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FDA Yaz Warning and FDA Yasmin Warning

FDA Yaz Warning and FDA Yasmin Warning

Yaz and Yasmin ads are misleading, says the FDA in a warning to consumers. The FDA has issued three warnings to the makers of Yaz and Yasmin (generic form: Ocella), some of the most popular forms of birth control in the United States. The FDA found that the TV advertisements were misleading consumers.

Warning letters: 2003 FDA Yasmin Warning, 2008 FDA Yaz Warning, and 2009 FDA Yaz Warning, showing that there were serious, ongoing issues with the marketing campaign. It is unknown how many women viewed these advertisements and were misled about the efficacy of the drugs, or were unaware of the life-threatening risk factors associated with their use.

What Issues Did the FDA Find?

  • Yasmin ads falsely implied that the drug is a safer alternative to other birth control methods.
  • Yasmin ads minimized the risks associated with using birth control that contains drospirenone.
  • Yaz ads overstate its efficacy by claiming that it treats acne and PMS. Yaz is only approved to treat moderate acne — not severe acne. It is not approved to treat PMS.
  • In 2009, Yaz ads failed to communicate any risk information. The FDA found this unacceptable, because Yaz has serious side effects including heart attack, stroke, deep vein thrombosis (DVT), pulmonary embolism (PE), and more.

First FDA Yasmin Warning for “Misleading” Ads

The FDA issued the first warning to the makers of Yasmin in October of 2003. The FDA found the advertisements misleading because they implied that Yasmin was a safer alternative to other birth control methods. The advertisements also minimized the risk factors.

The risk factors from using Yasmin may cause death. The FDA found that it was unacceptable that an advertisement would not warn consumers of these serious side effects. In the warning letter, the FDA wrote that “women and their healthcare providers must weigh Yasmin’s additional health risks when considering Yasmin over [other contraceptives] without drospirenone.”

Second FDA Yaz Warning for Ads “Misleading”, “Minimize Serious Risks”

The second FDA warning letter was sent in 2008. The FDA found that Yaz “TV Ads are misleading because they broaden the drug’s indication, overstate the efficacy … and minimize serious risks associated with the use of the drug.”

The FDA found that the Yaz commercials might mislead consumers, because the ads implied that the pill could treat PMS and severe acne. However, the FDA only approved Yaz to treat PMDD (premenstrual dysphoric disorder) and moderate acne. The drug marketers complied with the FDA requests, and ran a $20 million ad campaign. However, the new TV ads continued to mislead consumers.

Third FDA Yaz Warning for Ads that “Fail to Communicate Any Risk Information”

In 2009, the FDA sent the third warning letter. Again, they found that Yaz advertisements were “misleading because they … fail to communicate any risk information associated with the use of these drugs.”

Additionally, the FDA found that the advertisements failed to adequately communicate the drug’s indications. This same issue was found with the commercials in 2003 and 2008.

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