Tag Archives: kratom

MedShadow’s Top 10 Stories of 2018

What were the most popular stories we published in 2018? Our Top 10 includes two stories on drugs that have become popular among opioid abusers, as well as articles dealing with drug interactions, a controversial class of antibiotics and a first-person story on an herbal supplement that has come under attack from the FDA, among others. Here are excerpts of the stories with the highest readership.

1. Gabapentin’s Secret: The Drug Opioid Abuser’s Crave

By Ronni Gordon

For many people who take gabapentin – a drug prescribed to treat seizures and pain caused by shingles – side effects such as sedation can be a challenge, as those who take it off-label for neuropathic pain told MedShadow in the past.

But an increasing number of opioid abusers crave that side effect, reporting a calm feeling when combining gabapentin – developed by Pfizer under the brand name Neurontin – with opioids, muscle relaxants and anxiety medications. Some also get a marijuana-like high and an enhanced euphoria. But when overused or abused, it can cause significant organ or brain damage. Read more →

2. Managing Eczema: Are New Treatments Like Eucrisa Worth It?

By Madeline Vann

Eczema (atopic dermatitis) can feel like a moving target for people who live with it. They get control over one flare, only to have eczema redden and irritate another patch of skin. For some patients, changing their bathing and beauty habits along with a thick moisturizer and topical corticosteroid ointments are enough.

“Steroids are the mainstay of treating atopic dermatitis. They’ve been around for decades. They are generally inexpensive, and for the vast majority of patients, that’s how we start treatment,” explains dermatologist Amy Paller, MD, director of the Northwestern University Skin Disease Research Center in Chicago. American Academy of Dermatology (AAD) guidelines recommend using emollient moisturizers, lifestyle changes to avoid triggers, and corticosteroids at first. Read more →

3. How Imodium Became Appealing to Opioid Addicts

By Padma Nagappan

A sports injury from playing squash in high school lead to a herniated disc for Bob Johnson (name changed to protect his privacy), who was initially given codeine for his pain, and then bumped up to hydrocodone, which is more powerful and used to treat severe pain.

He stopped taking the drugs once he began recovering. All was well until he left for college in Philadelphia and started playing on the squash team — and his back began hurting again. He found it was easy to get access to drugs and began buying OxyContin (oxycodone) from a dealer. Read more → 

4. What is the Best Way to Treat Heat Rash?

By Dave Walker, RPh

Question: It’s summer and I’m going to be spending a lot of times outdoors. I’m susceptible to heat rash. What is the best treatment for it?

I remember anticipating summer vacation as a kid. We were always busy planning and participating in neighborhood sporting activities, biking, hiking, fishing and camping trips. The neighborhood moms always had a ready supply of Band-Aids, Bactine and antiseptic cream to take care of those expected and inevitable scratches, scrapes, cuts and insect bites along the way. Read more →

5. 4 Drugs That Interact with Anxiety Meds

By Christy Huff, MD

If you suffer from anxiety, panic disorder or insomnia, your doctor may have prescribed you a tranquilizer belonging to a class of drugs known as benzodiazepines.

Drugs such as Xanax (alprazolam), Valium (diazepam), Ativan (lorazepam), and Klonopin (clonazepam) are some of the most-prescribed medicines – more than 133.4 million such prescriptions were filled in the US in 2014. As with any medication, drug interactions can occur if you take a benzo with another medication, and in certain cases, may be life-threatening. Read more → 

6. Why Aren’t Seniors Getting the Shingles Vaccine?

By Rita Colorito

Nearly 12 years after the FDA approved Zostavax, the first vaccine to prevent shingles in adults 60 and older, the vast majority of seniors still haven’t received it. Only 30.6% of adults age 60 and older reported getting the shingles vaccine, according to the latest CDC (Centers for Disease Control and Prevention) assessment of vaccine coverage.

Since it became available, Zostavax has faced numerous barriers in terms of getting seniors vaccinated, the assessment found. In October, the FDA approved a new shingles vaccine, Shingrix, for people age 50 and older. Less than a week later, the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended Shingrix as the CDC’s preferred shingles vaccine for adults age 50 plus due to Shingrix’s better efficacy and fewer side effects compared to Zostavax. Read more → 

7. Floxed! The Painful, Life-Lasting Effects of Some Antibiotics

By Suzanne B. Robotti

Last week, we ran a news story on antibiotics causing “rare” damages to people. We had a very passionate response from more than 75 people who all claimed to be harmed by a particular type of antibiotics. More than 60,000 people have complained to the FDA about them. It begs the question, how unusual are these “rare” harms.

