New Important Safety Information Related to PERFOROMIST®

September 29, 2011

Dey Pharma, L.P. would like to inform you of important safety-related changes to the PERFOROMIST® (formoterol fumarate) Inhalation Solution, 20 mcg/2mL prescribing information.

PERFOROMIST® is a long-acting beta2-adrenergic agonist (LABA) indicated for long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with Chronic Obstructive Pulmonary Disease (COPD), including chronic bronchitis and emphysema.

New important safety information related to PERFOROMIST® includes:

  • Increased risk of asthma-related death in patients taking LABAs for treatment of asthma.
  • New prescribing guidelines.
  • All LABA, including PERFOROMIST® Inhalation Solution, are contraindicated in patients with asthma without the concomitant use of a long term asthma controller medication.
PERFOROMIST® has a risk evaluation and a mitigation strategy (REMS) that consists of a Medication Guide and a communication program. The PERFOROMIST® labeling includes a boxed warning to highlight the safety issue of asthma-related death.

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