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Leflunomide (Arava): FDA Adds Information on Severe Liver Injury to the Boxed Warning
The U.S. Food and Drug Administration (FDA) is adding information on severe liver injury to the Boxed Warning of leflunomide (Arava) to highlight the risk of severe liver injury in patients using this medicine. Leflunomide is used to treat rheumatoid arthritis. It is also sold under the brand name Arava. The information on severe liver injury now being added to the Boxed Warning states: - Patients with liver disease should not receive leflunomide. - Patients with elevated liver enzymes should not receive leflunomide. - Caution should be used in patients who are taking other drugs that can cause liver injury. - Liver enzymes should be monitored at least monthly for three months after starting leflunomide and at least quarterly thereafter. - If liver enzymes become too high while a patient is on leflunomide - leflunomide should be stopped, and additional treatment and monitoring provided as described in the prescribing information. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm218679.htm
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McNeil Expands Recall To Include Additional Lots of Benadryl Allergy Ultratab, Children's Tylenol Meltaways, Motrin, IB, Tylenol Extra Strength, and Tylenol PM
McNeil Consumer Healthcare is recalling 21 additional lots of over-the-counter medicines, including Benadryl Allergy Ultratab, Children's Tylenol Meltaways, Motrin, IB. Tylenol Extra Strength, and Tylenol PM. This recall is a follow-up to product recalls that McNeil Consumer Healthcare announced on January 15, 2010 and June 15, 2010. These three recalls are due to consumer complaints of a musty or moldy odor that has been linked to the presence of trace amounts of a chemical called 2,4,6-tribromoanisole (TBA). After a full investigation, it was determined that the source of TBA and odor was the result of a breakdown of a chemical that is applied to wood used to build wooden pallets that transport and store product packaging materials. Although consumers have reported stomach pain, diarrhea, and nausea with the recalled product, McNeil has determined that the risk of serious adverse medical events is very low. For more information and a list of the 21 recalled lots numbers, please visit: http://www.mcneilproductrecall.com/page.jhtml?id=/include/news_july.inc To view a complete list of products and lot numbers involved in all three recalls and to find out if a product you have has been recalled, please visit: www.mcneilproductrecall.com/page.jhtml?id=/include/prd_all.inc
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Date Published Title Drug Source
2010-07-13 Leflunomide (Arava): FDA Adds Information on Severe Liver Injury to the Boxed Warning Leflunomide FDA
2010-07-11 McNeil Expands Recall To Include Additional Lots of Benadryl Allergy Ultratab, Children's Tylenol Meltaways, Motrin, IB, Tylenol Extra Strength, and Tylenol PM Acetaminophen with Diphenhydramine Hydrochloride Manufacturer
2010-07-09 McNeil Expands Recall To Include Additional Lots of Benadryl Allergy Ultratab, Children's Tylenol Meltaways, Motrin, IB, Tylenol Extra Strength, and Tylenol PM Ibuprofen Manufacturer
2010-07-09 FDA Warns Using Malaria Medication for Leg Cramps Can Lead to Serious Side Effects Quinine Sulfate FDA
2010-07-06 Bristol-Myers Recalls Coumadin Blister Pack Samples Warfarin Manufacturer
2010-06-29 Two New Studies Suggest Diabetes Drug Avandia Increases Risk Of Heart Problems: FDA Safety Review Ongoing Glimepiride and Rosiglitazone MediGuard CRT
2010-06-25 P&G Recall: 4-Hour Nasal Decongestant Spray by Sinex Sold in U.S. Stores Oxymetazoline Manufacturer
2010-06-22 FDA: Pfizer Voluntarily Withdraws Mylotarg (gemtuzumab ozogamicin) From U.S. Market FDA
2010-06-18 Long-term Use of Isotretinoin Linked to Increased Risk of Ulcerative Colitis Isotretinoin MediGuard CRT
2010-06-18 FDA Warns That Generic Tamiflu From Internet Is Fake and Could Be Harmful Oseltamivir FDA
2010-06-16 McNeil Expands Recall To Include Benadryl Allergy Ultratab Tablets and Extra Strength Tylenol Rapid Release Gels Diphenhydramine Manufacturer
2010-06-15 FDA Warns Consumers About Correct Vitamin D Supplementation for Infants Ergocalciferol FDA
2010-06-14 Angiotensin-Receptor Blockers (ARBs) May Be Linked to Small Increased Risk of Cancer Telmisartan MediGuard CRT
2010-06-11 UCB Manufacturing, Inc and DSM Pharmaceuticals, Inc Recall Two Lots of Semprex-D Capsules Acrivastine and Pseudoephedrine FDA
2010-06-11 King Pharmaceuticals Inc, and Actavis Elizabeth LLC Recall Several Lots of Embeda Morphine and Naltrexone FDA
2010-06-11 Additional List of Recalled Lots of Daytrana Patches Published By FDA Methylphenidate FDA
2010-06-11 American Health Packaging and Rising Pharmaceuticals, Inc Recall Single Lot of Glycopyrrolate 2mg Tablets Glycopyrrolate FDA
2010-06-11 The U.S. Food and Drug Administration (FDA) Announces Ongoing Safety Review of Benicar and Risk of Heart Attack, Sudden Death, and Stroke Olmesartan and Hydrochlorothiazide FDA
2010-06-07 Recall of Several Lots of Acetasol HC and Hydrocortisone and Acetic Acid Ear Products FDA
2010-06-07 Generic Manufacturer Recalls Two Lots of Spironolactone 25 mg Tablets Spironolactone FDA