Ortho-McNeil Voluntarily Recalls Two Lots of Topamax 100 mg
Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., has announced a voluntary recall of two lots of Topamax (topiramate) 100mg tablets, bottles of 60 tablets. Lot numbers 0KG110 and 0LG222 are being recalled because the company has received four consumer reports of a strange odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole). TBA is a byproduct of a chemical preservative sometimes applied to wood used in pallets for storage and transportation. TBA is not considered to be toxic. However, TBA can generate an offensive odor and a very small number of patients have reported temporary gastrointestinal symptoms such as nausea and vomiting. At this time, there have been no reported serious adverse events caused by the presence of TBA in these recalled bottles of Topamax. Topamax contains the active ingredient topiramate and is in a class of medications called anticonvulsants. Topamax is used for the treatment of epilepsy and prevention of migraine headaches.. For more information, please visit: http://www.rxforsafety.com/sites/default/files/pdf/TopamaxPressRelease04142011.pdf and http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm251556.htm
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FDA Warns Consumers About Serious Side Effect Linked To the Use of Benzocaine Found in Over-the Counter Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, and Other Store Brands
The U.S. Food and Drug Administration (FDA) is warning the public that the use of benzocaine is associated with methemoglobinemia. Methemoglobinemia is a rare, but serious condition where the amount of oxygen carried by the blood is greatly reduced. In the most severe cases, methemoglobinemia can result in death. Signs and symptoms of methemoglobinemia may include: - pale, gray or blue colored skin, lips, and nail beds - shortness of breath - fatigue - confusion - headache - lightheadedness - rapid heart rate Symptoms of methemoglobinemia usually appear within minutes to one or two hours after using benzocaine gels or liquids. Methemoglobinemia can occur after the first time a person uses benzocaine, or after using a benzocaine product multiple times Benzocaine gels and liquids are sold over-the-counter (OTC) under different brand names such as Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, and store brands. Benzocaine is also sold in other forms such as lozenges and spray solutions. These products are used to relieve pain from a variety of conditions, such as teething, canker sores, and irritation of the mouth and gums. Labels of OTC benzocaine products currently do not contain warnings about methemoglobinemia and the FDA is concerned that consumers may not be aware of and monitor for this condition when using OTC benzocaine products. Methemoglobinemia with benzocaine use has been reported in adults and children. The FDA is particularly concerned about the use of OTC benzocaine products in children aged two years and younger. Consumers can look at the Drug Facts label when buying products used to treat pain in the mouth and gums to find out whether benzocaine is listed as the active ingredient. To view a list of common OTC products that contain benzocaine, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm250029.htm#list To view the FDA webpage "Questions & Answers: Reports of a rare, but serious and potentially fatal adverse effect with the use of over-the-counter (OTC) benzocaine gels and liquids applied to the gums or mouth," please visit: http://www.fda.gov/Drugs/DrugSafety/ucm250029.htm For more information about this safety alert, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm250024.htm and http://www.fda.gov/Drugs/DrugSafety/ucm250040.htm
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