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fentanyl transdermal system (cont.)

PREGNANCY: Fentanyl can cross the placenta and enter the fetus. Effects on the developing fetus are not known; however, fentanyl can slow breathing in newborn infants whose mothers were exposed to fentanyl. Routine use of fentanyl by pregnant women can lead to withdrawal reactions in the newborn. Thus, caution should be used if fentanyl is administered near the time of delivery.

NURSING MOTHERS: The effects of fentanyl on the infants of mothers who nurse is unknown. Since most drugs are concentrated in breast milk, it is advisable that women requiring fentanyl bottle-feed their infants.

SIDE EFFECTS: Mild physical dependence occurs commonly during therapy with opiate agonists such as fentanyl. Abruptly stopping the drug in patients can precipitate a withdrawal reaction. Symptoms of withdrawal include nausea, diarrhea, coughing, tearing, nasal discharge, profuse sweating, twitching muscles, and yawning.

Fentanyl can cause respiratory depression (decreased rate or depth of breathing). Nausea or vomiting, constipation, and itching can occur during treatment with fentanyl. Transdermal fentanyl can cause a variety of skin reactions. Commonly, redness occurs at the site of application and can last for 6 hours following removal of the patch.

Other side effects include a decrease in sexual drive, hypothyroidism (low thyroid hormone concentrations), dry mouth, abdominal pain, loss of appetite, drowsiness, confusion, headache, dizziness, nervousness, hallucinations, anxiety, depression and euphoria. The FDA is investigating reports of deaths and other serious side effects from the use of the fentanyl transdermal system as well as overdoses.

Some patches may cause burns of the skin if worn during an MRI (magnetic resonance imaging) scan.  Patients should tell their helathcare providers that they are using a medication patch prior to receiving an MRI scan.

Reference: FDA Prescribing Information


Last Editorial Review: 1/23/2008




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