News & Updates – March 1, 2013: Issue 179

Reckitt Benckiser Pharmaceuticals Inc. Receives FDA Response to Citizen’s Petition

Reckitt Benckiser Pharmaceuticals Inc. (RBP) announced that the U.S. Food and Drug Administration (FDA) has denied a Citizen’s Petition filed by the Company.  In the Citizen’s Petition, RBP presented a new evaluation of pediatric exposure data and recommended that the FDA adopt more stringent packaging standards and increased educational interventions to help reduce the number of children exposed to buprenorphine-containing products used to treat opioid dependence.  The FDA concluded that the safety data presented by RBP did not warrant these additional measures, deciding instead that existing labeling and safety programs were sufficient.

RBP is disappointed with the decision but will continue to work with the FDA on safety enhancements.  RBP remains committed to maintaining its own high level standards for safety, including the use of child-resistant, unit-dose packaging for its buprenorphine-based opioid dependence treatment products.  It will therefore carry on with the decision to discontinue the sale and cease distribution of SUBOXONE® Tablets (buprenorphine and naloxone) Sublingual (CIII) in the United States as of March 18, 2013, in light of the analysis evidencing an increased risk of pediatric exposure.

“As a pioneer in opioid dependence treatment, Reckitt Benckiser Pharmaceuticals Inc. strongly believes that child-resistant, unit-dose packaging and increased educational interventions are in the best interest of public health and safety, and we encourage other manufacturers to proactively implement these additional safeguards,” says Tim Baxter, M.D., Global Medical Director, Reckitt Benckiser Pharmaceuticals Inc.

The communication from the FDA also informed RBP that two manufacturers (see related article below) have now received approval to produce generic SUBOXONE Tablets.  The details of these manufacturers’ proposed safety programs have not been provided.

Source: PRNewswire/Reckitt Benckiser Pharmaceuticals Inc. – February 25, 2013

FDA Approves Amneal’s Generic Suboxone to Treat Opioid Drug Dependence

Amneal Pharmaceuticals, LLC, the 7th largest generic drug manufacturer in the U.S. market, has received U.S. FDA approval for one of the first generic versions of Suboxone® sublingual tablets for maintenance treatment of opioid drug dependence. Generic buprenorphine hydrochloride (HCl) and naloxone HCl dihydrate sublingual tablets are now available in 2 mg/0.5 mg and 8 mg/2 mg strengths, both in 30-count bottles.

Source: – February 25, 2013

Note: On February 26, 2013 the FDA also approved Actavis’ generic Suboxone for treatment of opioid dependence.

Source: – February 26, 2013

Blog – News Outlets Behaving Badly: Appalling Article by Bloomberg

“I don’t know if any of my readers caught that awful article on, criticizing methadone clinics and their patients. I’m not going to post a link to it because it doesn’t deserve a link. But I did write to the editor, the writer of the story, and a comment to their post:

I read this disjointed and error-ridden article with sadness. I wish you could spend a day with me, talking to the patients I treat with methadone for their opioid addiction. You’d hear how, for many patients, methadone has been a life-saver. Most of my patients are ordinary people who became addicted before they knew what was happening. A very small number are criminals, and those few get media attention, propagating the myth that all methadone patients are irresponsible criminals. This just isn’t true. My patients are housewives, blue collar workers, secretaries, and schoolteachers. Anyone can become addicted.”

The blog can be accessed at:

Source: Janaburson’s Blog – February 9, 2013

Addiction Expert: Treatment Providers Can Perpetuate Media Stereotypes of Patients

“Stereotypes about addiction, perpetuated by the media, can be unintentionally reinforced by addiction professionals, according to a New York addiction expert.

“When you go to a diabetes clinic, you don’t expect your doctor to have diabetes. But many people treating those who are addicted have themselves been treated for addiction, and tend to use the same lingo as their patients to make them feel more comfortable,” Dr. Edwin A. Salsitz, MD, Medical Director, Office-Based Opioid Therapy at Beth Israel Medical Center, said at a recent meeting, “Solutions to the Addiction Crisis.” “They use terms like ‘dirty’ or ‘clean’ to refer to a urine drug test, instead of the more medical ‘positive’ or ‘negative.’ Using slang in addiction medicine can be confusing and demeaning, and reinforce the stigma attached to addiction.”

