BIRTH CONTROL PILL MAY RAISE SEIZURE RISK FOR SOME WOMEN
A new study suggests that ethinyl estradiol, the primary component of oral contraceptives, could increase seizures in women with epilepsy.
“We were inspired by an earlier study which surveyed women with epilepsy and found that those using hormonal contraceptives self-reported 4.5 times more seizures than those that did not use oral contraceptives,” says Samba Reddy, professor of neuroscience and experimental therapeutics at Texas A&M Health Science Center College of Medicine.
Findings of the new study, published in the journal Epilepsy Research, show that when epileptic animal models received ethinyl estradiol, they not only had more frequent seizures, but the seizures were more likely to be uncontrolled. “We suspected for some time that hormonal birth control increases seizure activity in women with epilepsy, but now we know what part of the contraceptive is problematic.”
Epilepsy is more difficult to control in women once they reach sexual maturity, Reddy says. “The hormones that control menstruation and pregnancy can trigger seizures. Women often experience more seizures in the week before their period due to the change in these hormones.”
While epilepsy affects men more than women, women with epilepsy tend to experience seizures more frequently than men and women’s seizures are more likely to be uncontrolled. Uncontrolled seizures last longer than 30-40 seconds and are more likely to permanently damage the brain.
“Controlled seizures don’t tend to leave lasting damage, but uncontrolled seizures originate deeper in the brain,” says Reddy. “Some parts of the brain are more vulnerable to damage than others, for example the hippocampus, which has a role in regulating memory and spatial orientation. If that is damaged the person can suffer impairments to their normal functioning.”
Women of childbearing age with epilepsy should speak with their neurologist or endocrinologist about using non-hormonal forms of birth control such as a copper IUD or barrier methods like condoms, Reddy says.
Link to Abstract : Seizure facilitating activity of the oral contraceptive ethinyl estradiol
Source : Futurity (April 2016)
Merck Said to Agree to $100 Million NuvaRing Settlement
Merck & Co. (MRK) agreed to pay $100 million to settle several thousand lawsuits alleging the drugmaker’s NuvaRing contraceptive device causes potentially fatal blood clots, two people familiar with the accord said.
The settlement, which resolves cases in federal and state courts in Missouri and New Jersey, will provide an average payout of more than $58,000 a case and will be announced today, said the people, who asked not to be identified because they weren’t authorized to speak publicly about it.
Women accused Whitehouse Station, New Jersey-based Merck of selling NuvaRing knowing it posed a higher risk of heart attack-inducing blood clots than competing products.
The settlement allows Merck, the second-biggest U.S. drugmaker by sales, to pay less than Bayer AG (BAYN) and other competing contraceptive makers did to resolve lawsuits over their products. Bayer said last year that it has paid more than $1.6 billion to settle claims over its Yasmin and Yaz lines of birth-control pills. Women said Yaz also caused blood clots that led to strokes and heart attacks.
“Merck may be getting out much more cheaply than its competitors because proving the liability case against the NuvaRing device appears to be more difficult than against the other contraceptives,” Carl Tobias, who teaches product-liability law at the University of Richmond in Virginia, said in a phone interview.
Lainie Keller, a Merck spokeswoman, declined to comment on the settlement in an e-mail. Roger Denton, a plaintiffs’ lawyer in St. Louis who is leading the consolidated NuvaRing cases, didn’t return a call seeking comment.
FDA Report NuvaRing is a hormonal-vaginal contraceptive that combines both estrogen and progestin in a ring to prevent pregnancy. The product, which was linked in a 2011 U.S. Food and Drug Administration report to a higher risk for blood clots, has been sold in the U.S. since 2001.
Merck opened today down 5 cents to $53.72 at 9:36 a.m. in New York Stock Exchange trading.
Merck reported fourth-quarter earnings this week that fell short of estimates. Earnings excluding certain items were 88 cents a share, 1 cent below the average of 15 analysts’ estimates compiled by Bloomberg. The company also forecast 2014 profit of $3.35 to $3.53 a share, compared with $3.48 projected by analysts.
