of pain experts advised the FDA to reject Zohydro because of its abuse potential, voting 11-2 against approval of the drug.
Zohydro ER (Extended-Release Hydrocodone) Approved by FDA October 25, 2013
Zogenix Inc. (ZGNX) won approval to sell the first painkiller made of pure hydrocodone as U.S. regulators recommended restrictions on popular combination treatments with the drug. The decision helped Zogenix shares climb the most in eight months.
The Food and Drug Administration cleared the San Diego-based company's Zohydro for the management of pain severe enough to require continuous, long-term treatment, the agency said today in a statement. Zohydro is intended as an alternative to drugs including Vicodin that mix hydrocodone with less-potent medicines such as acetaminophen.
Zogenix is counting on the painkiller to boost its $44 million in 2012 revenue from sales of a migraine treatment Sumavel. FDA advisers recommended in December that Zohydro not gain market clearance until the agency examined greater measures to curb opioid abuse. The medicine doesn't contain tamper-proof technology that other drugmakers are using to prevent crushing and snorting of their pills, such as closely held Purdue Pharma LP's OxyContin.
The FDA asked Zohydro to study the drug's abuse potential while it's on the market, the agency said in the statement.
Posted Oct 11, 2013, 5:43 AM [ updated Nov 16, 2013, 9:47 PM ]
Desomorphine a.k.a. krokodil
October 10, 2013
The opioid drug desomorphine, also know as 'krokodil' (Russian for crocodile) after the scaly skin it can cause in its users, has reportedly made its way to the United States. The homemade drug krokodil first attracted attention in Russia back in 2010 when there was an increase in production, though reports of its use date back to 2003. Desomorphine is easily produced using codeine, an opiate painkiller that is available over-the-counter in many Western countries, as well as iodine and red phosphorus. When manufactured this way, the resulting desomorphine is filled with impurities and toxic byproducts. This is what makes the drug so dangerous and also the cause of the flesh-eating effect it can have in intravenous users of the drug.
The effects of krokodil are similar to that of heroin (diacetylmorphine), though the duration of the effects are much shorter. Krokodil's similarity to heroin combined with the wide availability of cheap, over-the-counter products containing codeine in Russia are the reasons for the huge increase in use of the drug among Russians. But it was only this September that reports of the drug in places like Arizona and Illinois started to surface. This article on Fox News today (Oct. 10, 2013) reports that krokodil has made it's way into a Chicago suburb, where a hit of the drug is available for one third of the price of a hit of heroin. (UPDATE 10/12/2013: Health officials are skeptical of claims of krokodil in the U.S. and the DEA has not received any confirmed samples of krokodil)
Below I have included a report aired by ABC News (Australian Broadcasting Corporation) in 2011 examining the rising use of krokodil among Russian injection drug users. There are a few images in the report that some individuals may find disturbing. Due to the crude, home-made production methods used to make krokodil and the chemicals involved, it is an especially dangerous drug to inject intravenously, and it is notorious for producing severe tissue damage, including gangrene, and which can sometimes result in limb amputation in long-term users. Speaking on krokodil's rapid increase in popularity in Russia, Colonel Evgeniy Beryozkin sums it up nicely in the video:
"It's a cheap drug with pretty much the same effect as heroin, but at a much lower price. That's why krokodil is becoming more and more popular."
If you are interested in reading more about desomorphine, a.k.a. krokodil, check out the links posted below the video.
Posted Oct 6, 2013, 6:50 PM [ updated Oct 11, 2013, 8:04 PM ]
I recently posted about Health Canada approving prescription heroin for some doctors in B.C. to use in a clinical trial. The federal government has now reversed this decision, effectively banning the prescription of heroin for any reason. The article at the Globe and Mail contains information about the numerous benefits of heroin-assisted treatment for those who have failed to benefit from convention treatments such as methadone. There is also a great explanation of how the whole process of heroin-assisted treatment works. In the last 20 years, several European countries (Switzerland, Denmark, Germany, the Netherlands, and the UK) have implemented prescription heroin programs, and it has been proven to be a safe and effective second-line treatment for the small percentage of addicts who don't respond to other treatments.
