Despite Safyral and Drospirenone Concerns, It’s Business As Usual at Bayer

Leverkusen, GermanyIt’s interesting to note that Bayer’s Third Quarter (Q3) report was released October 31, a date most equate with the observance of Halloween and all things scary. Dressing up is also a hallmark of the Halloween fun, and to that end, there is no shortage of dressing up in any typical corporate report that strives to dispense the required data to shareholders with minimal fuss. Is this why unsavory aspects, including legal implications of drugs such as Safyral, are left to the end?

Safyral is among the stable of Bayer contraceptive products based on drospirenone, a synthetic hormone that is thought to carry fewer undesirable side effects than older-generation birth control pills. Safyral is, in fact, the oral contraceptive Yasmin (drospirenone 3 mg /ethinyl estradiol 0.03 mg) with the added benefit of the B vitamin folate. Bayer has found a receptive market in contraceptive products that carry added value, such as the addition of folate that wards against rare neural tube defects in developing infants, should a woman become pregnant.

But due to the closeness of the two formulations, Safyral side effects constitute an automatic reference to Yasmin.

To that end, any reference to blood clots and deep vein thrombosis with regard to Yasmin, is also a reference to Safyral blood clots due to the fact the two contraceptives are, for all intents and purposes, one and the same.

However, by virtue of its Q3 summary, of all its contraceptive products, Bayer appears to be fixated on Yasmin and Yaz. What also appears to be an important aspect of any legal issue surrounding a product - including settlements with individuals or groups of individuals alleging drospirenone side effects - is that such settlements are put forward and undertaken without admission of liability.

From Bayer’s Q3 Report, dated October 31, 2013:

“As of October 18, 2013, Bayer had reached agreements, without admission of liability, to settle the claims of approximately 7,660 claimants in the US for a total amount of about US$1.575 billion. Bayer has only been settling claims in the US for venous clot injuries (deep ­vein thrombosis or pulmonary embolism) after a case-specific analysis of medical records on a rolling basis. Such injuries are alleged by about 2,300 of the pending unsettled claimants. Bayer will continue to consider the option of settling such individual lawsuits in the US on a case-by-case basis.”

It is interesting to note in spite of the thousands of cases alleging grievous drospirenone side effects inherent with oral contraceptives such as Safyral, Bayer is pressing on with plans to expand market share of drospirenone-based contraceptives even further. The Q3 report references YAZ Flex Plus U.S.A., which is described by Bayer as “oral contraception with flexible dosage regimen and folic acid supplementation.” Bayer refers to the latter as among the most important drug candidates in the approval process.

While there has been plenty of legal activity over Yasmin and Yaz with regard to blood clots and DVT, according to blogger Tom Lamb writing in Drug Industry Watch, there appears to be little interest on the part of Bayer in negotiating settlements involving alleged cases of arterial clots that can lead to strokes and other serious health consequences.

Safyral is among the drospirenone-based contraceptives referenced as a potential source for arterial Safyral blood clots.