All modern hormonal contraceptives combine hormones to prevent pregnancy. Like many products they come with “WARNINGS” inside their packaging. However, until April 2010 the YAZ WARNINGS or package inserts had not changed significantly. It is possible the WARNINGS or inserts will change yet again for DRSP (DROSPIRENONE) birth control pills following scheduled FDA hearings in December 2010.
Beginning in August 2009, the British Medical Journal (BMJ) began publishing emerging scientific literature and science that has continued into 2011 which underscores an elevated risk of blood clots from DRSP (DROSPIRENONE) containing birth control pills. FDA funded a study that also confirmed an significantly higher risk, estimated as 74% or 1.74x, in comparison to other pills.
YASMIN was the original DRSP (DROSPIRENONE) containing birth control pill sold in the US. It was aggressively marketed with slogans and commercials that heralded the new product line with a product benefit and implied produce superiority through “the difference a little chemistry makes“. This resulted in the FDA issuing a WARNING LETTER in July 2003 citing improper, overly aggressive promotion that failed to highlight then known risks.
YAZ was also promoted as offering women benefits “Beyond Birth Control” through TV, print and Internet portals. YAZ was heralded as offering women benefits as a lifestyle changing alternative to existing forms of birth control. In October 2008 the FDA issued a WARNING LETTER over the promotion of YAZ in direct to consumer advertising that failed to adequately warn consumers of risks, presented confusing messages about the benefits of use and failed to comply with a prior consent decree and settlement. This resulted in “corrective advertising” and the payment of $20 Million Dollars in fines to the Attorney General of 27 States.
Recent reports, on November 21, 2011, in BLOOMBERG, by Jef Feeley & Margaret Cronin Fisk, have arguably shed light on more problems with the promotion and aggressive advertising of DRSP (DROSPIRENONE) containing birth control pills. In “BAYER MAY HAVE TOUTED BIRTH CONTROL PILLS FOR UNAPPROVED USE, E-MAILS SHOW“, Feeley & Cronin Fisk, examine e-mail correspondence that appear to indicate that the then manufacturer, BERLEX, promoted DRSP (DROSPIRENONE) for uses that were “off-label” or not FDA approved. At the time, BERLEX, entered the hormonal contraceptive market with high hopes of acquiring market share through their novel progestin – DRSP (DROSPIRENONE). This story identifies a series of e-mail and other activities designed to allegedly promote the “off-label” use of YASMIN for PMS (Premenstrual Syndrome). There is no form of birth control approved for such a use. Additionally, this BLOOMBERG report identifies an interested executive as having a a role in one of the studies the manufacturer claims establishes the safety and effectiveness of the DRSP (DROSPIRENONE) line of contraceptives. The extensive role of the former executive with oversight of drug development, who later became lead author of the EURAS (European Active Surveillance Study), was not disclosed in the final results which were published in 2007, thus calling into question the failure to disclose a potential conflict of interest and affiliation.
Until April 2010 the warnings in packaging for DRSP (DROSPIRENONE) pills remained relatively the same. However, it was amended and may be subject to yet more changes in 2010 or early 2011, as FDA has set hearings to discuss conflicting and emerging science that reflects these pills pose a higher risk of blood clots than other forms of hormonal contraceptives.
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