Below are the 2 most recent journal entries recorded in topamaxdefects' InsaneJournal:

Wednesday, August 10th, 2011
12:20 am	Birth Defects, the Most Serious Topamax Side Effect Discovered There have been many reported side effects of Topamax, however, the birth defects are said to be the most serious side effect discovered by far. Topamax is manufactured by Ortho-McNeil, a subsidiary of Johnson & Johnson (J&J) for the treatment of epilepsy and prevention of certain types of migraine headaches. The Topamax birth defects are the least of the giant pharmaceutical’s problems with J&J forming a Special Regulatory and Compliance Oversight Committee. What makes it more ominous is the fact that Topamax’s potential to cause harm among infants whose mothers were prescribed the drug during their pregnancy were only made public this year, 15 years after it was first marketed 1996. The findings were the results of several studies in the US, and supported by similar data from the United Kingdom Epilepsy and Pregnancy Register which was published in 2008 in the journal Neurology. Among the birth defects associated with Topamax (Topiramate) are: * cleft palate * cleft lip * Hypospadias * heart defects * lung defects * brain defects * arm and limb defects The US Food and Drug Administration (FDA) validated the findings by issuing a warning March this year and elevating the classification of Topamax from pregnancy category C to D. "Health care professionals should carefully consider the benefits and risks of topiramate when prescribing it to women of childbearing age," Russell Katz, MD, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, says in a statement. "Alternative medications that have a lower risk of birth defects should be considered." Among the list of birth defects associated with Topamax, infants are said to be most susceptible to oral clefts. A Topamax cleft may range from a small notch in the lip to a groove which extends into the palate and may cause difficulty eating and talking, as well as ear infections. Data from the North American Antiepileptic Drug (AED) Pregnancy Registry shows that 1.4 percent of infants exposed to topiramate during pregnancy developed cleft lip or cleft palate, compared with 0.38-0.55 percent of infants exposed to other epilepsy drugs. The risk of these oral cleft birth defects was much lower at 0.07 percent among infants of mothers who did not take epilepsy drugs during pregnancy. Despite the seriousness of these Topamax side effects, it is not advisable to immediately stop taking the drug without consulting a healthcare professional. Doing so may put both mother and child at risk of other causes. Related Article: FDA Releases New Info on Topamax's Increased Risk for Cleft Palate (jameriter.wordpress.com) (Comment on this)
Wednesday, June 8th, 2011
2:11 am	Oral Birth Defects to Children Born to Mothers Taking Topamax Intake Uncovered March 2011 the Food and Drug Administration (FDA) issued a warning that Topamax significantly increases the risk of oral birth defects in children born to women treated with the drug during pregnancy. The FDA approved anticonvulsant drug Topamax, with the generic name topiramate, is prescribed to treat certain types of seizures in patients with epilepsy. It is also approved for prevention of migraine headaches. Previously sorted as Pregnancy Category C drug, Topamax may cause potential fetal risks as reflected on animal studies. However, there were not enough data from human clinical studies available by the time it was approved. But recent human studies imply an increased risk for oral clefts thus Topiramate was filed to Pregnancy Category D. Evidences of human fetal risk based on human records are noted on drugs sorted in this group. But there are some instances where the benefits outweigh the risks to the mother. Careful weighing of the benefits and risks must be done before prescribing the drug to gravid patients. The North American Antiepileptic Drug(NAAED) Pregnancy Registry reveal an increased risk of oral clefts in infants whose mother underwent topiramate treatment during the first three months of pregnancy. The prevalence of oral clefts was 1.4% compared to a prevalence of 0.38% - 0.55% in infants exposed to other antiepileptic drugs (AEDs), and a prevalence of 0.07 % in infants of mothers without epilepsy or treatment with other AEDs. The relative risk of oral clefts in topiramate-exposed pregnancies in the NAAED Pregnancy Registry was 21.3 as compared to the risk in a background population of untreated women (95% Confidence Interval:7.9 – 57.1). Relative results were from the UK Epilepsy were shown. The 3.2% incidence rate among infants subjected to topiramate monotherapy is about a 16-fold increase in risk compared to the risk in their background population at 0.2% Cleft lips and cleft palates are congenital defects in which the tissues of the mouth or upper lip don't form properly during fetal development. Both oral defects can be successfully corrected with surgery, especially so if conducted soon after birth or in early childhood. Both oral malformations can be surgically-corrected, especially when done soon after birth or in early childhood. With treatment, most children with cleft lip or palate do well. When left untreated, it may lead to complications such as difficulty eating and talking, hearing loss, ear infection, dental conditions, emotional and behavioral difficulties. Current Mood: accomplished (Comment on this)