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James Ronca
James Ronca
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The Topamax Problem: A Case Where Post Marketing Failures Lead to Birth Defects

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In any investigation of alleged wrongdoing, the questions are often asked “What did they know and when did they know it?” When dealing with a drug that is on the market and the negative side effects it can cause, another relevant question is “When should they have know?”

Topamax (also known as topiramate) was approved by the FDA for prevention of seizures in 1996. Seizures can be life-threatening events, so prevention of seizures is an important component of the decision by a doctor and a patient to use any seizure medication in women of child bearing age.

One thing that is not tested before the FDA approves a drug is the effect of the drug on pregnant women. It is unethical to give a drug whose safety has not yet been established to a pregnant mother because of the unknown effects on her unborn child. So, like many other drugs, Topamax was approved without knowing the effect on an unborn fetus or whether it increases the risk of birth defects.

BUT, the drug is tested on pregnant animals. Such testing can show that there is a risk that the drug causes birth defects and the positive results showing birth defects in animals increases the need for vigilance by the manufacturer of the drug for any sign of birth defects once the drug is on the market. By 1999, studies showed that Topamax was associated with cranio-facial defects (similar to cleft palate, or cleft lip in humans) in mice when given during pregnancy, limb malformations when given to rats and rib and vertebrae malformations in rabbits. These are huge red flags that a drug may cause these effects in humans. It is the responsibility of the manufacturer to find out.

So how does a manufacturer do that if you cannot test on pregnant women. There are several ways. The manufacturer could register and follow a large number of women of child bearing age and record and analyze the results on a regular basis. The manufacturer could also mine data from the large databases kept by hospital systems. The important point is one the warning is raised, the company must be vigilant in its response.

Whether the makers of Topamax were vigilant remains to be seen? The investigation that topiramate lawyers do as a necessary part of any lawsuit will reveal who knew what and when.