The side effects and adverse events associated with Cipro, Levaquin and other fluoroquinolones (FQs) can be significant and life altering. Yet many people who have been damaged by fluoroquinolones complain that there are too few warnings. Many claim that doctors don’t believe that their new illnesses have come from the FQs. Worse, sometimes FQs are prescribed when other, less risky — and just as effective — antibiotics are available. Read more →

8. The FDA Has It Wrong on Kratom: How the Herb is Helping People Like Me

By Andrew Turner

Some may ask who are the consumers of kratom, an herb used to treat pain, depression and anxiety that has been the subject of controversy lately in the news. It’s complicated.

We can be anyone. We are your neighbor, the veteran in the supermarket, your college professor and even your best friend. There’s a lot of misconceptions about kratom, how it’s used to treat certain ailments and its potential for addiction. Read more →

9. Can An Opioid Addiction Drug Treat Autoimmune Disorders

By Deborah Lynn Blumberg

A slew of drugs, both new and old, are used to treat autoimmune disorders like multiple sclerosis (MS), lupus and Crohn’s disease. Most of them come with side effects, some of them serious. But research and experience from patients and doctors are mounting that a drug used to treat substance abuse, when used in lower doses, can effectively treat autoimmune conditions with few side effects.

The drug is naltrexone, which was first approved in the 1980s to treat heroin addiction. In recent years, it has been prescribed more and more at a low dose for patients with autoimmune disorders. But is this off-label use (yet to be approved by the FDA) safe and effective? Read more →

10. Pros and Cons: Prednisone

By Tori Rodriguez

If you visit the doctor from time to time for anything other than a routine checkup, it’s likely that at some point you’ve received a prescription for a type of drug called corticosteroids. These are among the most commonly prescribed medications in the US, and they are used in almost every medical specialty.

In a study published last year, researchers at the University of Michigan found that 1 in 5 American adults with commercial health insurance had been prescribed a corticosteroid at least once over a 3-year period. Read more →

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.

How Patients Could Be Harmed If Kratom is Banned

A long-simmering battle between the FDA, DEA and patient advocates over the popular, yet controversial, herbal supplement kratom may soon be coming to a head. A recent STAT report indicates that the Department of Health and Human Services (HHS) has pressured the DEA to ban the supplement, used by millions as an alternative to opioids for pain and opioid withdrawal, among other ailments.

In a November 2017 letter reecently made available thanks to a STAT Freedom of Information Act request, HHS is recommending to the DEA that mitragynine and 7-hydroxymitragynine, two active compounds in kratom, should be classified as Schedule 1 substances, meaning they have “no currently accepted medical use” and a “high potential for abuse.” That would put kratom in the same group as heroin, LSD and marijuana. [Yes, despite marijuana being legal for recreational and medical use in many states, the feds still consider possession illegal.]

The FDA has not held back in its opposition to kratom, and has frequently posted on what it considers dangers associated with it. Just last week, it said it had found unsafe levels of heavy metals in some samples it had examined. And earlier this year, the FDA said there were salmonella outbreaks linked to kratom products. Note that these issues are really ones surrounding kratom’s manufacture – the presence of heavy metals and the salmonella outbreak – rather than with the drug itself.

Is Kratom Really As Dangerous As the FDA Claims?

The agency has also linked 44 deaths to kratom use. However, as a Huffington Post article points out, most of the 44 victims were found to have other substances in their body at the time of death, including illegal drugs that have deadly risks of their own. One was even shot before their death and another fell out a window.

The FDA has also said kratom has opioid-like qualities and is concerned that it could potentially be addictive. Mitragynine, one of the kratom compounds, does partially active a receptor in the brain that is also activated by other opioids like heroin, but kratom “seems to be much safer in the way it activates that receptor, so it avoids side effects like respiratory depression,” Columbia University researcher chemist Andrew Kreugel told the Huffington Post. He added that in 2014, there were 28,000 deaths from opioids (both legal and illicit) from respiratory depression compared to just one death potentially related to kratom.

If the DEA were to ban kratom anytime soon, the results would have a serious impact on patients – and not necessarily in a positive fashion.