Dozen Studies Lawyers for women suing over the NuvaRing product contend in court filings there are almost a dozen studies showing the type of progestin used in the device is twice as likely to cause blood clots. Such clots can block veins and cause heart attacks or travel to the lungs and cause other health issues.
The family of a Nebraska mother who used a NuvaRing device sued Merck in 2010 after the woman was found dead with a blood clot in her lung. Ann Tompkins’ family alleged in their suit that Merck misled users about the device’s health risks.
Women contend in court filings that Merck failed to provide proper warnings about NuvaRing’s higher clot risks on the device’s label to protect sales. Suits have been filed against Merck and Organon USA Inc., a unit that sold the device.
More than 1,500 NuvaRing suits were consolidated before U.S. District Judge Rodney Sippel in St. Louis in 2008 for pre-trial information exchanges. Sippel had set the first trial over the blood-clot claims for April.
Case Consolidation More than 200 suits also have been consolidated in New Jersey state court before Judge Brian Martinotti in Hackensack. Those cases also will be part of the settlement, the people said.
Last year, Martinotti threw out seven NuvaRing cases set as the first suits to go to trial in New Jersey after finding women couldn’t show the device caused their injuries.
The judge said plaintiffs also couldn’t show doctors wouldn’t have prescribed the birth-control device if Merck had included information about higher clot risks on its warning label.
Source : Bloomberg
Birth Control Pills Labeling Updates October 2013
- Modicon (norethindrone/ethinyl estradiol)
- Ortho Novum (norethindrone/ethinyl estradiol)
- Ortho-Cyclen (norgestimate/ethinyl estradiol)
- Ortho Tri-Cyclen (norgestimate/ethinyl estradiol)
- Ortho-Cept (desogestrel/ethinyl estradiol)
BOXED WARNINGWARNINGS: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING
- Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including ORTHO-NOVUM and MODICON, ORTHO TRI-CYCLEN and ORTHO-CYCLEN, and Ortho-Cept should not be used by women who are over 35 years of age and smoke.
- Persistent blood pressure values of greater than 160 mm Hg systolic or greater than 100 mg Hg diastolic
- the addition of thrombophilic conditions as contraindications
Elevated Blood Pressure
- Women with a history of hypertension or hypertension-related diseases, or renal disease70 should be encouraged to use another method of contraception. If these women elect to use oral contraceptives, they should be monitored closely and if a clinically significant persistent elevation of blood pressure (BP) occurs (greater than 160 mm Hg systolic or greater than 100 mm Hg diastolic) and cannot be adequately controlled, oral contraceptives should be discontinued. In general, women who develop hypertension during hormonal contraceptive therapy should be switched to a non-hormonal contraceptive. If other contraceptive...
- The changes update these sections to be consistent with labeling of Ortho Evra
Source : FDA (Oct 2013)
FDA Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone
[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.
Figure 1 shows the risk of developing a blood clot for women who are not pregnant and do not use birth control pills; for women who use birth control pills; for pregnant women; and for women in the postpartum period. For example: If 10,000 women who are not pregnant and do not use birth control pills are followed for one year, between 1 and 5 of these women will develop a blood clot.
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.
Brand name Generic name
Beyaz Drospirenone 3 mg, ethinyl estradiol 0.02 mg and levomefolate
calcium 0.451 mg
Drospirenone and ethinyl estradiol Drospirenone 3 mg and ethinyl estradiol 0.03 mg
Drospirenone and ethinyl estradiol Drospirenone 3 mg and ethinyl estradiol 0.02 mg
Gianvi Drospirenone 3 mg and ethinyl estradiol 0.02 mg
Loryna Drospirenone 3 mg and ethinyl estradiol 0.02 mg
Ocella Drospirenone 3 mg and ethinyl estradiol 0.03 mg
Safyral Drospirenone 3 mg, ethinyl estradiol 0.03 mg, and levomefolate
calcium 0.451 mg
Syeda Drospirenone 3 mg and ethinyl estradiol 0.03 mg
Yasmin Drospirenone 3 mg and ethinyl estradiol 0.03 mg
Yaz Drospirenone 3 mg and ethinyl estradiol 0.02 mg
Zarah Drospirenone 3 mg and ethinyl estradiol 0.03 mg
Table 1. Approved Oral Contraceptives Containing Drospirenone
Source : FDA
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Bayer Withheld Yasmin Data From U.S., Former Agency Chief Says
David Kessler, the former FDA commissioner, in a document unsealed yesterday in federal court in Illinois, said Bayer didn't include an analysis “that demonstrated an increase in the U.S. reporting rate” for venous thromboembolism, or clots, in a 2004 review of Yasmin's safety provided to the agency.
