Tag Archives: opioid use disorder

No Increased Adverse Event Risk With Opioid, Alcohol Abuse Drug

Healthcare professionals should feel confident in continuing to prescribe naltrexone for opioid and alcohol addiction as the drug doesn’t cause more adverse events compared to a placebo.

Researchers examined 89 randomized, controlled trials that enrolled nearly 11,200 people and involved oral naltrexone; studies involving opioid or ex-opioid users were excluded. Most of the trials studied alcohol-use disorder, though others included smoking, psychiatric disorders and impulse control disorders.

Side effects associated with naltrexone include nausea, vomiting, abdominal pain, decreased appetite and dizziness. The drug used to have a “black box” warning about a risk for drug-induced liver damage, but this has since been removed from its labeling.

While there was no increased risk of serious adverse events for naltrexone compared to placebo, a second analysis showed six marginally significant adverse events for naltrexone, though they were deemed mildly severe, according to results published in BMC Medicine.

“Though naltrexone is licensed for the treatment of alcohol addiction, it remains underutilized,” lead author Monica Bolton, MD, of the University of Manchester (UK), said in a statement. “It is cost-effective and could reduce deaths.”

Naltrexone is also available as a long-acting injection under the brand name Vivitrol.

2018: A MedShadow and FDA Year in Review

When the end of the year comes, many use it as a time of reflection. I am no different. I’d like to use my blog this week to reflect on some of the accomplishments MedShadow has achieved in 2018, as well as some observations about the FDA this year.

MedShadow’s Top 3 Achievements of 2018

1. The first thing to highlight about 2018 is that it was another year of growth in terms of people visiting the site and reading our content. We already have more than 1.3 million site visitors year-to-date, and we hope to make it to 1.4 million by Dec. 31. As far as content, we added the bi-weekly “Ask the Pharmacist” column from Dave Walker, who also happens to be on our MedShadow Medical Advisory Board. Also, this column, originally called FDA Watch, became known as Health Pulse and instead of running every other week, comes out weekly.

2. MedShadow also held its first-ever public event in November, Raising Awareness About the Side Effects of Medicines. It brought together patients, patient advocates, healthcare workers and political leaders to listen to medical professionals. The purpose was to improve efforts to inform the public about medications to improve their health care, as well as increase MedShadow’s exposure.

3. Last month, MedShadow filed an amicus curiae (“friend of the court”) brief in a US Supreme Court case, Merck v. Albrecht. The case involves the osteoporosis drug Fosamax (alendronate) and women who say their spontaneous fractures of the thigh bones were caused by the drug. At issue is how Merck dealt with updating the label of Fosamax when it became aware of the issue. Yesterday, Suzanne Robotti, MedShadow’s founder and executive director, had an op-ed piece published in STAT, one of the most well-respected health and medical websites that is followed by many in the pharmaceutical industry, about the case. The decision could impact how patients are able to hold drug companies accountable when they are harmed by a drug and seek damages in court.

Top 3 FDA Actions – and Inactions — of 2018

1. The FDA’s biggest offensive this year came in its assault on e-cigarettes amid growing numbers of young people using the devices. Between 2017 and 2018, the number of high school students using e-cigs increased by 78% from 2.1 million to about 3.6 million. Last month, the agency proposed new restrictions on the sale of flavored e-cigs, which are especially appealing to teens. In September, the FDA ordered the 5 biggest e-cig manufacturers to develop plans to curb use of their devices by teens. Earlier this year, the FDA conducted a surprise inspection of the offices of JUUL Labs, the nation’s largest e-cig manufacturer, seizing more than 1,000 documents.

2. Another product that found itself in the FDA’s crosshairs was kratom. The herb has a loyal following among many Americans who use it for its reported pain-relieving properties, as an alternative to opioids, to deal with the effects of opioid-use withdrawal, and even depression and anxiety. The FDA has issued several warnings on kratom this year. In February, the agency warned kratom has opioid-like qualities and can be potentially addictive. Earlier in the year, the agency issued several warnings about kratom products tainted with salmonella. Last month, the FDA said it found high levels of heavy metals in kratom samples it had tested. The FDA has linked at least 44 death to kratom, though kratom supporters say that is misleading as in nearly all those cases, the kratom was either adulterated with other substances or other potent drugs were found in the person’s system. The Drug Enforcement Agency may essentially ban kratom by making it a Schedule 1 substance – the same as heroin, LSD and marijuana – after the Department of Health and Human Services made the recommendation.

