Important Warnings About Fentanyl and It’s Detox

Anyone who has become dependent on the fentanyl patch orpatch fentanyl in any form, (whether using it legitimately for pain or for other reasons), as well as substance abuse counselors and professionals, need to know these important facts about fentanyl detox:

A safe fentanyl detox requires specialized medical detox knowledge and skills.

Fentanyl detox can sometimes require special, advanced medical detox protocols, to avoid the weeks or months of painful, step-down withdrawal similar to the advanced protocols used for high dose methadone detox.

What is fentanyl?

Fentanyl is a synthetic opioid first developed in 1959, similar to but more potent than morphine. Many doctors have been persuaded that it is better to prescribe the fentanyl patch than other opioids like:


The patch was developed by Alza Corporation, and approved by the FDA in 1990 as the Duragesic Patch for use by people with persistent, moderate-to-severe pain who have been taking other opioids. It is marketed by Janssen Pharmaceutical Products, LP. (Alza and Janssen are subsidiaries of Johnson & Johnson.)

If you have to take a dangerous narcotic drug, the patch seems to have advantages:

They don’t hurt.
You don’t have to suffer through a shot.
You don’t have to have an IV put in your arm.
The drug doesn’t have to be swallowed.
You don’t have to worry about a patient taking too much or too little or forgetting to take a dose.
You don’t have to get up in the middle of the night to take a pill.
The drug enters the bloodstream directly and doesn’t go through the stomach which is slower and thus doesn’t cause stomach irritations like some tablets or capsules.

Actiq lozenges and lollipops

Fentanyl is also marketed as Actiq lozenges and lollipops. Because they contain such a high amount of fentanyl, they are also subject to unknowing abuse. According to the National Institute of Drug Abuse, in its prescription form, fentanyl is known as Actiq, Duragesic, and Sublimaze. Street names for the drug include Apache, China girl, China white, dance fever, friend, goodfella, jackpot, murder 8, TNT, as well as Tango and Cash.

The NIDA warns:

When prescribed by a physician, fentanyl is often administered via injection, transdermal patch, or in lozenge form. However, the type of fentanyl associated with recent overdoses was produced in clandestine laboratories and mixed with (or substituted for) heroin in a powder form.

Mixing fentanyl with street-sold heroin or cocaine markedly amplifies their potency and potential dangers. Effects include: euphoria, drowsiness/respiratory depression and arrest (death), nausea, confusion, constipation, sedation, unconsciousness, coma, tolerance, and addiction.

Warnings About Prescribing the Fentanyl Patch

Because the fentanyl patch can be 100 times more potent that even a normal dose of heroin, one of the warnings on the label required by the FDA when the patch was approved is that the patch is only for someone who is currently taking an equivalent dosage of other opioids and has become “opioid tolerant”. Otherwise, the opioid released by the patch, just like too much heroin, methadone or OxyContin, can cause an overdose leading to respiratory failure and, if not immediately addressed, death.

Because it transfers the opioid through the skin directly into the bloodstream over a 72-hour period, it is very important that dosage being transferred through the patch is carefully calculated. The Duragesic patch is measured in micrograms — not milligrams.

For example, a person switching from 100 milligrams a day of OxyContin to the Duragesic patch should use no more than a 50 micrograms/hour patch. Many doctors may prescribe lower amounts of the patch because too high a dose can lead to respiratory depression and death in even a person who is accustomed to taking opioids for pain.

People who are not opioid tolerant can die

Opioid tolerant means that a person is used to taking narcotics like OxyContin. Many of us are aware that there are young people who had no prior exposure to OxyContin who took one pill and overdosed—some never were revived.

Unfortunately, some doctors ignored the FDA warnings and prescribed the patch for patients who had just come out of surgery but were not used to taking opioids. Many of these patients experienced severe respiratory depression and some died. Other doctors ignored the warning and prescribed the patches to address pain in children who had not previously used opioids, and they suffered severe respiratory depression and some of them also died.

An August 27, 2007, article in the Los Angeles Times by Ricardo Alonso-Zaldivar told the story of Army Master Sgt. Harold Kinamon. Sgt. Kinamon entered a military hospital in Ohio for routine respiratory surgery to help him sleep better. The operation, in October 2005, progressed smoothly. He went home with nothing more than a raw throat and the patch on his skin.

That night, Kinamon, 41, died in his sleep — killed by an overdose of the drug delivered through the patch.

This was three months after the FDA’s first warning that fentanyl patches should be used with great caution, and not for postoperative pain relief.

Leaking fentanyl patches lead to overdose

However, not all of the deaths attributed to the patch were from careless doctors or improper use by patients. Some of the patches produced by Janssen “leaked”. In 2004, Janssen was forced to recall 2.2 million Duragesic patches that were defective.

If a patch is leaking, then instead of being delivered over 72 hours, the drug is released much more rapidly and this can also lead to an overdose and death.

Janssen and Alza were sued by the family of 28-year-old Adam Hendelson following his death on December 17, 2003. Mr. Hendelson suffered chronic hip pain as a result of an automobile accident, and wore a Duragesic patch. Attorneys for the family were able to show that the death was caused by a leak in the patch that led to an opioid overdose, and the family was awarded $5.5 million.

In December of 2008, a Chicago jury awarded $16.5 million to the family of a woman who died because the patch “leaked” and the woman died of respiratory failure.

