What Is Topamax?
Topamax, which is also known as Topiramate, is an anti convulsant or seizure drug. It is used for the treatment of seizures in both adults and children. Topamax can also be taken to treat migraine headaches in both adults and children. It is used as a preventative treatment rather than a cure for a headache that has already commenced. For adults and children over the age of ten the dosage should start with two doses of 25mg per day. This can be increased up to a maximum of 400mg per day, via two doses of 200mg, if a doctor determines that this will be of benefit to the patient.
Topamax And Pregnancy
The Food and Drug Administration (FDA) approved Topiramate for the treatment of convulsions and seizures and also for the prevention of migraines. There has been research conducted into Topamax side effects and in particular when it comes to pregnant women. There have been links to Topamax birth defects and the FDA has classified the drug in Pregnancy Category D. Research has a discovered that Topiramate birth defects include oral clefts that happen when parts of the lip or palate do not properly fuse together during the first three months (first trimester) of pregnancy.
Citing research undertaken by the North American Antiepileptic Drug (AED) Pregnancy Registry, the FDA made an announcement about a possible increased risk of newborn babies experiencing oral cleft problems, which included cleft palate and cleft lip, where the mothers had taken Topamax in during their first trimester. The data from the research indicated that where mothers had taken Topamax during pregnancy their newborn babies were prone to a 1.4% prevalence of cleft difficulties compared to a 0.38% – 0.55% prevalence where the mothers had taken alternative anti convulsion drugs. Where no anti convulsion drugs were taken by the mother there was only a 0.07% prevalence of oral clefts in their babies.
It was as a result of this data indicating the Topiramate and pregnancy risk that the FDA moved Topamax from a Category C pregnancy drug to a Category D. Being classified as Category D means that there is a risk to the baby according to human studies and data but the risks may still be worth taking given the benefits of taking Topamax for some pregnant women.
The manufacturer has agreed to change the patient medication guide for Topamax and also the prescribing information to warn about the possibility of pregnant women who take the medication delivering babies that have birth defects such as cleft palate and cleft lip. These oral defects can cause a number of problems to the child in later life including ear infections, speech development and difficulties with eating. In a number of cases, surgery is required to close the palate and lip of the child.
Any woman that is pregnant or wants to be pregnant and is taking Topiramate should consult with their doctors and discuss the possibility of alternative options for the treatment of their conditions.
Side Effects Of Topamax
Topiramate side effects are not just confined to birth defects in newborn babies. There are a number of other Topamax side effects that users of the drug should be aware of and these include:
- Blood in the urine
- Experiencing tremors
- Loss of consciousness
- Irregular heartbeat
- Difficulty walking
- Allergic reactions which can include swelling of the face and mouth, hives, chest tightness, breathing difficulties and severe rashes
- Tiredness and lethargy
- Pains in the muscles or joints, side or back, stomach and chest
- Uncontrolled eye movements
- Bruising or bleeding
- Coordination difficulties and confusion
- Mood changes and depression and anxiety
- Menstrual cramps and other problems
- Skin problems such as redness, peeling, blisters or swelling
- Appetite loss
- Nausea and other stomach problems
- Flu symptoms including sore throats and a runny nose
If any of these side effects are experienced then you need to consult with your doctor immediately.
Johnson & Johnson Topamax Recall
Complaints were received by Johnson & Johnson in April 2011 about an unusual odor from the drug and recalled two lots of Topamax as a result of this. This recall of Topamax affected around fifty seven thousand bottles of the 100mg pills that were shipped in October and December of 2010 according to the Wall Street Journal. There was a suggested link between the strange odor and some short term gastrointestinal problems but no serious health issues were reported.
There have been a number of Topiramate lawsuits to date. If you or a family member was taking Topamax during pregnancy and delivered a baby with birth defects then you could be eligible for compensation. It is best to speak with an experienced Topamax lawyer.
Experienced Topamax lawyers are vital if you are to present a credible case. A qualified Topamax attorney will review all aspects of your case and advise you on the next steps.