Live ChatFDA Warned Berlex in 2003 About Down-Playing the Health Risks of Drosperinone
In 2003, the Food and Drug Administration (FDA) sent Berlex Laboratories a warning letter stating that its ads for Yasmin improperly minimized the risk of taking Yasmin, which contains the progestin drospirenone, and therefore raised “significant public health and safety concerns.”
The FDA specifically noted that drospirenone is a progestin which has antimineralocorticoid properties — properties that can work against the body’s normal mechanism for regulating salt (potassium) and water balance, a situation that can lead to hyperkalemia. Hyperkalemia can result in potentially serious heart and health problems. The FDA was concerned that women taking Yasmin needed to be aware of drug interactions that increase potassium, posing a serious danger when taken with the drospirenone in Yasmin.
The Misleading Commercial
At the time of this 2003 warning letter, Berlex Laboratories was running a 60-second television ad called “Goodbye Kiss.” The ad contained the tagline “Ask about Yasmin, and the difference a little chemistry can make.” It also contained the statement “You don’t settle when it comes to the guy … so why settle when it comes to the pill? The Yasmin birth control pill uses a different kind of hormone. One that may work with your body chemistry.”
The ad’s tagline suggests that Yasmin is better than other birth control pills because of drospirenone and the way in which it is metabolized in the body. This “chemistry” difference is presented as a product benefit, rather than the safety risk is presents to women taking the drug. The FDA stated it was not aware of clinical evidence that Yasmin was superior to other combined oral contraceptives (COCs) or that drospirenone was beneficial.
The FDA told Berlex that its inaccurate marketing did not warn women of the additional health risks when taking Yasmin over COCs without drospirenone, and the ad even suggested that Yasmin was better than other COCs because it contained a “different kind of hormone,” drospirenone, when in fact drospirenone is a safety risk rather than a clinical benefit. The ads also stated that drospirenone “may increase potassium” without disclosing that increased potassium is a risk.
It’s Not Your Fault If You Believed the Manufacturer’s Misleading Advertisments
Attorneys representing women injured by Yasmin believe that the slick advertising in the misleading commercial aired by Berlex implying that Yasmin worked better than other COCs and implying that increased potassium was a benefit, induced women to take Yasmin who would not otherwise have accepted the health risks of taking Yasmin. The FDA actions caused the commercial to be pulled from the air.
Have you or someone you love taken Yasmin and suffered painful side effects?
