Category Archives: Drug News

FDA Approves Non-Opioid Drug to Treat Opioid Withdrawal Symptoms

The US Food and Drug Administration (FDA) has approved Lucemyra (lofexidine hydrochloride) to treat opioid withdrawal symptoms in adults. This drug may lessen the severity of withdrawal symptoms; however, it may not prevent them.

Lucemyra is only approved for a treatment period of up to 14 days. The medication is not meant to be used as a treatment for opioid use disorder (OUD). It’s one part of a long-term treatment plan for patients with OUD.

Opioid Withdrawal Symptoms

When someone has been taking opioids over a period of time, he will develop a physical dependence on the drugs. This is to be expected, and doesn’t necessarily mean that a patient has become addicted to the medication. Withdrawal symptoms can occur in patients who have been using opioid pain medications as directed by their doctor and people with OUD.

These withdrawal symptoms include the following:

• Anxiety
• Cravings
• Diarrhea
• Difficulty sleeping
• Muscle aches
• Nausea
• Runny nose
• Sweating
• Vomiting

How Opioid Withdrawal is Typically Managed

For patients taking opioid pain medications as directed by a doctor, opioid withdrawal is typically managed by slowly tapering off the drug. This strategy is used to lessen the effects of withdrawal symptoms. Some patients are able to avoid experiencing withdrawal symptoms entirely.

In a patient with OUD, withdrawal is typically treated by substituting another opioid medication. In time, the dose is gradually reduced or the patient is switched to a maintenance therapy program. These medication-assisted therapy (MAT) treatments may use drugs like methadone, buprenorphine or naltrexone. Medications may be prescribed to treat specific symptoms, such as aches and pains or stomach upsets.

About Lucemyra

Lucemyra is taken orally and works by reducing the release of the brain chemical norepinephrine. Its actions are believed to play a role in several opioid withdrawal symptoms.

DEA Suspends Louisiana Pharmacy Distributor Over Suspicious Orders

The Drug Enforcement Administration (DEA) announced that it has issued and served a Suspension Order on Morris & Dickson Company. The wholesale pharmaceutical distributor is situated in Shreveport, Louisiana.

The DEA alleges that the distributor failed to identify “large suspicious orders for controlled substances.” These substances were sold to independent pharmacies that the DEA says had questionable need for the drugs.

Hydrocodone and Oxycodone Purchases

The investigation centered on purchases of hydrocodone and oxycodone. It revealed that in some instances, the pharmacies were allowed to buy six times as much as a normal order. Regulations are in place requiring distributors to identify orders which are out of the norm; the DEA is alleging that Morris & Dickson Company failed to identify these large orders. As a result, millions of hydrocodone and oxycodone pills were distributed, in violation of existing law.

DEA Acting Administrator Robert W. Patterson stated that pharmaceutical distributors have an obligation to make sure that all controlled substances being ordered are for legitimate purposes. Distributors have a duty to “identify, recognize and report” any suspicious orders to the DEA.

Company Failed to File Suspicious Order Reports

The DEA became aware of the high-volume orders involved in this investigation in October, 2017. The Agency’s records revealed that the company hadn’t filed any suspicious order reports on any of the pharmacies placing the large orders. On review, the purchases made weren’t in line with the pharmaceutical market:

• Independent retail pharmacies were buying more of the drugs than the largest chain pharmacies in the state.
• The pharmacies were buying more narcotics than several of the largest pharmacies in a single zip code.

The DEA states that more than four million people in the US are addicted to prescription pain medications. This figure includes 250,000 adolescents. Drug overdoses are the leading cause of death in the United States, surpassing deaths from motor vehicles accidents or deaths due to firearms.

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Dentist Group Announces Policy to Cut Opioid Painkiller Prescriptions

The American Dental Association its members to reduce the number of opioid painkillers they are prescribing. The Association announced a new policy stating that members should “essentially eliminate” opioids from the list of remedies they have at their disposal, “if at all possible.”

Weekly Limits for Narcotics

The Association also wants to have a time limit put in place on prescriptions of no more than one week at a time. Under the new policy, dentists would be required to complete a mandatory education program that encourages use of other pain relievers.

