![Following the convening of a joint panel of experts on 12.8.11 to discuss multiple independent studies related to the DRSP (DROSPIRENONE) family of contraceptives, on 4.10.12 the U.S. Food & Drug Administration issued the “FDA DRUG SAFETY COMMUNICATION” below. This communication has been reported in related news stories and “PR” from the manufacturer, BAYER HEALTHCARE PHARMACEUTICALS in a fashion that downplays the serious risk that this family of contraceptives, and their generic equivalents present to users. Moreover, the history of these pills, FDA sanctions against the manufacturer, over 11,000 pending civil lawsuits, allegations of “conflicts of interest” in the 12.8.11 Ad Comm Meeting, as well as testimony from Former FDA Commissioner D. Kessler regarding missing or hidden data is being complete ignored in recent reports. More information on the above and YAZ CLAIMS is available here YAZ RECALL.
FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone
This update is in follow-up to the FDA Drug Safety Communication posted on 9/26/11: Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone.
Safety Announcement
[4-10-2012] The U.S. Food and Drug Administration (FDA) has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Drospirenone is a synthetic version of the female hormone, progesterone, also referred to as a progestin. Based on this review, FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills. FDA is adding information about the studies to the labels of drospirenone-containing birth control pills. See Table 1 for a list of drospirenone-containing products.
Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use.
Healthcare professionals should consider the risks and benefits of drospirenone-containing birth control pills and a woman’s risk for developing a blood clot before prescribing these drugs.
The studies reviewed did not provide consistent estimates of the comparative risk of blood clots between birth control pills that contain drospirenone and those that do not. The studies also did not account for important patient characteristics (known and unknown) that may influence prescribing and that likely affect the risk of blood clots. For these reasons, it is unclear whether the increased risk seen for blood clots in some of the epidemiologic studies is actually due to drospirenone-containing birth control pills.
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.
To put the risk of developing a blood clot from a birth control pill into perspective: The risk of blood clots is higher when using any birth control pills than not using them, but still remains lower than the risk of developing blood clots in pregnancy and in the postpartum period.
These studieswere discussed at the joint meeting of the FDA’s Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011. FDA’s briefing document for this meeting is found here.
Previous Drug Safety Communications related to the risk of blood clots with birth control pills that contain drospirenone were posted on May 31, 2011, September 26, 2011, and October 27, 2011. The DSC posted in May 2011 updated the public about FDA’s ongoing safety review of two new studies that reported a greater risk of blood clots for women taking drospirenone-containing products as compared to the risk in women taking products containing other progestins. Previously published studies had reported conflicting findings. The DSC posted in September 2011 discussed preliminary results from a FDA-funded study suggesting an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing products compared to users of other hormonal contraceptives. The DSC posted in October 2011 released the final study report and appendices from the FDA-funded study in advance of the Joint Meeting of the Drug Safety and Risk Management Advisory Committee and Reproductive Health Drugs Advisory Committee Meeting.
Today’s communication is in keeping with FDA’s commitment to inform the public about the Agency’s ongoing safety review of drugs. FDA will communicate any new information on drospirenone-containing birth control pills and the risk of blood clots when it becomes available.
For more information: http://www.fda.gov/Drugs/DrugSafety/ucm299305.htm](http://24.media.tumblr.com/tumblr_m2bkc7HhCf1qmcbngo1_500.jpg)
Following the convening of a joint panel of experts on 12.8.11 to discuss multiple independent studies related to the DRSP (DROSPIRENONE) family of contraceptives, on 4.10.12 the U.S. Food & Drug Administration issued the “FDA DRUG SAFETY COMMUNICATION” below. This communication has been reported in related news stories and “PR” from the manufacturer, BAYER HEALTHCARE PHARMACEUTICALS in a fashion that downplays the serious risk that this family of contraceptives, and their generic equivalents present to users. Moreover, the history of these pills, FDA sanctions against the manufacturer, over 11,000 pending civil lawsuits, allegations of “conflicts of interest” in the 12.8.11 Ad Comm Meeting, as well as testimony from Former FDA Commissioner D. Kessler regarding missing or hidden data is being complete ignored in recent reports. More information on the above and YAZ CLAIMS is available here YAZ RECALL.
FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone
This update is in follow-up to the FDA Drug Safety Communication posted on 9/26/11: Safety review update on the possible increased risk of blood clots with birth control pills containing drospirenone.
Safety Announcement
[4-10-2012] The U.S. Food and Drug Administration (FDA) has completed its review of recent observational (epidemiologic) studies regarding the risk of blood clots in women taking drospirenone-containing birth control pills. Drospirenone is a synthetic version of the female hormone, progesterone, also referred to as a progestin. Based on this review, FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills. FDA is adding information about the studies to the labels of drospirenone-containing birth control pills. See Table 1 for a list of drospirenone-containing products.
Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use.
Healthcare professionals should consider the risks and benefits of drospirenone-containing birth control pills and a woman’s risk for developing a blood clot before prescribing these drugs.
The studies reviewed did not provide consistent estimates of the comparative risk of blood clots between birth control pills that contain drospirenone and those that do not. The studies also did not account for important patient characteristics (known and unknown) that may influence prescribing and that likely affect the risk of blood clots. For these reasons, it is unclear whether the increased risk seen for blood clots in some of the epidemiologic studies is actually due to drospirenone-containing birth control pills.
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.
To put the risk of developing a blood clot from a birth control pill into perspective: The risk of blood clots is higher when using any birth control pills than not using them, but still remains lower than the risk of developing blood clots in pregnancy and in the postpartum period.
