| Topamax Recall for Contamination From TBA, By-Product of Wood Treating Chemical |
Drugmaker Johnson & Johnson today recalled 57,000 bottles of its Topamax epilepsy and migraine drug due to complaints of an “uncharacteristic odor” associated with the tablets. A spokesman stated that the odor is caused by trace amounts of a compound called TBA, a by-product of a chemical used to treat wood in some countries. The wood is used to construct pallets on which products are transported and stored.
The two lots involved in the recall were shipped between Oct. 19, 2010, and Dec. 28, 2010, and distributed in the U.S. and Puerto Rico. The recall includes Topamax with NDC code 50458-641-65 and lot numbers OKG110 with an expiration date of 06-2012 and OLG222 with an expiration date of 09-2012. Although Johnson & Johnson claims TBA is not considered toxic, some patients taking the contaminated drug have reported gastrointestinal symptoms.
This recall follows shortly after the FDA safety announcement we previously reported that
Topamax can cause birth defects such as cleft lips and cleft palates in the children of women who took
Topamax while pregnant. To learn more about the potential dangers of
Topamax, go
HERE.
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| Migraine/Epilepsy Drug Topamax Causes Cleft Lip and Cleft Palate Birth Defects |
The FDA has announced that when pregnant women take Topamax (generic name Topiramate), there is an increased risk their babies will have cleft lips and cleft palates (oral clefts).
Topamax is approved for treating epilepsy and migraines.
The FDA’s safety announcement cautions that “[t]he benefits and risks of topiramate should be carefully weighed when prescribing this drug to women of childbearing age, particularly for conditions not usually associated with permanent injury or death. Alternative medications that have a lower risk of oral clefts and other adverse birth outcomes should be considered for these patients.” The FDA further warned that women should use effective birth control if they do take Topamax/Topiramate. This is particularly important because oral clefts occur in the first trimester of pregnancy, before many women know they are pregnant.
Although the FDA has only approved Topamax/Topiramate for use in treating epilepsy and migraines, unapproved or “off label” uses include bipolar disorder, cluster heahaches, weight loss, PTSD, and alcoholism. In April 2010, Topamax manufacturer Ortho-McNeil agreed to pay $6.14 million in criminal fines, and $75.37 million in civil penalties for illegally promoting
Topamax for treatment of psychiatric conditions.
Women of childbearing age who are currently taking Topamax or a generic equivalent should immediately consult their physicians. If women who gave birth to children with cleft lips or cleft palates were taking
Topamax while pregnant, these birth defects may have been caused by
Topamax.
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