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Angioedema: There have been postmarketing reports of angioedema in patients, some without reported previous history/episode, during initial/acute and chronic treatment with pregabalin. Specific symptoms included swelling of the face, mouth (tongue, lips, and gums), and neck, throat, and larynx/upper airway. There were reports of life-threatening angioedema with respiratory compromise requiring emergency treatment. Some of these patients did not have reported previous history/episode of angioedema. Discontinue pregabalin immediately in patients with these symptoms.
Exercise caution when prescribing pregabalin to patients who have had a previous episode of angioedema. Patients who are taking other drugs associated with angioedema (e.g., angiotensin converting enzyme inhibitors or ACE-inhibitors) may be at increased risk of developing angioedema.
Hypersensitivity: There have been postmarketing reports of hypersensitivity in patients shortly after initiation of treatment with pregabalin. Adverse reactions included skin redness, blisters, hives, rash, dyspnea, and wheezing. Discontinue pregabalin immediately in patients with these symptoms.
Serious Skin Reactions: There have been very rare postmarketing reports of serious cutaneous reactions, including Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), dermatitis exfoliative, bullous skin reactions, and erythema multiforme in patients treated with pregabalin. Most of the reports were in patients taking concomitant drugs also associated with the potential development of these serious skin reactions. Therefore, in most cases, causality in relation to pregabalin could not be clearly established. Patients should be advised that if they experience a skin rash, they should discontinue pregabalin treatment and contact their physician for assessment and advice.
Suicidal Behavior and Ideation: Antiepileptic drugs (AEDs), including pregabalin, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Monitor patients treated with any AED for any indication for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
Anyone considering prescribing pregabalin or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.
Inform patients, their caregivers, and families that pregabalin and other AEDs increase the risk of suicidal thoughts and behavior and advise them of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Report behaviors of concern immediately to healthcare providers.
Withdrawal Symptoms: After abrupt or rapid discontinuation of pregabalin, the following events have been reported: insomnia, headache, nausea, anxiety, diarrhea, flu syndrome, nervousness, depression, pain, convulsion, hyperhidrosis, and dizziness, suggestive of physical dependence. The patient should be informed about this at the start of the treatment.
Convulsions, including status epilepticus and grand mal convulsions, may occur during pregabalin use or shortly after discontinuing pregabalin.
Concerning discontinuation of long-term treatment of pregabalin, data suggest that the incidence and severity of withdrawal of symptoms may be dose-related.
As with all AEDs, withdraw pregabalin gradually to minimize the potential of increased seizure frequency in patients with seizure disorders. If pregabalin is discontinued, taper the drug gradually over a minimum of one week.
Dizziness and Somnolence: Pregabalin causes dizziness and somnolence. Inform patients that pregabalin-related dizziness and somnolence may impair their ability to perform tasks such as driving or operating machinery.
There have also been reports of loss of consciousness, confusion, and mental impairment.
Substance Misuse, Abuse and Dependence: There have been postmarketing reports of substance misuse and abuse with pregabalin. As with any CNS drug, patients should be carefully evaluated for a history of substance abuse and observed for signs of pregabalin misuse or abuse (e.g., development of tolerance, increase in dose, drug-seeking behavior).
Monotherapy for Seizure Control: In patients where pregabalin was used as add-on therapy, there are insufficient data on seizure control when concomitant AEDs were withdrawn and pregabalin was used as monotherapy.
Encephalopathy: Cases of encephalopathy have been reported, mostly in patients with underlying conditions that may precipitate encephalopathy. Some cases were reported in patients with a history of kidney or liver disease. Since there have been rare reports of renal failure with pregabalin, specific caution should be exercised when prescribing pregabalin to the elderly with age-related compromised renal function and patients with kidney disease or risk factors for renal failure.
Treatment of central neuropathic pain due to spinal cord injury: In general, CNS adverse reactions, particularly somnolence, was increased in the treatment of central neuropathic pain due to spinal cord injury. This may be attributed to an additive effect due to concomitant drugs (e.g., anti-spasticity agents) needed for this condition. This should be considered when prescribing pregabalin in this condition.