The report also didn't include an earlier draft opinion by company researchers that “spontaneous reporting data do signal a difference in the VTE rates for Yasmin” compared with other oral contraceptives, Kessler said, quoting the draft.
“Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin,” Kessler said. The company also promoted the oral contraceptive for unapproved uses, particularly for treatment of premenstrual syndrome, Kessler said.
Kessler's report and four other expert opinions were released yesterday by lawyers representing former users of Bayer's Yasmin family of contraceptives. The experts were paid by the plaintiffs' lawyers, who submitted the reports to the FDA, which is considering safety findings on Yasmin and its sister product Yaz at a hearing Dec. 8.
‘Matters of Litigation'
Rose Talarico, a U.S.-based spokeswoman for Bayer, said the company doesn't comment on ongoing lawsuits. “We have nothing further to add as these are matters of litigation,” she said in an e-mailed statement. “We expect them to be addressed further at trial.”
Morgan Liscinsky, an FDA spokeswoman, didn't immediately comment on the unsealed documents about the drugmaker's handling of the contraceptives.
The FDA didn't accept the documents for the hearing, according to an e-mail sent to plaintiffs' lawyer Ned McWilliams late yesterday.
“The deadline for all written submissions was on November 23, 2011,” Kalyani Bhatt, of the FDA's Division of Advisory Committee and Consultant Management, wrote. “We will not be able to accept any written submission at this time.”
McWilliams said in an e-mail response to Bhatt, ``I think the American public would want to know why the FDA has refused to consider important safety information that Bayer did not consent to be released to the public or the FDA until after the submission deadline.''
``Why not look at the documents and make your own independent objective evaluation?'' McWilliams said.
Bhatt didn't return a call after regular business hours yesterday seeking comment on that e-mail.
Bayer faces more than 10,000 lawsuits over injuries allegedly caused by the contraceptives. Lawyers suing the drugmaker cited FDA reports of at least 50 deaths tied to the pills from 2004 to 2008. The first trials are scheduled for next month in federal court in Illinois and state court in Philadelphia.
Bayer's contraceptives generated $1.58 billion (1.17 billion euros) in sales last year, making them the company's biggest-selling drugs after Betaseron, a multiple sclerosis medication. The contraceptives, which contain the hormone drospirenone, have been the focus of regulators who question their safety. Bayer's Yasmin was the No. 4 oral contraceptive in the U.S. this year as of September, with 4.6 percent of the market, according to data from IMS Health.
In October, the FDA warned that women taking the pills were 74 percent more likely to suffer blood clots than women on other low-estrogen contraceptives. The FDA examined data on 835,826 women who took pills containing the hormone, including Bayer's Yasmin line of birth-control pills, according to the FDA report. The agency set the Dec. 8 hearing to discuss the findings.
The lawsuits claim Bayer didn't sufficiently warn patients of the health risks of the Yasmin family of birth-control pills. They also claim Bayer's Berlex Laboratories Inc., acquired in the 2006 purchase of Schering AG, marketed the drug for unapproved uses.
This marketing campaign, according to the documents unsealed yesterday, included paying $450,000 to Los Angeles gynecologist Judith Reichman to sponsor a tour for a book she was writing on women's health issues, among other items, Kessler said.
Kessler said the Bayer unit withheld information about Yasmin's risks of clots before the drug was approved by the FDA in 2001.
Bayer didn't report to the FDA details on the risks of clots from an internal study and two cases of clots in patients on the pill prior to the drug's approval by the agency, Kessler said.
