In a posting aimed at health-care professionals posted to the agency’s Web site, the FDA said all vaccine recipients should remain seated or lying down and be closely observed for 15 minutes following vaccination “to prevent falls and injuries.”

Gardasil was approved in June 2006 and is designed to protect against four strains of the human papillomavirus, or HPV, two of which account for about 70% of cervical-cancer cases. It’s recommended that girls ages 11 to 12 receive the vaccine in a three-dose series before they are sexually active, and it coincides with recommendations on other vaccines.

The FDA said that since October 2007 a discussion about fainting has been in Gardasil’s labeling for both the health-care provider and the patient. However, warnings about fainting have been strengthened and moved to a more prominent place on the drug label and on information that is supposed to be given to patients before they are vaccinated. The new materials were approved by the agency Wednesday.

The FDA said that individuals who faint sometimes have jerking movements and seizure-like activity but it doesn’t mean a person is having a seizure.

The agency also said some patients who fainted had serious injuries from falling. Some injuries were seen while patients were still in the doctor’s office while others resulted in car accidents.

The FDA said fainting has been reported after administration of other types of adolescent and adult vaccines. It said it’s considering whether to strengthen fainting warnings on other vaccines.

The agency said that in an adverse-event database that tracks vaccine safety, 13% of Gardasil-related reports describe fainting.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com

©2012 An Inconvenient Woman. All Rights Reserved.

GlaxoSmithKline has aggressively pursued a vaccine-production capability in Asia with a Chinese flu shot joint venture and a new plant in Singapore to make pneumonia vaccines. The company inked an alliance with Shenzhen Neptunus to make flu vaccines for markets in China, Hong Kong and Macau; Glaxo gets a 40 percent initial stake in the JV in exchange for a contribution of cash and assets worth $34 million. Within two years, GSK plans to take a majority interest in the partnership.

Andrew Witty, CEO, GlaxoSmithKline

Meanwhile, Glaxo chief Andrew Witty went to Singapore to open its largest vaccine plant in Asia. Singapore Prime Minister Lee Hsien Loong said his city-state is “proud to be a part of this project” and said work at the $600 million, 85,000-square-meter plant could save 3 million lives per year worldwide. Over the next two years the plant will ramp up to 1,100 workers, setting up production processes and quality controls, Witty said. Glaxo expects commercial production to begin there in 2011. Lee noted that GSK and Singapore shared a longstanding and enduring relationship after it first set up a small sales office here in 1959, the year Singapore gained self-government. Since then GSK has invested S$1.5 billion and expanded its activities in Singapore into manufacturing, drug discovery and clinical research, making the city-state one of the company’s two global strategic manufacturing hubs and its regional headquarters for Asia Pacific. Lee said the republic might explore the possibility of offering the city-state to be the corporate base for global companies, both big and small. “In the past, global companies operated with just one corporate headquarters, where all their key decision-makers were based. However, Asia is now the main growth story in the world,” he said, adding that many companies were therefore looking to locate their key functions and decision makers closer to Asian markets. With more and more manufacturing and research and development taking place in the region, companies were also establishing ‘control towers’ to better manage and coordinate their research and production activities.

“Singapore’s stable and pro-business environment, excellent connectivity and competent workforce make us an ideal Asian base for these companies.“  — Singapore Prime Minister, Lee Hsien Loong

At the Singapore press conference, Witty also offered his views on the global economy: sluggish, with continued economic contraction. “This could be a relatively anemic economic backdrop for a while,” he said. “I’m not yet confident that anything is very different today than it was three months ago. I think we’re still seeing an environment very similar to the one we saw in the second half of last year.” In April, GlaxoSmithKline reported first quarter profit fell 13 per cent based on weak US pharmaceutical sales.
- see the China JV story from Reuters
- see the Bernama’s Singapore coverage
- get more from the Straits Times

©2012 An Inconvenient Woman. All Rights Reserved.

