Yasmin Birth Control Lawsuit

YAZ Birth Control Pill Recall Class Action Lawsuit

Nancy Konnerth

Associate Director, Advertising and Labeling

Drug Regulatory Affairs

Berlex Laboratories

340 Changebridge Road

P.O. Box 1000

Montville, NJ 07045-1000

Yasmin (drospirenone/ethinyl estradiol) Tablets

MACMIS ID# 11730

Dear Ms. Konnerth:

This letter notifies Berlex Laboratories (Berlex) that the Division of Drug Marketing, Advertising,

and Communications (DDMAC) has identified a direct-to-consumer (DTC) broadcast advertisement

(TV ad) for Yasmin (drospirenone/ethinyl estradiol) Tablets that is misleading and in violation of the

Federal Food, Drug, and Cosmetic Act (Act) and applicable implementing regulations. Specifically,

the 60-second TV ad entitled "Goodbye Kiss" is misleading because it makes implied clinical

superiority claims to other combination oral contraceptives and minimizes the important risk

information that distinguishes Yasmin from other combination oral contraceptives. As a result, the

TV ad raises significant public health and safety concerns.

Yasmin is a combination oral contraceptive ("COC" or "birth control pill") prescription drug product.

Yasmin, like any oral contraceptive, is associated with increased risks of several serious conditions

(including myocardial infarction, thromboembolism, stroke, hepatic neoplasia, gallbladder disease,

and hypertension), although the risk of serious morbidity or mortality is very small in healthy women

without underlying risk factors. The risk of morbidity and mortality increases significantly in the

presence of other underlying risk factors such as hypertension, hyperlipidemias, obesity, and

diabetes. (See the WARNINGS section of the Yasmin approved physician labeling (PI))

Yasmin contains the estrogen ethinyl estradiol and the progestin drospirenone. Drospirenone has

antimineralocorticoid properties, which means that it can work against the body's normal mechanism

for regulating salt and water balance, a situation that can lead to hyperkalemia in high risk patients,

resulting in potentially serious heart and health problems. This additional risk is described in the

Bolded Warning of Yasmin's PI:

Nancy Konnerth. 2

Berlex Laboratories

NDA 21-098

Yasmin contains 3 mg of the progestin drospirenone that has

antimineralocorticoid activity, including the potential for hyperkalemia in highrisk

patients, comparable to a 25 mg dose of spironolactone [a potassium-sparing

diuretic]. Yasmin should not be used in patients with conditions that predispose

to hyperkalemia (i.e., renal insufficiency, hepatic dysfunction and adrenal

insufficiency). Women receiving daily, long-term treatment for chronic

conditions or diseases with medications that may increase serum potassium,

should have their serum potassium level checked during the first treatment cycle.

Drugs that may increase serum potassium include ACE inhibitors, angiotensin --

II receptor antagonists, potassium-sparing diuretics, heparin, aldosterone

antagonists, and NSAIDs.

Consequently, Yasmin can exacerbate serious heart and health problems, in addition to the potential

problems common to all COCs. Women taking Yasmin must be concerned about drug interactions

that will increase potassium, in addition to the drug interactions common to all COCs. Therefore,

these women and their healthcare providers must weigh Yasmin's additional health risks when

considering Yasmin over COCs without drospirenone.

Prescription drug ads are false or misleading if they contain a drug comparison that represents or

suggests that a prescription drug is more effective or safer than another drug when it has not been

demonstrated to be safer or more effective by substantial evidence or substantial clinical experience

(21 CFR 202.1(e)(6)(ii)). The TV ad misleadingly overstates the efficacy and safety of Yasmin by

suggesting that Yasmin is unique and therefore clinically superior to other birth control pills because

it contains the chemically different progestin drospirenone. The unifying theme of the ad, typified by

Berlex should immediately discontinue the TV ad and all other promotional materials and activities

for Yasmin that contain the same or similar violative presentations. Berlex should submit a written

response to DDMAC on or before July 24, 2003, describing its intent and plans to comply with the

above. In its letter to DDMAC, Berlex should include the date on which these and other similarly

violative materials were discontinued.

Berlex should direct its response to the undersigned by facsimile at (301) 594-6771, or at the Food

and Drug Administration, Division of Drug Marketing, Advertising, and Communications HFD-42,

Rm. 8B-45, 5600 Fishers Lane, Rockville, Maryland 20857.

Nancy Konnerth. 4

Berlex Laboratories

NDA 21-098

In all future correspondence on this matter, please refer to MACMIS ID# 11730 as well as the NDA

number. DDMAC reminds Berlex that only written communications are considered official.

Sincerely,

Joan Hankin

Consumer Promotion Analyst

Division of Drug Marketing,

Advertising, and Communications