FDA MedWatch Quickies

Source:  FDA (U.S. Food & Drug Administration) Website. http://www.fda.gov/

Because there’s always time for a quickie. (Stop snickering).  The FDA is investigating the diabetes drug Lantus (insulin glargine) for a potential associated risk of cancer. No less than 4 observational studies recently published in the journal Diabetologia suggest such a risk.

It should be noted that even the FDA picked up on the fact that all 4 studies had inconsistencies which preclude any actual conclusions.  Hence the “investigation” and interim “warning.”  As with all medications you may be taking, please continue and consult with your physician if you have any specific questions.

The FDA has also revised the Warnings and Precautions label for Etravirine (Intlence) and HIV medication.  Apparently the severity of the potential skin reactions was at issue.  Apparently they are quite severe, potentially life-threatening and fatal.  Among them are: Stevens-Johnson syndrome; toxic epidermal necrolysis; and erythema multiforme.  If you think they sound nasty, you should Google them.

To their credit, Etravirine’s manufacturer, Tibotec, contacted the FDA to discuss labeling revisions after receiving 2 postmarketing reports of severe reactions to the drug.  I could quibble about the premarketing and marketing reports but I will be kind today.

posted by David Marc Schwadron, Esq.