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Reuters, 4/6/06 US FDA APPROVES FIRST SKIN PATCH FOR ADHD by Susan Heavey WASHINGTON -- U.S. health regulators on Thursday approved the first skin patch to treat children with attention deficit hyperactivity disorder, saying it would help parents give the drug to children who have trouble taking pills. The Daytrana patch, made by Britain's Shire Pharmaceuticals Group Plc and Noven Pharmaceuticals Inc., will deliver via the skin a generic version of one of the most popular ADHD treatments -- Swiss drug maker Novartis AG's Ritalin. The patch will carry the same warnings against use in children who already have heart problems carried by all ADHD drugs, which have come under recent scrutiny for possible psychotic behavior such as hallucinations as well as broader heart concerns. Some experts have called for additional warnings on the drugs, but FDA's Division of Psychiatry Products Director Dr. Thomas Laughren said the agency was still sorting out the data. "As with all ADHD products (the patch) should be used as part of a comprehensive treatment program for ADHD, including educational and social elements," he said. Daytrana will also carry a separate warning about possible skin sensitivity that includes redness and bumps. Ritalin, known generically as methylphenidate, is one of the most commonly abused drugs among young people. Johnson & Johnson also sells a version called Concerta. With the patch, some experts have expressed concerned because the drug can enter the blood stream more directly than with a pill. Some also have questioned whether the patch could be shared or abused by being cut up and chewed. FDA's Laughren said there was no sign of such problems during clinical trials, but the companies had promised to monitor for potential misuse. "Whether or not this will be a problem when it's used more broadly (in the market) is unknown," he said. He added that the patch would make it easier for some parents to treat their children. Outside experts told the agency "a substantial fraction of children have difficulty taking pills," he said. Daytrana is a once-daily patch for children ages 6 to 12 that is supposed to be applied early in the morning and removed 9 hours later. It should be worn on the hip, alternating left and right sides every day, and comes in fourth strengths. Besides skin irritation, side effects can include insomnia, anorexia, significant weight loss, nausea and vomiting. A Shire representative had no immediate comment on the approval. Representatives for Miami-based Noven could not be immediately reached. (Additional reporting by Lisa Richwine.) Copyright Reuters 2006 ----------------------------- Associated Press, 4/6/06 FDA OKs FIRST ATTENTION DEFICIT PATCH 9-HOUR SKIN PATCH APPROVED AMID CONTROVERSY OVER ADHD DRUG WARNINGS WASHINGTON -- The FDA on Thursday approved the first skin patch to treat attention deficit hyperactivity disorder in children. The patch called Daytrana, designed to be worn for 9 hours, contains methylphenidate, which has been shown to help children with ADHD. It is the same stimulant that is in Ritalin. The patch is made by Noven Pharmaceuticals Inc. of Miami. In December, a Food and Drug Administration panel of independent experts voted to recommend that the patch's label encourage its use as an alternative treatment for children ages 6 to 12 with ADHD, meaning doctors should prescribe it only if taking pills is too difficult for a child. Unlike pill forms of the drug, the patch can be removed if it causes side effects. Noven Pharmaceuticals in 2003 submitted a 12-hour version of the patch to the FDA. The agency rejected it and recommended that Noven test a nine-hour version. That is the version approved for use Thursday. U.K.-based Shire Pharmaceuticals Group PLC co-developed the patch with Noven Pharmaceuticals. Approval of the patch comes as use of methylphenidate and other ADHD drugs increases. Nearly 3.3 million Americans age 19 and younger used an ADHD drug last year, according to Medco Health Solutions Inc., a prescription drug benefit program manager. The FDA continues to grapple with whether to require more severe warnings on the labels of the drugs. A panel of outside experts recently recommended to the FDA that the drugs bear labels that caution users in plain language about possible dangers, including stroke and hallucinations. Earlier, another FDA panel recommended that the medicines include so-called "black-box" warnings. That is the strongest warning a prescription drug can bear. The Daytrana label for now will include the standard warnings other methylphenidate products bear, including cautionary statements about insomnia, decreased appetite and nausea, as well as a warning about sensitization, where patients can develop antibodies to the drug. Methylphenidate -- in any form -- cannot be taken if sensitization occurs. "We feel that the labeling approved with this product is adequate and adequately provides for safe and effective use," said Dr. Thomas Laughren, director of the FDA's Division of Psychiatry Products. The companies have pledged to study the sensitization issue, he added. Last year, an FDA reviewer initially said trials showed the patch produces troubling side effects too often to be considered safe. The reviewer later told a panel of experts that he had reconsidered his opinion and now judged the drug to be safe enough to