The safety of the HPV vaccine was studied in 5 clinical trials before it was licensed. There were over 21,000 girls and women ages 9 through 26 in these clinical trials.

Since it was licensed, CDC and FDA have been closely monitoring the safety of the HPV vaccine. There are 3 systems used to monitor the safety of vaccines after they are licensed and being used in the U.S.  These systems can monitor side effects already known to be caused by vaccines as well as detect rare side effects that were not identified during a vaccine’s clinical trials. The 3 systems are:

• The Vaccine Adverse Event Reporting System (VAERS)--a useful early warning public health system that helps CDC and FDA detect possible side effects or adverse events following vaccination.




• The Vaccine Safety Datalink (VSD) Project–a project between CDC and 8 health care organizations to study patterns in reports detected by VAERS and determine if a vaccine is causing a side effect.




• The Clinical Immunization Safety Assessment (CISA) Network–a project between 6 academic centers in the U.S. which conduct research on adverse events that might be caused by vaccines.

Reports to VAERS Following HPV Vaccination

As of December 31, 2008, more than 23 million doses of Gardasil were distributed in the United States.

As of December 31, 2008, there were 11,916 VAERS reports of adverse events following Gardasil vaccination in the United States. Of these reports, 94% were reports of events considered to be non-serious, and 6% were reports of events considered to be serious.

Based on all of the information we have today, CDC continues to recommend Gardasil vaccination for the prevention of 4 types of HPV. As with all approved vaccines, CDC and FDA will continue to closely monitor the safety of Gardasil.  Any problems detected with this vaccine will be reported to health officials, healthcare providers, and the public, and needed action will be taken to ensure the public’s health and safety.

Non-serious adverse event reports

VAERS defines non-serious adverse events as those other than hospitalization, death, permanent disability, and life-threatening illness.

The vast majority (94%) of the adverse events reports following Gardasil have been non-serious. Reports of non-serious adverse events after Gardasil vaccination have included fainting, pain and swelling at the injection site (the arm), headache, nausea and fever. Fainting is common after injections and vaccinations, especially in adolescents. Falls after fainting may sometimes cause serious injuries, such as head injuries, which can be easily prevented by closely observing the vaccinated person for 15 minutes after vaccination.

Serious adverse event reports

VAERS defines serious adverse events as adverse events that involve hospitalization, death, permanent disability, and life-threatening illness. As with all VAERS reports, serious events may or may not have been caused by the vaccine.

All serious reports (6%) for Gardasil have been carefully analyzed by medical experts. Experts have not found a common medical pattern to the reports of serious adverse events reported for Gardasil that would suggest that they were caused by the vaccine. The following is a summary of selected serious adverse event reports that were submitted to VAERS between June 8, 2006 and December 31, 2008.

Guillain-Barré Syndrome (GBS)

Guillain-Barré Syndrome (GBS) has been reported after vaccination with Gardasil. GBS is a rare disorder that causes muscle weakness. It occurs in 1-2 out of every 100,000 people in their teens.* A number of infections can cause GBS. There has been no indication that Gardasil increases the rate of GBS in girls and women above the rate expected in the general population, whether or not they were vaccinated.

Blood Clots

Rarely, people have reported blood clots after getting Gardasil. These clots have occurred in the heart, lungs, and legs. Most of these people had a risk of getting blood clots, such as taking oral contraceptives (the birth control pill).

Deaths

As of December 31, 2008, there have been 32 U.S. reports of death among females who have received the vaccine. There was no common pattern to the deaths that would suggest that they were caused by the vaccine.

More information is available at:

http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-oct08/12-3-hpv.pdf

Reports of adverse events after getting a vaccine can be submitted to VAERS by fax at 1-877-721-0366, online at https://secure.vaers.org/VaersDataEntryintro.htm, or by mail to Vaccine Adverse Event Reporting System, P.O. Box 1100, Rockville, MD 20849-1100.

