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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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