approve.That panel, the FDA's Psychopharmacologic Drugs Advisory Committee, voted unanimously to recommend approval. The patch form of the drug was studied in just two short-term clinical trials that included roughly 765 children, Laughren said. The patch has not been tested head-to-head against any other ADHD drugs, including the pill form of methylphenidate. The patch will be available in four doses: 10, 15, 20 and 30 milligrams per nine hours, Laughren said. Copyright 2006 The Associated Press ------------------------------ Philadelphia Inquirer, 4/12/06 ADVOCATE OF ADHD PATCH SAYS IT SHOULDN'T BE FIRST CHOICE It's deceptively tricky to use, he said, primarily because it shouldn't be worn more than 9 hours. by Dawn Fallik A member of the FDA panel that recommended approval of a new medicated patch for children with attention deficit hyperactivity disorder says he does not think it should be the first choice for parents. The patch, called Daytrana, contains the drug methylphenidate, the same stimulant used in Ritalin. The Food and Drug Administration rejected a form of the patch last year before granting its approval last week. The new formulation is aimed at children ages 6 to 12 and is expected to be on the market this summer. Richard P. Malone, a psychiatry professor at Drexel University's College of Medicine and the FDA panel member, recommended approval of the new patch but said he was "a little conservative" and feared that parents would fail to follow the patch's instructions. "Even though there might be directions that it's supposed to be on for nine hours, people might leave it on for longer," he said, possibly causing unwanted side effects, including tics, insomnia and weight loss. The demand for patch medications continues to grow, from a single motion-sickness drug 25 years ago to more than 30 prescriptions used by 12 million people worldwide for ailments ranging from bladder control to heart disease. Besides the ADHD patch, the first antidepressant patch was approved last month. But the FDA also announced last month that it was conducting an "exhaustive review" into the safety of transdermal patches, focusing on how they worked with heat. Repeated studies have found that patches cause the body to absorb as much as four times the amount of drug when heated, whether from soaking in a hot tub or from a high fever. In 2003, the FDA rejected the ADHD patch in a 12-hour form, citing too many reactions. As recently as June, agency officials had recommended that the patch not be approved because of potential for harm. But in December, an FDA advisory panel, including Malone, unanimously recommended approval of a nine-hour version, saying that the side effects mirrored those from pills. The patch's marketer, England-based Shire PLC, whose U.S. base is in Wayne [Pennsylvania], also makes Adderall XR, the world's most-prescribed ADHD drug. Company officials said that the patch might be beneficial for children who can't swallow pills, and can be easily removed if side effects occur. Although the recommended wear-time is nine hours, the drug's effects last for about 12 hours, said Liza Squires, a pediatrician and child neurologist who works for Shire. The patch will come in four doses for different ages. "It might be useful for weekends, when a child has a soccer game or a piano lesson and doesn't require a full day of ADHD therapy," she said. Nearly 3.3 million Americans age 19 and younger used an ADHD drug last year, a decline of five percent from 2004, according to Medco Health Solutions Inc., a prescription drug benefit program manager. The top drugs had about $3.5 billion in sales last year. In December, advisory panels worried about tests showing that as many as 22 percent of clinical trial subjects using the patch became so sensitive to the drug that they could not take methylphenidate at all. Shire officials said those results came from a clinical trial in which adults kept the patch on the same spot continuously for 21 days straight. The Daytrana patch is supposed to be left on for nine hours with 15 hours off, using alternate sites, Squires said. It also should not be used with heating pads or electric blankets, because that causes the drug to be absorbed much more quickly. ADHD drugs have come under scrutiny recently. Last month, FDA officials rejected a "black box" warning -- the strongest alert -- about psychiatric side effects, but another FDA committee recommended a similar warning about the cardiovascular risks. The Daytrana label will include warnings about insomnia, decreased appetite and nausea, as well as sensitization, in which some patients become so sensitive to the drug that they cannot take any more. William Pelham Jr., a professor of psychology and pediatrics at the University of Buffalo, conducted two trials of Daytrana, which is made by Miami-based Noven Pharmaceuticals. Although several children in one nine-hour trial withdrew because of severe side effects, Pelham said that sometimes happens the first time a child takes any ADHD drug, but usually does not occur the second time. He said the most significant side effect parents would see if their children wore the patch longer than nine hours would be an inability to sleep. Malone, however, said he wanted to see whether the patch and children were compatible. "I personally think it would be easier to use pills," he said.


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