Page last modified: April 10, 2009
Content source: Immunization Safety Office

* Editorial Note to Immunization Safety Office: The actual reference source did not say teens it referred to ‘people’

“About 1 or 2 people out of 100,000 develop Guillain-Barré Syndrome (GBS) each year1.
1.Shy ME (2008). Guillain-Barré syndrome section of Peripheral neuropathies. In L Goldman, D Ausiello, eds., Cecil Textbook of Medicine, 23rd ed., pp. 2802–2816. Philadelphia: Saunders Elsevier.

©2012 An Inconvenient Woman. All Rights Reserved.

Researchers can get lazy and start to use acronyms and initializations to save time and keystrokes. Apparently I have been guilty of using such abbreviations, without proper explanation.

Recently a reader sent an email asking me just what is VAERS anyway, who runs it, what information are they tracking, how do the get it and from whom. Rather that give my Inconvenient Woman readers a two second summary, back to saving keystrokes again, I ‘m using the VAERS description copy directly from the CDC site. That way I wont miss any of the important stuff, trying to save keystrokes. (Editorial note: I’m not a touch typist. Typing class was taught at the same time as Latin, and for reasons that escape me now, I chose conjugation of Latin verbs over a useful life skill.)

Vaccine Adverse Event Reporting System (VAERS)

Vaccines are developed in accordance with the highest standards of safety. However, as with any medical procedure, vaccination has some risks. Individuals react differently to vaccines, and there is no way to predict the reaction of a specific individual to a particular vaccine.

The National Childhood Vaccine Injury Act (NCVIA) requires health care providers to report adverse events (possible side effects) that occur following vaccination, so the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) established the Vaccine Adverse Event Reporting System (VAERS) in 1990. VAERS is a national passive reporting system that accepts reports from the public on adverse events associated with vaccines licensed in the United States. VAERS data are monitored to—

• Detect new, unusual, or rare vaccine adverse events
• Monitor increases in known adverse events
• Identify potential patient risk factors for particular types of adverse events
• Identify vaccine lots with increased numbers or types of reported adverse events
• Assess the safety of newly licensed vaccines

Approximately 30,000 VAERS reports are filed annually, with 10–15% classified as serious (causing disability, hospitalization, life-threatening illness or death). Anyone can file a VAERS report, including health care providers, manufacturers, and vaccine recipients or their parents or guardians. The VAERS form requests the following information: the type of vaccine received, the timing of vaccination, the onset of the adverse event, current illnesses or medication, past history of adverse events following vaccination, and demographic information about the recipient. VAERS forms can be completed online, or you can complete a paper form and mail or fax it to VAERS. To request a paper VAERS form to be faxed to you, or if you need assistance in filling it out, call (800) 822-7967.

A contractor, under the supervision of FDA and CDC, enters the information from VAERS forms into a database. Those reporting an adverse event to VAERS receive a confirmation letter containing a VAERS identification number. Additional information may be submitted to VAERS using the assigned identification number. Selected cases of serious adverse reactions are followed up at 60 days and one year post-vaccination to check the recovery status of the patient. The FDA and CDC use VAERS data to monitor vaccine safety and conduct research studies. VAERS data (without identifying personal information) are also available to the public.

While VAERS provides useful information on vaccine safety, the data are somewhat limited. Specifically, judgments about causality (whether the vaccine was truly responsible for an adverse event) cannot be made from VAERS reports because of incomplete information. As a result, researchers have turned more recently to large-linked databases (LLDB) to study vaccine safety. LLDB provide scientists with access to the complete medical records of millions of individuals receiving vaccines (all identifying information is deleted to protect the confidentiality of the patient). One example of a LLDB is the Vaccine Safety Datalink (VSD) Project.

Reporting Vaccine Adverse Events

• VAERS online reporting form
• VAERS paper reporting form (PDF)

Everyone is encouraged to report any clinically significant or unexpected event (even if uncertain that the vaccine caused the event) for any vaccine. The Reportable Events Table (RET) lists and explains injuries and conditions that are presumed to be caused by vaccines, and time periods in which the first symptom must occur after receiving the vaccine. It is used by the Vaccine Injury Compensation Program, which is operated by the U.S. Health Resources and Services Administration. Health care providers are required by law to report to VAERS any conditions on the RET, vaccine adverse events that are listed in the manufacturer’s insert, and clinically significant or unexpected events following vaccination.

