Office of Special Health Issues
Dear Colleague,
As part of our ongoing efforts to keep you informed about FDA issues, we want to make you aware of recent safety information and product approvals. We have included a list of the issues, a brief summary of each issue, and links to detailed information on the FDA Web site.
PRODUCT SAFETY INFORMATION:
FDA Announces Class I Recall of Ophthalmic Surgical Device (January 2)
The U.S. Food and Drug Administration announced a Class I recall of lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured by Advanced Medical Optics Inc. (AMO) of
OVDs are viscoelastic materials used to maintain space in the eye during surgery. Typically, OVDs are pre-packaged in a syringe and are applied using a small tube.
FDA Expands Warning to Consumers About Tainted Weight Loss Pills (December 22)
The U.S. Food and Drug Administration is expanding its nationwide alert to consumers about tainted weight loss pills that contain undeclared, active pharmaceutical ingredients. On December 22, 2008, FDA warned consumers not to purchase or consume 28 different products marketed for weight loss. Since that time, FDA analysis has identified 45 more tainted weight loss products that may put consumers’ health at risk.
PRODUCT APPROVALS:
FDA approved the cobas TaqScreen MPX Test, the first nucleic acid test that screens for the presence of two divergent types of HIV in donated blood plasma and tissue.
FDA Approves Drug for Patients with Advanced Prostate Cancer (December 29)
FDA approved the injectable drug degarelix, the first new drug in several years for prostate cancer. Degarelix is intended to treat patients with advanced prostate cancer. It belongs to a class of agents called gonadotropin releasing hormone (GnRH) receptor inhibitors. These agents slow the growth and progression of prostate cancer by suppressing testosterone, which plays an important role in the continued growth of prostate cancer.
FDA Approves First Imaging Agent to Enhance Scans of Blood Flow (December 24)
FDA approved Vasovist Injection (gadofosveset trisodium), the first contrast imaging agent for use in patients undergoing magnetic resonance angiography, or MRA, a minimally invasive test for examining blood vessels.
FDA Approves Gleevec to Prevent Recurrence of Rare Gastrointestinal Cancer (December 19)
FDA approved Gleevec (imatinib mesylate) for a new indication – keeping cancer from growing in patients following surgical removal of a gastrointestinal stromal tumor or GIST.
GIST is a fairly rare form of cancer that originates in cells found in the wall of the GI tract. These cells, known as interstitial cells of Cajal, are part of the autonomic nervous system, which helps to control the movement of food and liquid through the stomach and intestines.
ANNOUNCEMENTS:
FDA Patient Safety News (January 2009)
A video news show for healthcare professionals focusing upon recalls, prevention of medication errors and patients information.
FDA Commissioner's Fellowship Program (January 2009)
Beginning February 1, 2009, Applications Will Be Accepted for Next Year's Class
RESOURCES:
Andy's Take (January 2)
Commissioner for Food and Drugs Andrew von Eschenbach discusses weekly FDA issues of interest to the American consumer and occasionally preview upcoming FDA issues and events. Featured this week is FDA: Progress on Five Priorities
Sincerely,
Janelle Derbis, PharmD
312-596-6516 (
Brenda Evelyn, SBB(ASCP)
301-827-4460
Heidi Marchand, PharmD
301-827-4460
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