DURAGESIC® (fentanyl transdermal system) CII Pain Patch

2008 Duragesic - Answers About the Recall

Q1. Why were the patches recalled?
A1. The Duragesic 25 mcg/h (Fentanyl Transdermal System) and Sandoz 25 mcg/h fentanyl transdermal patches (CII) may have been cut along one side of the drug reservoir during manufacturing. This defect could result in the possibility of gel being released from the gel reservoir into the pouch in which the patch is packaged. This cut, open edge is evident upon opening the sealed foil pouch.

Q2. How many patches are defective?
A2. The defect rate, based upon manufacturing quantities and actual customer reports, is estimated to be less than 2 defects per million patches produced.

Q3. Has this problem been seen with other dosage strengths (e.g., 12, 50, 75, and 100 mcg/hr)?
A3. Only the 25 mcg/h strength is affected by this recall. All lots of DURAGESIC 25 mcg/h patches and Sandoz 25 mcg/h fentanyl transdermal patches with an expiration date on or before December 2009 are being recalled. The other dosage strengths (e.g., 12, 50, 75, and 100 mcg/h) are not being recalled. However, you should never use a patch that has been cut, damaged or changed in any way. DURAGESIC is a patch with a medicine gel sealed inside. The patch is designed to keep the medicine gel from getting on your hands or body. If the gel from the patch accidentally gets on your skin, wash the area with large amounts of water only. Do not use soap, alcohol, lotions, oils, or other products to remove the medicine gel because they may increase the medicine's ability to go through the skin.

Q4. How can patients determine if they have a patch affected by this recall?
A4. First check to see if their patches are marketed as DURAGESIC brand or SANDOZ generic, then determine if the strength is 25 mcg/h. The strength can be found on the front of the carton and on front of each pouch.
Anyone with 25 mcg/h DURAGESIC patches should call 800-547-6446.
Anyone with 25 mcg/h Sandoz Inc. patches should call 800-901-7236.

Q5. What should a patient or caregiver do if the patient is wearing a 25 mcg/h patch?
A5. Check the patch to see if it is DURAGESIC brand or Sandoz generic. Examine the patch to determine if the reservoir area looks cut, or if gel has leaked. If the patch appears to be intact, just leave the patch on the patient as you normally would. If the patch appears to be cut, remove the defective patch, wash the exposed area of the patient's skin with large amounts of water (do not use soap or rub excessively), and dispose of the cut patch without directly touching it by carefully folding the patch in half so that the sticky side sticks to itself, then flush the used patch down the toilet right away. Wash hands with clear water after handling a cut or used patch.

Q6. What should I do if I observe moisture or gel in the pouch containing a Duragesic patch?
A6. Do not use the patch and do not touch the gel. Without touching it directly, dispose of the un-used cut patch as follows: Remove the patches from its protective pouch and remove the protective liner. Fold the patch in half with the sticky sides together, and flush the patch down the toilet. Do not flush the pouch or the protective liner down the toilet. These items can be thrown away in a garbage can in a manner that will minimize its exposure or access to other people or animals. Immediately wash your hands thoroughly with lots of water after handling a cut patch. Be careful not to touch your eyes or mouth before you wash your hands.

Q7. What should I do if I inadvertently come into contact with the gel?
A7. If you have unintended contact with the gel immediately wash the affected area with large amounts of water only. Do not use soap, alcohol, lotions, oils, or other products to remove the medicine gel because they may increase the medicine's ability to go through the skin. If you still have concerns once you have thoroughly washed the affected area, speak with your pharmacist or physician for further instructions.

Q8. Can a patch be used if it is cut?
A8. No. You should never use a patch that has been cut, damaged or changed in any way. DURAGESIC is a patch with a medicine gel sealed inside. The patch is designed to keep the medicine gel from getting on your hands or body.

Q9. What should a patient do if they are currently on active therapy with DURAGESIC or Sandoz fentanyl 25 mcg/h patches?
A9. Patients must contact their physician or pharmacist to obtain a new supply of product or manage their opioid therapy in some other manner to avoid any gaps in therapy and possible emergence of withdrawal symptoms.

Q10. Should the 12, 50, 75, or 100 mcg/h patches be returned?
A10. No. Only the 25 mcg/hr patches are being recalled. Other strength patches (12, 50, 75, and 100 mcg/hr) are not affected, and are not being recalled. The patient may continue to use these other strength patches as prescribed by their health care provider.

