As noted in prior posts, FDA has scheduled a public hearing of two (2) joint panels of experts to discuss industry backed studies and emerging scientific literature, including an FDA funded study, that confirm an increase risk of blood clots from birth control pills containing DRSP (DROSPIRENONE). FDA’s analysis of related data confirmed a significantly higher risk of potentially life threatening blood clots, or venous thromboembolism (VTE) which can manifest themselves as pulmonary emboli (PE) in the lungs, or deep vein thrombosis (DVT) in the legs.
ConsumerBell a group dedicated to – “Making Safety Easier” – posted a recent blog entry that confirmed that FDA was undecided on a YAZ RECALL but that option remained open pending results of the 12.8.11 hearing. ConsumerBell helps manage and track product recalls and offers services to consumers, retailers and manufacturers. In “Birth Control Ingredient Could Increase Risk of Blood Clots“, ConsumerBell, noted that despite increased risk of blood clots there was no pending YAZ RECALL. Morgan Liscinsky, a press officer for FDA Center for Drug Evaluation and Research, is quoted as stating that “A determination one way or another has not been made“. He described the agency as being in a “wait and see pattern” given the 12.8.11 hearings and again quoted as stating that “the agency has not come to a conclusion one way or another over the risks involved“.
However, given that FDA’s own studies confirmed a significantly higher risk of blood clots in comparison to other pills, as well as multiple FDA WARNING LETTERS, a prior YAZ RECALL and label changes in April 2010 , it is possible that a past history of action and violations will lead to some assertive action by FDA. While women are undertaking some risk in choosing any form of birth control, to accept any risk they must be fully and adequately informed before they can evaluate the safety and effectiveness of any given product. Historically, the DRSP (DROSPIRENONE) family of birth control focused on hype, which resulted in Four (4) FDA WARNING LETTERS, corrective advertising, a failed inspection of manufacturing facilities and notable deficiencies in good current manufacturing practices, before the April 2010 change in the label. Only after achieving and maintaining a Blockbuster status – over $1Billion in annual sales – did information begin to emerge about the higher risk of blood clots from these pills. Could there be more victims, or survivors of DRSP (DROSPIRENONE) than those 10,000 that have come forward and filed lawsuits? Most likely, yes and time will tell whether they will come forward and connect the dots that have taken so long to materialize since these pills came to market.