Ban Would Make Studying Kratom More Difficult

Scheduling a drug as a Schedule 1 substance means it will make it far more difficult to determine the medicinal benefits of kratom. Why? Researchers need to get special permission from the DEA to study Schedule 1 substances, and that requires a ton of paperwork, special security and bureaucracy. It’s why there is relatively little research being conducted on the therapeutic benefits of marijuana.

The second is that banning kratom doesn’t mean that people will stop using it. It will simply create a black market where kratom product quality will get poorer and the potential for dangerous substances being added will increase. Even worse, people who have sought kratom as an alternative to opioid medication and have found success with it will likely return to prescription and illicit opioids — and the dangers inherent in those.

Could New Regulations Avoid Scheduling?

The FDA has not done due diligence in listening to groups that support kratom and scheduling meetings they have requested. Perhaps that’s why last week, the American Kratom Association, a leading kratom advocacy group, sent a letter to the heads of the DEA, FDA, HHS and National Institute on Drug Abuse (NIDA) asking to reconsider the Schedule 1 recommendation. It was signed by 12 scientists that have researched kratom.

The letter makes plenty of legitimate, fair arguments. In coming to its assessment on kratom, the scientists argue that the FDA neglected to include input from NIDA or kratom researchers. They want the DEA, along with NIDA, to examine the FDA’s abuse potential claim, as well as propose other regulatory alternatives to avoid scheduling kratom.

The letter also asks the FDA to work with industry groups to develop regulations on manufacturing kratom products. The American Kratom Association says it already has a good manufacturing practices program.

The FDA and DEA owe it to patients who are benefitting from kratom to address the issues laid out in the letter. While federal agencies like the FDA and the DEA have a responsibility in protecting the public, they should not make decisions zealously and without a complete assessment of all the facts. With kratom, a rush to move it to a Schedule 1 drug could lead to serious consequences for patients.

FDA Finds High Levels of Heavy Metals in Kratom Samples

The FDA, which has already issued numerous warnings on the plant-based supplement kratom, said it found “disturbingly high levels of heavy metals” in kratom products it tested. The agency noted it found levels of lead and nickel in some of the samples tested at levels not considered safe for human consumption.

FDA Commissioner Scott Gottlieb said in a statement that while one-time use of kratom was not likely to lead to heavy-metal poisoning, repeated use could.

FDA scientists tested 26 different kratom products. Although not legally marketed in the US, kratom has grown in popularity due to its purported pain-relieving effects, despite the FDA’s caution that the herb has opioid-like qualities. Anecdotal reports also indicate kratom is being used for depression and opioid withdrawal.

“To date, there have been no adequate and well-controlled scientific studies involving the use of kratom as a treatment for opioid use withdrawal or other diseases in humans,” Gottlieb noted.

Over the summer, the FDA reported of outbreaks of salmonella connected to kratom products. And earlier this year, the FDA warned kratom could be potentially addictive and linked 44 deaths to kratom use.

Quick Hits: FDA Threatens E-Cig Manufacturers, Elderly Polypharmacy and Falls & More

Saying youth smoking of e-cigarettes is reaching “epidemic proportions,” the FDA has ordered the manufacturers of the 5 top e-cigarettes to come up with plans on how to curb use by teens. The agency also threatened to pull flavored e-cigarettes – which are especially appealing to young people – from the market if they can’t demonstrate how they can keep the devices away from children. The manufacturers receiving letters are Juul Labs Inc., Vuse, MarkTen XL, Blu and Logic. Data from Nielsen Research indicates that Juul has more than two-thirds of the e-cigarette market. About 2.1 million middle and high school students used e-cigarettes last year, according to the CDC. Over the summer, the FDA said it issued more than 1,300 warning letters and fines to retailers who illegally sold e-cig products to minors as part of an undercover operation, the largest coordinated enforcement effort in the agency’s history. Posted September 12, 2018. Via FDA.

Elderly people that take several medications for sleeping, pain or incontinence are twice as likely to fall and suffer broken bones compared to those not taking any drugs. Researchers analyzed data on more than 70,000 older adults living in New Zealand. Those who were taking more than 3 Drug Burden Index medications – drugs that sedate or affect one’s cognition – were twice as likely to break their hip than those on no drugs, researchers reported in the Journals of Gerontology. Between 20% and 30% of those who broke their hip died within a year. Lead author Hamish Jamieson, PhD, of the University of Otago, Christchurch, New Zealand, said that multiple medications can cause falls in the elderly because of side effects in each of the medications and drug-drug interactions than can create additional side effects. Posted September 11, 2018. Via University of Otago.

