Final Rule for Antibacterial Soap Efficacy and Safety Released by Federal Regulators
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...]
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 … [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...]
Tylenol, Other OTC Drugs Recalled
Tylenol, Other OTC Drugs Recalled. A musty smell has prompted the recall of more Tylenol products, as well as other over-the-counter drugs including Rolaids, Motrin, Benedryl and St. Joseph Aspirin. Last November, Johnson & Johnson’s McNeil Consumer Healthcare unit recalled 5 lots of Tylenol Arthritis Pain Caplet 100 count … [Read more...]
FDA Unapproved OTC Ibuprofen Pain Gels
Unapproved Ibuprofen Pain Gels. Several makers of over-the-counter (OTC) topical ibuprofen pain gels have been issued warning letters from the Food & Drug Administration (FDA). According to the agency, topical ibuprofen pain gels are unapproved new drugs that require an approved new drug application in order to be legally … [Read more...]
OTC Pain Killers To Bear New Safety Warnings
OTC Pain Killers Safety Warnings. The makers of over-the-counter (OTC) pain medications and fever reducers have been told by federal regulators to include new warnings on their labels about potential side effects, including stomach bleeding and liver damage.- According to a Food & Drug Administration (FDA) statement, … [Read more...]
No OTC Cold Meds for Kids Under Four
OTC Cold Meds Tied To Overdoses And Deaths. Manufacturers of over-the-counter (OTC) children's cold medicines warned today that the drugs should not be given to kids younger than four-years-old. The advice, announced by the Consumer Healthcare Products Association on behalf of the industry, came less than a week after a Food & … [Read more...]
No Ban on OTC Children’s Cold Medicines, FDA Advisers Say
No Ban on OTC Children's Cold Medicines. There will be no ban on children’s over-the-counter cold medicines, Food & Drug Administration (FDA) advisers said yesterday, despite pleas from pediatricians that the agency take such action. While the FDA panel said that the safety and effectiveness of children’s cold needs … [Read more...]
OTC Cold Medicines for Infants are Dangerous
OTC Cold Medicines Are Dangerous For Infants. Over-the-counter (OTC) cold medicines don’t work for very young children, and they could very well be dangerous. That is the conclusion of a group of Food & Drug Administration (FDA) experts tasked with reviewing the safety and effectiveness of OTC decongestants and … [Read more...]
