The FDA has unveiled a major revision to the format of drug labels (package inserts) to give health care professionals clearer and more concise prescribing information. The plan also includes a government database that allows people to search for information online. The format is being revised for the first time in more than 25 years. [...]
Not all beta blockers have the same effect on cardiovascular risk factors in patients with diabetes. The Glycemic Effects in Diabetes Mellitus Carvedilol-Metoprolol Comparison in Hypertensives (GEMINI) trial found that, in the presence of an angiotensin-converting enzyme (ACE) inhibitor or an angio-tensin-receptor blocker (ARB), the beta blocker carvedilol (e.g., Coreg medication, Glaxo-SmithKline) preserved glycemic control, [...]
The FDA has approved sunitinib (Sutent, Pfizer), a targeted treatment for patients with advanced kidney cancer and gastrointestinal stromal tumors (GISTs), a rare stomach cancer. This action marks the first time that the agency has approved an oncology product for two indications simultaneously. Sunitinib, a tyrosine kinase inhibitor, deprives tumor cells of blood and nutrients [...]
The FDA has approved conivaptan HCl injection (YM087, Vaprisol, Astellas Pharma), an arginine vasopressin (AVP) antagonist for hospitalized patients with euvolemic hyponatremia. Euvolemic hyponatremia is a potentially life-threatening condition that occurs when the body’s blood sodium level falls significantly below normal. Hyponatremia affects almost 4% of hospitalized patients in the U.S. each year. Although many [...]