The FDA has issued warning letters to 2 companies for making unsubstantiated medical claims in selling products containing the herb kratom. The agency says that Chillin Mix Kratom and Mitra Distributing make claims that their kratom products can relieve opioid withdrawal and treat conditions including depression, anxiety and high blood pressure. The FDA noted that kratom may contain substances that contain opioids and the plant may have a high potential for abuse. Over the last year, the FDA has issued several public warnings about potential dangers associated with kratom. In February, the agency said it identified 44 deaths associated with the use of kratom. Posted September 11, 2018. Via FDA.

Quick Hits: Autism and Antipsychotics, Online Opioids & More

Kids with autism taking antipsychotics are more likely to experience side effects, according to a study from Swansea University. Researchers examined 3,028 children from birth up to 18 years old from the UK’s National Health Service who had been prescribed an antipsychotic. Analysts discovered that 2.8% of children with an intellectual disability or autism were more likely to be given an antipsychotic drug, and 75% of them had autism. Their evidence indicated that all of the young people on antipsychotics had higher rates of epilepsy, diabetes and respiratory infection requiring hospitalization. The results, which are published in the Journal of Child and Adolescent Psychopharmacology, indicated that antipsychotics were being prescribed to younger children with an intellectual disability or autism for a longer period of time, compared to those without autism. Posted April 4, 2018. Via Swansea University.

FDA Commissioner Scott Gottlieb has called on Internet service providers to rid the Internet of firms selling Rx opioids, such as fentanyl. “Internet firms simply aren’t taking practical steps to find and remove these illegal opioid listings,” Gottlieb said during a speech on April 4. “There’s ample evidence of narcotics being advertised and sold online.” Gottlieb shared some insight on a congressional investigation that identified just how easy it is to locate and purchase the powerful opioid fentanyl online. According to the commissioner, the drug can be purchased through online payment systems such as PayPal, and can also be received easily through the US Postal Service. This investigation pinpointed 500 transactions that were worth $230,000 with 300 people in 43 states, Gottlieb said. Alarmingly, they also identified 7 people who died of overdoses after receiving drugs online. There may soon be talks of requiring mandatory drug prescription and pain management training for healthcare professionals. Posted April 5, 2018. Via The Washington Post.

The FDA ordered a rare mandatory recall after a kratom manufacturer resisted a voluntary recall following reports their products were tainted with salmonella. The mandatory recall stemmed from “the imminent health risk posed by the contamination of this product with salmonella,” according to the agency. After many attempts to encourage Triangle Pharmanaturals to voluntarily recall their product, the FDA took matters into their own hands since the company failed to cooperate. All consumers are being advised to throw away any products that may contain kratom, including supplements such as Raw Form Organics Maeng Da Kratom Emerald Green, Raw Form Organics Maeng Da Kratom Ivory White, Raw Form Organics Maeng Da Kratom Ruby Red and any other kratom products made or handled by Triangle Pharmanaturals. Posted April 3, 2018. Via FDA.

Is Kratom Really As Dangerous As the FDA Makes It Out to Be?

America is in the midst of one of the worst epidemics in its history over opioids, which may be one of the reasons the FDA recently issued a warning that kratom, a plant-based supplement often used for pain, is potentially addictive since it has opioid-like qualities.

Kratom has also been used by some people to treat withdrawal from opioids. However, the agency stated that there is “no reliable evidence” to support this and “significant safety issues exist.” The FDA also said it has received reports of 44 deaths related to kratom use. However, as a recent Reason.com blog pointed out, in many of these cases, other substances were found along with kratom in the systems of the deceased, making it difficult to prove kratom was the cause of death.

In one of those deaths, a 22-year-old man had a cocktail of drugs in his system that included the antidepressant Prozac (fluoxetine), antipsychotics Seroquel (quetiapine) and Zyprexa (olanzapine), Lyrica (pregabalin), which is used for nerve pain, and several benzodiazepines (tranquilizers) – in addition to kratom. Also, as Jacob Sullum argued in another Reason.com blog, more people have died from prescription and over-the-counter pain relievers than kratom.

