FDA Warning Letter Regarding Yaz Birth Control Pills

In March 2009, the following letter was sent to the Bayer Healthcare Pharmaceuticals facility in Wayne, NJ, regarding issues with the company’s marketing of three drugs, including Yaz birth control pills.

Some of the known side effects for Yaz patients and those who have taken the older generation of the drug, Yasmin, include: blood clots, deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, and heart attack.

RE: NDA No. 21-676, 21-873, 22-045 YAZ® (drospirenone and ethinyl estradiol) Tablets

This letter notifies Bayer Healthcare Pharmaceuticals, Incorporated (Bayer), and, by copy, Schering Corporation (Schering), which markets Levitra on behalf of Bayer, that, as part of its monitoring and surveillance program, the Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) has reviewed Bayer’s sponsored links on internet search engines (e.g., Google.com) for YAZ® (drospirenone and ethinyl estradiol) Tablets (YAZ).

The sponsored links cited in this letter are misleading because they make representations and/or suggestions about the efficacy of YAZ, but fail to communicate any risk information associated with the use of these drugs. In addition, the sponsored links for YAZ inadequately communicate the drugs’ indications.

Furthermore, all of the sponsored links fail to use the required established name. Thus, the sponsored links misbrand the drugs in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA implementing regulations. See 21 U.S.C. 352(a) & (n), 321(n); 21 CFR 201.10(g)(1), 202.1(b)(1), (e)(3)(i), (ii) & (e)(6)(i).

Background
According to its FDA-approved PI, YAZ is indicated for the prevention of pregnancy in women who elect to use an oral contraceptive.

YAZ is also indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of YAZ for PMDD when used for more than three menstrual cycles has not been evaluated.

YAZ has not been evaluated for the treatment of premenstrual syndrome (PMS).

YAZ is also indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy, and have achieved menarche. YAZ should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.

YAZ is associated with a number of risks, as reflected in the Boxed Warning, Contraindications, Warnings, Precautions, and Adverse Reactions sections of its PI.

Omission of Risk Information
Promotional materials, other than reminder pieces, which include the name of the drug product but do not include indications or other representations or suggestions relative to the drug product are required to disclose risk and other information about the drug. Such materials are misleading if they fail to reveal facts that are material in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials.

The sponsored links present the following claims: YAZ® Birth Control Pill www.Yaz-US.com YAZ® Prevents Pregnancy, May Help Moderate Acne and PMDD.

These sponsored links make representations and/or suggestions about the efficacy of Levitra, YAZ, and Mirena, respectively, but fail to communicate any risk information. This omission of risk information is particularly concerning as one of these products, YAZ, has a Boxed Warning. For promotional materials to be truthful and non-misleading, they must contain risk information in each part as necessary to qualify any claims made about the drug.

By omitting the most serious and frequently occurring risks associated with the drugs promoted in the links above, the sponsored links misleadingly suggest that YAZ is safer than has been demonstrated. We note that these sponsored links contain a link to the products’ websites. However, this is insufficient to mitigate the misleading omission of risk information from these promotional materials.

Inadequate Communication of Indication/Overstatement of Efficacy
The sponsored link for YAZ provides a very brief statement about what the drug is for; however, this statement is incomplete and misleading, suggesting that YAZ is useful in a broader range of conditions or patients than has been demonstrated by substantial evidence or substantial clinical experience. Specifically, the sponsored link for YAZ misleadingly broadens the indication for YAZ by implying that all patients with moderate acne are candidates for YAZ therapy (“YAZ® Prevents Pregnancy, May Help Moderate Acne and PMDD”), when this is not the case. Rather, YAZ’s indication is limited to the treatment of moderate acne vulgaris in women at least 14 years of age who have achieved menarche, and it should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.

Failure to Use Required Established Name
None of the sponsored links present the full established name of the drugs being promoted, despite the requirement to do so. See 21 CFR 201.10(g)(1) & 202.1(b)(1).

Conclusions and Requested Action
For the reasons discussed above, the sponsored links misbrand YAZ in violation of the Act and FDA regulations. See 21 U.S.C. 352(a) & (n), 321(n); 21 CFR 201.10(g)(1), 202.1(b)(1), (e)(3)(i), (ii) & (e)(6)(i).

DDMAC requests that Bayer immediately cease the dissemination of violative promotional materials YAZ such as those described above.

For more information, read the FDA letter.

How a lawyer can help
If you have experienced serious health problems after taking Yaz, you may be entitled to file a Yaz lawsuit against the manufacturer.

A lawyer with experience in birth control litigation can help evaluate your claim.

Many women around the country have suffered from life-threatening Yaz pulmonary embolism side effects but are unaware they have a right to seek monetary compensation by filing a claim against Bayer.

For a free no-obligation case review of your possible Yaz lawsuit, please complete the form below. A representative of our firm will be in touch shortly.

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see also:

Oregon Settlement FDA Agreement With Bayer on Yaz Birth Control Advertising Campaign
Free lawsuit review if injured by use of Bayer Yaz birth control pills

Warning: TV ads Yaz Legal Case Review | Weitz & Luxenberg
Health problems linked to Yaz in addition to claims made in TV ads

Health Risks Yasmin Pills Carry Certain Health Risks | Weitz & Luxenberg News
Yasmin pills may cause stroke or gallbladder disease. Our attorneys are currently speaking with women who say they have experienced serious side effects