Drugs & Biologics Trainings

A drug is any substance that alters a body’s normal functions whenabsorbed into a living organism. In pharmacology specifically, a drug is achemical substance that is used to treat, mitigate, cure or diagnose diseasesor otherwise utilized to improve mental or physical well-being. Biologics, onthe contrary, is a drug, antitoxin or vaccine synthesized from living organismsor their products. These are made use of as a therapeutic, diagnostic orpreventive agent.

Food and Drug Administration (FDA) is warning that the bloodpressure drug olmesartan medoxomil (marketed as Benicar, Benicar HCT, Azor,Tribenzor, and generics) can cause intestinal problems known as sprue-likeenteropathy.  FDA has approved changes to the labels of these drugs toinclude this concern. Symptoms of sprue-like enteropathy include severe,chronic diarrhea with substantial weight loss. The enteropathy may developmonths to years after starting olmesartan, and sometimes requirehospitalization. If patients taking olmesartan develop these symptoms and noother cause is found, the drug should be discontinued, and therapy with anotherantihypertensive started. Discontinuation of olmesartan has resulted inclinical improvement of sprue-like enteropathy symptoms in all patients.Olmesartan medoxomil is an angiotensin II receptor blocker (ARB) approved forthe treatment of high blood pressure, alone or with other antihypertensiveagents, and is one of eight marketed ARB drugs.  Sprue-like enteropathyhas not been detected with ARB drugs other than olmesartan.

The Center for Drug Evaluation and Research (CDER) performs anessential public health task by making sure that safe and effective drugs areavailable to improve the health of people in the United States. As part of theU.S. Food and Drug Administration (FDA), CDER regulates over-the-counter andprescription drugs, including biological therapeutics and generic drugs. Thiswork 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 Centerwithin FDA that regulates biological products for human use under applicablefederal laws, including the Public Health Service Act and the Federal Food,Drug and Cosmetic Act. CBER protects and advances the public health by ensuringthat biological products are safe and effective and available to those who needthem. CBER also provides the public with information to promote the safe andappropriate use of biological products FDA will continue to evaluate the safetyof olmesartan-containing products and will communicate again if additionalinformation becomes available.