“Had I, or a medical review officer, known these facts prior to approval, further investigation would be warranted before a decision on Yasmin's NDA could be made,” he said, referring to the company's new drug application.
“These facts would impact the agency's risk-benefit equation about the drug and whether it could be approved,” Kessler said.
The FDA told Bayer in June 2003 that it was “very concerned” about the number of adverse events, particularly deaths, reported in Yasmin users, Kessler said, citing an agency letter to the company. This included six deaths in the U.S., five of which were first reported to the FDA after April 2, 2003, the agency said.
“Because of these recent reports, we believe that a change in Yasmin labeling and possibly additional actions are now warranted,” the FDA wrote to Bayer, according to the Kessler report.
Bayer responded that its data didn't show a higher risk for Yasmin. Internally, the company decided to produce a “White Paper,” to the FDA, which would be “a scientific write-up that lays out the issues,” according to a Bayer document quoted by Kessler.
The white paper would compare Yasmin to other oral contraceptives, or OCs, covering multiple adverse events including venous thromboembolism (VTE) and pulmonary embolism (PT).
In an early draft of that report, Bayer employees wrote, according to Kessler, “Compared to the three other OCs, Yasmin has a several fold increase in the reporting rates for DVT, PE, ATE and confirmed VTEs.”
In this draft, the employees added: “When considering only serious AEs (adverse events), the reporting rate for Yasmin was 10 fold higher than with the other products.” The total rate of confirmed VTEs per year was three or four times higher than the other three oral contraceptives reviewed, according to the data in the draft, Kessler said. The raw numbers were 6.9 per year for Yasmin and 1.5 for two of the other pills, according to the draft.
In a later draft, the Bayer employees said that “spontaneous reporting data do signal a difference in the VTE rates for Yasmin and other OC users.”
Such data wasn't the “preferred approach to assess the safety of a single product,” the researchers wrote. They said data from a direct comparison, such as two then-ongoing studies “should provide more insight.”
“The spontaneous reporting do NOT signal a difference in VTE rates for Yasmin,” another Berlex employee wrote to company colleagues in commenting on the draft, Kessler said. “Those comments were not accompanied by any additional data,” Kessler said.
Kessler agreed that spontaneous reporting of incidents has limitations, because of the voluntary nature of the reports, effects of media attention, different times of introduction for drugs, among other factors. The information still should have been included, he said.
“Even with its limitations, analysis of spontaneous reporting data is an important, recognized and vitally used tool by the FDA and the pharmaceutical industry for detecting safety signals” Kessler said in his report.
“Bayer's spontaneous reporting analysis demonstrated a safety signal about Yasmin and VTE risk,” he said. “Bayer had a duty to present a full and balanced view of all the data and analysis concerning Yasmin to the FDA and health-care professionals and failed to do so.”
Women suing Bayer over its line of birth-control pills contend the company and its units went to unusual lengths to market the medication for unapproved uses, according to court papers.
Bayer's Berlex unit came up with a plan to hire Judith Reichman, a Los Angeles-based gynecologist who writes a blog about women's health issues, “to engage in off-label promotion” of the Yasmin line of contraceptives, John Abramson, a Harvard medical school professor, concluded in his report.
Abramson was hired by plaintiffs' lawyers to review materials Bayer turned over about the marketing of the drugs. His report was also unsealed yesterday by a federal judge in Illinois who is overseeing a consolidation of Yaz cases.
Berlex officials said in an e-mail they'd agreed to pay Reichman $450,000 in return for her willingness to “mention off-label benefits of our products,” Abramson noted. The doctor was planning an upcoming book on women's health issues.
The company also planned to purchase 10,000 copies of the book, which contained “off-label claims” about the Yasmin line of contraceptives, the doctor noted. The purchase was part of a “strategy to have the book appear on the New York Times bestseller list,” Abramson added.
In her 2005 book, “Slow Your Clock Down,” Reichman wrote that Yasmin may help women with PMS-related symptoms such as “fluid accumulation and bloat,” or with depression.
The FDA approved Yasmin only as a contraceptive. The regulator hasn't cleared it as a treatment for any form of PMS or other ailments, according to the agency's website. Reichman was unavailable to comment about her work with Bayer because her husband died, her assistant, Deborah Cannon, said in an e-mail.
