CNN previously explored events leading up to the FDA’s 12.8.11 Advisory Committee and public hearings on the potential health risk posed by #DRSP (#DROSPIRENONE) containing birth control pills: #YASMIN, #YAZ, #BEYAZ, #OCELLA, #GIANVI and other generics.
In a narrow 15-11 vote the experts on the Advisory Committee decided that the pills were sufficiently effective in the prevention of pregnancy to outweigh the confirmed risk of blood clots they presented to users of all ages. Notably, a growing body of scientific evidence has repeatedly found the pills present a higher risk of blood clots. Estimates vary on the significantly higher risk they pose. However, a FDA funded study found that they are 75%-77% higher risk in comparison to other available birth control pills. The same experts voted that this risk was not adequately presented in current warnings associated with the product. This is significant because the warning labels and inserts had already been revised twice in less than a twenty-four (24) month period. As a result, it is anticipated that the confusing and arguably misleading labels will be revised yet again in coming months.
Sadly, #DRSP (#DROSPIRENONE) containing birth control pills have been available for over a decade in the United States. Recent science confirms that added risk were not communicated, and that scientific research is catching up with the #DRSP (#DROSPIRENONE) family of pills that delivered more risk than was communicated.
Gabriel F. Zambrano, P.A., is the author and sponsor of this post. Gabriel F. Zambrano, P.A., is actively representing girls and women that have suffered catastrophic injuries from blood clots associated with the DRSP (DROSPIRENONE) family of contraceptives. Additional information is available at DRSPRecall
Defunct manufacuturer, Poly Implant Prothese (PIP), has left a scandalous legacy as reported by CNN. Nearly 500,000 women worldwide are believed to have received their silicone breast implants that were recalled for unusually high failure rates. Recent news reports indicate the implants contained industrial, non-medical grade, silicone adding to questions over their safety and the risk women face moving forward. At least one news report has questioned whether a link to anaplastic large cell lymphoma (ALCL) is related to a removed PIP silicone breast implant further raising a specter of concern and anxiety for victims.
#NOVARTIS announced a massive #recall of over the counter pills on January 9, 2012. This recall applies to #EXCEDERIN, #BUFFERIN, #NODOZ and #GASX products. Emerging reports indicate that the facility, in Lincoln, Nebraska, where the pills were manufactured and packaged had failed repeated safety inspections by the FDA. Chips of different products were found in the wrong containers, indicative of a failure to ‘clear’ the manufacturing lines or machinery used for packaging. While this recall involves ‘over the counter’ medicines found in many households it should be taken seriously as a stray pill could lead to an allergic reaction or adverse event.
Of additional significance is the fact that, the FDA announced that ENDO PHARMACEUTICAL opiod products - or pain killers - should be carefully evaluated to confirm they are the intended prescription only product intended for consumers. Apparently, the prescription pain killers were also manufactured at the same facility and isolated incidents of confusion were reported, but averted, by pharmacists while filling prescriptions.
Refunds are available from Novartis by visiting the company website and following directions. Adverse events, allergic reactions or illness should be reported to the FDA and health authorities.