Drug Safety: Tip of the Iceberg

The 10 drugs with the largest numbers of reports sent directly to the FDA by healthcare practitioners and consumers in 2011 in order of frequency are Pradaxa, Coumadin, Levaquin, Carboplatin, Zestril, Cisplatin, Zocor, Cymbalta, Cipro and Bactrim.  It is interesting...

Drug Labels: Toxicity or Information Overload?

Side effect overload on drug labels has less to do with true toxicity and drug safety than with manufacturer liability.  Examination of more than 5600 drug labels yielded over half a million side effects.  An average drug label and the more commonly prescribed drugs...

Precedent-setting Lawsuit: Free Speech vs. Off-Label Drug Promotion

Allergan, the maker of Botox, is suing the federal goverment by asserting that marketing restrictions prevent the company from communicating practical medical information — like patient selection criteria or optimal dosing patterns — to doctors that could reduce the...

Enforced 15-day limit on FDA form 483 responses

Starting 15 September 2009, the FDA began enforcing a 15-day limit on post-inspection responses to an FDA-issued form 483  (Inspectional Observations).   Upon  completion of a facility inspection, the FDA may issue a form 483  to notify an inspected...