Dentists Prescribe Most Opioids to US Teens

Dental practitioners are the leading source of opioid prescriptions for US teens, even though they write less than seven percent of opioid prescriptions in the US. During the period from 2010-2015, the most notable increase in dental prescriptions was for patients aged 11-18. The rate jumped from close to 100 per 1,000 patients to 165 per 1,000 patients. Among all age groups, the rate increased from 131 per 1,000 patients to 147 per 1,000 patients.

Other Options Shown to be Just as Effective

The number of opioid prescriptions written by dentists continues to rise even though evidence has shown that ibuprofen and acetaminophen control most dental pain effectively, according to an analysis conducted on five studies. The results were published in the Journal of the American Dental Association. These over-the-counter medications are less risky than opioids, which are addictive.

When dentists prescribe opioids, they tend to prescribe Vicodin or Percocet to relieve the short-term pain from procedures such as wisdom teeth extractions, dental implants and root canal work.

Dr. Paul Moore, Professor at the University of Pittsburgh’s School of Dentistry and the co-author of the analysis, said that the fact dentists are still prescribing opioids when other options are just as effective most of the time is “a little disturbing.”

The Association’s new policy supports requiring dentists to complete continuing education courses on limiting opioid use to retain their license. A number of states have already adopted this policy.

Scientists May Have Found Cure for Cocaine Dependency

Researchers at New York’s Mt. Sinai Medical Center have pinpointed a specific protein produced by the body’s immune system which may be responsible for a person becoming addicted to cocaine. The scientists believe this discovery could be instrumental in helping to cure cocaine addiction, since they have successfully defeated cocaine dependency in laboratory mice.

The protein, granulocyte-colony stimulating factor (G-CSF), affects the brain’s reward centers. In cocaine users, levels of G-CSF increase in the brain with repeated use.

Medical Therapies for Treating Cocaine

Lead researcher Dr. Drew Kiraly, an assistant professor of psychiatry at the Icahn School of Psychiatry, explained that the results of the study are a very exciting development. Dr. Kiraly pointed out that cocaine addiction has traditionally been treated with psychotherapy and 12-step programs; to date, there are no medication-assisted therapy options available.

Researchers injected G-CSF into the nucleus acumbens (brain reward centers) of laboratory mice. They noted that the mice displayed a “significant increase” in seeking out and consuming cocaine. As the level of G-CSF doses was gradually increased, the mice worked harder to find even more cocaine.

When the research team tested a treatment to neutralize G-CSF, they discovered that the mice’s motivation to look for the drug disappeared. The changes in G-CSF levels were linked exclusively to urges to use cocaine. The mice were still as interested in other treats, such as sugar water, which also activate the reward centers in the brain.

The results of the study were published in Nature Communications. The scientists point out that addiction treatments are plagued with difficulties for several reasons, including issues with “side effects, routes of delivery, or abuse potential of agents tested.”

Future Non-Addictive Treatment Option Might Be Possible

The potential for substance abuse is a risk factor in other options currently in development. The risk is that patients are being weaned from one addictive substance in favor of another one.

The authors of the study feel that G-CSF has the advantage of being an option for reducing the urge to use cocaine while being non-addictive. Dr. Kiraly says there is work required to adapt the study’s findings to humans. However, there is a “high possibility” of it leading to future treatments for human clients.

Dr. Kiraly points out that medications that can change G-CSF are already available and are approved by the Food and Drug Administration. Once researchers are able to clarify the best ways to target G-CSF inhibitors to reduce addiction-related behaviors, there is every reason to be optimistic that treatments will be developed for patients.

States Looking to Rewrite Drug Laws with Focus on Addiction Treatment

Legislators and other policy makers throughout the country continue their efforts to combat the drug epidemic in America, especially with regards to heroin and other opiates. For example, lawmakers in Washington are seeking to change the way the Evergreen State approaches treating opioid addiction. House Bill 2489 and its counterpart in the Senate would make significant changes to the state law to make medication-assisted therapy the treatment of choice for opioid addiction, according to reports.

Treatments for Opioid Dependency

Medication-assisted therapy is one type of treatment where people dependent on the drugs are prescribed substitute medications such as buprenorphine or methadone to keep withdrawal symptoms under control while providing supportive counseling and other services.

