FDA chastises drug companies for eyebrow-raising claims


Every so often, the FDA has to slap the wrists of drug companies for … well, pretty much everything. On the naughty list this week were several companies that the FDA didn’t feel presented the whole truth and nothing but the truth. Among them:

– Cephalon received a nasty note for not including risks of taking cancer drug Treanda on its dosing card. According to the FDA letter, these risks include skin reactions, infection and death.

– Amylin and Eli Lilly were called out for misleading statements about the diabetes medication Byetta.

“On June 10, 2009, the Lilly representative claimed that 94% of patients in a study lost 7 to 8 pounds without diet or exercise in 30 days. On June 11, 2009, an Amylin representative claimed that 80% of patients in a study lost about 7 to 8 pounds over 30 weeks.”

Which one’s right, you ask? Neither, says the FDA.

Bayer got smacked down by the FDA for a script that linked the contraceptive Mirena to “looking and feeling great.” The Food and Drug Administration did not take kindly to that, apparently:

FDA is not aware of any evidence suggesting that women who are using Mirena for birth control look great or feel great. Patients using Mirena may experience various side effects, such as irregular bleeding, ovarian cysts, back pain, weight increase, breast pain/tenderness, and acne, in addition to the side effects indicated above.… If you do, in fact, have data to support these claims, you should submit them to FDA for review.

Moral of the story? Take pharmaceutical ads with a grain (or a shaker) of salt. They’re trying to sell you a drug, and the more positive associations your brain makes with that drug, the better for the companies – which is not the same thing as better for you. Always check the warning label. Unbiased drug information can be found at the FDA website, though drugs.com and rxlist.com may provide more user-friendly formats. And, at the risk of sounding like an ad myself, talk to your doctor about what’s right for you.