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Kratom in pill form / Source: Wikimedia Commons and Psychonaught

New Opioid Standards and Kratom Warning From FDA

Bill Donovan • Tue, July 16th, 2019

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The FDA has just issued new opioid standards and a stark warning about a potentially addictive herbal pain relief drug known as Kratom. Both will affect the practice of treating musculoskeletal pain. They are:

1. New Standards for Approving New Opioids

On June 20, FDA issued a draft of guidance for opioid manufacturers on how it will assess new applications for approval of opioid analgesic drugs.

Titled “Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework–Guidance for Industry,” it describes how the agency plans to change the ways in which it will apply the existing benefit-risk assessment framework for proposed new opioid treatments.

Most of the guidance is aimed only at new standards for manufacturers when they submit applications for new opioid formulations. However, one small detail, buried toward the bottom of the document, goes to how opioids are handled by caregivers.

Currently, FDA already requires that drug manufacturers write Risk Evaluation and Management Strategies (REMs) for classes of opioids (with a few exceptions), and that they provide unrestricted grants to providers of continuing medical education (CME) on how to abide by these REMs.

Under the proposal, FDA says it might require manufacturers to add product-specific REMs or parts of REMs and additional CME on these product-specific REMs.

“For example, an opioid analgesic drug that must be restricted to use in a monitored inpatient setting may need additional risk mitigation strategies to ensure the drug product does not leave the hospital,” the proposal says. “In short, the applicant for an opioid analgesic drug should include any proposed REMS that the applicant considers necessary to ensure a drug’s benefits outweigh its risks.”

The implication for physicians, nurses, and pharmacists is that FDA is aiming to require stricter, product-specific handling procedures for individual new opioid formulations and will demand additional CME for them. Exactly what such restrictions and training might entail seems to be something FDA wants manufacturers to decide on a product-by-product basis.

To gather information related to this proposals, FDA has scheduled a public hearing on September 17, 2019, “Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction” at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503 B/C), Silver Spring, MD 20993-0002.

2. Warning to Public on Kratom Implies Stronger Vigilance by Pain Med Prescribers

A nationwide, adverse phenomenon the FDA has cited in its previously announced plans to write situation-specific guidance for prescribing opioids is that some patients who have been denied legal opioid prescriptions under the one-size-fits-all 2016 Centers for Disease Control guidelines have moved to illegal opioids, often with devastating effects.

Now, on the same side of that coin, FDA has also taken official notice of a widely-reported upsurge in the use of the herb-derived drug kratom, which is falsely touted by its purveyors as a way to kick opioid addiction (it’s also probably addictive) and as an effective alternative to opioids.

The FDA didn’t say this in so many words, but a June 25 announcement implies a call to action for prescribers: dissuade patients from using kratom as either a pain killer or as a way to try to stop using opioid-based pain medication.

“As we work to combat the opioid crisis, we cannot allow unscrupulous vendors to take advantage of consumers by selling products with unsubstantiated claims that they can treat opioid addiction or alleviate other medical conditions,” said Acting FDA Commissioner Ned Sharpless, M.D.

Patients are seeing claims like these about kratom, the FDA said:

  • “Kratom acts as a μ-opioid receptor-like morphine.”
  • “In fact, many people use kratom to overcome opiate addiction.”
  • “Of course, people who are using kratom to overcome a preexisting opiate addiction may need to use kratom daily to avoid opiate withdrawal.”
  • “Usage: It is for the management of chronic pain, as well as recreationally.”
  • “Kratom is frequently used as a natural alternative to treat depression, anxiety, addiction, diabetes, chronic pain and fatigue…Kratom has been reported to have taken the place of brand name drugs like Hydrocodone or Oxycodone for individuals, all the way to weaning people off of Heroin.”
  • “Some researchers have even claimed that kratom can protect you against cancer!”
  • “Kratom is used for energy, to increase attention/focus, to relax, and also to treat pain and addiction. Here is just some of what our customers have used kratom to treat…Chronic Pain, Migraines, Opiate Addiction, ADHD/ADD, Anxiety, Depression, Arthritis, Insomnia and much more!”

“We have issued numerous warnings about the serious risks associated with the use of kratom, including warnings about the contamination of kratom products with high rates of salmonella that put people using kratom products at risk, and resulted in numerous illnesses and recalls. As part of our efforts to assess kratom for contamination in the products tested, we also found high levels of heavy metals in kratom products,” the statement from Dr. Sharpless said.

Bottom line: the FDA isn’t going to come out and say, “opioids are better,” but the reality is that a carefully monitored and controlled opioid prescription, issued within guidelines, poses fewer potential dangers than letting patients in pain experiment on their own with kratom.

The FDA comments came in an announcement that it had “issued warning letters to two marketers and distributors of kratom products—Cali Botanicals of Folsom, California, and Kratom NC of Wilmington, North Carolina—for illegally selling unapproved, misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms. The companies also make claims about treating pain, as well as other medical conditions like depression, anxiety and cancer.”

Along That Same Line, How’s This for Gall: DMSO Aka: “Arctic Blast”

A note from the writer: On the very day I was writing a draft on the FDA warning above about kratom, I received a spam email with the subject line:

“FDA Approved Pain Relief”

Not only is that subject line a pure lie in the context of the product being touted and misleading overall, but it’s also about a supposed alternative to opioids which consumers can get without a prescription, and about which reputable medical websites warn of health dangers.

“This topical pain miracle flushes out pain in 54 seconds,” the body of the email says.  The email is signed at the bottom by that very authoritative source, “Dr. F.”

I received three more spams about the same product (the day after I’d visited a kratom website, which made me wonder whether my email address had been harvested), under these subject lines:

“What celebrities use to relieve pain…”

“Want pain-relief NOW?”

New York Times calls it “the closest thing to a health wonder”

The product is Arctic Blast. Its key painkilling ingredient is a chemical, dimethyl sulfoxide, a.k.a. DMSO, a byproduct of wood processing, which has also been used as an industrial solvent since the mid-1800s.

Purveyors claim that over-the-counter DMSO “relieves pain and inflammation, improves joint mobility in osteoarthritis, rheumatoid arthritis,” but “Controlled studies as a topical application for DMSO and OA have yielded conflicting results. Few human studies,” says this page at the website of the Arthritis Foundation.

A WebMD article has both stronger doubts about its effectiveness against osteoarthritis and stronger warnings about its dangers:

“Other than its use as a prescription medicine, there is little or no scientific evidence to support other claims made about DMSO’s effectiveness…A recent analysis of studies on the use of DMSO to relieve osteoarthritis pain found that it was not significantly more effective than placebo in relieving joint pain.”

Also, WebMD says, “There are no studies that provide guidelines for determining the proper dose of DMSO. The gel used to treat osteoarthritis typically has a concentration of 25%…But DMSO sold without a prescription can range from 10% concentration to 90%.”

You might be able to tell if a patient is dosing on her/his own with a DMSO cream: it gives off a strong odor of garlic.