Keeping Topamax Side Effects Top of Mind

Washington, DCThere are so many issues with regard to Topamax side effects, it’s hard to know where to begin. But suffice to say that a medication designed to mitigate seizures and migraine headaches can prove a headache unto itself.

The tragedy is when expectant mothers consume Topamax for whatever reason and in so doing introduce a very real risk for Topamax birth defects in their unborn children. Meanwhile, the manufacturer of Topamax topiramate - pharmaceutical giant Johnson & Johnson - has quietly agreed to a multi-million-dollar settlement with regard to recalled drugs for quality control issues. Lots of Topamax were also recalled in 2010.

According to PRWeb Newswire (7/29/13), Topamax and pregnancy has been on the radar of the US Food and Drug Administration (FDA) for some time. In 2010, the US drug regulator issued an official Safety Review for topiramate in association with pregnancy and the potential for Topamax birth defects.

To that end, the FDA announced at the time it had received no fewer than 67 adverse event reports associated with Topamax pregnancy and resulting birth defects: 21 facial defects (11 reports of cleft lip/palate), 19 malformations and 15 cardiovascular defects. An official Drug Safety Communication with regard to Topamax and pregnancy was issued a year later, and the FDA also ramped up the cautionary scale by re-classifying Topamax to Pregnancy category “D,” up from a “C” designation. In so doing, the FDA tagged Topamax with a rating that suggests “there is positive evidence of human fetal risk based on human data.”

Meanwhile, a study published earlier this year in the Pediatrics issue of the Journal of the American Medical Association (JAMA Pediatrics 3/1/13) and published online in January found that use of Topamax in children found “limited evidence” to support the use of topiramate in combating migraine headaches suffered by children. While statistics indicate that 1 in 20 children in the US are susceptible to migraine headaches, “there are many - over 50 percent in most studies - children who do not need a drug for the migraine to resolve in a couple of hours,” said William Rodriguez, Pediatric Science Director of the Food and Drug Administration Office of Pediatric Therapeutics, in an e-mail to Bloomberg News (1/29/13). “Drug therapy appears to be effective in a certain subset of children with migraine.” Meanwhile, for those children who have been prescribed topiramate for whatever reason, the Topamax side effects in children can run the gamut from dry mouth to hypersensitivity and irritability.

Of course, Topamax side effects in women can be the most serious when they are expecting. A Topamax pregnancy is fraught with risk, and that caution comes straight from the FDA.

Meanwhile, Bloomberg News (7/17/13) reported that Topamax manufacturer Johnson & Johnson agreed to a $22.9 million settlement over the recall of various drugs due to alleged quality control issues, together with an allegation that the pharmaceutical giant misled investors over those issues.

In April 2011, Johnson & Johnson recalled two lots of Topamax after receiving complaints about an uncharacteristic odor from the medication. According to The Wall Street Journal (04/14/11), the Topamax recall affected approximately 57,000 bottles of 100 milligram Topamax tablets, shipped in October and December 2010. The problem was reportedly linked to chemicals used to treat wooden pallets.

The $22.9 million settlement does not encompass the Topamax recall. However, in its 2012 report to investors, Johnson & Johnson revealed 67 lawsuits pending with regard to topiramate.