Issue 467 Newsflash

Disetronic Medical Systems Inc. and FDA have recalled some ACCU-CHEK Spirit insulin pumps.
Hydroxycut Weight Loss Nutritional Products Recalled:

Disetronic Medical Systems Inc. and FDA have recalled some ACCU-CHEK Spirit insulin pumps.  See Notice

Disetronic Medical Systems Inc. and FDA notified healthcare professionals about a defect in the “up” and/or “down” buttons of some ACCU-CHEK Spirit insulin pumps. This failure may present as an intermittent or complete loss of function of the “up” and/or “down” buttons. If the buttons do not function, users may not be able to change any programmed setting on the pump. If this failure occurs, the pump may not respond with a vibration or acoustic confirmation signal to a button press and the display will remain unchanged. Users may contact ACCU-CHEK Spirit hotline noted in the Press Release for a replacement pump or for any other questions regarding this potential defect.

The announcement goes on to state; “Disetronic will replace pumps within the affected serial numbers (SN02119552 to SN10006093) that have intermittent or complete loss of function of the “up” and/or “down” button promptly upon contact from the customer with a new pump that is not affected by the potential button failure.”

Read the complete MedWatch 2009 Safety summary, including a link to the firm’s press release, at:
https://www.fda.gov/medwatch/safety/2009/safety09.htm#Spirit

Hydroxycut Weight Loss Nutritional Products Recalled: See Notice

[Posted 05/01/2009] FDA warned consumers to immediately stop using Hydroxycut products by Iovate Health Sciences, Inc. Hydroxycut products are associated with a number of serious liver injuries. Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names.

FDA has received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant. One death due to liver failure has been reported to FDA. Other health problems reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.

The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The FDA continues to investigate the potential relationship between Hydroxycut dietary supplements and liver injury or other potentially serious side effects.

Read the complete MedWatch Safety summary including links to the FDA news release, Q&A’s and a listing of all products included in this alert, at:
https://www.fda.gov/medwatch/safety/2009/safety09.htm#Hydroxycut