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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 said.
The FDA has more about this drug's history.