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Generic brand topamax, is the subject of legal action from the federal government, which in February filed a complaint alleging that the generic-drug manufacturer had committed fraud by failing to disclose in marketing literature and clinical trials that topamax had been associated with at least one patient-death. Topamax was also the subject of a Food and Drug Administration warning letter to GlaxoSmithKline in April 2013, after the company sold medicine for off-label uses, like treating depression. The federal investigation is ongoing, and GlaxoSmithKline has argued that topamax meets safety requirements under the Food, Drug, and Cosmetic Act, a law that Congress passed in 1938 to regulate drugs Topamax 100mg $551.58 - $2.04 Per pill and biologics allow the public to review safety of new drugs. In one of the company's most recent filings, GlaxoSmithKline asserted that while the drug was approved only for the treatment of rare inherited disease, a person can still die with a brain hemorrhage that occurs secondary to an overdose of opioids. The drug was never approved to treat the condition. "Topamax is an FDA-approved medication for the treatment of acute pain," company wrote in its legal motion. "However, the FDA has concluded that drug does not adequately address the risk that a person who is exposed to acute pain after a brain hemorrhage could die because of the adverse effects topamax on nervous system." The FDA has said that topamax does not need approval to treat people whose strokes resulted from an overdose of opioids. The drug has also been accused of causing serious or fatal liver disorders, like hepatitis and jaundice. The U.S. attorney in New Jersey, Paul Fishman, has accused Topamax distributors in multiple states of illegally repackaging, marketing, and selling the opioid with intent to defraud, and filing false health claims, the Justice Department said. On March 2, the judge in New Jersey ordered a stay temporarily blocking the government from obtaining information on patient deaths related to topamax. Glaxo withdrew the drug from market on March 12 and announced that it was voluntarily withdrawing from sales in the U.S. Attorney's Office had no comment. In a related action today filed in New Jersey, a group of plaintiffs called the New Jersey Coalition Against Doctors Who Perform Surgery or Just Topless filed a lawsuit on behalf of several women who say they contracted infections from their top surgery after being given topamax, a claim which Glaxo maintains could not have been caused by topamax. The women named in lawsuit are suing under the Lanham Act, a law that prohibits doctors from performing "an abortion, or in the practice course of medicine, a self-induced abortion, or any surgical procedure upon a female." "Any infection should not be attributed to Topamax alone," said John Guglielmi, assistant attorney general in the New Jersey State's Department of Health and Senior Services, which is leading the effort to stop FDA from proceeding with the pending litigation. "If Topamax is not responsible for these infections, then other causes must be considered." The plaintiffs who have sued Glaxo SmithKline say in their complaint that January 2014, they were told by their insurance that Topamax had been approved as an alternative to hysterectomies, and a top surgery is included in the list. According to complaint, in that same meeting, a representative of Glaxo was told that the company would not be distributing top surgery, and patients are encouraged to wait until they reach menopause to undergo the surgery at age they should to avoid risk of breast cancer. A few days later, after the women had their ovaries removed, they reported infections, fever, headaches, and chills "feeling a lack of control in their bodies," according to the complaint. One woman reported that she suffered an infection after undergoing her second top surgery. "The next day, while at the hospital, she experienced severe abdominal pain, nausea, vomiting, diarrhea, extreme fatigue, cramping, and pain in her lower abdomen," the complaint said. "She became depressed and thought she was going to die." A similar complaint regarding another patient involved in the lawsuit was filed late September.

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