PHARMACY

FDA says some OTC bowel cleansing systems should be RX-only

BY Michael Johnsen

LYNCHBURG, Va. Following the issuance of a Food and Drug Administration Safety Alert last week stating that oral sodium phosphates bowel cleansing solutions should be available by prescription only because of a potential risk of kidney injury, C.B. Fleet Company immediately announced a voluntary recall of their over the-counter products Fleet Phospho-soda and Fleet Phospho-soda EZ-Prep Bowel Cleansing System.

The recall decision was made to address FDA’s determination that oral sodium phosphate solutions used for bowel preparation prior to medical procedures such as colonoscopy should only be available by prescription, and consumers should not be using over-the-counter products for bowel cleansing.

The FDA last week added a Boxed Warning to the prescription oral sodium phosphate products Visicol and OsmoPrep to warn consumers about the risk of acute phosphate nephropathy (a type of acute kidney injury).

The FDA has also directed the manufacturer of these products to develop a risk evaluation and mitigation strategy, distribute a Medication Guide to alert patients to the risk of acute kidney injury associated with the use of these products and to conduct a postmarketing clinical trial to further assess the risk of acute kidney injury with the use of these products.

The agency stated that it is equally concerned about the risks associated with the use of OSP products that are available OTC when used at higher doses for bowel cleansing. The available data do not show a risk of acute kidney injury when these OTC products are used at the lower doses for laxative use, the FDA stated. However, when used for bowel cleansing, these products have the same risks as prescription OSP products.

“Though rare, these are serious adverse events associated with the use of oral sodium phosphates—both prescription and over-the-counter products,” stated Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research. “In some cases, these serious adverse events occurred in patients with no pre-existing health factors that would have put them at risk for developing kidney injury. We cannot rule out, however, that some of these patients were dehydrated prior to ingestion of OSP products or they did not drink sufficient fluids after ingesting OSP products.”

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
PHARMACY

Take Care opens three clinics in New Orleans area

BY Antoinette Alexander

CONSHOHOCKEN, Pa. Take Care Health Systems, which is owned by Walgreens, announced on Monday that it has opened three retail-based clinics in New Orleans, marking the first Take Care Clinics in the state of Louisiana.

Additional locations are slated to open in New Orleans in early 2009.

“We are excited to bring high-quality, affordable care to the citizens of New Orleans,” said Peter Miller, Take Care Health Systems’ president and chief executive officer. “We have watched this city overcome incredible obstacles in the past few years and we feel that its residents will greatly benefit from the increased access to health care offered by Take Care Clinics. Nearly one million patients have been treated at Take Care Clinics nationwide and we are proud to expand into New Orleans as part of our continued growth.”

Last year, Walgreens celebrated the opening of its 6,000th pharmacy location nationwide in New Orleans and has historically maintained a strong presence in the city.

Take Care Health Systems currently manages 312 clinics in 18 states.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?
PHARMACY

Medicine Shoppe teams with ADA on American Diabetes Month activities

BY Alaric DeArment

NEW YORK A retail pharmacy chain and the American Diabetes Association are collaborating to mark American Diabetes Month with free cards listing healthy recipes for people with diabetes.

Medicine Shoppe will distribute the cards, partially funded by Bayer HealthCare, listing 10 recipes that the ADA has approved as safe for diabetics, including chicken, turkey, potato, sausage and vegetable dishes.

The cards, titled the “Live Health Nutritional Recipe Cards,” list nutrition information and serving sizes for each recipe.

keyboard_arrow_downCOMMENTS

Leave a Reply

No comments found

TRENDING STORIES

Polls

Which area of the industry do you think Amazon's entry would shake up the most?