Many studies have shown that the incorporation of such medication can be beneficial, although most treatment specialists still recommend only short-term usage, as continuing to take the drugs for years results in its own dependency. However, used for stabilization and then a tapering process bolstered by intensive treatment can improve early relapse rates for many users.

Offering Many Forms of Treatment

The deputy chief medical officer for the Washington Health Care Authority, Charissa Fotinos, pointed out that updating the state treatment guidelines would help to put across the message that addiction is not a moral failing on the part of those affected. It may not encourage more people to seek help, but it will change the tone of the conversation for those who do reach out for assistance.

Opioid users themselves stated in a survey they were very interested in medications to help them reduce their drug use. They are interested in obtaining the most effective treatment for their addiction, according to the University of Washington’s Alcohol and Drug Abuse Institute, which conducted the survey of needle exchange clients.

The bill will change the current language, and it includes directions to expand access to treatment options across the state. Many of these expanded treatment provisions hinge on funding that will be provided in Governor Jay Inslee’s new budget.

The new bill and the funding would work together to create a “hub and spoke” treatment network in areas of Washington. Six pilot sites are operating in the western part of the state with federal funding received last fall.

Under this treatment model, clients are referred to a central hub to get started on their treatment. Once they are stabilized, they can get ongoing care, including counseling and medication, from a mobile provider or a clinic located closer to their home.

Buprenorphine for Addiction Treatment

States Expanding Access to Buprenorphine for Addiction Treatment

Buprenorphine for Addiction TreatmentThere continues to be a high demand for medication-assisted treatment (MAT) for opioid addiction. To date, however, states like Ohio only haveabout two percent of doctors that have completed the training necessary to prescribe or dispense buprenorphine. This is the main ingredient in the addiction treatment drug Suboxone, and other similar medications.

Plan to Double Healthcare Professionals Providing Buprenorphine

The state is planning to double the number of healthcare professionals certified to provide Suboxone (and other addiction treatment medications) to patients over the next 18 months. The federal government has provided $26 million in grant funding under the 21st Century Cares Act so that more healthcare providers can get training. Under existing law, doctors, as well as nurse practitioners and physician assistants (PAs) can dispense buprenorphine.

Waiver to Treat Patients for Opioid Addiction

Under the Drug Addiction Treatment Act of 2000 (Data 2000), doctors can apply for a waiver allowing them to treat patients with buprenorphine in their office, clinic, a community hospital or “any other setting where they are qualified to practice.” To qualify for a physician waiver, a doctor must be:

• Licensed under state law
• Registered with the DEA (Drug Enforcement Administration) to dispense controlled substances
• Agree to treat a maximum of 30 MAT patients during the first year
• Qualify to treat MAT patients, either by training or by professional certification

A doctor who has completed at least eight hours of classroom training focused on treating and managing patients with opioid use disorders can qualify for a waiver. The new training program for medical professionals is 1.5 days of classroom instruction, and participants are expected to continue their education through online courses and seminars.

Medication-Assisted Treatment Growing in the United States

The National Institutes of Health Studies says that MAT is a very effective method for treating opioid addiction. Studies conducted in 2014 revealed improved long-term recovery rates over traditional treatment methods, though it often takes finding the perfect balance for each individual as to how long they stay on the medication. Ideally, they would work toward being off of it in 2 years or less, and many people seek to use Suboxone for short-term tapering to simply ease opiate withdrawal symptoms.

alcohol consumption in young men

Alcohol Consumption in Young Men Heightens Risk of Liver Disease

The results of a published study confirm that when young men drink alcohol, they are putting themselves at a higher level of risk for severe liver disease over time. This risk factor depends on the number of servings the young men consume and affects them for up to 39 years, researchers have found.

Hannes Hagström, MD, PhD, from Stockholm’s Karolinska Institutet, explained that the precise amount necessary to damage the liver is not clear. Several factors determine alcohol’s influence on an individual’s liver, such as:

• Genetics
• Drinking patterns
• Type of alcohol ingested
• Diet

Multiple Risk Factors for Alcoholism

Dr. Hagström went on to say that the new study suggests that the risks associated with alcohol consumption are already present early in life. It’s likely that the risk increases the longer a man is exposed to alcohol, and that someone with a history of long-term alcohol use is at higher risk for developing severe liver disease.

