Drugs & Biologics Trainings

A drug is any substance that alters a body’s normal functions when absorbed into a living organism. In pharmacology specifically, a drug is a chemical substance that is used to treat, mitigate, cure or diagnose diseases or otherwise utilized to improve mental or physical well-being. Biologics, on the contrary, is a drug, antitoxin or vaccine synthesized from living organisms or their products. These are made use of as a therapeutic, diagnostic or preventive agent.

Food and Drug Administration (FDA) is warning that the blood pressure drug olmesartan medoxomil (marketed as Benicar, Benicar HCT, Azor, Tribenzor, and generics) can cause intestinal problems known as sprue-like enteropathy.  FDA has approved changes to the labels of these drugs to include this concern. Symptoms of sprue-like enteropathy include severe, chronic diarrhea with substantial weight loss. The enteropathy may develop months to years after starting olmesartan, and sometimes require hospitalization. If patients taking olmesartan develop these symptoms and no other cause is found, the drug should be discontinued, and therapy with another antihypertensive started. Discontinuation of olmesartan has resulted in clinical improvement of sprue-like enteropathy symptoms in all patients. Olmesartan medoxomil is an angiotensin II receptor blocker (ARB) approved for the treatment of high blood pressure, alone or with other antihypertensive agents, and is one of eight marketed ARB drugs.  Sprue-like enteropathy has not been detected with ARB drugs other than olmesartan.

The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines. For example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all considered "drugs."

Center for Biological Evolution and Research (CBER) is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products FDA will continue to evaluate the safety of olmesartan-containing products and will communicate again if additional information becomes available.