Officials with the U.S. Food and Drug Administration (FDA) just released the agency’s final rule concerning over-the-counter (OTC) consumer antiseptic hand soap products that are made with specific active ingredients, including triclocarban and triclosan. These soaps are no longer marketable and firms that make these products will … [Read more...]
Final Rule for Antibacterial Soap Efficacy and Safety Released by Federal Regulators
FDA Issues Multiple Warnings Over OTC Asthma Inhaler
Possibly Fatal Over-The-Counter Asthma Drug Inspectors from the U.S. Food and Drug Administration (FDA) recently released warnings concerning severe risks associated with an over-the-counter (OTC) asthma medication, a skin and hair product, and a mammography clinic. An OTC asthma drug was described as "Possibly Fatal," according … [Read more...]
FDA Safety Alert for OTC Chinese Cough Syrup that Contains Unidentified Morphine
The Food and Drug Administration (FDA) has issued a warning to consumers not to use Licorice Coughing Liquid, an over-the-counter cough syrup, because the product contains unidentified morphine. Ma Ying Long Pharmaceutical Group manufactures the cough syrup. The cough syrup’s label contains information written in English and … [Read more...]
Children’s Cough Syrups Recalled Because of Incorrect Dosing Cup
Perrigo Company of Dublin, Ireland, has initiated a voluntary recall of five batches of its children's cough syrups because some packages contain an oral dosing cup with incorrect dose markings and children could receive an overdose of the medicine. The recall includes two batches of guaifenesin grape liquid (100mg/5 mL) and three … [Read more...]
FDA Strengthens Heart Attack and Stoke Warnings for Nonsteroidal Anti-inflammatory Drugs
The Food and Drug Administration (FDA) has strengthened existing warnings on prescription and over-the-counter (OTC) nonsteroidal anti-inflammatory drugs (NSAIDs) Drug Facts labels to indicate that the drugs can increase the risk of a heart attack or stroke, which can lead to death. These side effects can occur as early as the first … [Read more...]
FDA Orders Stronger Warnings of Heart and Stroke Risks with Common Pain Relievers
After reviewing new safety information, the Food and Drug Administration (FDA) has requested drug makers to strengthen warnings that common painkillers like Motrin, Aleve, and Advil can increase the risk of a heart attack or stroke. These painkillers—nonsteroidal anti-inflammatory drugs—are widely used in both prescription and … [Read more...]
Acetaminophen to Carry New Warnings
FDA's Updated OTC Acetaminophen Drugs. A new draft guidance document issued by the U.S. Food and Drug Administration (FDA) orders new warnings on all over-the-counter (OTC) acetaminophen medications to include the risk of serious skin reactions. Last August, the agency warned that acetaminophen is associated with Stevens-Johnson … [Read more...]
