"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"...
Risks Related to Sudden Withdrawal of GABLOFEN
Advise patients and caregivers that sudden withdrawal of GABLOFEN, regardless of the cause, can result in serious complications that include high fever, confusion, muscle stiffness, multiple organ-system failure, and death. Inform patients that early symptoms of GABLOFEN withdrawal may include increased spasticity, itching, and tingling of extremities. If GABLOFEN withdrawal or a pump malfunction is suspected, patients should be brought immediately to a hospital for assessment and treatment.
Inform patients and caregivers that sudden withdrawal occurs most frequently due to a delivery problem with the catheter or the pump, or failure to refill the pump on schedule. Advise patients and their caregivers to pay careful attention to infusion system alarms. Instruct patients and caregivers that if they miss their scheduled pump refill, they should immediately contact their physician to reschedule the refill before the pump runs out of drug.
Inform patients and their caregivers that GABLOFEN overdose may occur suddenly or insidiously, and that symptoms may include confusion, drowsiness, lightheadedness, dizziness, slow or shallow breathing, seizures, loss of muscle tone, loss of consciousness, and coma. If an overdose appears likely, patients should be brought immediately to a hospital for assessment and possible emptying of the pump.
Operation of Automobiles and Other Dangerous Machinery
Advise patients that GABLOFEN may cause drowsiness, and that they should exercise caution regarding the operation of automobiles or other dangerous machinery, or activities made hazardous by decreased alertness.
Increased Risk of Drowsiness with Alcohol and Other CNS Depressants
Inform patients and their caregivers that the drowsiness associated with GABLOFEN use can be worsened by alcohol and other CNS depressants. Advise patients to read all medicine labels carefully, and to tell their physician about all prescription and nonprescription drugs they may use.
Last reviewed on RxList: 2/23/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Gablofen Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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