(PRWEB) September 27, 2012
The Consumer Justice Foundation, a for-profit corporation whose team of consumer advocates is dedicated to providing the public with real-time and important informational updates online with regards to the potential dangers of using certain prescription medications, hereby alerts the public to an article that appeared in the American Academy of Family Physicians (AAFP) newsletter. The article states that the REMS study regarding Qsymia, a new obesity medication, has begun. Qsymia contains topiramate, the active ingredient in Topamax.
The article, published online on September 19, 2012, states that VIVUS, the manufacturer of Qsymia, is beginning this REMS study as part of its approval process that was dictated by the Food and Drug Administration in July. The article goes on to state that Qsymia contains topiramate and that topiramate is considered a teratogenic substance that has been associated with orofacial clefts in infants whose mothers used Topamax during the first trimester of pregnancy to treat epilepsy.
The article specifically states that, “[t]hat risk of teratogenicity prompted the FDA to require a REMS for the drug that highlights the importance of pregnancy prevention for females of reproductive potential who receive the drug. The REMS includes a medication guide for patients, a training program for health care professionals, a patient brochure on risks associated with use of the drug and other education tools.”
Qsymia was launched in the United States earlier this week after obtaining this FDA approval and VIVUS is currently looking to obtain approval for sale, marketing and distribution on the European market through its regulatory agency. However, the concerns noted above regarding the presence of topiramate have been expressed by the European regulators as well.
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.