Topamax Recalled, Questions Remain

Titusville, NJIn addition to ongoing issues with regard to Topamax side effects surrounding pregnancy and risks of birth defects to infants, the manufacturers of the anti-seizure drug have a voluntary Topamax recall on their hands.

Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals Inc., announced yesterday that it had initiated a voluntary Topamax recall of two lots of the topiramate 100mg tablets, due to four consumer reports of an uncharacteristic odor associated with the tablets and thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole).

In a statement from company headquarters in Titusville, Ortho-McNeil identified TBA as the byproduct of a chemical preservative sometimes applied to wood used in the construction of pallets. Presumably, product stored on wood pallets treated with the preservative in question may have absorbed TBA.

Ortho-McNeil identifies the two lots as having been shipped between October 19 and December 28 of last year and distributed in the US and Puerto Rico. About 57,000 bottles of Topamax are affected by the recall, although Ortho-McNeil indicated, in its view, there are probably fewer than 6,000 bottles remaining in the marketplace.

"In January 2010, we instituted a number of actions to reduce the potential of TBA contamination, including requiring suppliers to verify that they do not use pallets made from chemically-treated wood," the statement said. "An internal investigation is underway with our suppliers to evaluate the potential source of this TBA issue. In addition, we are working with peer companies to better understand how and where TBA is entering and impacting our supply chains and what we can do to further mitigate this exposure."

Meanwhile, this recall aside, Topamax still faces added scrutiny since the US Food and Drug Administration (FDA) moved Topamax from Pregnancy Category "C" to "D," which further tempers the potential risk for Topamax birth defects—notably oral clefts.

As for other topiramate side effects, singer and activist Aisha wrote on her blog April 9 that she had met a judge who used Topamax," and he said it made him sick. He was unable to perform his job for a time, due to the terrible side effects of the drug. I've also read the testimonies of teachers and nurses, among others, stating they had to quit their jobs after taking Topamax, because it left them very debilitated, sick and unable to function."

Aisha says her own experience with Topamax "was very bad. I developed Metabolic Acidosis, which is a potentially fatal condition, but by God's grace I did not die (but I came close to it)."

As serious as that might have been, Topamax side effects in children are the most heartbreaking of them all.