Heat and the fentanyl patch can lead to overdose

Heat on the patch will increase the amount of the opioid released into the body, possibly creating an overdose that can lead to death. People using the patch when they had fevers overdosed and some died. People wore the patch in saunas or applied heating pads to the area or sunbathed while wearing the patch and overdosed and some died.

Other deaths attributed to fentanyl

The Los Angeles County Coroner’s Office investigated 32 accidental deaths related to fentanyl in 2006, the same number as in 2005, the year the FDA issued its first warning. Florida authorities reported 126 accidental deaths related to fentanyl in 2006, a rate one expert in the state described as “steady.”

In 2007, the Division of Public Health Sciences, Wake Forest University School of Medicine, and the Institute for Safe Medication Practices performed an Adverse Events Reporting System Review of the FDA’s most dangerous drugs. The study discovered fentanyl to be the second most dangerous drug available on the market with the second highest number of suspect drug deaths. During the study, fentanyl was involved in no fewer than 3,500 suspect drug deaths during the 8-year period.

Major side effects of fentanyl

More than 10% of the patients taking fentanyl report one or more of these side effects:

Dry mouth
Weakness and fatigue
Abdominal pain
Anxiety and depression
Shortness of breath

Withdrawal From the Fentanyl Patch

Because the patches contain very dangerous narcotics, it requires skill and knowledge to safely withdraw people from the fentanyl patch. Depending on the amount of the drugs in the patch, the withdrawal can be similar to withdrawal from other opioids, like OxyContin as described in our article “Opiate and Opioid Withdrawal”, but can also require a protocol similar to the ones used in high dose methadone withdrawal.

In July of 2005, the FDA issued an alert warning doctors and patients about the problems being experienced by people using the patch. They explained that over 120 people using the patch had died. However, people continued to die and doctors continued prescribing the patch inappropriately.

Accordingly, on December 21, 2007, the FDA issued a new Drug Safety Public Health Advisory, which is quoted in part here:

In July 2005, FDA issued a Public Health Advisory and Information for Healthcare Professionals that emphasized the appropriate and safe use of the fentanyl transdermal system (fentanyl patch), marketed as Duragesic and generics. Despite these efforts FDA has continued to receive reports of death and life-threatening adverse events related to fentanyl overdose that have occurred when the fentanyl patch was used to treat pain in opioid-naïve patients and when opioid-tolerant patients have applied more patches than prescribed, changed the patch too frequently, and exposed the patch to a heat source.

The fentanyl patch is only indicated for use in patients with persistent, moderate to severe chronic pain who have been taking a regular, daily, around-the-clock narcotic pain medicine for longer than a week and are considered to be opioid-tolerant. Patients must avoid exposing the patch to excessive heat as this promotes the release of fentanyl from the patch and increases the absorption of fentanyl through the skin which can result in fatal overdose. The directions for prescribing and using the fentanyl patch must be followed exactly to prevent death or other serious side effects from fentanyl overdose. These directions are provided in the current prescribing information and Instructions for Applying a Fentanyl Transdermal Patch and the new Medication Guide for patients.

At a news conference given on the day the new alert was released, Dr. Bob Rappaport, director of the FDA’s Division of Anesthesia, Analgesia, and Rheumatology Products, acknowledged that people were still dying from the improper use of the patch.

As part of its second alert, the FDA ordered manufacturers of fentanyl patches to create medication guides for patients that describe in detail the dangers of fentanyl overdoses and simple directions about proper use.

Because the deaths keep climbing, the FDA released another public health advisory in July of 2009 about the Fentanyl Transdermal Patch. In part the warning said:

Despite issuing an advisory in July 2005 that emphasized the safe use of the fentanyl patch, FDA continues to receive reports of death and life-threatening side effects in patients who use the fentanyl patch. The reports indicate that doctors have inappropriately prescribed the fentanyl patch to patients for acute pain following surgery, for headaches, occasional or mild pain, and other indications for which a fentanyl patch should not be prescribed. In addition, the reports indicate that patients are continuing to incorrectly use the fentanyl patch by replacing the patch more frequently than directed in the fentanyl patch instructions, applying more patches than prescribed, or applying a heat source to the patch, all resulting in dangerously high fentanyl levels in the blood.

The fentanyl patch contains fentanyl, a very potent narcotic pain medicine. It is only intended for treating persistent, moderate to severe pain in patients who are opioid-tolerant, meaningthose patients who take a regular, daily, around-the-clock narcotic pain medicine. This is extremelyimportant because patients who are opioid-tolerant are more resistant to the dangerous side effects of narcotic pain medicines than patients who only occasionally take these medicines. For patients who are not opioid-tolerant, the amount of fentanyl in one fentanyl patch of the lowest strength is large enough to cause dangerous side effects, such as respiratory depression (severe trouble breathing or very slow or shallow breathing) and death.

Healthcare professionals who prescribe and patients who use the fentanyl patch should be aware of the signs of fentanyl overdose including the following:

Trouble breathing or slow or shallow breathing
Slow heartbeat; severe sleepiness
Cold, clammy skin
Trouble walking or talking
Feeling faint, dizzy, or confused.

If these signs occur, patients or their caregivers should get medical attention right away.

Patients prescribed the fentanyl patch should tell their doctor about all the medicines that they take. Some medicines may interact with fentanyl causing dangerously high fentanyl blood levels and serious, life-threatening breathing problems.

February 4, 2015


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