3. One area where the FDA could have – and should have – done more is to tighten regulation of the supplement industry. We have reported on many occasions about supplements being recalled for one reason or another. While drugs are also sometimes recalled, supplements do not have to conduct clinical trials to prove they actually say what they do in order to make it onto the market. Americans spend more than $40 billion a year on supplements, and in many, many cases, they are using products that are likely useless, and potentially harmful. It’s time for the FDA to require more rigorous testing of these products so that the claims on their labels are actually backed by scientific evidence.

Treating Opioid Addiction With Meds: A Closer Look

On July 12, 2016, my son died of a heroin overdose, alone in his apartment bathroom in Los Angeles. Had he not been living alone and without Narcan (naloxone), an opioid-reversing drug, he might be alive today.

I witnessed the power of naloxone in 2008 when I had to call the paramedics because my son, with a heroin addiction, had shallow breathing and was gurgling in his throat as he laid on the living room sofa not responding to me,

The paramedics rushed him to a hospital where he was administered an injection of Narcan. It revived him, but gave him a terrible headache.

Naloxone works by moving opioids — such as heroin, morphine, OxyContin (oxycodone), fentanyl, hydrocodone and codeine — out of opioid receptors found in the brain.

Because naloxone kicks out the opioid, a person can go into acute withdrawal. Consequently, most of the acute side effects are those of withdrawal from opioids: aches, nausea, vomiting, irritability, sweating, runny nose and diarrhea. These effects are incredibly uncomfortable but, importantly, not life-threatening. They may last a few hours or a few days, but they will not kill a person.

While the side effects are uncomfortable, the advantages of naloxone are undeniable: It cannot be used to get a person high and you can’t overdose on it. It can be used for more than 1 overdose. It can be used in combination with buprenorphine for drug dependence treatment. And most states have legalized the sale of Narcan without a prescription.

Buprenorphine/Suboxone as Maintenance Treatments

While naloxone alone is used in opioid overdoses to reverse the effects in the brain, Suboxone and Subutex are used for maintenance treatment for those in recovery and help stop the cravings for opiates. Suboxone is a combination of buprenorphine and naloxone, while Subutex is just buprenorphine. Subutex is used for pregnant women. After my son got out of the hospital, he was put on a regimen of Suboxone.

Joseph Shrand, MD, an addiction psychiatrist and chief of adolescent psychiatry at High Point Treatment Center in Brockton, MA, also prescribes Suboxone or plain buprenorphine to patients who cannot tolerate the nausea that may occur as a side effect to naloxone. He notes that buprenorphine — which itself is an opioid — alone can get a person high and is much more easily abused than Suboxone.

Jeffrey Walker, 29, a content writer in Salt Lake City, knows this only too well. After he was prescribed sublingual Subutex, Jeffrey discovered it had a high potential for abuse. Water- soluble, without the presence of Naloxone, Jeffrey snorted or shot up the Subutex. “This led me to taking higher doses and asking for early refills. I had a high tolerance and high dependency.”

Withdrawing from Subutex was rough for Jeffrey: Nine days in bed writhing and sweating in his bedroom. “It was the most brutal withdrawal I have ever experienced.”

Shrand explains to patients some of the risks of going on Suboxone.

“Patients do develop physiologic dependence on Suboxone. If they miss a dose, they may experience withdrawal symptoms just like they did with their opiate of choice. Coming off Suboxone can take a long time, but it is the ultimate goal of treatment. That’s why the person has to also be in therapy, so they can learn skills to stay sober.”

There are also a host of side effects associated with Suboxone, though mostly rare. It can cause allergic reactions in the form of swelling of your face, lips, tongue or throat. It can slow your breathing and make you feel lightheaded, confused. You can also experience nausea, upper stomach pain, jaundice, loss of appetite, dark urine and clay-colored stools.

It’s also not wise to take this medicine if you have conditions such asthma, COPD (chronic obstructive pulmonary disease), sleep apnea, kidney disease, thyroid disorder or curvature of the spine, as it can cause respiratory depression. If you combine Suboxone with alcohol or certain medications such as benzodiazepines, you are at risk of severe side effects.

Dr. Shrand says that patients must be carefully weaned off Suboxone as well, or else they can experience severe withdrawal effects. Withdrawal symptoms can last for 1 month to several. The first 72 hours are generally the worst, with physical symptoms such as nausea and vomiting.

