The FDA Drug Safety Communication I'd Like to See

FDA (Food and Drug Administration): Drug Safety Communication - Excessive FDA Drug Safety Communications

[Posted 09/17/2011]

AUDIENCE: Physicians, Patients

ISSUE: FDA has notified healthcare professionals and patients of ongoing safety review and labeling changes for drugs such as Zofran (ondansetron, ondansetron hydrochloride and generics). It has been determined by the FDA that the FDA may be on the brink of creating a "Boy Who Cried Wolf" scenario by notifying doctors of prolonged QT intervals in drugs twenty years after their first market approval. Further, notifications such as these included two studies from 2005 and 2008 which were both written by the same lead author. The FDA realizes it is now 2011. An FDA investigation to determine if this same author now works for the FDA is ongoing.

BACKGROUND: Zofran (ondansetron) is in a class of medications called 5-HT3 receptor antagonists and is one of the few effective and remarklably safe drugs that doctors have used for years. While QT-prolonging effects with this medication have been seen in small controlled trials (see the FDA's references), realize that limitations to at least one of those trials existed, since 21% of an 85-patient study had prolonged QT before the drug was administered. Also note that the second trial only included a whopping 8 patients in the study group.

RECOMMENDATION: The FDA recommends that FDA Drug Safety Communications be inspected closely. Errant recommendations based on dated, single-center studies are becoming the norm and doctors are advised that excessive FDA Safety Communications may be forthcoming because certain government exployees are working hard to perform exhaustive literature searches with litle relevance to clinical experience.

That is all.

As always, healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[09/17/2011 - Drug Safety Communication - FDA]

-Wes

See also WhiteCoat's take.