August 9, 2019

FDA Approves First Lyrica Generics

In late July, the FDA approved the first generic versions of Lyrica (pregabalin), granting approvals to a total of nine pharmaceutical companies for five different conditions. Lyrica is seen in many workers’ comp claims for the treatment of neuropathic pain, and these generic approvals could result in greater utilization across claims with reduced costs.

This approval covers the following indications:

  • The management of neuropathic pain associated with spinal cord injury
  • Neuropathic pain associated with diabetic peripheral neuropathy
  • The management of postherpetic neuralgia (shingles pain)
  • Use as an adjunctive therapy for the treatment of partial onset seizures
  • The management of fibromyalgia

The most common side effects reported in the clinical trials for Lyrica in adults are dizziness, somnolence, dry mouth, swelling, blurred vision, weight gain and abnormal thinking (primarily difficulty with concentration/attention). Pregabalin may cause dizziness and drowsiness and impair ability to drive or operate machinery.

According to the FDA, pregabalin warnings include the risk of angioedema (swelling of the throat, head and neck), which may be associated with life-threatening respiratory compromise requiring emergency treatment. Increased seizure frequency or other adverse reactions may occur if the drug is rapidly discontinued. Antiepileptic drugs, including pregabalin, increase the risk of suicidal thoughts or behavior.

For further information, read the FDA News Release.

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