THE ASSOCIATED RISKS OF ON-LABEL AND OFF-LABEL DRUGS USED IN OBESITY
Abstract:
The treatment of obesity includes along with lifestyle modification, pharmacological therapy. Until now there are only few drugs approved by FDA for the treatment of obesity, therefore physicians often prescribe off-label drugs. In this article we review tolerability, side effects and contraindication of both on-label and off-label drugs used in obesity treatment. Currently there are 5 approved drugs for long-term use (phentermine/topiramate, bupropion/naltrexone, orlistat, lorcaserin and liraglutide) and 4 approved drugs for short-term use (phentermine, diethylpropion, benzphetamin, phendimetrizine). On-label therapy is generally well tolerated, with specific contraindication for each drug. On the other side, off-label therapy can be considered safe only for drugs that have already long-term safety data (metformin, phentermine). For other drugs (pramlintide, zonisamide, GLP-1 agonists) off-label prescribing should be limited to clinical trials due to their unknown adverse effect profile.
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