Topamax birth defects (part 2)

April 26, 2011 @ 02:37 PM -- by

Texas Topamax birth defects lawyers are also aware of other Food & Drug Administration problems with Topamax and its makers. For example, two Johnson & Johnson ("J&J") subsidiaries, Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals Inc, were accused by the United States Department of Justice of promoting Topamax in an "off-label" way to doctors for patently unapproved purposes. Essentially, the government held that Ortho-McNeil had hired speakers to promote the off-label use of Topamax. The case was settled, and the makers of the brand name version of Topamax plead guilty. They also paid a $6,140,000.00 criminal fine, as well as $75,370,000.00 for violating the False Claims Act. 

The history of Topamax is interesting. It was originally approved by the United States FDA on December 24, 1996 to treat total and partial seizures. Topamax was approved to treat migraines in 2004. Interestingly, many women took the drug to prevent seizures during their pregnancy which could harm the development of the fetus. Fortunately, the March 4, 2011 FDA announcement told doctors that when the drug is compared to various other epileptic preventative drugs, the "alternative medications that have a lower risk of oral clefts and other adverse birth outcomes should be considered for these patients." The FDA also reported that many of the oral cleft and other malformations happen during the first trimester when the mother is taking Topamax. Topamax’ maker was required by the FDA to change the warning label with the risk. The FDA even moved Topamax to drug classification "Category D." This classification essentially says that there is "positive evidence of human fetal risk based on human data."

On a chemical basis, topiramate (Topamax) is a sulfamate-substituted monosaccharide, which is a rather odd chemical structure for an anticonvulsant. Topamax is quickly absorbed when taken orally. Approximately seventy percent of Topamax is excreted in the urine unchanged.

The exact mechanism of the drug action is unknown, but four properties which might contribute to Topamax’s antiepileptic and antimigraine effectiveness include (1) a blockage of voltage-dependent sodium channels, (2) inhibition of the carbonic anhydrase enzyme, (3) augmentation of gamma-aminobutyrate acid activity at some subtypes of the GABA- A receptors, and (4) antagonism of AMPA/kainate subtype of the glutamate receptor.

If you are taking Topamax, you have to be aware of the following risks (in addition to the birth defects) :

Do not eat primrose (seizure threshold decreased).

Watch out for things which require mental alertness and coordination until you know what the drug effects are.

Topamax might impair heat regulation, especially with children. Be careful when doing activities which could lead to an increased core temperature, such as long and strenuous exercise, dehydration, or exposure to extreme heat.

Topamax can decrease the effectiveness of estrogen-containing oral contraceptives.

Topamax should not be suddenly discontinued (this may cause an increased seizure activity).

Contact Texas Topamax birth defects attorney Scott Nelson if you need help with a Topamax birth defects case. Mr. Nelson serves all of Texas.