FDA NEWS

Drug Shortage: Digitek (digoxin tablets, USP)
Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalled of all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP). Other manufacturers of digoxin tablets are available and listed on the Drug Shortage website.

Important Information about Albuterol Metered Dose Inhalers (MDIs)
After December 31, 2008, albuterol CFC MDIs are prohibited from being sold or distributed in the United States. Therefore, patients are encouraged to talk with their health care providers now to begin the transition to an HFA propelled albuterol MDI. After the transition is complete, it is anticipated that supplies of albuterol HFA and levalbuterol HFA MDIs will continue to meet the total market demand. FDA is working closely with manufacturers to ensure that there is adequate supply of the HFA propelled albuterol and levalbuterol MDI products available. (more information)

FDA's Chief Scientist Asks Science Board Subcommittee to Review Research on Bisphenol-A
Frank M. Torti, M.D., M.P.H., the FDA's principal deputy commissioner and chief scientist, this week asked Science Board Chairwoman Barbara J. McNeil, M.D., Ph.D., head of Health Care Policy at Harvard Medical School, to establish a subcommittee to assess BPA, a substance used in some plastic baby bottles, food containers, and water bottles.

FDA Approves Diaphragm-Pacing Device
The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator.

Antipsychotics, Conventional and Atypical
New studies show an increased risk of mortality in elderly patients treated for dementia-related psychosis with conventional antipsychotic drugs.

Drug to be Discontinued: Kemadrin (procyclidine hydrochloride)
Kemadrin (procyclidine hydrochloride), Dear Healthcare Professional Letter available for more information.

Morphine Sulfate 60 mg and 30 mg Extended Release Tablets
UPDATE - Additional lots of morphine sulfate 60 mg extended release tablets, and specific lots of morphine sulfate 30 mg extended release tablets, were recalled due to the possible presence of oversized tablets.

FDA Takes Action against Seafood Processing Company, Executives
The U.S. Food and Drug Administration today filed a complaint for permanent injunction against seafood processor Captain's Select Seafood, Inc., Minneapolis, Minn., and two of its top officers for violating the Federal Food, Drug and Cosmetic Act.

Myfortic (mycophenolate acid)
Dear Healthcare Professional Letter sent by manufacturer regarding reports of Progressive Multifocal Leukoencephalopathy in patients treated with Myfortic.

Drug to be Discontinued: Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP)
Cortisproin Otic Suspension (neomycin and polymyxin B sulfates and hydrocortisone otic suspension, USP), Dear Healthcare Professional Letter available for more information.