Showing promise in B.C., prescription heroin now in peril October 5, 2013
At 59, Doug Lidstrom says he is close to overcoming the heroin addiction that has dominated three-quarters of his life. Participation in a groundbreaking clinical trial has helped stabilize his habits and, perhaps within weeks, he will be among the first in North America to receive prescription heroin to help further combat his addiction.
But a swift decision by the federal government announced this week has halted Health Canada's authorization of doctors to prescribe the drug. This means when doctors run out of Mr. Lidstrom's three-month supply of diacetylmorphine (heroin) – which hasn't arrived yet – the Vancouver resident must turn back to the conventional treatments that have failed him many times before.
In her announcement Thursday, Health Minister Rona Ambrose described the change as the closing of a "loophole" that allowed for the exploitation of a federal program. By banning doctors from prescribing "dangerous drugs like heroin, cocaine, ecstasy and LSD," effective immediately, Ms. Ambrose made good on a vow of two weeks earlier, when her department first authorized the applications: to ensure it never happened again.
"This is turning me into a yo-yo," Mr. Lidstrom said. "It's playing with people's lives."
The Pivot Legal Society, which is representing Mr. Lidstrom and others in his position, will be exploring legal options that could include a constitutional challenge, said lawyer Scott Bernstein.
Posted Oct 4, 2013, 6:12 AM [ updated Oct 14, 2013, 6:02 AM ]
Health Canada has given some doctors in B.C. special prescribing privileges for diacetylmorphine (heroin). The doctors will be using this special authorization in the Study to Assess Long-term Opioid Maintenance Effectiveness (SALOME), a clinical trial that will compare diacetylmorphine (heroin) to hydromorphone (Dilaudid®) in treating opioid addicts who have not benefited from other treatments such as methadone maintenance. Heroin-assisted treatment is already used in several European countries, including Switzerland, Germany, Netherlands, and the UK and has been found to be an effective treatment for those patients who do not benefit from traditional opiate-replacement therapies (i.e. methadone and buprenorphine). It seems that the Conservative government is going to try to reverse the decision by Health Canada, though. This is not at all surprising considering their past efforts to shut down InSite, Canada's first and only supervised-injection site, despite all the research showing the numerous benefits of keeping it open.
B.C. doctors given Health Canada approval to prescribe heroin
September 20, 2013
After years of petitioning by health officials in British Columbia, Health Canada has authorized some B.C. doctors to prescribe heroin for select patients who have failed to respond to conventional opioid addiction treatments. But within moments of the authorization, Federal Health Minister Rona Ambrose blasted the department's decision, saying it flies in the face of the Conservative government's anti-drug policy, and vowed to ensure it never happens again.
Health Canada on Friday authorized doctors to prescribe heroin to around 15 patients, The Globe and Mail has learned. The doctors had applied to Health Canada under its Special Access Programme (SAP), which grants doctors access to non-marketed or otherwise unapproved drugs for patients with "serious or life-threatening conditions when conventional therapies have failed, are unsuitable or unavailable," according to a description on Health Canada's website.
The doctors had recently renewed their calls for allowing prescription heroin in light of the ongoing SALOME trial, a three-year project launched by researchers from Providence Health Care and the University of British Columbia to determine whether hydromorphone – a powerful but legal opiate – is as effective as diacetylmorphine (prescription heroin) in helping severely addicted heroin users.
A previous study (NAOMI) by the same researchers, published in the New England Journal of Medicine, had concluded prescription heroin is a safe and effective treatment for the small subsection of addicts who did not benefit from conventional treatments such as methadone. Participants who took prescription heroin were more likely to stay in treatment, reduce illegal drug use and avoid illegal activities, researchers found.