National Surveillance Data for Vaccine Adverse Events

VAERS Data: When evaluating data from VAERS, it is important to note that for any reported event, no cause-and-effect relationship has been established. VAERS receives reports on all potential associations between vaccines and adverse events. Therefore, VAERS collects data on any adverse event following vaccination, be it coincidental or truly caused by a vaccine. The report of an adverse event to VAERS is not documentation that a vaccine caused the event.

Recent Research

In 2006, FDA licensed RotaTeq, a new rotavirus vaccine. The same year, CDC implemented a post-licensure vaccine safety study of the RotaTeq vaccine.

Other Resources

2008 VAERS brochure: full color (PDF-3.8MB) or text only (TXT-5KB) Gardasil vaccine reports to VAERS Scientific articles published by members of the VAERS Team VAERS Annual Letter to Health Care Providers (PDF-636KB)

Scientific Articles

1. Varricchio F, Iskander J, Destefano F, Ball R, Pless R, Braun MM, Chen RT. Understanding vaccine safety information from the Vaccine Adverse Event Reporting System. Pediatric Infectious Disease Journal 2004;23(4):287–294.
2. Zhou W, Pool V, Iskander JK, English-Bullard R, Ball R, Wise RP, Haber P, Pless RP, Mootrey G, Ellenberg SS, Braun MM, Chen RT. Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS)—United States, 1991–2001. MMWR 2003;52(1):1–24.
3. Chen RT, Rastogi SC, Mullen JR, Hayes SW, Cochi SL, Donlon JA, Wassilak SG. The Vaccine Adverse Event Reporting System (VAERS). Vaccine 1994;12(6):542–550.

Please note: Some of these publications are available for download only as Portable Document Format (PDF) files, which require Adobe^® Acrobat^® Reader to view. Please review the information on downloading and using Acrobat Reader software.

To download a PDF of VAERS report: Quadrivalent Human Papillomavirus Vaccine (HPV4): Post-licensure Safety Update, Vaccine Adverse Event Reporting System (VAERS), United States Advisory Committee on Immunization Practices, 10-22-08,
Click here

Page last modified: May 12, 2008
Content source: Immunization Safety Office

©2012 An Inconvenient Woman. All Rights Reserved.

with Merck’s dangerous, but profitable,

HPV vaccine, Gardasil

The Adverse reaction reports keep rolling in, yet the FDA and the CDC still stand by this expensive and dangous vaccine.

©2012 An Inconvenient Woman. All Rights Reserved.

But since it’s an abortion drug, since it weathered a congressional investigation two years ago–and since it’s in short supply–researchers have yet to test its full potential.

That, says Amy Allina, program director of the Washington-based National Women’s Health Network, is the story on mifepristone. “This drug has the potential to make women healthier in many ways,” says Allina. “But the politics surrounding it have made it difficult to secure funding for more research, and scientists are shying away from studying the drug because they fear getting research protocols approved will be difficult.”

A 2006 paper in the medical journal Gynecological Endocrinology agreed, saying “association with abortion limits the clinical applications of mifepristone.”

Susan Wood, former director of the U.S. Food and Drug Administration’s Office on Women’s Health and now a research professor at the George Washington University School of Public Health and Health Services in Washington, D.C., says Election Day might make a big difference.

“A new presidential administration could change the atmosphere at the National Institutes of Health, which funds medical research, and the FDA, which oversees it,” says Wood, who resigned from the FDA in 2005 to protest delays in granting emergency contraceptives over-the-counter status. “A new administration has the potential to reduce the hesitancy that government and private funders might have about mifepristone.”

Short Supplies

Kevin Fiscella, an associate professor at New York’s University of Rochester Medical Center, says studies on mifepristone’s applications beyond abortion have been limited by a shortage of the drug.