“Done correctly, slowly, and thoughtfully, a person can be off Suboxone when they are ready to come off, and use the many skills and supports they have developed to remain sober,” notes Shrand.

Naltrexone — not to be confused with naloxone — is another drug that is primarily used for opioid recovery treatment. A long-acting injection version that is administered once a month is Vivitrol. But it can cause many of the side effects found in Narcan (naloxone) that are similar to opioid withdrawal. More serious side effects of naltrexone are depression and suicidal ideation.

The prescribing information for Vivitrol also contains a warning for the potential of liver damage. Cases of liver damage and significant liver dysfunction were observed during Vivitrol trials and since it has been in the market. Some physicians may require liver function tests before and while on naltrexone.

Methadone: The Older Detox Drug

Unlike naltrexone and Suboxone, methadone is an older detox drug. Available by prescription, it comes as a tablet, powder or liquid. But methadone is controversial and has been criticized for substituting an opioid with an opioid.

However, its main advantage is that it is a long-acting opioid whereas heroin is a short-acting one. It is, however, still a narcotic, with a high chance of addiction and potentially dangerous side effects: irregular heartbeat, depressed respiratory function, tremors, unstable gait, fainting, seizures, anaphylactic reactions and death from overdose.

Even when a person uses methadone only briefly, they may notice these side effects: drowsiness, dry mouth, lightheadedness, urinary retention, gastrointestinal distress and sexual impotence.

However, Susan F. Neshin, MD, medical director of JSAS Health Care, a substance abuse treatment facility in Neptune, NJ, says that most people end up sticking with methadone treatment. “Methadone has the advantages of retaining patients and thereby has a higher success rate.”

When it comes to what works best for maintenance treatment, it differs by individual.

“Sobriety really depends on the person, their community and their access to support….Some people are afraid to get triggered by getting a shot every month and remembering putting a needle into their arm,” says Shrand.

“Some people want the daily routine of going to a methadone clinic, saying it makes them feel accountable to someone else,” he adds. “Others want the relative freedom and responsibility of taking a medication every day, an action that reminds them they are an active participant in their own recovery.”

Quick Hits: Questions Over Accelerated Approval and Availability of Drugs Under Expanded Access

A new study is questioning whether accelerated approvals for cancer drugs have benefitted patients. In 2012, Congress approved legislation that included the Breakthrough Therapy (BT) Program, in which promising drugs for serious or life-threatening diseases receive an expedited review and approval process. Researchers analyzed the efficacy and safety of cancer drugs approved through the program and compared findings with those associated with non-breakthrough drugs approved through 2017. Of the 58 new cancer drugs approved, 25 received the BT designation. The study examined 7,000 patients treated with BTs and around 12,000 patients treated with drugs that did not receive the designation. The results found that BTs did not offer substantially improved efficacy or safety when compared with non-breakthrough drugs. Around 38% of patients experienced serious adverse events while being treated with BT drugs, while 36% of those treated with non-BT drugs experienced serious side effects. Additionally, death unrelated to the progression of disease was 6% for BT drugs and 4% for non-BT drugs. Posted June 20, 2018. Via Journal of Clinical Oncology.

Many experimental drugs have been made available through FDA’s expanded access program, according to a new study. Researchers analyzed the timing and duration of expanded access (EA) programs for investigational drugs that have yet to receive FDA approval. Through ClinicalTrials.gov, researchers identified 92 FDA-approved drugs and biologics with associated EA programs between 1996 and June 2017. Drugs to treat cancer (50%); metabolic, endocrine and genetic diseases (17.4%); and infectious diseases (15.2%) were the most common treatments in the EA programs. The results found that the median premarket expanded access availability was 10 months. Also, of 92 EA programs, 64 (69.6%) were initiated just before or after new drug application submission, 24 (26.1%) were initiated during the 6-month period before, and 40 (43.5%) in the 6 months after. The study was released just weeks after President Trump signed “Right-to-Try” legislation, a similar, though controversial, program that allows patients with terminal diseases access to experimental medicines. Posted June 15, 2018. Via JAMA Network Open.

