"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...
The following serious adverse reactions are discussed elsewhere in the labeling:
- Hepatic Injury [see WARNINGS AND PRECAUTIONS]
- Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
- Allergy and Hypersensitivity [see WARNINGS AND PRECAUTIONS]
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in practice.
A total of 1020 adult patients have received OFIRMEV in clinical trials, including 37.3% (n=380) who received 5 or more doses, and 17.0% (n=173) who received more than 10 doses. Most patients were treated with OFIRMEV 1000 mg every 6 hours. A total of 13.1% (n=134) received OFIRMEV 650 mg every 4 hours.
All adverse reactions that occurred in adult patients treated with either OFIRMEV or placebo in repeated dose, placebo-controlled clinical trials at an incidence ≥ 3% and at a greater frequency than placebo are listed in Table 3. The most common adverse events in adult patients treated with OFIRMEV (incidence ≥ 5% and greater than placebo) were nausea, vomiting, headache, and insomnia.
Table 3: Treatment-Emergent Adverse Reactions Occurring
≥ 3% in OFIRMEV-treated Patients and at a greater frequency than Placebo
in Placebo-Controlled, Repeated Dose Studies
|System Organ Class - Preferred Term||OFIRMEV
|Nausea||138 (34)||119 (31)|
|Vomiting||62 (15)||42 (11)|
|General Disorders and Administration Site Conditions|
|Pyrexia*||22 (5)||52 (14)|
|Nervous System Disorders|
|Headache||39 (10)||33 (9)|
|Insomnia||30 (7)||21 (5)|
|* Pyrexia adverse reaction frequency data is included in order to alert healthcare practitioners that the antipyretic effects of OFIRMEV may mask fever.|
Other Adverse Reactions Observed During Clinical Studies of OFIRMEV in Adults
The following additional treatment-emergent adverse reactions were reported by adult subjects treated with OFIRMEV in all clinical trials (n=1020) that occurred with an incidence of at least 1% and at a frequency greater than placebo (n=525).
Blood and lymphatic system disorders: anemia
General disorders and administration site conditions: fatigue, infusion site pain, edema peripheral
Investigations: aspartate aminotransferase increased, breath sounds abnormal
Metabolism and nutrition disorders: hypokalemia
Musculoskeletal and connective tissue disorders: muscle spasms, trismus
Psychiatric disorders: anxiety
Respiratory, thoracic and mediastinal disorders: dyspnea
A total of 355 pediatric patients (47 neonates, 64 infants, 171 children, and 73 adolescents) have received OFIRMEV in active-controlled (n=250) and open-label clinical trials (n=225), including 59.7% (n=212) who received 5 or more doses and 43.1% (n=153) who received more than 10 doses. Pediatric patients received OFIRMEV doses up to 15 mg/kg on an every 4 hours, every 6 hours, or every 8 hours schedule. The maximum exposure was 7.7, 6.4, 6.8, and 7.1 days in neonates, infants, children, and adolescents, respectively.
Other Adverse Reactions Observed During Clinical Studies of OFIRMEV in Pediatrics
The following additional treatment-emergent adverse reactions were reported by pediatric subjects treated with OFIRMEV (n=355) that occurred with an incidence of at least 1%.
Blood and lymphatic system disorders: anemia
Cardiac disorders: tachycardia
Gastrointestinal disorders: abdominal pain, diarrhea
General disorders and administration site conditions: injection site pain, edema peripheral, pyrexia
Investigations: hepatic enzyme increase
Musculoskeletal and connective tissue disorders: muscle spasm, pain in extremity
Nervous system disorders: headache
Psychiatric disorders: insomnia
Renal and urinary disorders: oliguria
Skin and subcutaneous tissue disorders: periorbital edema, rash
Vascular disorders: hypertension, hypotension
Read the Ofirmev (acetaminphen for injection) Side Effects Center for a complete guide to possible side effects
Effects of other Substances on Acetaminophen
Substances that induce or regulate hepatic cytochrome enzyme CYP2E1 may alter the metabolism of acetaminophen and increase its hepatotoxic potential. The clinical consequences of these effects have not been established. Effects of ethanol are complex, because excessive alcohol usage can induce hepatic cytochromes, but ethanol also acts as a competitive inhibitor of the metabolism of acetaminophen.
Chronic oral acetaminophen use at a dose of 4000 mg/day has been shown to cause an increase in international normalized ratio (INR) in some patients who have been stabilized on sodium warfarin as an anticoagulant. As no studies have been performed evaluating the short-term use of OFIRMEV in patients on oral anticoagulants, more frequent assessment of INR may be appropriate in such circumstances.
Last reviewed on RxList: 11/5/2013
This monograph has been modified to include the generic and brand name in many instances.
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