Source: – February 5, 2013

Sharp Rise in Buprenorphine-Related Emergency Department Visits from 2005 To 2010

According to a new Substance Abuse Mental Health Administration (SAMHSA) Drug Abuse Warning Network (DAWN) report, Emergency Department (ED) visits involving buprenorphine increased substantially from 3,161 in 2005 to 30,135 visits in 2010 (Figure 1). This trend likely reflects the increased availability of buprenorphine after the Food and Drug Administration approved its use for treatment of opioid dependence in 2002, and the increasing number of physicians who subsequently became certified to prescribe it.

Figure 1. Emergency Department (ED) Visits Involving Buprenorphine: 2005 to 2010

Most buprenorphine-related ED visits fell into one of three types of visits: patients seeking detoxification or substance abuse treatment, adverse reactions to medications, or nonmedical use of pharmaceuticals. Nonmedical use includes taking more than the prescribed dose of a prescription medication or more than the recommended dose of an over-the-counter (OTC) medication or supplement, taking a prescription medication prescribed for another individual, being deliberately poisoned with a pharmaceutical by another person, or misusing or abusing a prescription medication, an OTC medication, or a dietary supplement.

In 2010, 52 percent of buprenorphine-related ED visits involved nonmedical use of pharmaceuticals, 24 percent involved patients seeking detoxification or substance abuse treatment, and 13 percent involved adverse reactions to medications (Figure 2).

Figure 2. Emergency Department (ED) Visits Involving Buprenorphine, by Type of Visit: 2010

Demographic Characteristics

In 2010, most buprenorphine-related ED visits involving nonmedical use of pharmaceuticals involved male patients (66 percent). Patients aged 26 to 34 accounted for the highest proportion of visits for nonmedical use (38 percent), followed by patients aged 18 to 25 (24 percent), aged 35 to 44 (15 percent), and aged 45 to 54 (13 percent).

Drug Combinations with Buprenorphine

In 2010, 41 percent of buprenorphine-related ED visits involving nonmedical use of pharmaceuticals involved buprenorphine only (Figure 3). In the remaining 59 percent of these visits, another drug was involved. More specifically, pharmaceuticals were combined with buprenorphine in 43 percent of visits The most common types of pharmaceuticals were benzodiazepines, which are commonly prescribed to treat anxiety and insomnia (27 percent of visits). A specific benzodiazepine, alprazolam (Xanax®), was combined with buprenorphine in 12 percent of visits. Narcotic pain relievers other than buprenorphine were involved in 12 percent of visits; more specifically, 6 percent of visits involved the narcotic pain reliever oxycodone and 3 percent of visits involved an unspecified opiate.

Figure 3. Drug Combinations among Emergency Department (ED) Visits Involving Buprenorphine,
by Type of Visit: 2010


The report can be accessed at:

Source: Substance Abuse Mental Health Administration (SAMHSA) Drug Abuse Warning Network (DAWN) – January 29, 2013

Fatal Drug Overdoses in U.S. Increase for 11th Consecutive Year

hospital sign“Fatal drug overdoses have increased for the 11th consecutive year in the United States, new data show. According to a research letter published Tuesday from the National Center for Health Statistics, 38,329 people died of drug overdoses in the United States in 2010, an uptick from the previous year and the latest sign of a deadly trend involving prescription painkillers.

In 2010, 57% of overdoses, or more than 22,000, involved known prescription drugs. Three-quarters of those involved painkillers like Oxycontin and Percocet while another 9,400 involved some unidentified drug cocktail.”,0,1564869.story

Source: -February 19, 2013

Heroin: Small Cities, Even Rural Towns Face Growing Problems

“For years, heroin was considered an affliction mainly of poor urban neighborhoods. But these days, the drug is becoming popular in affluent suburbs, small cities, and even rural towns—especially among young people.

From Arizona to New Jersey, many communities that never imagined they would have a heroin problem now face a rising toll of addiction, overdoses, and even deaths.

“You would have to go pretty remote to find a place that didn’t have this,” says Kathleen Kane-Willis, a researcher at Roosevelt University in Chicago who has tracked heroin use since 2004. “It’s just everywhere”.

Source: – January 25, 2013

Target ‘Super-spreaders’ to Stop Hepatitis C

Each intravenous drug user contracting Hepatitis C is likely to infect around 20 other people with the virus, half of these transmissions occurring in the first two years after the user is first infected, a new study estimates.

The work, led by researchers from Oxford University, suggests that early diagnosis and treatment of Hepatitis C in intravenous drug users could prevent many transmissions by limiting the impact of these ‘super-spreaders’ (a highly infectious person who spreads a disease to many other people).