“For more than a decade, it was difficult for American researchers to get their hands on mifepristone because there wasn’t a U.S. supplier,” says Fiscella. “Now it’s available through Danco Laboratories, a relatively small supplier that may not be able to produce quantities needed for larger studies.”

Mifespristone was the subject of congressional hearings in 2006 that followed the deaths of six U.S. women and one Canadian who took it to terminate unwanted pregnancies.

All the women died of bacterial infections, and the FDA strengthened the drug’s warning label to stress the risk, though it was never withdrawn for use in medical abortion.

In the two years since the hearing, authorities have not established a definitive link between those fatalities and the use of mifepristone to induce abortions, but widespread research into the drug remains sidelined by an anti-choice federal government.

More than 900,000 U.S. women and more than 2 million women in 37 other countries have used mifepristone in medical abortions, according to its New York-based manufacturer, Danco.

More than 97 percent of users surveyed would recommend the method to a friend, according to the New York-based Planned Parenthood Federation of America.

Even so, the FDA has received reports of more than 950 problems (mostly hemorrhaging and infection) associated with mifepristone’s use for abortions.

Higher Risk for Medical Abortion

Though only 0.016 percent of users experience these side effects, medical abortion still carries 10 times the risk of death associated with surgical abortion, according to Planned Parenthood.

Mifepristone is offered by 60 percent of U.S. abortion providers and accounts for 13 percent of all abortions and 22 percent of those before nine weeks’ gestation, according to the New York-based Guttmacher Institute.

In 2006, Ohio legislators passed a measure that would restrict the drug’s use for abortions and as a research subject in the state but the law was struck down by a federal court.

In 2007, two mifepristone researchers in Canada reportedly received death threats from anti-choice activists, but nevertheless moved forward with their research.

Mifepristone was in various stages of research investigation before the scare in 2006.

Fiscella, at the University of Rochester Medical Center, is investigating the drug’s potential to treat fibroids. His research shows taking mifepristone can lead to a 40 percent reduction in the size of fibroids, noncancerous uterine growths that can impair fertility and cause pelvic pain and anemia.

“In small doses, mifepristone blocks the reproductive hormone progesterone, which is why it may help with progesterone-affected conditions such as fibroids, endometriosis, breast cancer and ovarian cancers,” says Fiscella. “In larger doses, mifepristone blocks glucocorticoid hormones released during stress, which is why it may help treat conditions affected by these hormones, such as depression and Cushing’s syndrome.”

Studies Showed Promise

Mifepristone studies underway before the 2006 congressional hearings include ones related to breast cancer (the University of California); depression (Stanford University); ovarian cancer (the University of South Dakota); and endometriosis, or the growth of uterine tissue outside the uterus (the Colorado Center for Reproductive Medicine). All these studies showed positive outcomes before 2006.

Although rarely prescribed this way, mifepristone can work as an emergency contraceptive if taken within five days of unprotected sex, though it is a different drug from Plan B, also called the “morning-after” pill.

“Mifepristone can serve as emergency contraception as safely and effectively as it terminates early pregnancy,” says Beverly Winikoff, president of the New York-based Gynuity Health Projects.

Other studies have found possible applications of the drug for Alzheimer’s disease, glaucoma, ulcers, meningiomas (tumors that arise from the membranes lining the brain and spinal cord) and Cushing’s syndrome (a condition in which prolonged exposure to stress hormones causes stretch marks, high blood pressure and other health problems).

If patients want to try mifepristone for other applications besides its FDA-approved use to induce abortion, doctors may prescribe it “off label,” a common practice in which physicians can write prescriptions for a drug approved for one purpose for that drug’s use in a second purpose.

Off-label use is considered safe if it is supported by research. In fact, many drugs prescribed to women for pregnancy-related conditions are prescribed off-label. Drugs developed specifically to treat pregnant women are rarely developed by pharmaceutical companies and no new classes of drugs for pregnancy-related treatments have been developed in the past two decades, according to a study published in January.

