That Drug Was Approved by the FDA. Why the New Warnings Now?

It seems reasonably logical to lead off today’s blog post with the proverbial glass-half-full-or-empty query that often accompanies head-scratching realities.

The spotlight today is on regulatory approvals of drugs offered to American consumers.

Specifically, the focus is on the central research findings of an unquestionably careful and thorough study that appears in the most recent volume of the Journal of the American Medical Association.

To wit: Researchers have concluded that nearly one-third of all drugs approved for public use by the FDA from 2001 through 2010 subsequently had post-approval warnings regarding use tacked on years following their entry into the marketplace.

The glass-half-full take on that finding comes courtesy of the study’s lead author, who states that the deluge of post-approval modifications necessitated by new discoveries regarding previously unknown dangers in dozens of drugs is actually a positive thing.

In fact, notes Yale University professor Dr. Joseph Ross, the proliferation of new warnings indicates that the health agency “is kind of doing a great job” in its monitoring of pharmaceuticals.

That is not the study takeaway for drug safety guru Thomas Moore, who says that the results are alarming and call into material question the thoroughness and integrity of the FDA’s testing process at the critically important pre-approval stage.

Moore’s glass-half-empty analysis clearly suggests that a more rigorous pre-approval vetting would largely eliminate the need for regulators to put new warnings on many drugs years after they have already been introduced into the marketplace.

The study, notes a national media report, “counted black-box warnings for dozens of drugs.” Those warnings are deemed the most serious of all label notifications, signifying “deaths or life-threatening conditions linked with the drugs.”

Our readers in Connecticut and elsewhere will likely find many of the drugs noted in the study as requiring new warnings to be quite familiar names. They include the pharmaceuticals Abilify, Pradaxa, Bextra and Humira.