FDA Approves Milnacipran for Fibromyalgia

Forest Laboratories and Cypress Bioscience announced January 14 that the Food and Drug Administration (FDA) has approved milnacipran (Savella; (NDA) 022256), a dual serotonin- and norepinephrine-reuptake inhibitor (SNRI), for the management of fibromyalgia.

Drug Details

Drug Name(s)	SAVELLA (Brand Name Drug)
FDA Application No.	(NDA) 022256
Active Ingredient(s)	MILNACIPRAN HYDROCHLORIDE
Company	FOREST LABS
Original Approval or Tentative Approval Date	January 14, 2009
Chemical Type	1 New molecular entity (NME)
Review Classification	S Standard review drug

Savella™ is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the management of fibromyalgia. Savella is not approved for use in pediatric patients.

-----------------WARNINGS AND PRECAUTIONS SIDE EFFECTS----------------

• Suicidality: Monitor for worsening of depressive symptoms and suicide risk
•Serotonin Syndrome: Serotonin syndrome has been reported with SNRIs and SSRIs. Concomitant use of serotonergic drugs is not recommended.
• Elevated blood pressure and heart rate: Cases have been reported with Savella. Monitor blood pressure and heart rate prior to initiating treatment with Savella and periodically throughout treatment
•Seizures: Cases have been reported with Savella therapy. Prescribe Savella with care in patients with a history of seizure disorder.
•Hepatotoxicity: More patients treated with Savella than with placebo experienced mild elevations of ALT and AST. Rarely, fulminant hepatitis has been reported in patients treated with Savella. Avoid concomitant use of Savella in patients with substantial alcohol use or chronic liver disease
•Discontinuation: Withdrawal symptoms have been reported in patients when discontinuing treatment with Savella. A gradual dose reduction is recommended
• Abnormal Bleeding: Savella may increase the risk of bleeding events. Caution patients about the risk of bleeding associated with the concomitant use of Savella and NSAIDs, aspirin, or other drugs that affect coagulation.
• Male patients with a history of obstructive uropathies may experience higher rates of genitourinary adverse events

More information:

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails