GSK counters FDA claim of withheld Avandia safety information
Washington According to the Food and Drug Administration, GlaxoSmithKline failed to properly disclose studies about its diabetes drug Avandia, but a spokeswoman for the pharmaceutical company said none of the withheld information raised new concerns about potential safety risks.
Avandia has been under fire for about the last year, after it was linked to a 43 percent increased risk of heart attacks
The violations “are serious and may be symptomatic of underlying post-marketing safety reporting failures,” the FDA said in a letter posted today on its Web site. The agency said it was never told about nine studies and an additional 11 weren’t included in required annual reports from 2001 to 2007.
“Of the studies that were actually omitted from the FDA in any type of reporting, those studies did not show safety events,” GSK spokeswoman Nancy Pakerek said. “The information that the FDA needed was provided to them before [the agency changed the prescribing information.]”
The FDA found unreported research while inspecting paperwork at GSK’s offices in Research Triangle Park, North Carolina from August to November, according to the letter, after reports of side effects from the drug.
Teva pays $7.5 million to settle IVAX lawsuit with Depomed
MENLO PARK, Calif. Depomed will receive a one-time payment of $7.5 million from Teva Pharmaceuticals generic unit IVAX in relation to a settlement of a patent lawsuit, according to published reports.
Depomed had sued IVAX in January 2006 claiming patent infringement by IVAX’s Glucophage XR, a diabetes medication.
Under the terms of the settlement, Depomed will also get up to $2.5 million in royalties, for granting Teva a non-exclusive license allowing it to continue marketing the generic version of Glucophage XR.
SynaMed launches free online PHR
NEW YORK SynaMed has launched its free online personal health record, which will be available to all patients.
“SynaMed simplifies record keeping so that patients do not have to rely on memory. A personal health record can also provide lifesaving medical information when a patient is not able to speak for themselves,” according to Holly DeMuro, SynaMed’s director of operations. SynaMed’s personal health record system uses a Web browser-based application service provider model, which allows patients access anytime, from anywhere with Internet connection.
Patients using SynaMed’s personal health record will be able to record all of their medical history, doctor’s visits, check insurance coverage for medications, and receive health maintenance reminders about wellness issues and checkups. “Going forward, SynaMed will be expanding the Personal Health Record to include overall health information such as mood, weight, diet, and exercise trackers. This feature will be the first complete online wellness center,” DeMuro said.
In addition to a state of the art PHR, SynaMed offers a free fully integrated electronic medical record and practice management system to medical practitioners.