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FDA Warnings About Fentanyl

Doctors And Patients Have Known About The Dangers Of Using This Opiate Since At Least 2005

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.

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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, meaning those patients who take a regular, daily, around-the-clock narcotic pain medicine. This is extremely important 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.

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