The FAA has established certification procedures for a new diabetes medication, Victoza (liraglutide), a once-daily injectable medication called a glucagon-like peptide-1 receptor agonist (GLP-1). It works by helping the pancreas make more insulin following a meal. The “fine print” for FAA medical certification purposes is a little complicated, but here’s the synopsis:
It is acceptable as a single agent therapy or in combination with other types of medications, including metformin, sulfonylureas, or thiazolidinediones. Victoza can be used with beta blockers, used to treat high blood pressure, but cannot be used with insulin.
If it’s being taken for the first time in combination with a sulfonylurea or a meglitinide-type of drug, there is a 60-day observation period to determine stability and tolerance.
If used as a stand-alone drug or in combination with metformin or a thiazolidinedione (TZD), the observation period is 30 days. If it’s being added to an established regimen of a sulfonylurea or a meglitinide, the 30-day observation period is also required. However, if being added to metformin or a TZD, the observation period is only 14 days.
As you can see, the FAA is very particular about the sequencing of how Victoza is prescribed and used alone and with other medications. Diabetes is one of the most prolific medical problems facing the United States, and Victoza is one of a growing number of drugs gaining FDA approval and subsequent FAA acceptance.
September 13, 2011