FDA NEWS

Drug to be Discontinued: Tilade Inhaler (nedocromil sodium inhalation aerosol)
Dear Healthcare Professional Letter is available.

Drug Approved for Irritable Bowel Syndrome with Constipation
FDA has approved Amitza (lubiprostone) for the treatment of irritable bowel syndrome with constipation in adult women aged 18 and over

Pregnant Women to Benefit from Better Information
A proposed rule will give women and their health care professionals better information concerning the effects of medications taken during pregnancy or while breastfeeding.

Bayer Removes Remaining Trasylol Stock
Bayer will begin removing the remaining Trasylol, a drug used to control bleeding during heart surgery, from the U.S. market.

Enbrel (etanercept)
Prescribing information revised to include a BOXED WARNING regarding the risk of infection including tuberculosis.

Combating Antibiotic Resistance
Misuse and overuse of antibiotics have contributed to antibiotic resistance, a phenomenon that reduces or eliminates the effectiveness of antibiotics.

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).

Controlling Cholesterol with Statins
When diet and exercise alone are not enough to reduce cholesterol to goal levels, doctors often prescribe statin medications. These drugs can reduce the risk of heart attack, stroke, and death.