What Does “FDA Approved” Really Mean?

Women use products every day that are regulated by the FDA including cosmetics, medicines and  hormones. But does an “FDA Approved” claim mean that it’s safe and effective?  In a recent article in the New England Journal of Medicine, “Lost in Translation- FDA Drug Information That Never Reaches Clinicians,” two researchers at Dartmouth wrote that;

“FDA approval does not mean that a drug works well.  It means only that the agency deemed its benefits to outweigh its harms.  Much of what the FDA knows about a drug’s safety and effectiveness is not included on the label. You really need to know more to see whether it’s worth the cost.”

So what does this mean for mid-life women whose physicians recommend hormone therapy to manage hot flashes, biphosphonates to prevent bone loss, sleeping pills to help with menopause-related sleep disorders and perhaps a little Zantac for heartburn?  You have to do your own, thorough research, including monitoring updated FDA information, and know what the side effects and possible consequences are of taking the medicine.

For example,  read the FDA alert on biphosphonates, which addresses the association between drugs like Actonel, Fosamax and Boniva with severe musculoskeletal pain.   My previous  blogpost about the possible connection between common acid suppressing medications and hip fractures, is another example.

With so many drug-makers promoting their brands in television commercials, it’s easy to be lulled into thinking that a remedy is only a prescription away.  Many physicians are quick to prescribe as well. Until the FDA requires fuller disclosure about clinical trial results and more oversight on labeling (right now, the drug-makers write their own labels emphasizing the benefits, not the harms) do as much research as you can before taking any medicine and ask your doctor if it’s really necessary to take it.