FDA approves revised safety label for Xenical
BETHESDA, Md. The Food and Drug Administration on Wednesday notified healthcare professionals and patients that it has approved a revised label for Xenical to include new safety information about cases of severe liver injury that have been reported rarely with the use of the medication.
The agency also is adding a new warning about rare reports of severe liver injury to the OTC Drug Facts label for GlaxoSmithKline’s Alli.
Xenical and Alli are medications used for weight-loss that contain different strengths of the same active ingredient, orlistat. Xenical (orlistat 120 mg) is available by prescription and Alli (orlistat 60 mg) is sold over-the-counter without a prescription.
This new safety information, originally announced in August 2009, is based on FDA’s completed review of orlistat.
FDA: Prolonged PPI use may increase risk of bone fractures
SILVER SPRING, Md. Prolonged use of a common class of drugs for treating digestive problems may increase the risk of bone fractures, the Food and Drug Administration said Tuesday.
The FDA issued a warning to consumers and healthcare professionals based on a review of several epidemiological studies that long-term use of prescription and OTC proton-pump inhibitors or use of the drugs in high doses could increase the risk of fractures of the hip, wrist and spine. Information about the possible risks will be included on revised product labels for PPIs, the FDA said.
“Epidemiology studies suggest a possible increased risk of bone fractures with the use of proton-pump inhibitors for one year or longer, or at high doses,” FDA division of gastroenterology products deputy director for safety Joyce Korvick said. “Because these products are used by a great number of people, it’s important for the public to be aware of this possible increased risk and, when prescribing proton-pump inhibitors, healthcare professionals should consider whether a lower dose or shorter duration of therapy would adequately treat the patient’s condition.”
PPIs are used to great gastroesophageal reflux disease, ulcers, esophageal inflammation and heartburn. Prescription PPIs include AstraZeneca’s Nexium, which IMS Health ranks as one of the top-selling drugs in the world, with 2009 sales of $6.3 billion, and Takeda’s Dexilant (dexlansoprazole). OTC PPIs Prilosec OTC (omeprazole), marketed by Procter & Gamble, and Prevacid 24HR (lansoprazole), marketed by Novartis, under licenses from AstraZeneca and Takeda, respectively.
AstraZeneca spokesman Blair Hains told Drug Store News the company recently had received the notice from the FDA and would respond within the allotted 30 days.
“We’re all working toward the same thing,” Hains said. “We want prescribers and patients to have the best healthcare information that’s out there.”
Viral infection linked to juvenile diabetes
SAN DIEGO Researchers presented findings at the 110th general meeting of the American Society for Microbiology in San Diego that suggested an association between Type 1 diabetes and enteroviral infections.
Researcher Antonio Toniolo of the University of Insubria and Ospedale di Circolo in Verese, Italy, and colleagues tested the blood of 112 children at the time of time of diagnosis for the existence of enteroviral DNA. Low-level enteroviral infectivity and genome fragments were detected in 83% of Type 1 (juvenile) diabetes patients, compared with only 7% of healthy controls.
"We studied the possible association of enterovirus infections with Type 1 diabetes at time of diagnosis," said Toniolo. "Literature suggests that infection by different enteroviruses may be linked to the early stages of diabetes," although he warned that the data did not provide a "causal relationship," but suggested environmental factors may be involved.
Enteroviral infections, commonly found in infants and adolescents, cause such syndromes as hand-foot-and-mouth disease, polioviruses and coxsackieviruses.