In the warning letter the FDA sent to Bayer in October of 2008, the agency faulted Bayer for misleading commercials the company had been airing for the birth control drug Yaz. In addition to inaccurately implying that Yaz could be used to treat all severities of acne as well as PMS, according to the FDA Bayer was also over-promising how well the drug treated the symptoms of PMDD.

In the warning letter, the FDA informed Bayer that its 60-second TV ads, “Not Gonna Take it” and “Balloons,” improperly implied that Yaz would relieve the symptoms of PMDD completely, and was inaccurate marketing. The misleading commercials showed visuals of balloons containing symtoms of PMDD floating away as the ad’s theme song “Good-Bye to You” played in the background.

The FDA stated that the visuals and audio improperly implied that women taking Yaz would “say good-bye” to or be completely relieved of the symptoms of PMDD. This misleading information was contrary to the results of the primary clinical trial that served as the basis for approval of Yaz, according to the FDA.

Although the ads stopped airing due to the FDA actions, they were seen by a large number of women in the U.S. Attorneys representing women injured by Yaz and Yasmin have filed lawsuits against Bayer alleging that women who would not otherwise have taken Yaz due to the health risks were induced to take the drug by the misleading information that their symptoms of PMDD would stop completely.

You may have questions if you were one of the women who took Yaz after seeing one of these misleading commercials, and you had serious Yaz side-effects. If you’re looking for answers for yourself or someone you know, contact us to find out the latest information on the litigation filed against Bayer.

Source:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048110.htm

The FDA warning letter to Bayer in October of 2008 told the manufacturer that its TV ads for Yaz, “Not Gonna Take It” and “Balloons,” were inaccurate marketing because the ads implied that if you took Yaz, you would have completely clear, acne-free skin. Both of these misleading commercials showed close-up images of women with completely clear skin and audio that stated Yaz will “help keep skin clear.”

FDA Says Bayer Wrongly Implied Yaz Clears Skin

In the warning letter the FDA told Bayer that the ads improperly implied that taking Yaz would give you clear skin, contrary to substantial clinical evidence detailed in the warning letter that demonstrated that taking Yaz did not give a typical woman completely clear skin.

Bayer pulled the deceptive ads due to the FDA actions, and then aired a $20 million corrective advertising campaign, but it’s believed that the misleading commercials induced many women to take Yaz in the belief that their acne would completely disappear or “float away” as was advertised by Bayer. Many of these women would never have taken Yaz because of the risk to their health.

Attorneys are currently filing lawsuits on behalf of women who were injured after seeing these commercials and taking Yaz. You may have questions because you or someone you know took Yaz and were injured. Contact us today and tell us your Yaz story.

Source:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048110.htm

The birth control pill Yaz was approved in 2006 by the FDA for the treatment of premenstrual dysmorphic disorder (PMDD) in women who were also seeking birth control. In 2008 Bayer began airing the 60-second TV ads “Not Gonna Take it” and “Balloons”  to promote the new drug.

After numerous complaints from women injured by taking Yaz, the FDA sent Bayer a warning letter stating that Bayer’s ads improperly implied that Yaz was approved for the treatment of premenstrual syndrome (PMS), and was inaccurate marketing. The FDA took issue with the fact that the misleading commercials failed to adequately convey that Yaz was only appropriate for women who experienced the symptoms of PMDD, not the less severe syndrome PMS.

Misleading Yaz Commercials

The misleading commercials contained a list of symptoms such as anger, irritability, depressed mood, anxiety, bloating, change in appetite, headaches, and muscle aches, and the audio stated that “Yaz is the only birth control pill proven to treat the emotional and physical premenstrual symptoms that are severe enough to impact your life.” The FDA stated that this claim failed to distinguish between PMS and PMDD, making the ads misleading.

FDA Confirms Yaz Not Approved to Treat PMS

The FDA noted that the statement in the ads’ text that “Yaz treats PMDD” along with small print that “PMDD is a mood disorder related to the menstrual cycle” was not sufficient to communicate that Yaz was not approved for the treatment of PMS, or to overcome the implied message created by the visuals and images in the ads that Yaz would be an appropriate treatment for any woman who experienced the symptoms listed in the ads.

The FDA also noted that the statement in the ads that “Yaz is the only birth control pill proven to treat the emotional and physical premenstrual symptoms that are severe enough to impact your life” failed to communicate that Yaz is not approved for the treatment of PMS and failed to distinguish between PMS and PMDD.

Many women who began taking Yaz after seeing these misleading commercials suffered severe injury or death. Many of these women would not have started taking Yaz if the ads had properly informed them of the conditions Yaz was approved to treat, and of the risks involved in taking Yaz.

Due to the FDA actions, Bayer was forced to pull these ads and air a $20 million corrective advertising campaign to tell consumers the original ads were not clear.

Have you ever taken Yaz because you thought it would treat your PMS? Did your health suffer as a result?

Source:
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048110.htm

Please share our latest post Headline: FDA Warned Bayer about Quality Control!

