Topamax Recalled for “Uncharacteristic” Odor

Pharmaceutical giant Johnson & Johnson is issuing yet another drug recall, this time for 57,000 bottles of its controversial epilepsy and migraine medication, <"http://www.yourlawyer.com/topics/overview/topamax_birth_defects">Topamax, over complaints of an “uncharacteristic odor,” said WebMD. Ortho-McNeil Neurologics, a division of Ortho-McNeil-Janssen Pharmaceuticals, a Titusville, New Jersey-based Johnson & Johnson company, made the recall announcement.

J&J spokesman Mark Wolfe told WebMD that this Topamax (generic: topiramate) recall concerns two lots of 100-milligram tablets; each bottle contains 60 tablets, wrote WebMD. Wolfe says the firm believes about 6,000 bottles are still in the marketplace.

Wolfe did not describe the odor, but did tell WebMD that the odor is caused by what he described as trace amounts of TBA, a wood treatment chemical by-product used in some countries. The wood is used for construction of pallets used to move and store products, explained WebMD. Johnson & Johnson said TBA is not considered toxic but can generate an “offensive odor” adding that a “very small number of patients” have reported gastrointestinal issues, quoted WebMD.

Patients who detect the odor or who are concerned about the odor should speak to their physicians or the firm at 1.866.536.4398, said Wolfe, wrote WebMD. Four consumers reported the odor and no serious adverse events have been reported, to date, in connection with this recall.

The company stated that both recalled lots were shipped October 19, 2010 through December 28, 2010 and distributed in the United States and Puerto Rico. Topamax tablets with NDC code 50458-641-65, and lot number OKG110 with an expiration date of 06-2012 and lot number OLG222 with an expiration date of 09-2012 are involved, said WebMD.

According to the company, it took steps in January to minimize TBA contamination, such as mandating its suppliers verify that they do not use pallets constructed of chemically treated wood and says it is investigating the matter and what is “impacting our supply chains and what we can do to further mitigate this exposure,” quoted WebMD. The company advises consumers who notice an odor with their Topamax to return the tablets to their pharmacist or contact their health care professional.

Topamax oral clefts occur when parts of the lip or palate do not completely fuse together early in the first trimester of pregnancy, a time when many women are not aware of their pregnancy.

We recently wrote that another medical group issued a warning to patients about the dangers associated with the anticonvulsant medication when used by expectant mothers. The American Academy of Family Physicians (AAFP) is warning family physicians about the increased likelihood of infants being born with cleft lips or cleft palates in women taking Topamax during pregnancy.

Late last month, we wrote that The American Headache Society said that women of childbearing age should be careful about using Topamax to treat migraine headaches because of its birth defect risk. The society’s advice followed the U.S. Food & Drug Administration’s (FDA) recent warning that women who take Topamax while pregnant are 20 times more likely to give birth to a child with a cleft lip or cleft palate.

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