Berlex officials understood the value of such publicity, Abramson noted. For example, Talarico, a then-spokeswoman for Berlex, flagged a copy of a 2006 story about Yaz in Allure magazine that touted the benefits of Yaz for treating PMS.
Richard Salem, Berlex's vice president for communications, congratulated Talarico for getting the article placed in the magazine.
“The value of these placements is astronomical,” Salem said in an e-mail, according to court filings.
Internal e-mails also show officials of Bayer and its Berlex unit engaged in an extensive public relations campaign to market Yaz that was “designed to circumvent FDA restrictions on marketing” because they saw the limits “as a threat to the commercial success of Yaz,” Abramson said in his report.
The Kessler and Abramson reports were sent to the FDA by McWilliams, a lawyer with Levin, Papantonio, Thomas, Mitchell, Rafferty & Proctor PA in Pensacola, Florida.
“Although these reports were prepared for litigation, they contain relevant information obtained from Bayer that has not been previously provided to the FDA that will assist the committee and the FDA in its own evaluation of the benefits and risks of drospirenone-containing oral contraceptives,” McWilliams wrote to the agency.
The case is In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices and Product Liability Litigation, 09-md-02100, U.S. District Court, U.S. District Court, Southern District of Illinois (East St. Louis).
--With assistance from Drew Armstrong in Washington and Dawn McCarty in Wilmington, Delaware. Editors: Mary Romano, Glenn Holdcraft
Source : Bloomberg Business Week
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More Detail on Risk Urged for a Contraceptive Label
Labels on the popular birth control pills Yaz and Yasmin should be strengthened to include more information about the possibility that the pills could lead to greater risk of blood clots in women, an advisory committee to the Food and Drug Administration said on Thursday.
he panel, which voted 21 to 5 in favor of changing the labels, stopped short of recommending that they warn that the drugs are more likely than other contraceptive pills to cause blood clots. Instead, the experts suggested that the labels note that the evidence about blood clots is conflicting. Currently, the labels suggest that these contraceptives have blood clot risks similar to those of other birth control pills that combine estrogens and progestins.
Morgan Liscinsky, an F.D.A. spokeswoman, said the panel “definitely felt that stronger labels were needed, that the labels need to be updated to reflect current data and acknowledge that it is conflicting.”
The advisory committee also concluded, by a closer vote of 15 to 11, that the benefits of the pills still outweigh their risks. The F.D.A. does not have to follow the panel’s recommendations, but the agency has indicated concern in recent months as some studies, including its own, have shown an elevated risk.
The question of whether these contraceptives, which use a newer synthetic form of progestin called drospirenone, can make women more prone to blood clots has been a subject of debate. Studies have shown differing results. Bayer, the German company that makes the drugs, has said that they pose no greater threat than other contraceptive pills, all of which somewhat elevate the risk of stroke and blood clots in the legs and lungs.
The company has said that studies that show otherwise contain methodological flaws that undercut the strength of their results.
But other recent research has suggested that drospirenone may somewhat increase the risk of blood clots. An F.D.A. analysis reported that about 10 in 10,000 women taking pills with drospirenone will experience a blood clot or venous thromboembolism in a year, compared with 6 in 10,000 women using other hormonal contraceptives.
And a study of 1.3 million Danish women published in October in the journal BMJ found that women taking Yaz or Yasmin had double the risk of blood clots, compared with women taking the older contraceptives.
Before Thursday’s meeting, an F.D.A. briefing document acknowledged that studies had yielded conflicting results and said new studies were needed. But the scientists recommended that labels on the pills should be changed to inform the public of possible risks.
Although the agency could not determine whether the increased risk resulted from use of the drugs or some other cause, “we believe that, because of the consistency in recent reports for an increased risk, product labeling should reflect that very real possibility,” the scientists wrote.
More than 10,000 lawsuits have been filed against Bayer claiming that women have been harmed by taking Yaz or Yasmin, including accusations of about 100 deaths linked to the contraceptives.
