A strengthened and modernized post-market drug safety program has resulted in a substantial improvement in the U.S. Food and Drug Administration’s oversight of drugs once they reach the American public.

The U.S. Food and Drug Administration (FDA) is warning of possible risks when using blood pressure medicines containing aliskiren with other drugs called angiotensin converting enzyme inhibitors ( ACEIs ) and angiotensin receptor blockers ( ARBs ) in patients with diabetes or kidney (renal) impairment.

FDA has received additional reports of fungal endophthalmitis (eye infections) in patients who were given Brilliant Blue G ( BBG ) during eye surgery since the FDA Warning to Physicians was posted on March 19, 2012.

FDA has received additional reports of fungal endophthalmitis (eye infections) in patients who were given Brilliant Blue G ( BBG ) during eye surgery since the FDA Warning to Physicians was posted on March 19, 2012.

The U.S. Food and Drug Administration (FDA) has completed its review of recent observational ( epidemiologic ) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills.

The U.S. Food and Drug Administration (FDA) is clarifying dosing and warning recommendations for the antidepressant Celexa ( citalopram hydrobromide ; also available in generic form).

FDA lab tests have confirmed that a counterfeit version of Roche’s Altuzan 400mg / 16ml ( bevacizumab ),an injectable cancer medication, found in the U.S. contains no active ingredient.

The U.S. Food and Drug Administration issued a warning letter to Breathable Foods Inc., makers of AeroShot , for false or misleading statements in the labeling of their product, and told the company that the Agency has questions about the safety of the “caffeine inhaler.” The FDA also expressed concern about the use of AeroShot by children and adolescents and in combination with alcohol. The company claims AeroShot is designed to provide “breathable energy, anytime, anyplace.” The company also claims on its website that its product is intended to be ingested by swallowing. T...

Korlym ( mifepristone ) was approved by the U.S. Food and Drug Administration to control high blood sugar levels (hyperglycemia) in adults with endogenous Cushing’s syndrome.

Regeneca , Inc. notifed the public of a nationwide recall of RegenArouse , Lot Number 130100. FDA lab analysis confirmed the presence of Tadalafil , an FDA-approved drug used as treatment for male Erectile Dysfunction (ED), making this product an unapproved new drug.