FDA Alerts
FDA Drug Safety Communication: Pradaxa
The U.S. Food and Drug Administration (FDA) is alerting the public to important storage and handling requirements for Pradaxa ( dabigatran etexilate mesylate ) capsules.
(UPDATE 12/19) FDA Drug Safety Communication: Multaq (dronedarone)
The U.S. Food and Drug Administration (FDA) is reviewing data from a clinical trial that was evaluating the effects of the antiarrhythmic drug Multaq ( dronedarone ) in patients with permanent atrial fibrillation.
FDA Reminder: Do Not Give Infants Cough and Cold Products Designed for Older Children
In January 2008, manufacturers voluntarily removed over-the-counter (OTC) infant (less than 2 years of age) cough and cold products from the market due to safety concerns.
Later in fall of 2008, manufacturers also voluntarily relabeled these cough and cold products to state: “do not use in children under 4 years of age.” However, there are concerns that many parents may be giving cough and cold products that remain on the market - those designed for older children - to their infants. FDA reminds all caregivers never to give a child under two years of age any kind of cough and cold p...
FDA Drug Safety Communication: Tamiflu
The U.S. Food and Drug Administration (FDA) is informing the public of important product safety changes to the influenza drug Tamiflu ( oseltamivir phosphate) for oral suspension.
FDA Unveils Final Cigarette Warning Labels
The U.S. Food and Drug Administration (FDA) today unveiled the nine graphic health warnings required to appear on every pack of cigarettes sold in the United States and in every cigarette advertisement.
FDA Examines Ways To Improve Consumer Understanding Of Prescription Drug Ads
Findings from three studies conducted by the US Food and Drug Administration (FDA) confirm that the way information is conveyed and displayed in printed drug advertising affects consumer understanding of prescription medications.
FDA Sheds Light on Sunscreens
T he Food and Drug Administration (FDA) is taking steps to help protect consumers from skin damage caused by excessive sun exposure.
Medication Errors Resulting From Name Confusion
The U.S. Food and Drug Administration (FDA) is alerting the public to medication error reports in which patients were given risperidone ( Risperdal ) instead of ropinirole ( Requip ) and vice versa. In some cases, patients who took the wrong medication needed to be hospitalized.
US Nutrition Issues Allergy Alert
US Nutrition, of Ronkonkoma , New York is recalling Daily Multiple for Women 50 + Tablets, because certain lots contain undeclared fish (fish gelatin). People who have an allergy or severe sensitivity to fish run the risk of a serious or life-threatening allergic reaction if they consume these products.
Global Wellness, LLC Conducts a Nationwide Voluntary Recall of VIA XTREME ULTIMATE SEXUAL ENHANCER
Global Wellness, LLC. Hollywood, FL is conducting a voluntary nationwide recall of VIA XTREME ULTIMATE SEXUAL ENHANCER DIETARY SUPPLEMENT FOR MEN to the consumer level. The product was distributed throughout the U.S. Puerto Rico, and Canada to internet and retail consumers.