However, health advocates say mifepristone’s widespread use for emergency contraception and for the treatment of endometriosis, fibroids, cancer and other illnesses will only come with more study and with official FDA approval for these uses. Off-label prescriptions are not encouraged until research on a drug is definitive.

“The Bush administration has been staunchly opposed to reproductive choice in general and to the use of mifepristone in particular,” Allina says. “But having a new administration after the 2008 election could result in less stigma, more federal and private funding and eventual FDA approval for more uses.”

By Molly M. Ginty – WeNews correspondent

Molly is a freelance writer based in New York City.

Reprinted with Permission:

Copyright 2008 Women’s eNews. The information contained in this Women’s eNews report may–with the prior written authorization of Women’s eNews–be published, broadcast, rewritten or otherwise distributed. To obtain permission, go to http://www.copyright.com/ccc/do/showConfigurator?WT.mc_id=PubLink and provide the publication or broadcast date and the name of the newspaper, magazine, radio or television station, cable network, Web site, newsletter or list serve where it will be replicated. Please include the approximate size of the audience you intend to reach. Answers to your most frequently asked questions about permissions to reprint or repost Women’s eNews content are available here: http://www.womensenews.org/reprint_faq.cfm

©2012 An Inconvenient Woman. All Rights Reserved.

Many believe the worst day at work can be curbed by inhaling a big tub of ice cream, but now scientists have found new evidence suggesting that bingeing isn’t our fault — it’s biology.

A new study shows that bingeing when stressed might be biological.

Researchers studying the diet choices made by monkeys say the results may explain why some humans binge after a tough day at work. They say that bingeing may not be entirely the fault of all those tantalizing food commercials that draw people to fatty foods.Researchers at the Yerkes Primate Research Center in Atlanta found that stressed monkeys ate more fat and sugar than those who weren’t under stress.There are two classes of monkeys: the dominant ones and the subordinate ones. By studying these two varieties, researchers have learned why some

Surprisingly, dominant monkeys normally ate slightly more of the low-fat, high-fiber food than subordinate monkeys. Apparently, the constant bowing to their superiors curbed the subordinates’ appetite.

But things changed when researchers replaced the healthy food the monkeys normally eat with fatty, sugary banana pellets. While the dominant monkeys dabbled in the new food, the subordinates started bingeing on the tasty cuisine after dark.

“We found the subordinate animals were indeed going out at night and feeding,” said neuroscientist Mark Wilson, a researcher at the center.

Researchers believe the monkeys that are harassed all day long by high-ranking monkeys may just be contemplating the days’ events and coping.

“Eating high-fat, high-caloric foods … they increase … dopamine levels, they increase serotonin and endorphins, all chemicals that make us feel good,” said psychiatrist Julie Holland.

Even so, research shows that while monkeys felt better after their late-night binges, humans tended to feel guilt. But maybe the 72 million Americans on a diet will feel better knowing that binge eating has something to do with biology.

Source: Good Morning America SHARYN ALFONSI, KIRAN KHALID and STEPHANIE DAHLE

©2012 An Inconvenient Woman. All Rights Reserved.

Researchers found patients given the drugs were a third more likely to die within a month of surgery than those given a dummy pill.

Those on the blood pressure-lowering drugs also had double the risk of having a stroke.

The study, by Canada’s McMaster University, appears in The Lancet.

“There is a real potential that beta blockers are causing serious harm in the surgical setting”

— Dr PJ Devereaux, McMaster University

Although use of the drugs did reduce the risk of a heart attack following surgery, the researchers concluded that on balance they did more harm than good.

They estimate use of the drugs before surgery may have contributed to at least 800,000 deaths worldwide in the past decade.

Professor Peter Weissberg, medical director of the British Heart Foundation, said the research emphasised the importance of undertaking large clinical trials, rather than assuming that drugs will only do what is expected of them.

