FDA Alerts
FDA: Don't Take Diamond 3500
The Food and Drug Administration (FDA) is advising consumers not to purchase or use Diamond 3500, a product promoted and sold for sexual enhancement on various websites and in some retail stores.
FDA Warns Against Sex Enhancement Pill
The Food and Drug Administration (FDA) is advising consumers not to purchase or use Eros Power Zone 1900, a product promoted and sold for sexual enhancement on various websites and in some retail stores.
ED Supplement May Pose Health Risk
The Food and Drug Administration (FDA) is advising consumers not to purchase or use Triple MiracleZen Gold 1750 mg, a product promoted and sold for sexual enhancement on various websites and in some retail stores.
Male Enhancement Product May Pose Health Risk
The Food and Drug Administration (FDA) is advising consumers not to purchase or use Xtra Zone 2400, a product promoted and sold for sexual enhancement on various websites and in some retail stores.
Second in New Cholesterol Rx Class Approved
The U.S. Food and Drug Administration today approved Repatha (evolocumab) injection for some patients who are unable to get their low-density lipoprotein (LDL) cholesterol under control with current treatment options.
Cholesterol Rx Gets FDA Nod
The U.S. Food and Drug Administration today approved Praluent (alirocumab) injection, the first cholesterol-lowering treatment approved in a new class of drugs known as proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors.
Ranbaxy Issues Voluntary Nationwide Recall of Atorvastatin Calcium
On November 9, 2012, Ranbaxy Inc. initiated a voluntary recall of 41 affected lots of atorvastatin calcium tablets (10 mg, 20 mg and 40 mg) which is a solid oral dosage form, to the retail level.
FDA Announces Safety Changes In Labeling For Some Cholesterol-lowering Drugs
Important safety changes to the labeling for some widely used cholesterol-lowering drugs known as statins are being announced today by the U.S. Food and Drug Administration.
These products, when used with diet and exercise, help to lower a person’s “bad” cholesterol (low-density lipoprotein cholesterol). The products include: Lipitor ( atorvastatin ), Lescol ( fluvastatin ), Mevacor ( lovastatin ), Altoprev ( lovastatin extended-release), Livalo ( pitavastatin ), Pravachol ( pravastatin ), Crestor ( rosuvastatin ), and Zocor ( simvastatin ). Combination products include: Advicor (...
FDA Approves Drug for Acute Coronary Syndromes
The U.S. Food and Drug Administration today approved the blood-thinning drug Brilinta ( ticagrelor ) to reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS).
(UPDATE 12/15) FDA Announces New Safety Recommendations For High-Dose Simvastatin
The U.S. Food and Drug Administration today is announcing safety label changes for the cholesterol-lowering medication simvastatin because the highest approved dose--80 milligram (mg)--has been associated with an elevated risk of muscle injury or myopathy , particularly during the first 12 months of use.