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"We are very concerned about the recent reports involving phentermine use among children and adolescents," Dr. John R. Daley, director of the division addiction services at U.S. Food and Drug Administration (FDA) wrote in a letter to Dr. Thomas J. LaRoche of the manufacturer phentermine.
Daley wrote that the manufacturer of phentermine has "committed to implement and maintain appropriate controls" in response to Daley's letter.
Phentermine, also known by the brand name Provigil, is marketed by Teva Pharmaceutical Industries Ltd. for the treatment of sleep Buy adipex from canada online disorders in adults and adolescents.
In 2009, Daley wrote to Teva CEO Shai El-Rafael, citing allegations that Teva manufactured a drug called divalproex sodium "through a complex, well-coordinated, and profitable scheme involving several U.S. and foreign subsidiaries to unlawfully promote a prescription drug and its off-label uses in U.S. markets."
The letter outlined a series of complaints filed in 2009 with numerous regulatory agencies regarding the manufacture of Provigil and divalproex sodium, including complaints filed with FDA, the U.S. Internal Revenue Service (IRS), Canada's Health Canada and the European Union's Medicines Agency.
Provigil is the third-best-selling drug among children in the UK, with about 5 million doses given out for sleep disorders in 2013 alone.
The FDA in September sent a letter to Provigil maker Teva informing it that, "under the Federal Food, Drug, and Cosmetic Act, drug distributors have a duty to ensure compliance with their representations."
"That is why, even though a manufacturer has the legal right to make representations that 'there is no medical use for a particular drug,' it is unlawful for a drug distributor to represent that its drug is not for medical use," the letter stated.
Provigil has never been registered for use children, and Teva's Teva Pharmaceuticals' website explains that it is considered "not currently approved for pediatric use and may not function as intended or are entirely effective in addressing its intended uses," according to a 2010 notice regarding its import from Germany.
El-Rafael did not respond to a request for comment by ABC News.
"Teva is in this for profit," said Dr. Steven C. Zdrodowski, chairman of the board trustees American Academy of Pediatricians to ABC News.
"I think parents need to realize that this is not about a medicine for kids, it's about a drug for profit. Children cannot consent to this," Phentermine 37.5mg 60 pills US$ 260.00 US$ 4.33 he said.
In addition to complaints with the FDA, Canadian physicians have also complained about Teva making it harder for them to treat their patients.
"I am very disappointed with Teva in that they have attempted to block our ability prescribe," Dr. Michael Rheisen, chairman of the pediatrics department at University of Toronto Medical Center, told Daily Online.
"Teva has been very effective in blocking us from prescribing and also in making the supply of Teva available in Canada a very limited supply," he added. "I think that's a serious problem because if Teva can limit access to a drug then that means no-one can afford to get that therapy even. Teva wants to control our distribution so obviously that's not good for anything," he said.
He said has filed two complaints with the Canadian government, both of which have been received. The first was with Health Canada, which directed him to bring his complaint directly the Office of Medical Cannabis.
The second complaint was with Health Canada, which forwarded it to Health Canada's Directorate General for Products and Food.
"I've been frustrated over the years trying to get Teva stop blocking my access to this one effective therapy for sleep disorders," he said.
Rheisen, who also leads the Canadian Pediatric Sleep Disorders Society, said he had hoped Teva would move Provigil onto the OTC market in Canada and allow more doctors to prescribe it.
"We've heard there is a new version of divalproex now called 'Eskalith' and that is not on the market yet, and it may change the market and make it more appealing to pediatric patients." "It makes sense to have a newer version on the phentermine 375 buy uk market rather than just trying to get the old stuff off market," he said.
Rheisen, who is also a physician and professor of pediatrics at the University Toronto's Canadian Institutes of Health Research, told ABC News that he believes the FDA should be encouraging development of new medical uses off-label drugs.
"In America they have been much more cautious but I hope they"