In September of 2009, the Food and Drug Administration (FDA) sent Bayer a warning letter stating that Bayer was not following proper quality control protocol in calculating ingredients for its drugs at one of its manufacturing plants in Germany. The plant provides many of the hormones used in manufacturing Yaz and Yasmin birth control pills for the consumption by women in the U.S.

Bayer’s Response Didn’t Address Problems at Yaz Manufacturing Plant

The warning letter was a follow-up to a notification it gave to Bayer after a March 2009 inspection at the German plant. Bayer responded to the FDA that the quality of the drug was not affected, but the warning letter states that Bayer’s response does not adequately address some of the deficiencies found in the March inspection.

According to the warning letter, Bayer used a testing method where test results were averaged rather than reporting test results from individual batches. According to the FDA, the individual batches were out-of-specification and should not have been released. It is estimated that at least eight batches tested with the improper method were shipped to the U.S. The FDA may delay imports from the plant as it reviews a list of all batches of the hormones which were tested improperly and shipped.

Attorneys representing women injured by Yaz and Yasmin believe Bayer’s handling of the quality control issues in the German plant demonstrates a disregard for the safety of its drugs distributed to women in the U.S. Women taking the drugs have experienced severe Yaz side effects and Yasmin side effects from taking the drugs, including surgery and even death.

Source:
http://www.manufacturing.net/News-FDA-Warns-Bayer-Over-German-Manufacturing-Plant-091509.aspx?menuid=282
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm182206.htm

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?

Source:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies/UCM168914.pdf

We posted a blog about how the FDA Warned Bayer about Advertising Yaz for Acne. This is an important post, please share out with your friends in Facebook and Twitter.

After purchasing Berlex Laboratories, the maker of Yasmin, Bayer developed a lower dosage Yasmin drug called Yaz, which was approved in 2006 by the FDA for the treatment of moderate acne in women who were also seeking birth control.

In October of 2008, after receiving many complaints from women injured by taking Yaz and Yasmin, the Food and Drug Administration (FDA), through its Division of Drug Marketing, Advertising and Communications (DDMAC), sent Bayer a warning letter. The warning letter stated that Bayer’s 60-second TV ads “Not Gonna Take It” and “Balloons” for Yaz improperly implied that Yaz was approved for acne of all severities, and was inaccurate marketing.

Inaccurate Marketing and Misleading Commercials

The FDA took issue with the fact that in “Not Gonna Take It” the word “ACNE” appeared in large print on the screen while audio claimed that “It can also help keep your skin clear,”and a visual of a woman with completely clear skin was displayed. The FDA also took issue with the fact that in “Balloons,” the word “ACNE” appeared in a balloon floating away from a woman with completely clear skin while audio claimed that Yaz “also helps keep skin clear.”

The FDA also stated that the claim in small print that Yaz was approved for the treatment of moderate acne did not diminish the misleading impression created by the audio and visual claims in the ads that Yaz was approved for all severities of acne.

Many of the women injured by Yaz and Yasmin have hired attorneys who believe that the fancy advertising in these misleading commercials aired by Bayer that Yaz could treat all severities of acne induced women to take Yaz who would not otherwise have accepted the health risks of taking Yaz. The FDA actions caused the commercials to be pulled from the air and Bayer was forced to air a $20 million dollar corrective advertising campaign.

Have you suffered painful or even life-threatening side effects of Yaz? Get in touch with someone who can help.

Sources: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2008/ucm1048110.htm

The main difference between Yasmin and Yaz is in the amount of the estrogen component (ethinyl estradiol) that each contains. Yasmin contains more of the estrogen component than Yaz. Yasmin was approved in 2001 while Yaz was approved in 2006. Ocella is simply the generic, more affordable version of the drug.

The birth control pill Yasmin, manufactured by Bayer Healthcare Pharmaceuticals, was originally manufactured by Berlex Laboratories. In 2003, the Food and Drug Administration (FDA), sent Berlex Laboratories a warning letter stating that its misleading commercial for Yasmin improperly implied that the birth control pills were superior to the other combined oral contraceptives (COCs) then on the market, and improperly down-played the risks to the health of women taking the drug.

At the time of this 2003 Warning Letter, Berlex Laboratories was running a 60-second television ad called “Goodbye Kiss.” The FDA warned Berlex that the ad was misleading due to claims its drug was superior to other COCs on the market, and because Berlex did not adequately inform consumers in the ad that taking Yasmin had risks different than other birth control pills.

The FDA informed Berlex that its inaccurate marketing raised “significant public health and safety concerns” and ordered Berlex to immediately discontinue running the ad.

The FDA specifically objected to the statement in the ad, “Ask about Yasmin, and the difference a little chemistry can make.” The FDA stated that they were “not aware of substantial evidence or clinical experience demonstrating that Yasmin is superior to other COC’s [combination oral contraceptives] or that the drosperinone in Yasmin is clinically beneficial. On the contrary, FDA is aware of the added clinical risks associated with drosperinone.”

Source:
FDA Warning Letter to Berlex Laboratories (.pdf download)