Safety Alerts & Recalls

Search all Safety Alerts & Recalls

Latest Alerts

McNeil Lowers Maximum Tylenol Dose to Prevent Overdoses
McNeil Consumer Healthcare has announced plans for new dosing instructions lowering the maximum daily dose for single-ingredient Extra Strength Tylenol (acetaminophen) products sold in the U.S. The new guidelines lower the maximum daily dose from 8 pills per day (4,000 mg) to 6 pills per day (3,000 mg). The change is designed to help encourage appropriate acetaminophen use and reduce the risk of accidental overdose and liver toxicity. McNeil is working closely with other manufacturers of acetaminophen products to help ensure the dosing instructions are the same across similar products. The new dosing instructions will appear on Extra Strength Tylenol product packages in the U.S. beginning in the fall of 2011. McNeil will also be lowering the maximum daily dose for Regular Strength Tylenol and other adult acetaminophen-containing products beginning in 2012. For more information, please visit: http://www.jnj.com/connect/news/all/mcneil-consumer-healthcare-announces-plans-for-new-dosing-instructions-for-tylenol-products
Learn More

FDA Warns of Possible Serious Neurological Reactions When Linezolid (Zyvox) Is Given To Patients Taking Certain Medicines for Depression, Anxiety, Bipolar Disorder, Insomnia
The U.S. Food and Drug Administration (FDA) has issued a warning about a potential drug interaction between linezolid (marketed as Zyvox) and psychiatric medications that work through the serotonin system of the brain (serotonergic medications). Linezolid is commonly used to treat infections, including pneumonia, infections of the skin, and infections caused by a resistant bacterium (Enterococcus faecium). Linezolid may cause serious central nervous system (CNS) reactions when given to patients who are taking certain medicines used for depression, anxiety, bipolar disorder, and insomnia. Although the exact mechanism of this drug interaction is unknown, linezolid inhibits the action of monoamine oxidase A—an enzyme responsible for breaking down serotonin in the brain. It is believed that when linezolid is given to patients taking serotonergic medications, high levels of serotonin can build up in the brain, causing a condition known as Serotonin Syndrome. Signs and symptoms of Serotonin Syndrome include mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination, and/or fever. To view a list of the serotonergic medications that may interact with Linezolid, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm265305.htm#table For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm265305.htm
Learn More

Date Published Title Drug Source
2011-08-01 McNeil Lowers Maximum Tylenol Dose to Prevent Overdoses Acetaminophen Manufacturer
2011-07-27 FDA Warns of Possible Serious Neurological Reactions When Linezolid (Zyvox) Is Given To Patients Taking Certain Medicines for Depression, Anxiety, Bipolar Disorder, Insomnia Linezolid FDA
2011-07-27 FDA Warns of Possible Serious Neurological Reactions When Methylene Blue Is Given To Patients Taking Certain Medicines for Depression, Anxiety, Bipolar Disorder, Insomnia Methylene Blue FDA
2011-07-22 Reducing Fever and Relieving Pain in Children: Safe Use of Acetaminophen Acetaminophen FDA
2011-07-22 FDA Reviewing Results of Study Multaq (Dronedarone) in Patients with Permanent Atrial Fibrillation Dronedarone FDA
2011-07-22 FDA Reviewing of Oral Bisphosphonates and Potential Increased Risk of Esophageal Cancer Ibandronate Sodium FDA
2011-07-21 Non-Safety-Related Recall of Several Lots of Daytrana Patches Methylphenidate Manufacturer
2011-07-19 D.S.C. Laboratories Recalls Single Lot of Anecream Lidocaine 4% Cream Lidocaine FDA
2011-07-19 Teva Recalls Several Lots of Prazosin Capsules, 1 mg Prazosin FDA
2011-07-19 King Pharmaceuticals Recalls Single Lot of Cortisporin Otic Solution Otosporin FDA
2011-07-19 Bayer Health Recalls Single Lot of Genuine Bayer Aspirin Aspirin FDA
2011-07-19 Teva Recalls Several Lots of Hydralazine Tablets, 10 mg, 25 mg, 50 mg and 100 mg Hydralazine FDA
2011-07-19 Pfizer Recalls Select Lots of Nitrostat (Nitroglycerin) Tablets, 0.4mg Nitroglycerin FDA
2011-07-19 Drug Interaction Warnings Added to Prescribing Information for Seroquel Quetiapine FDA
2011-07-13 CDC Revises Recommendations for the Use of Birth Control Methods During the Initial Period After Childbirth MediGuard CRT
2011-07-12 Fetal Exposure To Valproate Medicine During Pregnancy May Cause Cognitive Delay Divalproex Sodium FDA
2011-07-07 Chantix: New Study Links Drug to Heart Problems Varenicline MediGuard CRT
2011-06-30 New Study Suggests High-Dose Statins May Cause Diabetes Simvastatin MediGuard CRT
2011-06-30 McNeil Recalls Single Lot of Tylenol Extra Strength Caplets, 225 count Acetaminophen Manufacturer
2011-06-28 Qualitest Recalls Four Lots of Butalbital, Acetaminophen, and Caffeine Tablets and Four Lots of Hydrocodone Bitartrate and Acetaminophen Tablets Butalbital FDA
Back to Consumer Med Safety