Tag Archives: FDA

FDA Alert: Clarcon Skin Products Have High Levels of Bacteria

The Food and Drug Administration warns consumers not to use skin sanitizers and skin protectants manufactured by the Clarcon Laboratory of Roy, Utah.  A recent inspection found high-levels of disease-causing bacteria in the products. Some of the bacteria can cause infections in the skin and underlying tissues which may need surgical treatment. This is especially concerning since the products are promoted as anti-microbials that treat open wounds and damaged skin and protect the skin against disease. Consumers who have the products should not use them and throw them away in household trash.

Colorectal Cancer News in Brief: May 15

Despite more resources in large cities, patients were more often diagnosed with cancer at a late stage in cities in Illinois compared to rural areas. Phone calls and personalized diet and exercise plans helped long-term cancer survivors lose weight and gain strength, and scientists have found changes in the blood of family caregivers that promote inflammation and may lead to illness. In other headlines, both patients and doctors liked virtual, computer videoconferencing visits, and the FDA reports that shortages of fentanyl patches have been resolved.

FDA Warns: Don't Eat Raw Alfalfa Sprouts

The Food and Drug Administration recommends that consumers not eat raw alfalfa sprouts or combinations of sprouts that include alfalfa due to potential contamination with Salmonella Saintpaul. The Centers for Disease Control, working with the FDA and state health departments, have identified 31 cases of illness traced to alfalfa sprouts in six different states since mid-March.  All either ate sprouts in a restaurant or bought them in retail stores. Because the outbreak is widespread, the FDA suspects the problem may be in the seeds used for sprouting and how they are handled.

Colorectal Cancer News in Brief: April 17

This week we have research reports about risk of complications after hand-assisted laparoscopic colectomies, the benefit of music therapy during hospice treatment, and a gene that predicts better response to cetuximab. In other headlines, we found an excellent overview of the progress made in colorectal cancer treatment with data and references.  In addition, there is information about management of colonoscopy sedation in HIV patients receiving antiretroviral medicines and a lifting of the FDA ban on concentrated liquid morphine for terminally ill patients until an acceptable substitute can be found.

FDA: Influend Cough and Cold Products Recalled

Ion Labs, Inc. of Clearwater Florida is voluntarily recalling all Influend cough and cold products, both tablets and liquids, sold on or after May 30, 2008.  Because of testing issues, the products may contain more active ingredients and have the potential to be extra potent. While the lots in question were sold in Huntsville, Alabama, Ion is recalling all Influend products to be safe.

FDA Recommends Avoiding Pistachios Due to Salmonella

Setton Pistachio of Terra Bella in California has recalled over a million pounds of pistachios after Salmonella was found in Back To Nature Trail Mix by Kraft Foods.  Kraft traced the contamination back to Setton. Setton is recalling both its large bulk shipments of pistachios to other manufacturers and Setton Farms brand roasted salted shelled pistachios in 9 oz. film bags.  The Setton Farm bags of pistachios were distributed in South Carolina, Georgia, Florida, North Carolina, Virginia, Tennessee, and Kentucky and have UPC Code: 034325020252 with a “Best Before” date between 01/06/10 and 01/19/10.

Leucovorin Shortage Update

The Food and Drug Administration has updated information on the ongoing leucovorin shortage as of 3/23/09. Both Bedford Laboratories and Teva Pharmaceuticals are reporting manufacturing delays for leucovorin.  Spectrum Pharmaceuticals has limited supplies of Fusilev® (levoleucovorin) which is a different formulation.  Fusilev dosages are not equal to leucovorin doses and need to be used with care.

FDA Warns Against Long Term Use of Reglan

The Food and Drug Adminstration is requiring that manufacturers of Reglan® (metoclopramide) to add a boxed warning to its label.  Long term or high dose use can lead to tardive dyskinesia, involuntary and repetitive movements of the body, even after the drug is discontinued. FDA will also require the development of a risk evaluation and mitigation strategy, or REMS, that will provide a medication guide for patients to explain the risk.

FDA Increasing Oversight of Opioid Pain Medicine

The Food and Drug Administration is increasing its requirements for safe prescription and use of pain medicines that contain opiates beginning with a meeting in early March with manufacturers.  Additional input is planned through discussions with other government agencies, the addiction and pain treatment communities, and patient advocates. The intensive new program is designed to reduce risk of misuse or accidental overdoses of powerful pain medicines and will probably put new requirements on physicians who prescribe them, pharmacists who dispense them, and patients who need them. Manufacturers will be required to develop Risk Evaluation and Mitigation Strategies (REMS) to ensure that benefits of using the drugs outweigh their risks.