[B]ecause of new human data that show an increased risk for oral clefts, topiramate is being placed in Pregnancy Category D.
(PRWEB) January 31, 2012
The Consumer Justice Foundation, a for-profit corporation that’s comprised of a team of professional consumer advocates whose mission is to alert the public of information regarding certain prescription medications, hereby shares the information reported in a recent article posted on the Pharma Times Online Web site that releases the sales figures for Topamax in 2011 as originally reported by Johnson & Johnson, the company that manufactures this medication.
Specifically, the Pharma Times Online report indicated that sales of Topamax in 2011 stood at $121 million, which was described as ‘flat’ when compared to the sales figures generated by Topamax in 2010. The term ‘flat’ refers to sales figures that are similar in nature. The same report indicated that Johnson & Johnson suffered an 88.8 percent earnings slump overall in the fourth quarter of 2011.
The announcement of these Topamax earnings for 2011 come at the end of a year when the FDA issued a Drug Safety Communication entitled, “Risk of oral clefts in children born to mothers taking Topamax (topiramate)” that was issued on March 4, 2011. This communication strengthened the warnings regarding the potential for Topamax side effects that affected the children of mothers who were using Topamax during pregnancy. Specifically, these potential Topamax side effects included the possibility of children developing oral clefts.
This FDA communication specifically stated that, “because of new human data that show an increased risk for oral clefts, topiramate is being placed in Pregnancy Category D. Pregnancy Category D means there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women may be acceptable in certain situations despite its risks."
About the Consumer Justice Foundation
The Consumer Justice Foundation, whose Web site can be found at http://www.consumerjusticefoundation.com, is a for-profit organization that serves two purposes for consumers: (1) to provide educational information regarding the policies and procedures of large corporations and how they affect the average consumer; and (2) to provide news updates and resources that continue to update consumers regarding developments taken by corporations that include pharmaceutical drug companies, auto manufacturers and insurance companies so that consumers who have been harmed can use these informational resources to connect to an experienced professional who can help them. The team at the Consumer Justice Foundation is staffed by experienced and passionate consumer advocates whose mission is to raise the awareness of issues that could pose a risk of harm to those who may not otherwise be aware of the dangers they face.
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