These studieswere discussed at the joint meeting of the FDA’s Reproductive Health Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 8, 2011. FDA’s briefing document for this meeting is found here.
Previous Drug Safety Communications related to the risk of blood clots with birth control pills that contain drospirenone were posted on May 31, 2011, September 26, 2011, and October 27, 2011. The DSC posted in May 2011 updated the public about FDA’s ongoing safety review of two new studies that reported a greater risk of blood clots for women taking drospirenone-containing products as compared to the risk in women taking products containing other progestins. Previously published studies had reported conflicting findings. The DSC posted in September 2011 discussed preliminary results from a FDA-funded study suggesting an approximately 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing products compared to users of other hormonal contraceptives. The DSC posted in October 2011 released the final study report and appendices from the FDA-funded study in advance of the Joint Meeting of the Drug Safety and Risk Management Advisory Committee and Reproductive Health Drugs Advisory Committee Meeting.
Today’s communication is in keeping with FDA’s commitment to inform the public about the Agency’s ongoing safety review of drugs. FDA will communicate any new information on drospirenone-containing birth control pills and the risk of blood clots when it becomes available.
For more information: http://www.fda.gov/Drugs/DrugSafety/ucm299305.htm
February 28, 2012
”Women Warned Over Popular Birth Control Medication” by Sandra Chapman, of Indianapolis, 13, WTHR.COM, explores the history of DRSP (DROSPIRENONE) containing birth control pills and the claim of one woman who suffered a DVT (Deep Vein Thrombosis). As previously reported on this blog, DRSP LAWSUITS, or DROSPIRENONE LAWSUITS continue to exceed 11,000 as of February 2012. The story does not address the December 8, 2011 Advisory Committee vote that found the warnings were inadequate and do not (even as of this writing) communicate the elevated risks of blood clots associated with #DRSP #DROSPIRENONE containing birth control pills. Additional information on that subject is available at DRSPRecall.
INDIANAPOLIS -
It was one the best selling birth control pills on the market. But now, a warning for women.
Fifty patients have reportedly died from taking the contraceptive and thousands of others say it causes potentially life-threatening side effects, prompting a trusted drug maker to spend millions to highlight the risks.
Linda Rosenberg was the picture of a healthy baby. She recalls growing up on Bayer Baby Aspirin and planned to care for her own baby in the same way, someday.
In 2007, motherhood was still in the future when her doctor told her about Yaz, a new oral contraceptive manufactured by Bayer. It was sweeping the country with a flashy ad campaign.
“There was no reason to believe the product was, you know, that there was any danger in taking it,” explained Rosenberg.
But two years after taking daily doses of Yaz, Linda began experiencing unexplainable swelling. At her doctor’s urging, she got an ultrasound. It probably saved her life. A blood clot was discovered in her ankle.
“Yes and right behind my knee, which was causing the swelling in the ankle,” she told 13 Investigates.
Linda went through 18 months of treatment. But along the way, she lost more than she could have imagined.
“Now, I can’t have children,” she revealed.
The treatment for the blood clot left her unable to conceive children and her trust in a childhood name was gone. Rosenberg is now among hundreds of women nationwide blaming Bayer’s Yaz birth control for devastating health effects.
“I’d like to see it off the shelves, if it’s not safe,” Linda insists.
“It doesn’t happen just with Yaz,” according Dr. Sara Sayger.
Sayger has prescribed Yaz as the medical director at the Purdue Health Center and Women’s Clinic in West Lafayette. In fact, Sayger concludes all oral contraceptives come with some risk.
“Blood clotting is an uncommon side effect. A real danger, but an uncommon side effect,” she said.
But according to lawsuits nationwide, Yaz is being blamed for the deaths of at least 50 women, including young college students.
Dr. Sayger confirms the new ingredient.
“We’ve seen a couple of new synthetic progesterones that have come onto the market. Yaz is one of those new synthetic progesterones,” she said. Sayger describes Yaz as a “niche” contraceptive and evaluates closely whether it’s a good fit for each patient. “It’s a pill that’s been very positively received by women who have been on other products and still had very extreme emotional, premenstrual mood swings. Yaz seemed to be a good answer for those people” she found in her practice. But Sayger agrees it’s not for everyone. In 2008, the FDA sent Bayer a warning letter regarding its advertising for Yaz. The FDA took issue with claims by Yaz to treat PMS and acne of all severities, even though Yaz had not been evaluated to do such. The FDA also said “Yaz has additional risks because it contains the progestin, Drospirenone…which may result in potentially serious heart and health problems” in high risk patients. The FDA said Bayer knew about the risks, the information came from the company’s own studies. Yet it’s warning labels failed to adequately disclose the potential danger. Bayer declined an on-camera interview with 13 Investigates about Yaz, but in a released statement said “..the benefits…outweigh the potential risks” and that “labels…do not adequately reflect the risk…and should be revised to include additional information from available studies.” Bayer is now airing corrective ads. Sayger points out that the FDA shares responsibility to ensure products for women are safe and wants to see more studies. “Birth control pills have been on the market for 50-plus years. We now have three or four generations of pill users, so we have lots of experience with birth control pills,” Sayger said. But it’s too late for Linda Rosenberg. “Had I known that it could have been an issue, or a problem, I certainly would have not chosen to go that route,” she said, hoping to warn other women. The FDA did not take Yaz off the market. Sayger says fewer college students are using that contraceptive, but for other reasons. She says Yaz costs around $70 a month, compared to other brands that range from $9 to $20. Bayer is facing 10,000 lawsuits surrounding its Yaz and Yasmin birth control.