The researchers looked at data from a 1969-1970 Swedish national population study. All the 49,321 participants (men aged 18-20 years) had been enlisted for conscription, and 43,296 were available to answer follow-up questions in 2009.

The participants filled out questionnaires about their alcohol consumption. The results were as follows:

• 43.2 percent reported 1-5 grams per day
• 4.6 percent reported more than 60 grams per day
• 6.1 percent abstained from consuming alcohol

In the US, a standard alcoholic beverage (5 ounces of wine, 12 ounces of beer, 1.5 ounces of liquor) contains 14 grams of alcohol.

Study Participants Followed for Years

During a follow-up conducted over the next 39 years, 2,661 men received a formal alcohol abuse diagnosis. Of these men, 243 were later diagnosed with severe liver disease. The average time from the participants’ conscription to the first diagnosis of severe liver disease was 25.5 years.

Compared to men who didn’t drink alcohol, the risk for an alcohol abuse diagnosis increased moderately for men who reported 1-5 grams per day. It was highly elevated for men who reported a consumption rate of more than 60 grams per day.

The researchers admit that the study has limitations: drinking at a young age is only one part of a person’s lifetime pattern of alcohol use. It didn’t take the effect of binge drinking into account, for example.

This shows that even people who may not be considered addicts, alcoholics or even heavy users are still likely to cause considerable damage to themselves over time.

Opioids for ER Patients

Over-the-Counter Pain Relievers as Effective as Opioids for ER Patients

For a number of patients, their first introduction to opioid pain medications occurs when they seek treatment in an Emergency Room (ER). Since doctors have more than one option for treating pain, what would happen if they offered over-the-counter pain medications instead of these strong, potentially addictive drugs instead?

A new study looked at what would happen if doctors took this approach to patients who visited the ER for treatment of sprains and broken bones. The results found that pain relievers sold under brand names as Tylenol and Motrin were as effective as opioids for treating severe pain.

Treating Acute Pain Without Opioids

The study involved 411 adult patients who sought treatment in two Emergency Rooms in New York City. All of them received ibuprofen (the main ingredient in Motrin) and acetaminophen (the main ingredient in Tylenol) or one of three opioid drugs: codeine, oxycodone or hydrocodone. All patients received standard doses, and none were told which medication was being administered.

The patients rated their pain levels on a score of 1-10 before being given their pain medication and again two hours later. The researchers found that for an average patient, the pain levels dropped from a 9/10 to approximately 5/10. There was little difference reported between the two groups.

Dr. Andrew Chang, Professor of Emergency Room Medicine at Albany Medical College in New York State, explained that ibuprofen and acetaminophen affect different pain receptors in the body. He went on to say that using them together may be especially effective.

These results dispute the standard ER practice used for treating acute pain. It could lead to changes that could help prevent new patients from being given opioids, which have such a high potential for abuse.

Although the study didn’t continue to follow the patients after they left the hospital, it is likely that the pain relief continued while taking the OTC remedies.

Study Has Potential to Help Opioid Crisis

Over two million people in the US are addicted to prescription painkillers or heroin. According to experts, changes in how ER doctors prescribe drugs could potentially put a dent in the current opioid crisis and help save lives.

Long-term opioid use often starts after patients are introduced to the drugs in an acute pain treatment situation. Emergency Rooms have given them to patients more often in recent years, although more states have limited the number of pills that can be given out. According to previous studies, approximately one-third of ER patients received an opioid painkiller during their visit. Approximately 20 percent of ER patients leave the hospital with a prescription for an opioid pain medication.

opioid epidemic

Addiction Expert Explains Three Main Groups of Opioid Epidemic

For the average person reading news stories or listening to the situation being discussed on the air, it seems as though the situation is mainly about young people who have moved from a prescription opioid dependency to a heroin addiction and that fentanyl is causing many of the overdose deaths. Popular news stories imply that efforts to stop people from becoming addicted to prescription drugs have not helped, but only made the issue worse.

