Waismann Method® Applauds FDA’s Opioid Label Changes but Cautions New Guidelines Are Not Enough
BEVERLY HILLS, Calif., April 10, 2019 — The U.S. Food and Drug Administration’s recent efforts to stem the tide of the opioid epidemic have received backlash from pain management doctors and chronic pain patients. By curtailing access to prescription opioids for everyone, the FDA also cut off patients who rely on these medications and have no alternative options for pain control. Patients dependent on prescription opioids suffer distressing withdrawal symptoms and pain when opioid use is suddenly decreased or discontinued. Furthermore, a large number of these patients have severe pain for multiple reasons, including hyperalgesia and other medical conditions.
The sudden restrictions on prescribing opioids have denied safe and effective treatment to hundreds of thousands of patients. People find themselves experiencing such a level of pain and desperation that they often become suicidal. The FDA is now responding to this safety concern by requiring changes to the prescribing information for opioid medications intended for use in outpatient settings, according to an FDA press release issued April 10, 2019.
The label changes will “provide expanded guidance to health care professionals on how to safely decrease the dose in patients who are physically dependent on opioid pain medicines when the dose is to be decreased or the medicine is to be discontinued.”
FDA’s New Label Changes Address Multiple Consequences from Other Opioid Regulations
These most recent changes are meant to benefit chronic pain patients. Not only have these patients suffered unnecessary increased pain from changes to their medication availability, but they also have been confused with people who are drug-seeking or doctor shopping for purposes of opioid abuse. Some of these patients suffer from hyperalgesia as well, which is a poorly understood condition in which a person develops an increased sensitivity to pain.
The FDA is working to address the consequences of rapid prescription opioid discontinuation. These prescribing method changes will hopefully prevent patients from trying to treat their pain and withdrawal symptoms with illicit opioids or, even more importantly, provide patients adequate treatment options for pain and dependence.
In light of these serious safety concerns, the FDA is now saying “health care professionals should not abruptly discontinue opioids in a patient who is physically dependent.” This is a welcome guideline for patients and doctors alike, as doctors have faced increasing pressure from the FDA, Centers for Disease Control and Prevention, and the Drug Enforcement Agency. The threat of prosecution for overprescribing has scared some doctors to the point of stopping prescribing opioids completely. The combination of these agencies’ efforts to end the opioid crisis has inadvertently victimized chronic pain sufferers and people dependent on prescription opioids.
Common-Sense Guidelines for Patient-Specific Treatment Plans
The FDA now is advising health care professionals to “create a patient-specific plan to gradually taper the dose of the opioid and ensure monitoring and support … to avoid serious withdrawal symptoms, worsening of the patient’s pain, or psychological distress.” It says there is no standard opioid tapering schedule for all patients. Instead, health care professionals should agree on a tapering schedule with their patients based on various factors specific to each patient, such as:
- The dose of the drug
- The duration of the treatment
- The type of pain being treated
- The patient’s physical and psychological attributes
Additionally, the FDA’s press release recommended that patients taking opioid pain medicines long term not suddenly stop taking their prescription opioid medication. Patients should instead discuss a plan with their health care professional to slowly decrease the dose of the opioid and continue to manage their pain.
To help FDA track safety issues with medicines, people can report side effects from opioids or other medicines to the FDA MedWatch program using the information in the Contact FDA page. The FDA also is including new prescribing information on other side effects of opioid pain medicines, including central sleep apnea and drug interactions. It also is updating proper opioid storage and disposal guidelines on its website.
Providing More Treatment Options for Patients on Opioid Drugs
Although the FDA’s newest guidelines correctly recommend individualized treatment plans for patients, the guidelines are limited to tapering off opioids slowly. There is not just one solution for all people struggling with opioid dependence. Some patients are candidates for other treatment options, such as medical opiate detoxification in a hospital. If the FDA and other agencies continue to make sweeping recommendations that aren’t multifaceted, they might continue to inadvertently create more victims caught in between the various guidelines.
“Patients need to be treated as individuals, and their treatment plans need to address their specific physical and emotional needs,” said Clare Waismann, CATC and founder of Waismann Method® Advanced Treatment for Opiate Dependence. They need comprehensive assessment of various factors, including:
- Physical conditions
- Emotional state
- Degree of opioid dependence
With every new rule, some people benefit and others suffer. The team at Waismann Method® is glad the FDA and other agencies are working on reducing the tragic effects of the opioid crisis. As people are becoming more aware of the suffering already imposed on pain patients — from a lack of regulations to too many regulations — the Waismann Method® team hopes adequate efforts will prevent further suffering and suicides. Hopefully, patients and doctors will be able to create comprehensive and responsible treatment plans to improve patients’ health and quality of life.
About the Waismann Method® Experts
Clare Waismann, certified addiction treatment counselor, is the founder of Waismann Method® Advanced Treatment of Opiate Dependence and Domus Retreat. As an addiction treatment specialist with over 20 years’ experience, Waismann has served as an advocate for patients suffering from opioid use disorder and mental illness, working to provide the public with the proper education to eliminate the stigma associated with both conditions. Waismann, her team, and Waismann Method® have been featured in The New York Times, USA Today, Fox News, Vogue Magazine, WIRED Magazine, and many other media outlets around the world.
Dr. Michael H. Lowenstein, M.D., serves as the medical director for Waismann Method®. He is quadruple board-certified in anesthesiology; addiction medicine; pain management; and anti-aging, restorative, and regenerative medicine. Dr. Lowenstein is recognized by the international community as a leader in opiate detox and has provided cutting-edge medical treatment for patients suffering from opioid use disorder for over two decades. Dr. Lowenstein continues to enhance detoxification protocols to offer medical treatment for additional substances in a safer and more effective manner. Our commitment to the well-being of our patients is as strong now as it was 20 years ago when it all started.