“Fortunately, the practice of giving beta blockers to all patients at risk of vascular disease before surgery is not widespread in the UK.”

“Also, the results of this trial – of a relatively high dose of a beta blocker given before surgery – do not mean patients stabilized on long-term beta blocker therapy will be at increased risk if they have surgery.”

Researcher Dr PJ Devereaux said: “There is a real potential that beta blockers are causing serious harm in the surgical setting.”

“If my mother was undergoing surgery and given a beta blocker, I would be extremely upset based on this evidence.”

Counter to stress

It has long been thought that using beta blockers before major surgery protects the heart against the stress of the procedure.

Surgery often raises levels of stress hormones known as catecholamines, which drive up a person’s blood pressure and heart rate.

Beta blockers block the effects of increased catecholamines.

However, the body can also go into a state of shock after surgery during which blood pressure falls. The researchers suspect that beta blockers may amplify this state.

The McMaster team studied more than 8,000 patients in 23 countries who were undergoing major surgery unrelated to the heart, but who had or were at risk of clogged arteries.

Half were given the beta blocker metoprolol two to four hours before and 30 days after their surgery. The other half got a placebo.

The results suggests that the use of beta blockers could prevent 15 out of every 1,000 people with similar risks undergoing similar surgery from having a heart attack.

However, eight more people would die, five more would have a stroke, 53% would have abnormally low blood pressure and 42% would have an abnormally slow heart beat.

Overall, the risk of death rose from 2.3% for the placebo group to 3.1% for those given beta blockers in the 30 days after their operation.

Source: BBC NEWS and The Lancet

©2012 An Inconvenient Woman. All Rights Reserved.

The prescribing information for the Ortho Evra Contraceptive Transdermal Patch is being updated with results of a new study on the risk of venous thromboembolism. This study found that women aged 15-44 who used the birth control patch were at higher risk of developing venous thromboembolism than women using birth control pills.

These findings support an earlier study that also concluded that women in this group were at higher risk of venous thromboembolism. Another earlier study found that women using the patch did not have a greater risk.

However, the results from the two positive studies support concerns that the patch could increase the risk of blood clots in some women. The label continues to recommend that women with concerns or risk factors for thromboembolic events talk with their healthcare provider about using Ortho Evra versus other contraceptives.

Additional Information:

FDA MedWatch Safety Alert. Ortho Evra Contraceptive Transdermal Patch.

©2012 An Inconvenient Woman. All Rights Reserved.

Jim Brown
OneNewsNow.com
February 6, 2007

Texas Governor Rick Perry’s ties to the manufacturer of an HPV vaccine are being scrutinized in the wake of his order that all sixth-grade girls in the Lone Star State receive the medication against the sexually transmitted virus that causes cervical cancer.

The head of a Texas pro-family group believes “corruption” is behind Governor Rick Perry’s plan requiring all schoolgirls entering sixth grade to get vaccinated against the Human Papilloma Virus.

On Friday Governor Perry issued an executive order requiring all sixth-grade girls to get Gardasil, Merck and Company’s new vaccine against HPV, beginning the fall of 2008. Perry reportedly has extensive ties to Merck, and received $6,000 from Merck’s political action committee during his re-election campaign.

Texas Eagle Forum president Cathie Adams believes “corruption” is at play. Adams explains that Governor Perry’s former chief of staff, Mike Toomey, is now a lobbyist for Merck, the manufacturer of the vaccine.

“Not only that,” continues the family acvocate, “his current chief of staff is the daughter-in-law of the chairman of the health committee in the State House of Texas — and she’s also a member of Women in Government.” Adams describes that group as a “Merck-supported, – funded, and -organized group of legislators.”

Adams says what is most remarkable about the situation is that Perry is “usurping” the rights of parents and the Legislature when there is no cervical cancer crisis in Texas. According to Associated Press, Merck could generate billions in sales if Gardasil were made mandatory across the country. The three-shot regimen, which is covered by most insurance companies, costs $360.

©2012 An Inconvenient Woman. All Rights Reserved.