Safety Alerts & Recalls

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Latest Alerts

FDA Warns Pregnant Women to Not Use Certain Migraine Prevention Medicines
The U.S. Food and Drug Administration is alerting healthcare 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 should not 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. Medicines that contain valproate already have a boxed warning for fetal risk, including birth defects. The recently published Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study found additional evidence of the IQ risk, leading to the strengthened warnings. Valproate products have several other FDA-approved uses including treatment of epilepsy (seizures); and treatment of manic episodes associated with bipolar disorder (manic-depressive disorder). For these other approved uses — bipolar disorder and seizures — valproate may have some value in pregnant women, but the benefits and risks of the medicine should be weighed. Typically, valproate is only taken during pregnancy if other medications have not controlled the symptoms or are otherwise unacceptable. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm350684.htm
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Recall of Levoxyl Produces Medication Shortage
King Pharmaceuticals, a subsidiary of Pfizer, has recently issued two recalls of Levoxyl (levothyroxine sodium), which is used to treat hypothyroidism (low thyroid hormone levels) and certain types of goiter. The first recall was issued after learning of complaints from pharmacists and patients of an unusual odor coming from the Levoxyl bottles. It was determined that the odor was caused by an oxygen-absorbing canister added to the pharmacy bottles to improve the stability of the product. Pfizer conducted a health assessment of the situation and determined that this odor was not likely to cause any adverse health issues. However, out of caution, the company decided to voluntarily recall the product to the pharmacy level. The second recall was issued because some tablets didn't meet potency standards and may have lower levels of the thyroid hormone medicine. Pfizer said the use of less potent Levoxyl tablets carries a rare risk of serious adverse events because it may affect the management of hypothyroidism. Only three batches of Levoxyl tested for stability produced results outside of the quality specifications, but as a conservative measure the company decided to recall all batches at the pharmacy level. For more information, please visit: http://www.endo-society.org/advocacy/insider/2013/LEVOXYL_Recalled_Due_to_Odor_Likely_Unavailable_Until_2014.cfm and http://www.medscape.com/viewarticle/804201?nlid=31349_745&src=wnl_edit_medp_phar&uac=163689AN&spon=30
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Date Published Title Drug Source
2013-05-07 FDA Warns Pregnant Women to Not Use Certain Migraine Prevention Medicines Divalproex Sodium FDA
2013-05-24 Recall of Levoxyl Produces Medication Shortage Levothyroxine Manufacturer
2013-05-24 Physicians Total Care Recalls Single Lot of Plavix 75 mg Clopidogrel FDA
2013-05-29 L. Perrigo Co. Recalls Select Lots of Liothyronine Sodium Tablets, 5 mcg Liothyronine FDA
2013-05-29 The Last of the CFC-Containing Inhalers To Be Taken Off the Market Maxair FDA
2013-06-10 Nephron Pharmaceuticals Corporation Recalls EZ Breathe Atomizer and Asthmanefrin Starter Kit FDA
2013-06-10 Nephron Pharmaceuticals Corporation Recalls EZ Breathe Atomizer Ipratropium FDA
2013-06-13 Zydus Pharmaceuticals Recalls One Lot of Warfarin 2 mg Tablets Warfarin FDA
2013-06-19 FDA Investigates Reports of Two Deaths Following Injections of Zyprexa Relprevv (Olanzapine Pamoate) Olanzapine FDA
2013-06-20 One Lot of Rugby Labeled Enteric Coated Aspirin 81 mg Tablets Recalled - May Contain Acetaminophen 500 mg Tablets Aspirin FDA
2013-07-03 FDA Updates Prescribing Information for Blood Pressure Medicine Olmesartan to Include Link to Intestinal Problems (Sprue-Like Enteropathy) Hydrochlorothiazide, Amlodipine, and Olmesartan FDA
2013-07-08 Sandoz Announces Voluntary Recall of One Lot of Estarylla Ethinylestradiol with Norgestimate FDA
2013-07-29 FDA Places Strict Limits on Oral Ketoconazole (Nizoral) Use Ketoconazole FDA
2013-07-29 FDA Warns: Healthy Life Chemistry By Purity First B-50 Contains Possibly Harmful Anabolic Steroids Vitamin B Complex FDA
2013-07-29 FDA Strengthens Warnings for Antimalarial Drug Mefloquine For Serious Psychiatric and Nerve Side Effects Mefloquine FDA
2013-07-30 Nova Diabetes Care Recalls of Several Lots of Nova Max Glucose Test Strips Tolazamide Manufacturer
2013-08-05 FDA Warns: Purity First’s Expands Recall and Now Includes Healthy Life Chemistry B-50, Vitamin C and Multi-Mineral Vitamin B Complex FDA
2013-08-05 FDA Warns of Rare But Serious Skin Reaction with Acetaminophen FDA
2013-08-19 FDA Strengthens Neuropathy Warnings for Fluoroquinolone Class of Antibiotics Gemifloxacin FDA
2013-08-29 FDA Investigating Report of Progressive Multifocal Leukoencephalopathy (PML) in Patient Taking Gilenya (Fingolimod) Fingolimod FDA