Durogesic Patch Adverse Reactions

Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonably associated with the use of fentanyl based on the comprehensive assessment of the available adverse event information. A causal relationship with fentanyl cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Clinical trial data: The safety of DUROGESIC was evaluated in 216 subjects who participated in a multicenter, double-blind, randomized, placebo-controlled clinical trial (FEN-EMA-1) of DUROGESIC. These subjects took at least one dose of DUROGESIC and provided safety data. This trial examined patients over 40 years of age with severe pain induced by osteoarthritis of the hip or knee and who were in need of and waiting for joint replacement. Patients were treated for 6 weeks with DUROGESIC by titrating to adequate pain control starting from 25 mcg/h to a maximum dose of 100 mcg/h in 25 mcg/h increments. Adverse reactions reported for ≥1% of DUROGESIC-treated subjects and with an incidence greater than placebo-treated subjects are shown in Table 6.

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Adverse reactions not reported in Table 6 that were reported by ≥ 1% of DUROGESIC treated subjects (N=1854) in 11 clinical trials of DUROGESIC used for the treatment of chronic malignant or nonmalignant pain (which includes trial FEN-EMA-1) are shown in Table 7. All subjects took at least one dose of DUROGESIC and provided safety data. (See Table 7.)

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Adverse reactions reported by <1% of DUROGESIC-treated subjects (N=1854) in mentioned clinical trial dataset are shown in Table 8.

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All adverse reactions reported by ≥1% of DUROGESIC-treated pediatric subjects (<18 years; N=289) from 3 clinical trials are shown in Table 9. Although the enrollment criteria for the pediatric trials restricted enrollment to subjects who were a minimum of 2 years of age, 2 subjects in these trials received their first dose of DUROGESIC at an age of 23 months. (See Table 9.)

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Post-marketing data: Adverse reactions from spontaneous reports during the worldwide post-marketing experience involving all indications with DUROGESIC that met threshold criteria are included in Table 10. The adverse reactions are ranked by frequency, using the following convention: Very common ≥ 1/10; Common ≥1/100 and <1/10; Uncommon ≥ 1/1000 and <1/100; Rare ≥1/10000 and <1/1000; Very Rare <1/10000, including isolated reports.
The frequencies provided below reflect reporting rates for adverse reactions from spontaneous reports, and do not represent more precise estimates that might be obtained in clinical or epidemiological studies. (See Table 10.)

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As with other opioid analgesics, tolerance, physical dependence, and psychological dependence can develop on repeated use of DUROGESIC (see Precautions).
Opioid withdrawal symptoms (such as nausea, vomiting, diarrhea, anxiety, and shivering) are possible in some patients after conversion from their previous opioid analgesic to DUROGESIC or if therapy is stopped suddenly (see Dosage & Administration). There have been very rare reports of newborn infants experiencing neonatal withdrawal syndrome when mothers chronically used DUROGESIC during pregnancy (see Use in Pregnancy and Lactation).