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FDA approval

BUT MY PRESCRIPTION IS FDA APPROVED…

October 10, 2011 by James Bogash

Apparently, there are still many people who believe that, because a drug is approved, that it must be both really effective and without serious side effects. Must be pretty dark in that cave.

The reality is far from the perception. There are no shortage of accusations and historical examples that the FDA’s job of regulating drugs is under strong influence from the drug companies themselves. Kind of like the proverbial fox guarding the hen house.

Many drugs that are approved are later pulled off the market or giving black box warnings years after their initial approval. Frequently, much damage occurs before the mistake is realized. Vioxx was a perfect example, with estimations of over 100,000 heart attacks related to its use before it was pulled off the market.

As far as efficacy, many times a drug is approved without any advantage over currently available, cheaper drugs. These are referred to as the “me too” drugs.

So, in this particular study, authors questioned almost 3,000 adults and found that misinformation is quite common. 39% believed that the FDA only approves drugs that are extremely effective. One quarter of the group believed that the FDA only approves drugs that are without significant side effects. A little misguided, but probably not surprising given the money the drug companies spend on direct to consumer advertising to steer the sheep towards new drugs.

Furthermore, when these participants were educated about the realities, they were more likely to chose a drug with a longer history of safer and a drug with documented positive outcomes (in this case a drug preventing heart attacks vs just lowering cholesterol).

Filed Under: Drug Research Tagged With: black box warnings, FDA approval, prescription drugs

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