FDA NEWS

May 2008 Patient Safety News
Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients.

Mommy's Bliss Nipple Cream
Product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants.

Solodyn (minocycline HCL) Extended Release Tablets 90 mg
Recall of certain lots because one bottle of Solodyn contained Azasan (azathioprine).

Mycophenolate Mofetil (marketed as CellCept) and Mycophenolic Acid (marketed as Myfortic)
FDA issues an FDA Alert and Information for Healthcare Professional sheet for Mycophenolate Mofetil (MMF) and Mycophenolic Acid (MPA).

FDA Proposes New Rule to Provide Updated Information on the Use of Prescription Drugs and Biological Products during Pregnancy and Breast-feeding
The proposed changes to prescription drug labeling would give health care professionals more comprehensive information for making prescribing decisions and for counseling women who are pregnant, breast-feeding, or of child-bearing age about using prescription medications.

Viril-ity Power (VIP) Tablets
Product recalled because it contains a potentially harmful, undeclared ingredient that may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels.

Trasylol (aprotinin injection)
Bayer Pharmaceuticals notified the FDA of their intent to remove all remaining supplies of Trasylol from hospital pharmacies and warehouses.

Xiadafil VIP Tablets
Consumers advised not to purchase or use the product, marketed as a dietary supplement, because it contains a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects.