Early Communication about an Ongoing Safety Review of Montelukast (Singulair)

This report reflects the FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug product and the emerging safety issue. Nor does it mean that FDA is advising health care professionals to discontinue prescribing this product. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.

To access the Safety Review visit //www.fda.gov/Cder/drug/early_comm/montelukast.htm.