Posted Sep 23, 2013, 7:02 AM [ updated Oct 11, 2013, 8:13 PM ]
The authors of a new study from Johns Hopkins report that prescriptions for opioid medications have skyrocketed in the last decade, while pain identification and management has largely stayed the same. Opioid addiction and overdose are also on the rise. The results of this study come at an interesting time, as the FDA just recently announced more stringent labeling for extended-release opioid medications, urging that prescriptions for these medications be restricted to management of only the most extreme cases of round-the-clock chronic pain. Many have viewed this move by the FDA as an attempt at addressing the opioid addiction problem in the USA. However, what effect this will have remains to be seen, and some are not so convinced that it will have any effect at all.
As Opioid Use Soars, No Evidence of Improved Treatment of Pain
September 16, 2013
A new study led by the Johns Hopkins Bloomberg School of Public Health finds that during a decade when prescription opioid use has skyrocketed, the identification and treatment of pain has failed to improve, and the use of non-opioid analgesics has plateaued, or even declined. The study was published online September 13 in the journal Medical Care.
"There is an epidemic of prescription opioid addiction and abuse in the United States," notes G. Caleb Alexander, MD, MS, associate professor of Epidemiology and Medicine and co-director of the Johns Hopkins Center for Drug Safety and Effectiveness. "We felt it was important to examine whether or not this epidemic has coincided with improved identification and treatment of pain."
Alexander and his fellow researchers used the National Ambulatory Medical Care Survey, designed by the CDC/National Center for Health Statistics, to analyze trends from 2000 to 2010 associated with patients seeking medical treatment for non-cancer pain. They found no significant change in the proportion of pain visits – approximately one-half - treated with pain relievers.
During this time, non-opioid (analgesic) prescriptions remained stable, consisting of 26-29 percent of pain visits. However, opioid (morphine-related) prescriptions nearly doubled, from 11 percent in 2000 to 19 percent in 2010. Of approximately 164 million pain visits in 2010, roughly half were treated with some kind of pain relieving drug: 20 percent with an opioid and 27 percent with a non-opioid pain reliever.
Posted Sep 18, 2013, 9:27 PM [ updated Oct 14, 2013, 6:01 AM ]
The Food and Drug Administration (FDA) in the Unites States recently took another step toward restricting use of extended-release prescription opioid medications, such as OxyContin®. The FDA has ordered new labeling guidelines for extended-release opioids in move to stem the growing prescription opioid addiction epidemic.
FDA orders more stringent labeling for opioid drugs
September 10, 2013
Physicians will be urged to prescribe OxyContin and other powerful painkillers only for patients with the greatest need. Public health and addiction experts call the action insufficient.
Responding to calls to stem a growing epidemic of prescription drug addiction and overdose deaths, federal officials are urging doctors to reserve the most powerful pain drugs for patients who need long-term, around-the-clock treatment that can't be managed by other means.
Leaders of the Food and Drug Administration said they hoped new drug labeling guidelines unveiled Tuesday would prompt doctors to be more cautious in prescribing long-acting and extended-release forms of oxycodone, morphine and other narcotic painkillers, known as opioids.
Such drugs — sold as OxyContin, Opana and other brand names — account for less than 10% of all opioid prescriptions written in the U.S. More widely prescribed, fast-acting opioids, including hydrocodone, were not affected by the FDA action.
A recent study was done in Thailand which looked pre-exposure preventative treatment for HIV in injection drug users. Pre-exposure prophylaxis (PrEP) is a treatment used before exposure to a disease with the purpose of preventing, rather than treating or curing a disease. In this case, the study was using this method of preventative treatment for a group of individuals (injection drug users) which has a high-risk of contracting HIV. Results were quite positive, especially in the patients with perfect compliance.
Officials: HIV drug can protect drug users
June 12, 2013
U.S. health officials say doctors should consider giving a daily AIDS drug to another high risk group to prevent infection — people who shoot heroin, methamphetamines or other injection drugs.
A similar recommendation is already in place for gay men and heterosexual couples.
The new advice was triggered by a study done in Thailand. Drug users who took the daily pill were about 50% less likely to become infected with HIV than those given a dummy pill.
Drug users represent about 1 in 13 new infections in the U.S. but they account for the majority of cases in Eastern Europe and central Asia.
The research was done by the Centers for Disease Control and Prevention and the Thai government. The findings were released Wednesday by the journal Lancet.
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