The U.S. Food and Drug Administration is alerting health care providers and patients that medications including and related to valproate sodium can cause decreased IQ scores in children whose mothers took the medication during pregnancy. Therefore, these drugs are being contraindicated for (should never be used by) pregnant women for the prevention of migraine headaches. Valproate products include valproate sodium (Depacon), divalproex sodium (Depakote, Depakote CP, and Depakote ER), valproic acid (Depakene and Stavzor), and their generics.
Category Archives: Food Safety News
FDA approves Plan B One-Step emergency contraceptive without a prescription for women 15 years of age and older
The U.S. Food and Drug Administration today announced that it has approved an amended application submitted by Teva Women’s Health, Inc. to market Plan B One-Step (active ingredient levonorgestrel) for use without a prescription by women 15 years of age and older.
FDA approves Procysbi for rare genetic condition
The U.S. Food and Drug Administration today approved Procysbi (cysteamine bitartrate) for the management of nephropathic cystinosis in children and adults. Procysbi was granted orphan product designation because it is intended to treat a rare disease or condition.
FDA approves Kcentra for the urgent reversal of anticoagulation in adults with major bleeding
The U.S. Food and Drug Administration today approved Kcentra (Prothrombin Complex Concentrate, Human) for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding. Plasma is the only other product approved for this use in the United States.
Smart & Final issues Recall – Allergy Alert Undeclared Wheat, Milk and Eggs in La Romanella Tri-Color Cheese Tortellini
Smart & Final of Los Angeles, Calif. is recalling 2.5 lb. La Romanella Tri-Color Cheese Tortellini because it may contain undeclared wheat, eggs and milk. People who have an allergy or severe sensitivity to wheat, eggs and /or milk run the risk of serious or life-threatening allergic reaction if they consume these products.
Read The Complete Story!
FDA launches partnership to protect against counterfeit anti-malarial medicines with FDA-developed handheld detection tool
The U.S. Food and Drug Administration today announced a public-private partnership to help identify counterfeit or substandard anti-malarial medicines, including falsified products, with the deployment of the FDA-developed Counterfeit Detection Device, called CD-3.
FDA announces voluntary nationwide recall by Balanced Solutions Compounding Pharmacy
Balanced Solutions Compounding Pharmacy (Balanced Solutions), a division of Axium Healthcare Pharmacy, Inc., of Lake Mary, Fla., is voluntarily recalling all lots of its sterile non-expired drug products due to a lack of sterility assurance and concerns with product quality controls.
Natura Pet Expands Voluntary Recall of Dry Pet Foods Due to Possible Health Risk.
Natura Pet Products is voluntarily expanding its March 29, 2013 recall of dry pet foods because they have the potential to be contaminated with Salmonella
Read The Complete Story!
FDA approves abuse-deterrent labeling for reformulated OxyContin
The U.S. Food and Drug Administration today approved updated labeling for Purdue Pharma L.P.’s reformulated OxyContin (oxycodone hydrochloride controlled-release) tablets. The new labeling indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting).
Wegmans Food Markets Announces Voluntary Recall of Select Wegmans Food You Feel Good About Roasted Red Pepper Dip, 8 oz., Due to Undeclared Milk and Eggs
Wegmans Food Markets is recalling approximately 1,100 affected units of Wegmans Food You Feel Good About Roasted Red Pepper Dip, 8 oz. tub, with a best-by date of 5/17/13, because some of the tubs may have an incorrect ingredient label that does not list milk and eggs. People who have an allergy or severe sensitivity to milk or eggs run the risk of serious or life-threatening allergic reaction if they consume these products.
Read The Complete Story!