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FDA MedWatch Safety Alerts: December 2009

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The risk: The label for the green night product appears under some of the blue day product and vice versa. Consumers using the affected product may not be aware of the warnings regarding an antihistamine in the product that could cause drowsiness.

Recommendations:

  • Stop using the recalled product.
  • Contact your health care professional if you have a medical concern.
  • Contact Bayer Consumer Care at 800-986-3307 with any other questions or for instructions on a refund or replacement.

Recall: Thermoflect Products

Encompass Group has recalled its Thermoflect product line for relabeling regarding its use with magnetic resonance (MR).

FDA has recommended that Thermoflect blankets and other Thermoflect products not be used for patients undergoing magnetic resonance imaging (MRI), a technology that uses the body’s natural magnetic properties to produce detailed images of parts of the body.

In addition to being used in hospitals and by the military, Thermoflect products may be used by consumers for camping or other outdoor activities because they can help prevent dangerously low body temperature (hypothermia). In addition to blankets, Thermoflect products include jackets, pants, vests, and caps for adults and children.

The risk: An injury occurred in a patient undergoing MRI, which may have been related to the Thermoflect blanket used.

Voltaren Gel and Liver Damage

New warnings and precautions regarding the risk of liver damage have been added to the labeling of Voltaren Gel (diclofenac sodium topical gel) 1% and other drugs that contain diclofenac sodium. Voltaren Gel is a non-steroidal anti-inflammatory drug used to relieve pain from osteoarthritis of the joints, such as the knees and those of the hands.

The risk: Liver damage (hepatotoxicity) has been reported in people in the first month of using Voltaren Gel, although this damage can occur at any time during use of the drug. Severe reactions including liver cell death (necrosis), yellowing of the skin and whites of the eyes (jaundice), hepatitis, and liver failure have been reported. Some of these cases resulted in death or liver transplantation.

Recommendations:

  • Let your health care professional know if you have any liver problems before you use Voltaren Gel.
  • Contact your health care professional if after using Voltaren Gel you have side effects, such as nausea, fatigue, lethargy, diarrhea, itching, jaundice, stomach tenderness, or flu-like symptoms.

 

For more information about topics for your health, visit the FDA Consumer Information Center (http://www.fda.gov/ForConsumers/default.htm).  

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