FDA investigates liver injury claims from weight-loss medication users
ROCKVILLE, Md. The Food and Drug Administration on Monday announced that it is reviewing adverse event reports of liver injury in patients taking the weight-loss drug orlistat, marketed as the prescription drug Xenical (Roche) and the over-the-counter medication Alli (GlaxoSmithKline).
Between 1999 and 2008, the FDA has received 32 reports of serious liver injury in patients taking orlistat. Of those cases, 27 reported hospitalization and six resulted in liver failure. Thirty of the adverse events occurred outside the United States. The most commonly reported adverse events included yellowing of the skin or whites of the eyes (jaundice), weakness, and stomach pain.
The FDA is reviewing additional data submitted by orlistat manufacturers on suspected cases of liver injury, and the issue has been discussed at the FDA’s Center for Drug Evaluation and Research Drug Safety Oversight Board.
“The issues here are complex, but FDA has benefited from the input of the board, including comments from representatives from three FDA Centers and several other Agencies in the Department of Health and Human Services,” stated Steven Osborne, executive director of the board.
The FDA’s analysis of these data is ongoing, and no definite association between liver injury and orlistat has been established at this time. Consumers taking Xenical should continue to take it as prescribed, and those using over-the-counter Alli should continue to use the product as directed.
The FDA urges both health care professionals and consumers to report suspected side effects from the use of orlistat to FDA’s MedWatch Adverse Event Reporting program.
Wild Child provides natural way to ‘Quit Nits’
LOS ANGELES Wild Child, an Australian-based natural healthcare products company showcased its Quit Nits head lice products at ECRM Health Care.
According to the company, from a survey of 1,002 parents of children ages 6 to 13, 69% of parents said it was extremely important that any lice solution they buy not contain any toxic chemicals. And 61% responded that the product should be safe for use by pregnant women. In addition, over 3-in-5 parents (64%) were bothered by the fact that many head lice treatments currently contain toxic ingredients with possible negative side effects.
Teva launches ‘Patient First’ project
WASHINGTON The world’s largest generic drug maker has started an initiative to tell stories of Americans who have difficulty paying for their prescription medications, and push for a regulatory approval pathway for biosimilars.
Teva Pharmaceuticals USA announced Thursday the “Patient First” project, part of its broader Year of Affordable Healthcare campaign.
One story is of Rob Day, who was diagnosed at age 19 with the rare blood disorder paroxysmal nocturnal hemoglobinuria, for which he must take an unspecified biotech drug that costs him $389,000 a year. Teva said a Food and Drug Administration approval pathway for biosimilars would help lower prices for drugs like the one Day takes.