Q11. Should the patient stop using their patches?
A11. Do not stop using DURAGESIC suddenly. Stopping DURAGESIC suddenly can make you sick with withdrawal symptoms (for example, nausea, vomiting, diarrhea, anxiety, and shivering). Your body can develop a physical dependence on DURAGESIC. If your doctor decides you no longer need DURAGESIC, ask how to slowly reduce this medicine so you don't have withdrawal symptoms. Do not stop taking DURAGESIC without talking to your doctor.

Q12. Should the patient switch doses?
A12. Do not change your dose unless your doctor tells you to. Your doctor may change your dose after seeing how the medicine affects you. Do not use DURAGESIC more often than prescribed. Call your doctor if your pain is not well controlled while using DURAGESIC.

Boxed Warning

DURAGESIC^® (fentanyl transdermal system) CII contains a high concentration of a potent Schedule II opioid agonist, fentanyl. Schedule II opioid substances which include fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone have the highest potential for abuse and associated risk of fatal overdose due to respiratory depression. Fentanyl can be abused and is subject to criminal diversion. The high content of fentanyl in the patches (DURAGESIC^®) may be a particular target for abuse and diversion.

DURAGESIC^® is indicated for management of persistent, moderate to severe chronic pain that:

Requires continuous, around-the-clock opioid administration for an extended period of time, and
Cannot be managed by other means such as nonsteroidal analgesics, opioid combination products, or immediate-release opioids

DURAGESIC^® should ONLY be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to DURAGESIC^® 25 mcg/hr. Patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid.

Because serious or life-threatening hypoventilation could occur, DURAGESIC^® is contraindicated:

In patients who are not opioid-tolerant
In the management of acute pain or in patients who require opioid analgesia for a short period of time
In the management of postoperative pain, including use after outpatient or day surgeries (e.g., tonsillectomies)
In the management of mild pain
In the management of intermittent pain (e.g., use on an as needed basis [p.r.n.])

(See CONTRAINDICATIONS section of the full Prescribing Information for further information.)

Since the peak fentanyl levels occur between 24 and 72 hours of treatment, prescribers should be aware that serious or life-threatening hypoventilation may occur, even in opioid-tolerant patients, during the initial application period.

The concomitant use of DURAGESIC^® with all cytochrome P450 3A4 inhibitors such as (ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, amiodarone, amprenavir, aprepitant diltazem, erythrocin, fluconazole, fosamprenavir, grapefruit juice, and verapamil) may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. Patients receiving DURAGESIC^® and any CYP3A4 inhibitors should be carefully monitored for an extended period of time and dosage adjustments should be made if warranted. (See CLINICAL PHARMACOLOGY-Drug Interactions, WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections of the full Prescribing Information for further information.)

The safety of DURAGESIC^® has not been established in children under 2 years of age. DURAGESIC^® should be administered to children only if they are opioid-tolerant and 2 years of age or older. (See PRECAUTIONS - Pediatric Use section of the full Prescribing Information.)

DURAGESIC^® is ONLY for use in patients who are already tolerant to opioid therapy of comparable potency. Use in non-opioid tolerant patients may lead to fatal respiratory depression. Overestimating the DURAGESIC^® dose when converting patients from another opioid medication can result in fatal overdose with the first dose. Due to the mean elimination half-life of 17 hours of DURAGESIC^®, patients who are thought to have had a serious adverse event, including overdose, will require monitoring and treatment for at least 24 hours.

DURAGESIC^® can be abused in a manner similar to other opioid agonists, legal or illicit. This risk should be considered when administering, prescribing, or dispensing DURAGESIC^® in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion.

Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). Patients should be assessed for their clinical risks for opioid abuse or addiction prior to being prescribed opioids. All patients receiving opioids should be routinely monitored for signs of misuse, abuse, and addiction. Patients at increased risk of opioid abuse may still be appropriately treated with modified-release opioid formulations; however, these patients will require intensive monitoring for signs of misuse, abuse, or addiction.

DURAGESIC^® patches are intended for transdermal use (on intact skin) only. Do not use a DURAGESIC^® patch if the seal is broken or the patch is cut, damaged, or changed in any way. Using a patch that is cut, damaged, or changed in any way can expose the patient or caregiver to the contents of the patch, which can result in an overdose of fentanyl that may be fatal.

Avoid exposing the DURAGESIC^® application site and surrounding area to direct external heat sources such as heating pads or electric blankets, heat or tanning lamps saunas, hot tubs and heated water beds while wearing the system. Avoid taking hot baths or sunbathing. There is a potential for temperature-dependant increases in fentanyl released from the system resulting in possible overdose and death. Patients wearing DURAGESIC^® systems who develop fever or increased core body temperature due to strenuous exertion should be monitored for opioid side effects and the DURAGESIC^® dose should be adjusted if necessary.

Please see the Full Prescribing Information and Important Safety Information.