In documents released recently in those lawsuits, David Kessler, a former F.D.A. commissioner working as an expert witness for the plaintiffs, said that Bayer researchers found increased reports of blood clots in women using Yasmin in the United States, compared with those using three other pills, but did not provide that information to the F.D.A. in a 2004 safety review.
“Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin,” Dr. Kessler testified. He also said the company promoted the pill for alleviating premenstrual syndrome, when it was not approved for that use.
Dr. Pamela A. Cyrus, a vice president for Bayer HealthCare Pharmaceuticals, said on Thursday that Bayer had consistently worked with the F.D.A. and other regulatory authorities around the world as new data have become available, had worked with the agencies to make label updates as appropriate and “will continue to do so.”
Bayer said it would not comment on Dr. Kessler’s testimony because it is part of continuing litigation.
Source : New York Times
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Birth control pills may alter memory
A new study conducted at the University of California says women who use birth control pills remember emotional events differently than women who don't.
"What's most exciting about this study is that it shows the use of hormonal contraception alters memory," said UCI graduate researcher Shawn Nielsen.
Birth control pills cause lower levels of the reproductive hormones progesterone and estrogen, which are linked to women's "strong" left brain memory.
"This new finding may be surprising to some, but it's a natural outgrowth of the research we've been doing on sex differences for 10 years," said neurobiologist Larry Cahill whose study had shown that men and women remember things differently.
The fact that women on oral contraceptives remembered different elements of a story clarifies that estrogen affects how women remember emotional events, researchers say.
Nielsen and fellow researcher Nicole Ertman believe that the findings could lead them to identify how men remember differently than women as they typically rely more on right-hemisphere brain activity to encode memory.
The study indicates that medications do not hurt memory or cause a deficit, but induce a change in the type of information that is remembered, Science Daily reported.
Source : LaLeva.org
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New studies point to clot risk of Bayer's Yasmin
New evidence emerged on Friday that women taking Bayer's best-selling contraceptive Yasmin may run a higher risk of dangerous blood clots than those using older birth-control pills.
Two studies showed that users of pills containing drospirenone, one of the hormones used in Yasmin, had a two to threefold higher risk of venous thromboembolism than did users of those containing the older synthetic hormone levonorgestrel, according to British Medical Association's bmj.com site.
In the study cited by bmj.com, based on U.S. medical claims data, researchers found a twofold increased risk of non-fatal venous thromboembolism in women using drospirenone-containing contraceptives compared with women using levonorgestrel.
Thromboembolis is the medical term for a blood clot in the veins, often in the legs, that gets dislodged and can cause fatal clogging in the lungs' arteries.
The second study, based on data from the British General Practice Research Database, even found a threefold increased risk.
Still, the researchers described the overall risk as low, with rates for blood-clotting cases in U.S. study of 30.8 per 100,000 women years on drospirenone versus 12.5 in the control group.
Bayer said in a statement that the methodology used showed "significant flaws."
"Given the already large and robust scientific body of evidence, in Bayer's opinion, these studies do not change the overall assessment about the safety of Bayer's oral contraceptives," the company said, citing 10 years of safety study results since the pill came to market.
Studies assessing the blood clotting risk of drospirenone had yielded inconsistent results in recent years with some studies showing elevated risks and others suggesting drospirenone was as safe as levonorgestrel.
In March 2010, Bayer put additional risk warnings on the European product label for the Yasmin pill but said at the time that the overall benefit-risk profile remained unchanged.
Bayer said in its 2010 annual report that there were about 6,850 lawsuits pending in the United States with plaintiffs claiming they had suffered injuries from Bayer's Yasmin and Yaz pills or generic copies sold by Teva's Barr Laboratories.
In 2010 Bayer realized 1.1 billion euros ($1.6 billion) of sales from drospirenone-based pills such as Yasmin, down 13 percent from a year earlier, still making it Bayer's second-best-selling pharmaceutical product after multiple sclerosis drug Betaseron.
Yasmin revenue is slipping because of cheap generic copies on sale in the United States but also in part because of concern about a heightened risk of thrombosis.
Source : Reuters April 2011
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