FDA NEWS

FDA Requests Labeling Change for Leukotriene Modifiers
The U.S. Food and Drug Administration today provided further updated safety information on a class of asthma drugs known as leukotriene modifiers. FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling) regarding neuropsychiatric events (behavior, mood changes) that have been reported in some persons taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR).
Source: www.fda.gov

FDA Warns Web Sites against Marketing Fraudulent H1N1 Flu Virus Claims
The U.S. Food and Drug Administration is enforcing the laws that protect consumers from illegal products marketed through the Internet that claim to diagnose, prevent, mitigate, treat or cure the 2009 H1N1 flu virus.
Source: www.fda.gov

November 2008
MedWatch November 2008 Drug Safety Labeling Changes
Source: www.fda.gov

Sirolimus (marketed as Rapamune)
FDA notified healthcare professionals of clinical trial data that suggest increased mortality in stable liver transplant patients after conversion from a calcineurin inhibitor (CNI)-based immunosuppressive regimen to sirolimus (Rapamune). The trial was conducted by sirolimus manufacturer, Wyeth. The Agency will continue to examine the data on mortality and other adverse events in this study, and will make further recommendations, as appropriate. The FDA is determining whether a labeling change for sirolimus is needed. In the interim, physicians should continue to use the drug’s professional labeling as a guide to therapy. See the FDA Healthcare Professional Information sheet for current FDA recommendations.
Source: www.fda.gov

Nestle Toll House Prepackaged, Refrigerated Cookie Dough
FDA and the CDC are warning consumers not to eat any varieties of prepackaged Nestle Toll House refrigerated cookie dough due to the risk of contamination with E. coli O157:H7 (a bacterium that causes food borne illness). Since March 2009 there have been 66 reports of illness across 28 states. Twenty-five persons were hospitalized; 7 with a severe complication called Hemolytic Uremic Syndrome. No one has died.E. coli O157:H7 causes abdominal cramping, vomiting and a diarrheal illness, often with bloody stools. Most healthy adults can recover completely within a week. Young children and the elderly are at highest risk for developing HUS,which can lead to serious kidney damage and even death.
Source: www.fda.gov

Levemir Insulin (Novo Nordisk)
Patients advised to check personal supply of insulin to identify possible stolen and dangerous product.
Source: www.fda.gov

Digoxin, USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand)

Source: www.fda.gov