This is one part of the opioid crisis but it isn’t the full story. As Andrew Kolodny, the co-director of opioid policy research at Brandeis University Heller School for Social Policy and Management pointed out, there are three opioid epidemics impacting North America.

The Three Opioid Epidemics in North America

1. Longtime Addicts

This, according to Kolodny, is the smallest group. Most of them are between the ages of 50-70 and started using heroin in the 1970s and 1980s. They lost a number of their friends to addiction. Fentanyl is responsible for killing off people in this group, due to the heroin supply being “laced” with this powerful pain reliever.

2. Young Rural and Suburban Users

The second group is the middle one, and is between 20-40 years of age. This is the group that gets most of the press coverage. They are people who are being found dead of an overdose, often with needles still in stuck in their arm.

In many instances, the road to addiction starts out with prescription opioids. The person may have started taking medications prescribed for someone else. They may have originally been prescribed the pain medication, but started using it more often than as directed. When their supply ran out, they turned to buying pills on the street.

At some point the cravings for pills increased. The cost was high and heroin could satisfy the cravings at a cheaper price. Switching from pills to heroin wasn’t anything new, according to Kolodny. Again, when dealers started adding fentanyl to their heroin supply around 2011 because it was a cheap filler, the number of overdose victims skyrocketed.

3. Middle-Aged and Senior Adults

The largest group, which has remained mostly under the popular press’ radar, is made up of people in their mid-40s through to their 80s. Their deaths due to opioid abuse are under-reported.

People in this age group may have been taking pain medications prescribed by their primary care doctors for several years. When they pass away from heart disease or another cause, no one wants to think of their long-term opioid use as being a contributing factor. Families also don’t think to ask whether their loved one may not have been using their opioid medication appropriately, whether there was an interaction with other medications (over the counter or herbal supplements included). They wouldn’t ask whether alcohol use and opioids may have been an issue.

The fact there are three sub-groups among this epidemic is why the number of overdose deaths have continued to rise. This isn’t a typical substance abuse problem, as the number of lives lost have actually reduced the average life expectancy in America.

To solve this problem Kolodny suggests investing money in building a new treatment system at an estimated cost of $60 billion. Although there are a ton of addiction programs doing great things, the system as a whole isn’t slowing the number of deaths, so more must be done.

injection treatment for opioid addiction

Monthly Injection Treatment for Opioid Addiction Approved by FDA

The FDA (US Food and Drug Administration) has approved a monthly treatment for addiction that is the first of its kind. The new option can be used for those struggling with substance abuse issues stemming from an addiction to narcotics such as prescription painkillers or heroin.

Sublocade, from Indivior Plc, is buprenorphine given by injection. The drug reduces the sensations of withdrawal symptoms in addiction patients. Administering the drug monthly could help patients comply to the treatment schedule, compared to other versions currently available such as daily oral doses in the form of pills or dissolving strips.

Effort to Reduce Stigmas Around Drugs

Approving the new drug treatment product is part of the Administration’s plan to reduce stigmas surrounding this class of medications. Buprenorphine is a synthetic opioid, and critics have expressed their opposition to medication assisted treatment (MAT). Instead, they favor changing users’ behavior to combat the current opioid crisis.

The FDA and other federal agencies are supporting MAT, which involves administering drugs and providing counseling to those affected. The White House referred to the situation as a “public health emergency” in October.

The FDA commissioner, Scott Gottlieb, released a statement recently that said the FDA is “committed to expanding access to treatments that can help people pursue lives of sobriety.”

New Medication Available Early in 2018

According to reports, Sublocade will be made available to patients early in 2018, according to Indivior. The National Institute on Drug Abuse reports that in 2016, drug overdoses were responsible for taking the lives of more than 64,000 Americans. This figure includes overdoses caused by prescription drugs, such as fentanyl and OxyContin, and illicit ones like heroin. Clients who receive medication assisted treatment for drug addiction reduce their risk of death from all causes in half, according to the FDA, making this option a valuable one.

Mr Gottlieb stated that the FDA is currently working on guidelines that will get further treatment options for treating opioid addiction into the market more rapidly.