Drug Criteria & Outcomes: New FDA Approvals
March 1, 2003 2 minutes read
Drug Criteria & Outcomes: New FDA Approvals
These drugs recently received final approval from the U.S. Food and Drug Administration (FDA):
• New indication for lamotrigine (Lamictal) tablets by GlaxoSmithKline. The FDA has approved lamotrigine (Lamictal) tablets as add-on therapy in partial seizures in children ages 2 years and older. This new indication expands the already-approved indications for adjunctive use in adults with partial seizures, and for the generalized seizures of Lennox-Gastaut Syndrome in children two years of age and older.
Because the rate of serious rash is greater in pediatric patients than in adults, it bears emphasis that Lamictal is approved only for use in pediatric patients younger than age 16 who have partial seizures or seizures associated with the Lennox-Gastaut syndrome.
• Interferon beta-1a (Avonex) by Biogen. The FDA has approved Interferon beta-1a (Avonex) to include treatment of patients with a first multiple sclerosis (MS) attack if brain MRI scan abnormalities characteristic of MS are shown.
Interferon beta-1a should be used with caution in patients with depression or other mood disorders and in patients with seizure disorders. Pregnant women should not use the drug. Patients with cardiac disease should be closely monitored. Patients also should be monitored for signs of hepatic injury. Routine periodic blood chemistry and hematology tests are recommended during treatment with Avonex. Rare cases of anaphylaxis have been reported.
• Adalimumab (Humira) by Abbott Laboratories. The FDA has approved adalimumab (Humira) for treatment of rheumatoid arthritis. Adalimumab is produced by recombinant DNA technology; it is a human-derived antibody that binds to human tumor necrosis factor-alpha (TNF-alpha). The drug can be used alone or in combination with methotrexate or other anti-rheumatic drugs.
Adalimumab is administered as a single subcutaneous injection every other week. The package insert carries a bolded warning stating that serious, sometimes fatal, infections (including cases of tuberculosis and sepsis) have been reported with the use of TNF-blocking agents including adalimumab.
These drugs recently received final approval from the U.S. Food and Drug Administration (FDA):
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