Tuesday, February 20, 2018

title pic What is the FDA Thinking?

Posted by Deborah Pujoue on January 13, 2012

What is the FDA Thinking?

In yet another bull-headed move by the FDA, the drug regulators seem to have backtracked on their previous warnings about SSRI antidepressant medications like Zoloft, Prozac and Paxil’s links to persistent pulmonary hypertension in newborns (PPHN). The FDA now is saying that there is not enough consistent research to prove that the SSRIs cause the condition.

Wait, what?! That doesn’t make any sense. It’s enough to make me wonder just how the FDA benefits from taking the drug companies’ side in these matters. Then again, common sense would tell me that the FDA just doesn’t want to look stupid after approving the drug and letting sit on the market for so long even after research proves how dangerous these medications really are. But I’m getting off track.

Anyway, the newest announcement occurred on December 14 and claimed that the labels for different SSRIs like Paxil, Zoloft, Prozac, Celexa and Lexapro that included PPHN should be changed to show that the drugs’ links to PPHN are inconclusive.

“The initial Public Health Advisory in July 2006 on this potential risk was based on a single published study,” the agency’s announcement reads. “Since then, there have been conflicting findings from new studies evaluating this potential risk, making it unclear whether use of SSRIs during pregnancy can cause PPHN.”

Thanks to this newfound change in the FDA’s opinion, regulators are planning on little else other than updating the drugs’ labels. The FDA has also decided to tell doctors to use their own judgment in deciding the proper risks-to-benefits ratio when prescribing SSRIs to pregnant women. Considering this new decision by the FDA, it is no wonder that recent surveys are showing that drug recalls are up an astounding 400 percent in recent years. This announcement can take the guesswork out of why that is: Clearly the FDA leaves dangerous drugs on the market for far too long, and is eager to play nice with drug companies at the consumer’s risk.

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