Recent Blog Posts

FDA Inspects Bayer Plant and Finds Violations of U.S. Manufacturing Laws

Kiesel Boucher Larson, LLP — Mon, 28 Jun 2010 16:38:00 GMT

In early March, 2009, the FDA inspected Bayer's active pharmaceutical ingredient (API) facility in Bergkamen, Germany. This is the plant that makes the key ingredient in Yaz and Yasmin, drospirenone. The inspection revealed several deviations from U.S. current good manufacturing practices (CGMP). As a result, the FDA declared that Bayer had violated the Federal Food, Drug, and Cosmetic Act. Under this Act, drugs manufactured in facilities that do not operate in accordance with CGMP are considered "adulterated."

In its warning letter to Bayer, the FDA points out that Bayer "failed to establish and follow adequate written procedures for cleaning and maintenance of [production] equipment." Additionally, the FDA expressed concern that Bayer had established deficient internal procedures for running its quality management system. Investigators noted that Bayer measured the quality of its drugs, including drosperinone, by averaging the results of several samples, rather than reporting individual test results. According to the FDA, this method for product sampling and testing amounted to an "unacceptable practice." Concerned about releasing adulterated batches of drugs into the marketplace, the FDA demanded that Bayer take corrective action to conform to CGMP

To read the FDA warning letter, click here.

Bayer Makes Changes to Yaz/Yasmin Labels in the United States

Kiesel, Boucher & Larson — Fri, 11 Jun 2010 18:17:00 GMT

In April, 2010, Bayer, the manufacturer of the oral contraceptives Yaz and Yasmin, updated both drugs' labels in the United States. In its older labels, the company had acknowledged that the use of oral contraceptives is associated with an increased risk of venous thromboembolism (VTE), or the formation of blood clots within the veins. Yaz and Yasmin are distinct from previously formulated oral contraceptives because they contain the newer progestin drospirenone. The new labels now admit that two epidemiological studies suggest that the risk of VTE occurring in Yasmin users is higher than that for users of earlier generation birth control pills containing the progestin levonogestrel. Even with these new warnings in place, Bayer continues to sell and aggressively market the products while denying the increased risk associated with them, cursorily arguing that the conclusions from the two independently funded studies should be disregarded.

FDA Warns Manufacturer of Yaz/Yasmin About Misleading Marketing Practices

Kiesel Boucher & Larson — Fri, 11 Jun 2010 18:10:00 GMT

On three separate occasions in 2003, 2008 and 2009, the FDA reviewed promotional and advertising materials for Yasmin and Yaz and in each instance concluded that the content of the materials was misleading.

In 2003, the FDA sent a letter to Berlex Laboratories (the manufacturer of Yaz and Yasmin at that time) requesting the immediate removal of its 60-second TV ad for Yasmin. The letter explains that the advertisement "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 letter then informs Berlex that "the FDA is aware of the added clinical risks associated with drospirenone…"

To read the FDA's 2003 letter to Berlex, click here.

Five years later, in 2008, the FDA warned Bayer that two of its TV commercials for Yaz were in violation of the Federal Food, Drug, and Cosmetic Act. This time, the FDA explained that the ads "encourage use of Yaz in circumstances other than those in which the drug has been approved, over-promise the benefits and minimize the risks associated with Yaz." Additionally, the warning letter points out that any risk disclosures contained in the commercials are countered by "distracting visuals, numerous scene changes, and other competing modalities such as the background music which combine to interfere with the presentation of the risk information."

To read the FDA's 2008 warning letter to Bayer, click here.

Most recently, in a 2009 letter, the FDA again criticized Bayer's marketing practices, informing the drug manufacturer that its sponsored links for Yaz on internet search engines (such as Google) are misleading. In this newest warning, the FDA not only mentions Bayer's inadequate communication of the drug's indications, but also cites Bayer's failure to communicate any risk information associated with the drug.

To read the FDA's 2009 letter to Bayer, click here.

Welcome to our Yaz Side Effects Blog

Yaz Attorney — Fri, 11 Jun 2010 16:14:00 GMT

Our Yaz attorneys are pleased to announce the launch of our Yaz Side Effects blog with an RSS feed available at http://www.yazexperts.com/Blog/Entire-Blog-Feed/RSS.xml.