WHITEHOUSE STATION, N.J. (AP) – Merck & Co. said it received marketing approval for its asthma treatment Dulera, but the drug will come with a serious warning that it can increase risk of death.
The Food and Drug Administration cleared Dulera, which comes in an inhaler, for use in patients 12 and older, the company said.
Dulera, which combines two types of medication, is meant only for patients with poorly controlled asthma. That’s because of the slight risk that one component – formoterol fumarate, part of the drug class called long-acting beta agonists – could cause asthma-related death. These drugs relax muscles around stressed airways, which could keep patients from noticing dangerous inflammation building up in their airways.
The FDA is mandating that Dulera carry its strongest warning, in a black box in the detailed package insert, as is required for four asthma medicines in the same class: Advair, Symbicort, Foradil and Serevent.
Earlier this month, the agency strengthened rules it announced in February for all long-acting beta agonists, or LABAs. Besides carrying the warning about risk of death, these drugs are to be used along with an inhaled corticosteroid. Also, patients should use LABAs only until asthma control is achieved and maintained, then gradually stop using them.
Dulera’s second component is an inhaled corticosteroid, mometasone furoate, for reducing airway inflammation. That drug is sold under the brand name Asmanex as an allergy treatment. It was developed by Schering-Plough Corp., which Merck bought last November.
Merck said Dulera should be available around the country by the end of July, in two strengths.
Filed Under: Drug Discovery
