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.
Auro-Dri sponsors The World’s Largest Swimming Lesson
OVERLAND PARK, Kan. More than 10,000 children on four continents will bob, float and flutter-kick their way into the record books by participating in The World’s Largest Swimming Lesson on June 3 as part of an event sponsored by Insight Pharmaceutical’s Auro-Dri, event organizers announced Monday.
Hundreds of aquatic facilities from Disney’s Typhoon Lagoon near Orlando, Fla., to swim schools in Orange Country, Calif. to community centers in the Bronx, N.Y., to locations as far reaching as Zambia, Lebanon, Dubai and the USAG-Humphreys in South Korea are participating in the program to build awareness about the vital importance of teaching children to swim to help prevent drowning.
Disney’s Typhoon Lagoon water park has been designated as the official headquarters location for the international event that will set a new Guinness World Record.
Tragically, drowning is the second leading cause of unintended, injury-related death of children ages 1 to 14 years. In fact, more than one in four fatal drowning victims are children 14 years and younger. And, research shows if a child doesn’t learn to swim before the 3rd grade, they likely never will.
Gold medalists Rowdy Gaines and Janet Evans are championing the WLSL effort to help convey that loss of life from drowning can be prevented through awareness and training. As parents, both athletes feel a strong commitment to teaching children how to be safe in and around the water.
Gaines, 11-time world record holder and “voice of American swimming” for the Olympic Games, will be master of ceremonies for the WLSL event at Typhoon Lagoon. “I’m thrilled to be working with The World’s Largest Swimming Lesson to help spread the word that swimming lessons save lives,” Gaines said. “Learning to swim and the exposure to the water safety messages that swimming lessons offer provide a fundamental first step for drowning prevention.”
Evans, considered the greatest female distance swimmer of all time, will be on site for the WLSL event at the Blue Buoy Swim School in Tustin, Calif. “It is so important to draw attention to this issue, particularly at the beginning of the summer season,” said Evans. “The World’s Largest Swimming Lesson is a perfect way to bring the message to life for kids and adults.”
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.”