The FDA approved the first generic version of Suboxone (buprenorphine and naloxone) sublingual film, a drug to treat opioid dependence. Buprenorphine reduces opioid withdrawal symptoms and the desire to use opioids, while naloxone reverses and blocks the effect of opioids. According to the agency, the brand name and generic films should be used as part of a complete treatment plan known as medication-assisted treatment (MAT) that includes counseling and psychosocial support, and may only be prescribed by Drug Addiction Treatment Act-certified prescribers. Common side effects associated with the film include numbness, burning and inflammation in the mouth, headache, nausea, vomiting, excessive sweating, constipation, signs and symptoms of withdrawal, insomnia, pain and peripheral edema. Posted June 14, 2018. Via FDA.

Quick Hits: New Opioid Withdrawal Treatment, Prices in Drug Commercials & More

The FDA has approved the first non-opioid drug, Lucemyra (lofexidine hydrochloride), to curb opioid withdrawal symptoms in adults. The oral drug is only approved for treatment of up to 14 days, and it may not completely eliminate withdrawal symptoms. The pill may help ease withdrawal symptoms such as anxiety, sleep problems, muscle aches, sweating, nausea, vomiting, diarrhea and drug craving. The FDA indicated that Lucemyra is not a treatment for opioid use disorder (OUD), but could be “used as part of a broader, long-term treatment plan for managing OUD.” Some of the noted side effects include low blood pressure, slow heart rate, sleepiness, dizziness and — in a few cases — fainting. The FDA is requiring the drug to undergo further testing in teens and newborns of mothers addicted to opioids, and potentially for longer use in people weaning off opioids. Posted May 16, 2018. Via FDA.

The FDA is beginning to explore whether drug companies should list product prices in commercials. At a forum in Washington, FDA Commissioner Scott Gottlieb said that the agency is looking into whether it has “the ability to compel this kind of speech under the current regulations.” The discussion also focused on another important question: Which price should drug companies disclose? Gottlieb acknowledged that the list price may not serve as a good indicator of what a consumer would actually pay at the counter because of rebates, discounts or insurance coverage, which typically reduce the drug’s list price. Gottlieb noted that the agency will explore which price system is best moving forward. Posted May 15, 2018. Via Modern Healthcare.

Colorado is looking to curb opioid abuse by limiting prescriptions to a 7-day supply. A new bill in Colorado’s General Assembly would restrict the number of opioid pills a healthcare practitioner — including, but not limited to, physicians, nurses, dentists and veterinarians — may prescribe. The limit is a 7-day supply on an initial prescription, and a refill for a 7-day supply, with some medical exceptions. Also, the 7-day limit is only applicable to the initial prescription for acute pain, not for chronic pain or cancer-related pain. Posted May 16, 2018. Via Colorado Public Radio.

Panel Urges FDA to Change How It Evaluates Opioids

When approving opioids, the FDA should go beyond examining the risks and benefits of the drug on the individual and also look at how such an approval would impact society at large and other members of a patient’s family, according to a new report.

The report, “Pain Management and the Opioid Epidemic: Balancing Societal and Individual Benefits and Risks of Prescription Opioid Use,” was issued by the National Academies of Science, Engineering and Medicine. It calls for a new “action plan” to fight the opioid abuse epidemic that will require the FDA, other federal agencies, state and local governments, healthcare providers and other health organizations to work together in a long-term effort.

Recommendations include promoting more judicious prescribing of opioids, boosting access to treatment for opioid abuse, preventing more overdose deaths, and spending more money on research to understand pain better and develop alternatives that are not addictive.

In addition, education about the risks and benefits of opioids should be improved for both the general public and healthcare providers. Pain-related education should be mandatory for doctors that treat people with pain, while basic training in the treatment of opioid use disorders should be provided for other healthcare professionals. Prescribers and pharmacists should also be trained to recognize patients who are at risk for abuse or overdose and how to help them.

The committee that wrote the report, which was requested by the FDA last year, is also calling on the agency to complete a review of the safety and effectiveness of all approved opioids. At 1, 4, and 7 years post-approval, the FDA should also reexamine an opioid to make sure post-marketing data is being submitted, according to Medscape. Also, the agency should take a more active role in monitoring opioids, rather than wait for reports to come in.

Reducing opioid addiction has become a top priority for the FDA under Commissioner Scott Gottlieb, who in May established an Opioid Policy Steering Committee to find ways of tackling the problem better.

“One of the areas in which we can have the greatest impact is in reducing the rate of new addictions by helping to make sure that only appropriately indicated patients are prescribed opioids, and that the prescriptions are for durations and doses that properly match the clinical reason for which the drug is being prescribed in the first place,” Gottlieb said in a statement after the report was released.