So is kratom really as dangerous as the FDA makes it out to be?

It’s hard to say. But it may be harder to get your hands on kratom. The FDA has already blocked importation of the substance. And in 2016, the Drug Enforcement Agency (DEA) ruled to classify kratom as a Schedule 1 drug, putting it in the same class as marijuana, LSD and heroin as substances with no currently accepted medical use and a high potential for abuse. The DEA backpedaled a bit later in the year following outcry from the public. However, the FDA’s warning could make it more likely for kratom’s Schedule 1 designation to go through.

To me, it seems the FDA is making a bit of a rash decision. Although the FDA says it conducted its own medical analysis of kratom, there is a lot of existing research supporting kratom as effective for conditions such as PTSD and depression. Did they consider this before issuing a warning?

Much like the FDA’s and DEA’s position on marijuana, it seems that decisions are being made based on incomplete examinations of the positives and negatives of herbal substances. The FDA and DEA owe it to patients who use kratom and find benefit from it to conduct a more thorough investigation before deeming it unsafe for public consumption.

Quick Hits: Abuse Warning for Rx Testosterone, a Second Chance for Kratom & More

The FDA is adding a warning to all prescription testosterone products regarding abuse and dependence risks. Prescription testosterone was already designated a Schedule III controlled substance due to safety risks impacting the heart, brain, liver, mental health and endocrine system if taken more than directed. Additional case reports indicate that abuse of testosterone can lead to withdrawal symptoms such as depression, fatigue, irritability, loss of appetite, decreased libido and insomnia. Testosterone is prescribed to men as hormone replacement therapy, usually due to medical conditions such as genetic issues or chemotherapy. Posted October 25, 2016. Via FDA.

The DEA (Drug Enforcement Administration) will hold off on banning kratom, a plant said to have analgesic effects and an alternative to opioid painkillers, to entertain public comment. In late August, the DEA said it would designate kratom a Schedule I drug, meaning it has no medicinal value and a high risk of abuse. Other drugs in this category include heroin, LSD and marijuana. The DEA also said it will receive a scientific and medical recommendation on kratom from the FDA. The comment period ends on December 1, 2016. Posted October 13, 2016. Via Federal Register.

A new antipsychotic in development has been shown to have no additional side effects compared to a placebo in a late-stage trial. The drug, known as ITI-007, also demonstrated significant reduction in psychosis 4 weeks after patients began treatment. The researchers said the drug may provide similar efficacy to Risperdal (risperidone), but without the side effects associated with that drug. Whether ITI-007 will be approved by the FDA is questionable since a second Phase III trial of the drug showed no better efficacy than a placebo. Posted October 18, 2016. Via Medscape Medical News.

Quick Hits: Opioid/Benzodiazepine Warning, DEA Set to Ban Supplement & More

“Black box” warnings – the strongest the FDA can mandate – will be added to the labeling of prescription opioid drugs and benzodiazepines amid growing concern about side effects when the medications are taken together. An FDA review found cases where people taking both drug classes experienced serious side effects, including slowed or difficulty breathing, and even death. Both opioids, which are used to treat pain, and benzodiazepines, which are tranquilizers, depress the body’s central nervous system. The agency is also advising health care professionals to limit prescribing of opioids and benzodiazepines together only to patients for whom no other alternatives are available. Posted August 31, 2016. Via FDA.

The DEA is set to ban kratom, a plant-derived drug currently sold as a dietary supplement, over concerns it is addicting and has no medicinal value. The DEA wants to list kratom as a schedule I drug under the Controlled Substances Act, putting it in the same class as heroin and LSD. Kratom is known for its sedative properties, and has even been used by some as a pain reliever. There have also been anecdotal reports of people using kratom to come off dependence on prescription opioids or heroin. However, in July, the CDC noted that kratom can be abused, and between 2010 and 2015, poison control centers received more than 660 calls related to kratom. Posted August 31, 2016. Via Federal Register.

The FDA has approved a biosimilar version of the autoimmune disease treatment Enbrel (etanercept). The approval is only the second time the agency has approved a biosimilar – in essence, a generic version – of a biologic based drug, which can costs tens of thousands of dollars per year. Like Enbrel, Erelzi (etanercept-szzs) is indicated to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis. Posted August 30, 2016. Via FDA.