Warnings & Recalls for Duragesic
Public Health Advisory and Black Box Warnings
In June 2005, the
U.S. Food and Drug Administration announced a
Public Health Advisory highlighting the warning of potential
death and
serious injury caused by
overdoses while using Duragesic.
The
FDA released a second
Public Health Advisory in December of 2007 regarding the fact that doctors were
irresponsibly prescribing Duragesic and patients had continued to use the patch
improperly, consequently leading to more
deaths and
adverse reactions.
In February 2008, the FDA called for
revisions of Duragesic labeling. Adjustments warn patients that Duragesic contains
high levels of fentanyl and
should not be used for
intermittent pain. Duragesic should not be used if the seal is
broken or if there are any
cuts in the patch. The statement also emphasizes that if Duragesic is not applied on the skin properly, this medication can cause
serious adverse side effects.
Duragesic Recalls
In 2004 Janssen Pharmaceuticals recalled
25 mcg/hr Duragesic patches of lot Control Number 0327192 because of a large slit in the patches which can
directly expose patients or healthcare providers to high doses fentanyl.
In 2008, PriCara issued a
voluntary recall of 25 mcg/hr Duragesic patches due to a concern that cuts in the patch could lead to
overexposure in patients or
unintended exposure to those handling the product. 25 mcg/hr patches sold by Sandoz had also been recalled. These patches have an expiration date of 2009 and
should not be handled directly.
In
February of 2011, production of Duragesic was stopped when "
mycroscopic crystallization" was found during the manufacturing of the
Durasegic 100 µg/hr patches. The problem was resolved immediately and production of Duragesic patches resumed shortly after.
Duragesic and Interactions
Heat Interaction
If you are wearing a Duragesic patch, it is important to
avoid heat during treatment. This includes
exposure to the sun by sunbathing, hot water in baths or hot tubs, saunas, heating pads, heating lamps, tanning beds, or heated water beds. Heat can
increase the amount of fentanyl absorbed into the body and can be raised to dangerous levels causing
injury,
breathing problems, or even
death.
Drug Interactions
Many drugs can
interact with Duragesic,
altering the
removal of fentanyl from your blood stream. The following may affect your use of Duragesic: narcotics, narcotic antagonists, herbal products, cimetide, anti-depressants (nefazodone), St. John's wort, anti-fungals, calcium channel blockers, HIV medications, immunosuppressants,
rifamycins, and particular seizure treatments. Tell your doctor about any drugs you are taking to avoid harm.
Monoamine oxidase inhibitors (
MAO inhibitors) should not be taken within
14 days of using Duragesic.
Duragesic and Pregnancy
Duragesic is an FDA
pregnancy Category C. It is unknown if Durgesic may cause harm to a fetus in a pregnant woman using this patch. However, if taken during
pregnancy, Duragesic can cause side effects in newborns such as:
- breathing issues
- seizures
- addiction or withdrawal
Duragesic may be passed through breastmilk and cause addiction or withdrawal in a nursing baby. Do not breastfeed while taking Duragesic. Before using Duragesic tell your doctor if you are pregnant, may become pregnant, or are breastfeeding.
General Warnings
Duragesic may be
addictive and is a drug that is at a high risk for
abuse. Duragesic should be stored away properly and not given to anyone who is not prescribed to use this medication. If you have used Duragesic for an extended period of time, you may suffer from
withdrawal symptoms after ending the treatment. See "Side Effects" tab for more information.
Avoid drinking alcoholic beverages or taking any
medications which may increase
drowsiness. Combining these drugs with Duragesic can cause
extreme fatigue and
breathing issues.
Do not wear a Duragesic patch if you will be undergoing an
MRI (magnetic resonance imaging). Wearing Duragesic during the procedure could potentially
burn and
damage your skin.
Before using Duragesic, let your doctor know if you:
- have liver disease
- have kidney disease
- have or have a history of head injuries or brain tumors
- have any heart disorders
- have a breathing disorder, especially chronic COPD(chronic obstructive pulmonary disease)
- are pregnant, planning to become pregnant or are breastfeeding
Elderly patients using Duragesic may be more sensitive to side effects and should use caution.
Duragesic Treatment and Use
Duragesic | Fentanyl Transdermal is an opioid skin patch marketed by Janssen Pharmaceutica, approved by the U.S. Food and Drug Administration in January of 2005 for treating moderate to severe pain. Duragesic may be prescribed to patients with chronic pain who are already taking pain relievers and have a high opiate tolerance.
Duragesic is not for treating mild pain, short-term pain or pain induced by surgery.
Duragesic should not be used on children or pets.
How Does Duragesic Work?
Duragesic reduces pain by releasing fentanyl which is absorbed the skin over 72 hours. Fentanyl attaches to opioid mu-receptors (opioid receptors) in the central nervous system that cause feelings of pain. By blocking these signals, Duragesic causes a decrease in the pain previously felt.
How to Use Duragesic
Duragesic comes in the form of a patch which should be applied to the skin only. Do not leave Duragesic on longer than recommended. Do not use more than prescribed. Read all instructions before using Duragesic.
- Wash skin before use and do not apply any lotions or chemicals to the area where Duragesic will be placed. Duragesic should be applied in areas that have flat surfaces, are dry and hairless such as the chest, back, side or upper arm for optimal results.
- Press patch on skin firmly for 30 seconds using the palm of your hand. Be sure to put pressure on the sides of the patch so edges will stick to the skin. Leave on for as long as 72 hours.
- To remove the patch, fold it in half with the sticky side in and dispose the patch by flushing it down the toilet.
- If you are applying a new patch, do not put it in the same area as before.
Do not use Duragesic if the skin patch has been split open or damaged. Avoid heat while being treated with Duragesic, see “Warnings and Recalls” tab for more details.
