Can You Overdose on an Opioid Patch? FDA Says Yes
On July 8, 2005, the Food and Drug Administration (FDA) announced that extensive revisions had been made to the professional product labeling, or package insert, for the potent synthetic morphine-like, or opioid, pain reliever fentanyl skin patches (DURAGESIC). Major changes were made to the drug’s black box warning, which appears below. A black box warning is the strongest type of caution that the FDA can request a manufacturer to place in a...
Can You Overdose on an Opioid Patch? FDA Says Yes
On July 8, 2005, the Food and Drug Administration (FDA) announced that extensive revisions had been made to the professional product labeling, or package insert, for the potent synthetic morphine-like, or opioid, pain reliever fentanyl skin patches (DURAGESIC). Major changes were made to the drug’s black box warning, which appears below. A black box warning is the strongest type of caution that the FDA can request a manufacturer to place in a drug’s professional product labeling.
Fentanyl skin patches are produced by Janssen Pharmaceutica of Titusville, N.J. This drug is a top seller, with more than 4.1 million prescriptions dispensed in 2004 in the United States and sales exceeding $1.2 billion for the year. These phenomenal sales for a drug that should only be used in a limited population of patients are likely due in part to the way that Janssen has advertised the drug to prescribers and other health professionals.
On Sept. 3, 2004, the FDA issued Janssen a Warning Letter about illegal false and misleading advertising of fentanyl skin patches. The company was distributing advertising material that made unsubstantiated safety and effectiveness claims about the drug. According to the FDA, Janssen was suggesting that fentanyl patches had a lower potential for abuse than other potent opioid painkillers. In effect, Janssen was encouraging the unsafe use of the drug, which could result in serious or life-threatening hypoventilation (respiratory depression). All opioid painkillers can depress respiration.
Fentanyl patches are classified as a Schedule II controlled substance. This is the most restrictive classification for drugs that can be legally sold in the United States. Schedule II drugs carry the greatest risk of dependence and diversion to be sold on the street. Other drugs that fall under this classification include hydromorphone (DILAUDID), methadone (DOLOPHINE), morphine (MS CONTIN), oxycodone (OXYCONTIN), and oxymorphone (NUMORPHAN).
The drug, in the form of the patch, should only be used in patients who are opiate-tolerant. These patients have been taking opiate-containing products for a significant length of time.
As the black box warning suggests, fentanyl skin patches should not be used in the following situations:
- in patients who have not previously been prescribed opioid painkillers
- in the management of acute pain or in patients who require opioid pain killers only for a short period of time
- in the management of post-operative pain, including use after out-patient or same-day surgeries, for example tonsillectomies
- in the management of mild pain
- in the management of intermittent pain
Fentanyl skin patches interact with a number of drugs that can increase the amount of fentanyl in the blood to dangerous levels. These drugs include ritonavir (KALETRA, NORVIR), ketoconazole (NIZORAL), itraconazole (SPORANOX), troleandomycin (TAO), clarithromycin (BIAXIN), nelfinavir (VIRACEPT), and nefazodone (SERZONE).
Damaged or cut fentanyl skin patches should not be used. Damage to the skin patch can lead to the rapid release of its contents and absorption of a potentially fatal dose of fentanyl.
It should be noted that fentanyl is commonly used as an anesthetic agent in an injectable dosage form for the duration of a surgical procedure. This article refers only to the use of fentanyl in the Duragesic patch.
What You Can Do
You should not use fentanyl skin patches in the circumstances listed as inappropiate in this article. If you are using the drug under any of these circumstances, contact your physician immediately.
DURAGESIC 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:
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/h. 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 (fentanyl transdermal system) is contraindicated:
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 potent cytochrome P450 3A4 inhibitors (ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, and nefazodone) 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 potent CYP3A4 inhibitors should be carefully monitored for an extended period of time and dosage adjustments should be made if warranted.
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.
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. Using damaged or cut DURAGESIC patches can lead to the rapid release of the contents of the DURAGESIC patch and absorption of a potentially fatal dose of fentanyl.