FDA Sends Warning Letter to Makers of Yaz – Yasmin

As if the makers of Yasmin / Yaz didn’t have enough to worry about with pending lawsuits related to major side-effects, now they’ve been served a warning letter from the FDA for quality control problems at a plant in Germany that manufactures one of the ingredients in the drug. FDA inspectors discovered the problems during an inspection in March, 2009, and informed Bayer. Bayer claims that the quality of the drug was not affected.

Unacceptable Testing Method
According to the FDA warning letter, Bayer used a testing method that averaged the test results rather than reporting the test results for individual batches. The average was within specified parameters, but individual batches were out-of-specification (OOS), and according to the FDA letter should not have been released. At least eight batches that were tested with this method were shipped to the U.S.

After the March inspection, Bayer reviewed the batches it had shipped to the U.S. between 2007 and 2009. They responded to the FDA in April, 2009, claiming that there was no problem with the quality and an explanation of why it believes this. This recent letter from the FDA states that Bayer’s “response does not adequately address some of the deficiencies.”

Bayer is now required to give the FDA a list of all the batches shipped to the U.S. that may have been tested with the unacceptable method. The FDA may also delay imports from the plant.

Yasmin / Yaz Plagued with Problems
This is just the latest problem Bayer has faced with Yaz / Yasmin birth control medications. Life threatening side effects have already prompted multiple lawsuits against the drug maker. Yasmin is a birth control pill that uses a combination of the hormones drospirenone and ethinyl estradiol to prevent pregnancy. Drospirenone can cause elevated potassium levels leading to heart problems and other health problems.

Yaz/Yasmin side effects may include deep vein thrombosis (DVT), pulmonary embolism (PE), heart attack, stroke, cardiac arhythmias, gallbladder disease, and sudden death. The generic version of Yasmin is called Ocella, and carries the same risks.

One of the biggest reported risks of Yaz/Yasmin is the development of blood clots, leading to stroke or heart attack in women who were healthy before taking the drug and were not at risk for either life threatening event. DVT is blood clot in the legs. PE is blood clot in the lungs. In young, healthy women these blood clots are often overlooked or misdiagnosed, leaving them in grave danger.

Even when the clots are discovered and treated the effects can be long-term and can mean a lifetime of taking medications to prevent more clots from forming.

Are you experiencing any of these side effects? Click here to report your symptoms.

Read the letter from Dept of Health & Human Services to Makers of Yasmin

Excerpt from the letter to the makers & marketers of Yasmin from the Dept. of Health & Human Services :

"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."

Read the entire letter here!

Were you mislead? Contact us today.

Yaz & Yasmin News | Yaz Judge to Limit Questing about Sex Lives

Yaz Judge Likely to Limit Questioning About Plaintiffs’ Sex Lives

The judge presiding over hundreds of Yaz birth control pill injury lawsuits has indicated she will not allow attorneys for the drug’s maker to delve too deeply into the sexual history of women bringing the lawsuits.

Attorneys for Bayer Healthcare Corp. want to ask the plaintiffs some questions about their sex lives, including other types of contraceptives they have used. Philadelphia Common Pleas Court Judge Sandra Mazer Moss said while she may allow some questions, she does not intend to turn the questioning into a sleazy examination of how many sexual partners the plaintiffs have had, according to a Law.com report.

The use of Yaz, Yasmin and a Ocella contraceptives has been linked to life-threatening blood clots, pulmonary embolism, deep vein thrombosis, stroke, heart attack, breast cancer, gallbladder injuries or liver tumors. The pills use the same type of the hormone progestin, which can raise the levels of potassium in the blood, leading to health problems.

Hundreds of plaintiffs have sued the maker of the drug, accusing them of causing injuries and seeking financial compensation for their medical bills and other damages.

JUDGE TO LIMIT SEXUAL QUESTIONS

It’s not unusual for defense attorneys to ask for permission to pepper plaintiffs with tons of questions, including on taboo topics such as their sex lives in an effort to discourage them from pursuing their legal rights. Some women who claim they were injured by Yaz or related contraceptives may be scared off at the thought of having to expose their personal lives in court. This could be particularly for girls as young as 15 who are among those suing for Yaz-related injuries, attorneys said.

“Such an intimate exploration of their sexual practice is irrelevant, unduly intrusive into very private and personal matters, and appears to be designed to intimidate, rather than discover, relevant information,” the plaintiffs’ attorneys said in a legal brief.

It looks like the Yaz plaintiffs have a friend on the bench in Judge Mazer Moss. During a recent hearing, the judge even joked that she was surprised the defense attorneys haven’t asked for permission to ask female plaintiffs how many sexual partners they have had, Law.com reports.

“Then we could put out a brochure and everyone will know,” the judge said.

For the record, attorneys for the women said they do not object to questions about other contraceptives the plaintiffs have used or releasing complete medical records for the women. The judge ordered attorneys for both sides to try and hammer out a compromise questionnaire to be given to plaintiffs.

Yaz & Yasmin Lawsuits | Do you have a claim?

Yaz®-Yasmin®

The best selling birth control pill, Yaz®, and its predecessor, Yasmin, have been linked to serious side effects. If you or someone you know has suffered blood clots, pulmonary embolism, deep vein thrombosis, stroke, heart attack, liver tumors, breast cancer or death after taking Yaz or Yasmin, you should contact an attorney.

Manufactured by Bayer HealthCare Pharmaceuticals, Yasmin® and Yaz® are oral contraceptive combination drugs.

Although there are numerous brands of birth control pills available, Yasmin® and Yaz® dominate the market with more than a quarter market share between them.

One of the reasons for the popularity of Yaz® was Bayer’s aggressive promotion. However, certain television advertisements for Yaz caused the FDA to issue a warning letter to Bayer saying that the commercials overstated the drug’s benefits while understating its risks. The Attorney Generals of 27 states joined the FDA in claiming that Bayer’s ads ran afoul of federal laws against promoting unapproved uses of a drug. The ads allegedly implied that Yaz® could be used to treat or cure a variety of other conditions associated with menstruation such as premenstrual syndrome (PMS), acne, and muscle aches.

The warning letter also noted that Yaz® actually has additional risks compared to other birth control pills because it contains drospirenone, a progestin that can increase potassium levels. The side effects of drospirenone include an increased risk of serious heart and other health problems. Thus, Yaz® and Yasmin® are linked to life-threatening injuries including blood clot, stroke, heart attack, and pulmonary embolism.

In response, Bayer agreed to run a $20 million advertising campaign to correct the misrepresentations. Bayer also agreed to submit all Yaz®ads for federal screening for the next six years. Yaz® and Yasmin®are already the subject of multiple federal lawsuits. The lawsuits allege that Bayer failed to warn of the increased risk of injury associated with these birth control pills while overpromoting their benefits. Furthermore, the FDA has allegedly received many more reports of adverse events for Yaz® and Yasmin® than for other birth control pills that have been on the market longer.
 Individuals who have suffered injuries as a result of Yaz® or Yasmin® birth control are eligible to seek compensation for their losses by filing a lawsuit. If you or a loved one has been harmed by the use of Yasmin® or Yaz®, you need to explore your legal options before it is too late. The Kansas City, Missouri law firm of Peterson & Associates has successfully resolved thousands of cases involving pharmaceutical and medical device manufactures. Let us put our experience and expertise to work for you. Contact the law offices of Peterson & Associates for a free consultation by calling 816-LAW-FIRM.