THURSDAY, June 24 (HealthDay News) -- Merck & Co.'s Dulera
inhaler has been approved for people 12 and older whose asthma
isn't controlled with other medication, the company said Thursday
in a news release.
Dulera combines a corticosteroid (mometasone furoate) and a
long-acting beta agonist (formoterol fumarate). The latter class of
drug increases the risk of asthma-related hospitalization in
children and teens, Merck said, so Dulera should only be used by
people whose asthma isn't adequately controlled with a different
class of drug.
FDA approval of Dulera was based on clinical testing of 12-to-26
weeks among 1,509 people aged 12 and older. The most common adverse
reactions included sinus inflammation (sinusitis) and headache.
Dulera isn't a rescue medication and does not replace a
fast-acting inhaler to treat symptoms that begin suddenly, Merck
FDA has more about this drug's history.