Indicated for:

Management of Neuropathic Pain Associated with Diabetic Peripheral Neuropathy (Adults)

Management of Postherpetic Neuralgia (Adults)

Adjunctive Therapy for the Treatment of Partial-Onset Seizures in Patients 1 Month of Age and Older

Management of Fibromyalgia (Adults)

Management of Neuropathic Pain Associated with Spinal Cord Injury (Adults)

Antiepileptic drugs (AEDs), including LYRICA, 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.

When discontinuing LYRICA, taper gradually over a minimum of 1 week.

The effect of dose escalation rate on the tolerability of LYRICA has not been formally studied.

LYRICA treatment may cause weight gain. Weight gain was not limited to patients with edema.

LYRICA treatment may cause peripheral edema.

LYRICA may cause dizziness and somnolence. Inform patients that LYRICA-related dizziness and somnolence may impair their ability to perform tasks such as driving or operating machinery.

LYRICA treatment was associated with creatine kinase elevations.

LYRICA treatment was associated with a decrease in platelet count.

LYRICA treatment was associated with PR interval prolongation.

Reports of  blurred vision.

There have been postmarketing reports of angioedema in patients during initial and chronic treatment with LYRICA. Specific symptoms included swelling of the face, mouth (tongue, lips, and gums), and neck (throat and larynx). There were reports of life threatening angioedema with respiratory compromise requiring emergency treatment.

Exercise caution when prescribing LYRICA to patients who have had a previous episode of angioedema. In addition, patients who are taking other drugs associated with angioedema (e.g., angiotensin converting enzyme inhibitors [ACE-inhibitors]) may be at increased risk of developing angioedema.

As the thiazolidinedione class of antidiabetic drugs can cause weight gain and/or fluid retention, possibly exacerbating or leading to heart failure, exercise caution when co-administering LYRICA and these agents.

Because there are limited data on congestive heart failure patients with New York Heart Association (NYHA) Class III or IV cardiac status, exercise caution when using LYRICA in these patients.

There is evidence from case reports, human studies, and animal studies associating LYRICA with serious, life-threatening, or fatal respiratory depression when co-administered with central nervous system (CNS) depressants, including opioids, or in the setting of underlying respiratory impairment. When the decision is made to co-prescribe LYRICA with another CNS depressant, particularly an opioid, or to prescribe LYRICA to patients with underlying respiratory impairment, monitor patients for symptoms of respiratory depression and sedation, and consider initiating LYRICA at a low dose.

The efficacy of add-on LYRICA in patients taking gabapentin has not been evaluated in controlled trials. Consequently, dosing recommendations for the use of LYRICA with gabapentin cannot be offered.

May cause fetal harm. Advise of potential risk to the fetus.

Because of the potential risk of tumorigenicity, breastfeeding is not recommended during treatment with LYRICA.

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• Use in patients under the age of 1 month for partial-onset seizures. GoToSource

• Generalized anxiety disorder, social anxiety disorder and panic disorder. GoToSource

• Preventive treatment for migraines. GoToSource

• Bipolar disorder. GoToSource

• Epilepsy. GoToSource

• Restless legs syndrome. GoToSource

• Combination of pregabalin and ketamine as postoperative analgesia for total hip arthroplasty. GoToSource

• Combination of meloxicam and pregabalin for pain in knee osteoarthritis. GoToSource

• Adjunctive therapy with gabapentin for prevention of chronic postsurgical pain. GoToSource

• Irritable bowel syndrome. GoToSource

• Essential tremor. GoToSource

• Idiopathic small fiber neuropathy. GoToSource

• Drug and alcohol withdrawal symptoms. GoToSource

• Acute herpes zoster pain. GoToSource

• Neurogenic claudication. GoToSource

• Cancer pain. GoToSource

• Prurigo nodularis. GoToSource

• Chronic pruritus. GoToSource

• Menopausal insomnia. GoToSource

Blockage of new brain synapses reducing potential for rejuvenating brain plasticity causing declining brain function. GoToSource

Suicidal thoughts and behaviors. GoToSource

Gynecomastia (enlargement of male breast tissue). GoToSource

Dependence, abuse or withdrawal symptoms. GoToSource

Birth defects. GoToSource

Rash, stevens–johnson syndrome, angioedema with swelling of the face, tongue, lips, gums, throat and larynx, myoclonus (involuntary muscle jerk) and asterixis (hand-flapping tremor). GoToSource

Heart failure. GoToSource

Arrhythmias (irregular or abnormal heart rhythm) or contractile dysfunction. GoToSource

Prolongation of the PR interval. GoToSource

Hyponatremia (low blood sodium level), confusion and disorientation. GoToSource

Liver injury. GoToSource

Thrombocytopenia (low blood platelet count). GoToSource

Creatine kinase elevations (test used to detect inflammation of muscles or muscle damage due to muscle disorders). GoToSource

Blurred vision, ataxia (lack of muscle coordination), peripheral edema (soft-tissue swelling) and weight gain. GoToSource

Lawsuits filed for suicidal ideation and behavior, angioedema and memory loss.