Working out ‘who has infected who’ in fast-spreading diseases such as influenza is often relatively straightforward, but in slow-spreading diseases such as Hepatitis C and HIV, where instances of transmission are spread over months or years, it is extremely difficult. The new approach, developed by a team from Oxford University, University of Athens and Imperial College London, combines epidemiological surveillance and molecular data to describe in detail, for the first time, how Hepatitis C spreads in a population.

Source: University of Oxford – February 1, 2013

Rockefeller Urges Federal Agencies to Take Stronger Steps Against Prescription Drug Abuse

prescription drugsSen. Jay Rockefeller, D-W.Va., is asking three federal agencies to step up efforts to
counter prescription drug abuse, an increasing problem in West Virginia.

Rockefeller wrote to the Government Accountability Office, the Centers for Medicare
and Medicaid Services and the U.S. Food and Drug Administration (FDA).

He requested that the GAO study the neonatal abstinence syndrome. He asked the Centers for
Medicare and Medicaid Services for information about how the agency monitors prescription
drug abuse by people on Medicaid and Medicare. Rockefeller also asked the FDA about efforts
to improve education about methadone for both patients and those who prescribe it.

The press release can be accessed at:

Source: – February 12, 2013

Affordable Care Act Will Expand Mental Health and Substance Use Disorder Benefits and Parity Protections for 62 Million Americans

The Assistant Secretary for Planning and Evaluation (ASPE) for the Secretary of the Department of Health and Human Services (HHS) has issued a Research Brief on the expansion of mental health and substance use disorder benefits.

Through the Affordable Care Act, 32.1 million Americans will gain access to coverage that includes mental health and/or substance use disorder benefits that comply with federal parity requirements and an additional 30.4 million Americans who currently have some mental health and substance abuse benefits will benefit from the federal parity protections.  By building on the structure of the Mental Health Parity and Addiction Equity Act, the Affordable Care Act will extend federal parity protections to 62 million Americans.

Individuals who will gain mental health, substance use disorder, or both benefits under the Affordable Care Act, including federal parity protections Individuals with existing mental health and substance use disorder benefits who will benefit from federal parity protections Total individuals who will benefit from federal parity protections as a result of the Affordable Care Act
Individuals currently in individual plans 3.9 million 7.1 million 11 million
Individuals currently in small group plans 1.2 million 23.3 million 24.5 million
Individuals currently uninsured 27 million n/a 27 million
Total 32.1 million 30.4 million 62.5 million


The 4-page brief can be accessed at:

Source: The Assistant Secretary for Planning and Evaluation (ASPE) fir the Secretary of the Department of Health and Human Services (HHS) – February 2013

Are Drugs Today Really Cheaper, Purer, and More Available Than Ever? Blog by Rafael Lemaitre Communications Director, The Office of National Drug Control Policy

“You’ve probably heard this claim: Despite decades of effort, we’ve failed to make any significant progress in reducing drug use in this country. Some critics go so far as to say that “illegal drugs are cheaper, purer, and more available today” than ever before. This is a compelling argument and a powerful sound bite, to be sure. There’s just one problem: It’s not true.

So what do the data show? Simply put, our national drug problem is substantially smaller than it used to be, and progress continues to be made.”

Source: – February 12, 2013

Prepaid Card Designed to Help Those in Recovery From Addiction Manage Money

Three men who met while in recovery have developed a prepaid card designed to help others who are recovering from addiction manage their money, the New York Daily News reports.

They have launched the Next Step Prepaid MasterCard, a reloadable card designed for people in recovery, and for those who are financially supporting them. The card gives family members and guardians control over funds, while teaching people in recovery how to manage their money, the article notes. – January 31, 2013

National RX Drug Abuse Summit in Orlando FL April 2-4 2013

The 2013 National Rx Drug Abuse Summit will focus on ways to make an Impact in the fight against prescription drug abuse. The Summit is the largest national collaboration of professionals from local, state, and federal agencies, business, academia, clinicians, treatment providers, counselors, educators, state and national leaders, and advocates impacted by Rx drug abuse.

The Summit will be held in Orlando FL April 2-4 2013.

Keynote speakers include R. Gil Kerlikowske, Director, White House Office of National Drug Control Policy (ONDCP), and Dr. Nora D. Volkow, Director, National Institute on Drug Abuse (NIDA)

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