Hartsell & Associates National Legal Nurse Consultants Newsletter

Botox, Botox Cosmetic (Botulinum toxin Type A), and
Myobloc (Botulinum toxin Type B)

Posted 02/07/2008
" FDA issued an early communication about an ongoing safety review regarding Botox and Botox Cosmetic. FDA has received reports of systemic adverse reactions including respiratory compromise and death following the use of botulinum toxins types A and B for both FDA-approved and unapproved uses. The reactions reported are suggestive of botulism, which occurs when botulinum toxin spreads in the body beyond the site where it was injected. The most serious cases had outcomes that included hospitalization and death, and occurred mostly in children treated for cerebral palsy-associated limb spasticity. Use of botulinum toxins for treatment of limb spasticity (severe arm and leg muscle spasms) in children or adults is not an approved use in the U.S. See the FDA's "Early Communication about an Ongoing Safety Review" for Agency recommendations and additional information for healthcare professionals."

Source: The U.S. Food and Drug Administration

E. Coli - Does Tainted Food Smell Bad?

You can't tell whether a food is contaminated with E. coli by the way it looks, smells or tastes. Most types of the bacteria Escherichia coli (E. coli) are harmless. But a few nasty strains, such as E. coli O157:H7, can cause serious food-borne illness. To protect yourself from E. coli and other food-borne illnesses, follow basic food safety guidelines. Rinse raw produce thoroughly. Wash your hands, utensils and kitchen surfaces with hot, soapy water before and after preparing or eating food. Keep raw foods separate from ready-to-eat foods. Cook your food thoroughly, especially ground beef. Refrigerate or freeze perishable foods promptly. Avoid unpasteurized juices, ciders and dairy products. Don't drink untreated water from lakes or streams.

Source: The Mayo Clinic

For More on E Coli: Click Here
http://www.mayoclinic.com
/health/e-coli/DS01007

Nationwide Recall of Icy Hot Heat Therapy Products Due to 1st, 2nd, and 3rd Degree Burns

Chattem, Inc. and FDA informed consumers and healthcare professionals of a voluntary nationwide recall of its Icy Hot Heat Therapy products, including consumer "samples" that were included on a limited promotional basis in cartons of its 3 oz Aspercreme product. The products were recalled because of consumer reports of first, second and third degree burns as well as skin irritation. All lots and sizes of the following Icy Hot Heat Therapy products were recalled:

1. Icy Hot Heat Therapy Air
     Activated Heat - Back
2. Icy Hot Heat Therapy Air
     Activated Heat - Arm, Neck,
     and Leg
3. Icy Hot Heat Therapy Air
     Activated Heal - Arm, Neck,
     and Leg single consumer use
     "samples" on a limited
      promotional basis in cartons
      of 3 oz. Aspercreme Pain
      Relieving Cream

Source: U.S. Food and Drug Administration