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? … [Read more]