Since Bayer Revised YAZ Label In April 2012 There Has Been More Medical Evidence That DRSP Pills Increase Risks Of Blood Clot Side Effects Like DVT And PE
(Posted by Tom Lamb at DrugInjuryWatch.com)
The drug labels for Yasmin, YAZ, Safyral, and Beyaz were revised by Bayer and the FDA in April 2012 by adding information about the several different (in terms of their conclusions) medical studies concerning the increased blood clot risks associated with drospirenone-containing birth control pills.
For more details about this April 2012 drospirenone (DRSP) label revision announcement by the FDA, see: "FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone".
From that FDA document we get this summary of that April 2012 Bayer YAZ label change:
The revised drug labels (Beyaz, Safyral, Yasmin and Yaz) will report that some epidemiologic studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone-containing products. The labels also will include a summary of the previously released results of an FDA-funded study of the blood clot risk.
In the past few years following that April 2012 YAZ label change there has emerged more medical evidence in support of the contention that birth control pills containing drospirenone (DRSP) are associated with higher rates of side effects caused by blood clots, such as DVTs and PEs.
From this July 22, 2015 article, "Newer oral contraceptive combinations associated with higher VTE risk", published online at Healio.com, we get this overview of an important and relatively recent medical study concerning drospirenone-containing birth control pills:
Newer preparations of oral contraceptives increased the risk for venous thromboembolism compared with second-generation drugs, according to study results.
Although oral contraceptives are known to increase the risk for VTE, the risk of individual third-generation drugs had not been quantified, according to study background. Previous analyses have also been inconclusive on the risk for VTE with combinations of these drugs.
Yana Vinogradova, a research fellow and statistician at the University of Nottingham, United Kingdom, and colleagues sought to quantify the associations between the use of combined oral contraceptives and VTE risk, adjusting for comorbidities and other factors.
“VTE risks associated with different progestogens used in combined oral contraceptives fall into two distinct groups,” Vinogradova told HemOnc Today. “Newer formulations, containing drospirenone, desogestrel, gestodene or cyproterone are associated with risks from 1.5 to 1.8 times higher than older ones using levonorgestrel, norethisterone or the relatively newer norgestimate....
The subject of this Healio.com article is "Use of combined oral contraceptives and risk of venous thromboembolism: nested case-control studies using the QResearch and CPRD databases", published in May 2015 by the BMJ medical journal.
Beyaz / Safyral / YAZ / Yasmin / Ocella / Gianvi
Free Case Evaluation
Strictly Confidential, No Obligation.
We wrote our own article about that BMJ medical journal article and a related Editorial piece by the well-regarded Susan S. Jick back in May 2015: "Beyaz / Safyral / YAZ / Yasmin: These Drospirenone Containing Birth Control Pills Have A Higher Risk Of Blood Clot Side Effects Than Older Options".
This "new" (vis-à-vis the April 2012 YAZ label change) medical evidence raises the possibility of there being another revised label for drospirenone birth control pills with a stronger and more clear, i.e., less ambivalent, warning about the increased risks of side effects like deep vein thrombosis (DVT), pulmonary embolism (PE), strokes, and heart attacks.
There is a precedent for there being more than one such drug label change required by the FDA for contraceptive products like YAZ, Yasmin, Beyaz, and Safyral.
Back in 2008 we wrote this blog post, "Blood-Clot Warning On Ortho Evra Birth Control Patch Increased, Again, In January 2008", which had as its sub-title: Label For "The Patch" No Longer Has Conflicting Information About Its Increased Risk Of Blood Clots.
From that post we get this report:
A January 18, 2008 WebMD article, "Stronger Warning for Birth Control Patch", provided a concise summary of the latest news about the Ortho Evra Contraceptive Transdermal (Skin) Patch manufactured by Ortho-McNeil Pharmaceuticals, a division of Johnson & Johnson (JNJ):
The FDA today strengthened its warning on the risk of serious blood clots in women using the Ortho Evra birth control skin patch.
The warning about venous thromboembolism -- clots in veins that may be life-threatening if they travel to the lungs and cause pulmonary embolism -- isn't new. It's been on the Ortho Evra patch label since September 2006.
What's new is that now, the patch's label no longer notes conflicting information about that risk.
Previously, the Ortho Evra patch's label mentioned mixed results from two studies on clotting risk. One study showed that patch users were twice as likely as birth control pill users to develop venous thromboembolism. The other study showed that patch users and pill users were equally likely to develop venous thromboembolism.
Now, results from a third observational study are in, and that study shows that the odds of developing venous thromboembolism are higher for women who use the Ortho Evra patch than for women using birth control pills.
Today, the FDA ordered the results of that new study to go on the Ortho Evra patch label.
Given the mounting medical evidence that there is a real increased risk -- not an arguable or theoretical risk -- of developing a DVT, PE, stroke, or heart attack while using Beyaz, Safyral, Yasmin, or YAZ, one wonders whether DRSP birth control pills will follow the course of there being another blood clots warning label change, as was done with the Ortho Evra patch.
DrugInjuryLaw.com: Legal & Medical Information About Drug Side Effects (All website content by attorney Tom Lamb)
Drug Injury Case Evaluation - Free. Confidential. No Obligaion. (Case review done by attorney Tom Lamb)