Peripheral Edema: In controlled studies, peripheral edema occurred more frequently in patients treated with pregabalin than in patients treated with placebo. Peripheral edema was not associated with laboratory changes suggestive of deterioration in renal or hepatic function.
Congestive Heart Failure: There have been postmarketing reports of congestive heart failure in some patients receiving pregabalin. These reactions are mostly seen in elderly cardiovascular compromised patients during pregabalin treatment for a neuropathic indication. Pregabalin should be used with caution in these patients. Discontinuation of pregabalin may resolve the reaction.
Weight Gain: Pregabalin treatment may cause weight gain. Pregabalin-associated weight gain was related to dose and length of exposure, but did not appear to be associated with baseline body mass index, gender or age. Weight gain was not limited to patients with edema and was not necessarily due to edema-related events.
Although weight gain was not associated with clinically important changes in blood pressure in short-term controlled studies, the long-term cardiovascular effects of pregabalin-associated weight gain are unknown.
While the effects of pregabalin-associated weight gain on glycemic control have not been systematically assessed in controlled and longer-term open label studies with diabetic patients, pregabalin treatment did not appear to be associated with loss of glycemic control.
In accordance with current clinical practice, some diabetic patients who gain weight on pregabalin treatment may need to adjust hypoglycemic drugs.
Gastrointestinal Effect: There have been postmarketing reports of events related to reduce lower gastrointestinal tract function (e.g., intestinal obstruction, paralytic ileus, constipation) in patients, some without reported previous history/episode, during initial/acute and chronic treatment with pregabalin, primarily in combination with other drugs that have the potential to produce constipation such as opioid analgesics. Some of these events were considered serious and required hospitalization. When pregabalin and opioids will be used in combination, measures to prevent constipation may be considered, particularly in female patients and the elderly as they may be at increased risk of experiencing lower gastrointestinal related events.
Renal Failure: There are reports of patients, with or without previous history, experiencing renal failure while receiving pregabalin alone or in combination with other drugs. Discontinuation of pregabalin should be considered as it has shown reversibility of this event in some cases. Caution is advised when prescribing pregabalin to the elderly or those with any degree of renal impairment.
Creatine Kinase Elevations: Treatment with pregabalin was associated with creatine kinase elevations. In premarketing studies, some patients had events reported as rhabdomyolysis; however the relationship between these myopathy events and pregabalin is not completely understood. Pregabalin should be discontinued if myopathy is diagnosed or suspected or if markedly elevated creatine kinase levels occur.
Ophthalmological Effects: In controlled studies, a higher proportion of patients treated with pregabalin reported blurred vision than did patients treated with placebo. In the majority of cases, blurred vision resolved with continued dosing. If blurred vision persists, further assessment should be considered.
In postmarketing experience, visual adverse reactions have also been reported, including loss of vision, visual blurring or other changes of visual acuity, many of which were transient. Discontinuation of pregabalin may result in resolution or improvement of these visual symptoms.
Patients should be informed that if changes in vision occur, they should notify their physician. If visual disturbance persists, further assessment, including discontinuation of pregabalin, should be considered. More frequent assessments should be considered for patients who are already routinely monitored for ocular conditions.
Renal Impairment: There have been reports of patients, with or without previous history, experiencing renal failure while receiving pregabalin alone or in combination with other drugs. Discontinuation of pregabalin showed reversibility of this event in some cases. Because pregabalin is eliminated primarily by renal excretion, the dose of pregabalin should be adjusted as noted for elderly patients or those with renal impairment. In patients with a medical history of significant renal insufficiency, daily dosages should be reduced accordingly.
Effects on Ability to Drive and Use Machine: Pregabalin may have minor or moderate influence on the ability to drive and use machines. Pregabalin may cause dizziness and somnolence and therefore may have an influence on the ability to drive or use machines. Patients are advised not to drive, operate complex machinery or engage in other potentially hazardous activities until it is known whether this medication affects their ability to perform these activities.
Use in Children: The safety and efficacy of pregabalin in pediatric patients have not been established.
Use in the Elderly: Pregabalin treatment has been associated with dizziness and somnolence, which may increase the occurrence of accidental injury (falls) in the elderly population.
