U.S. Food and Drug Administration Updates for Health Professionals
As part of the FDA’s efforts to keep health professionals informed about FDA issues, below is included a list of the issues, a brief summary of each issue, and links to detailed information on the FDA Web site.
PRODUCT SAFETY:
FDA Warns Consumers about Counterfeit Alli (Jan. 18)
FDA is warning consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit). Preliminary laboratory tests conducted by GlaxoSmithKline (GSK)—the maker of the FDA approved over-the-counter weight-loss product— revealed that the counterfeit version did not contain orlistat, the active ingredient in its product. Instead, the counterfeit product contained the controlled substance sibutramine.
Rapamune (sirolimus): Drug Monitoring Recommendations (Jan. 11)
Wyeth notified healthcare professionals of changes to the Rapamune Prescribing Information regarding changes in the performance of an immunoassay used for therapeutic drug monitoring (TDM) of sirolimus. The TDM results reported from the assay are both assay and laboratory-dependent. In addition, the results may change over time. Therefore, adjustment to the targeted therapeutic range must be made with a detailed knowledge of the site-specific assay used. It is critical that the clinician caring for a patient on sirolimus maintain communication with their laboratory to determine whether the assay used for measuring sirolimus concentrations has been changed.
PRODUCT APPROVAL:
FDA Approves New Drug for Rheumatoid Arthritis (Jan. 11)
FDA approved Actemra (tocilizumab) to treat adults with moderate to severe rheumatoid arthritis who have not adequately responded to or cannot tolerate other approved drug classes for rheumatoid arthritis.
ANNOUNCEMENTS:
CDRH FY 2010 Strategic Priorities (Jan. 20)
CDRH has identified four priority areas of activity for the coming year, each of which presents significant opportunities to improve our effectiveness in fulfilling our mission.
Commissioner’s Letter to Health Care Professionals (Jan. 15)
Attached is a Dear Healthcare Professional letter from Dr. Margaret Hamburg, Commissioner of Food and Drugs. The letter updates the FDA/CDC experience with the H1N1 vaccination program and provides some details on the current vaccine safety monitoring program.
FDA Updates Earlier Guidance on Respiratory Treatment Spiriva HandiHaler (Jan. 14)
FDA announced that data from a recent review of the Spiriva HandiHaler, a long-acting respiratory treatment for chronic obstructive pulmonary disease (COPD), do not support an increased risk of stroke, heart attack, or death in patients using the medicine.
New Deputy Commissioner for Foods (Jan. 13)
Michael R. Taylor, J.D., was named Deputy Commissioner for Foods at the FDA, on
Jan. 13, 2010. He is the first individual to hold the position, which was created along with a new Office of Foods in August 2009 to elevate the leadership and management of the Foods Program.
Moban (molindone hydrochloride) to be Discontinued (Jan. 13)
Moban (molindone hydrochloride) 5 mg, 10 mg, 25 mg, and 50 my Tablets have been discontinued and supplies are anticipated to be depleted by June 30, 2010.
FDA Unveils First Phase of Transparency Initiative (Jan. 12)
FDA unveiled the first phase of its Transparency Initiative which is designed to explain agency operations, how it makes decisions, and the drug approval proces