Consumer Lawyers

Archive for April, 2013|Monthly archive page

April 30, 2013 News: Lipitor Linked to Type 2 Diabetes Risk in Women

In Uncategorized on April 30, 2013 at 6:24 pm

News this week about Lipitor:

More than 20 million Americans take cholesterol-lowering drugs known as statins. These drugs, including the brand name Lipitor, have been linked to a high risk of Type 2 diabetes, especially in middle-aged and older women.

A study conducted by the Women’s Health Initiative of 150,000 postmenopausal women found that those taking a statin such as Lipitor were almost twice as likely to get a diabetes diagnosis. Studies published in the Journal of the American College of Cardiology and the Journal of the American Medical Association also reported a higher risk of diabetes for people taking statins.

The FDA has issued a warning about side effects of Lipitor, including the risk of diabetes. Data from large clinical trials reveal the danger of developing Type 2 diabetes from Lipitor is particularly high in women with existing risk factors including:

High blood sugar

Elevated triglycerides (a type of blood fat)

High blood pressure

Animas Corporation 2020 Insulin Infusion Pump: Class I Recall – False Alarm or Warning Sound

In FDA REcalls on April 8, 2013 at 2:51 pm

SSUE: Animas identified a component issue affecting Animas 2020 Infusion Insulin Pumps manufactured from March 1, 2012 to November 30, 2012. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following:

  • “Loss of prime”
  • “Occlusion”
  • “No Cartridge detected”

If you receive any of these alarms, the pump may prompt you to complete the rewind, load and prime sequence to clear this alarm. Failure to follow the pump’s safety instructions and disconnect your infusion set from your body before the “rewind, load and prime” steps can lead to unintended delivery of insulin, placing you in danger of potential serious health risks, such as hypoglycemia.

The Animas 2020 Insulin Pump also has a software limitation that will impact the ability of the pump to function past December 31, 2015. After this date, the pump will no linger deliver insulin and will generate a “Call Service Alarm.”

BACKGROUND: The Animas 2020 Insulin Pumps are used to deliver insulin directly into your blood for the treatment of diabetes.

RECOMMENDATION: Customers with the device should contact Animas’ Product Fulfillment Center at 877-280-2339 between the hours of 6 a.m. and 12 a.m. EST to schedule shipment of your free replacement pump. Customers with technical questions or who want to report a concern should contact Customer Technical Support Center at 866-793-5253.

 

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm346788.htm