February 27, 2012
For the second time this year, certain birth control medications are being recalled over a packaging error.
Glenmark Generics Inc. has announced a voluntary recall of seven lots of its Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg.
The recall is being implemented because of a packaging error, where select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and making the lot number and expiry date visible only on the outer pouch.
February 15, 2012
By Sasha Issenberg
On Jan. 22, a young woman in a socially conservative corner of southwestern Ohio received a blast email from Stephanie Cutter, a deputy campaign manager for Barack Obama. Years earlier, the young woman had registered for updates on Obama’s website, completing a form that asked for her email address and ZIP code. For a while, the emails she received from Obama and his Organizing for America apparatus were appeals to give money and sign petitions, and she responded to one that required that she provide her name. The emails kept on coming, rarely with anything an Obama supporter could disagree with, and certainly not the type of hard-edged political message that could scare one away.
But Cutter’s note was different. She boasted of a new administration rule that would require insurance plans to fully cover contraception as part of the president’s health care reform law, and encouraged her recipients to see the policy as reason to rally around Obama’s re-election. “Think about how different that is from what the candidates on the other side would do,” Cutter wrote. “Our opponents have been waging a war on women’s health—attempting to defund Planned Parenthood, overturn Roe v. Wade, and everything in between.”
It was a message that sat well with the young Ohioan who received it. She was single, liberal, sensitive to medical costs—but she had never told the campaign any of those things, and the one piece of information she had provided (her ZIP code) could easily mark her as the type of traditionalist Midwestern woman who would recoil at efforts to liberalize access to birth control. Indeed, she found it hard to believe that many other residents of her ZIP code would look as favorably upon a rallying cry to defend Planned Parenthood as she did.
Those who have worked with Obama’s data say that it is an email that would have never been sent in 2008. The campaign knew very little about the 13 million people who had registered for online updates, not even their age or gender or party registration. Without the ability to filter its recipients based on those criteria, the campaign stuck to safe topics for email blasts and reserved its sharp-edged messages for individual delivery by direct mail or phone call. In those channels, the campaign could be certain of the political identities of those it was reaching, because the recipients had been profiled based on hundreds of personal characteristics—enough to guarantee that each message was aimed at a receptive audience.
February 1, 2012
Pfizer announced it’s recalling 1 million packets of birth control over a packaging mix-up that could raise the risk for an unplanned pregnancy.
Unsafe sex? Poll shows where young people do it most
The mix-up affects 28 lots of birth control pills: 14 lots of Lo/Ovral-28 tablets and 14 lots of generic Norgestrel and Ethinyl Estradiol tablets. Both products are manufactured by Pfizer Inc. and marketed in the U.S. by Akrimax Rx Products under the Akrimax Pharmaceuticals brand.
What’s wrong with the pills? Pfizer found that some birth control packets had too many active tablets, while others had too few. That’s an issue, since oral birth control products use a series of 21 drug tablets and 7 inactive sugar tablets to regulate the menstrual period for the month while providing contraception. That could leave women with an inadequate dose of the hormones and raise the risk that they will get pregnant accidentally. The recalled pills do not pose a safety risk.
“Consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately,” Pfizer spokesperson Grace Ann Arnold, said in a written statement.
A company spokeswoman said the problem was caused by both mechanical and visual inspection failures on the packaging line and the problem has since been corrected.
The affected packets have expiration dates ranging between July 31, 2013, and March 31, 2014. Lot numbers are available at the FDA’s website.
If you have a pill package that has a recalled lot number, the FDA says notify your doctor and return it to the pharmacy.
November 16, 2011
The Vancouver Sun
By Amy Chung
“Every time you look, there is another story about a pharmaceutical drug that is causing horrible side effects. I thought there things were supposed to be ‘safe’ and effective?” –KTRN
Rates of prostate cancer around the world could be linked to oral contraceptives, a new study suggests.
Dr. Neil Fleshner and Dr. David Margel from Princess Margaret Hospital in Toronto say they have found a significant association between oral contraceptives, prostate cancer and mortality, especially in developed countries in North America and Europe where there is a high use of birth control pills.
The study was published on the online medical journal BMJ Open on Monday.
The authors suggested that estrogen from birth control pills may be excreted through women’s urine, ending up in water supply systems. This, they say, could be boosting rates of prostate cancer.
The authors say the oral contraceptives could be acting as endocrine disturbing compounds (EDCs) — chemicals that interfere with hormones that could result in side effects such as cancer.
“Temporal increases in the incidence of certain cancers (breast, endometrial, thyroid, testis and prostate) in hormonally sensitive tissues in many parts of the industrialized world are often cited as evidence that widespread exposure of the general population to EDCs has had adverse impacts on human health,” said the study.
November 3, 2011
By Dr Christiane Northrup
The hormonal health of any woman depends upon the delicate dance of progesterone and estrogen. Estrogen is meant to be the predominant hormone in the first half of the menstrual cycle and progesterone the predominant one in the second half. However, for most women in the industrialized world this is not the case.
There are many causes of hormone imbalance, but at the base of the problem is something called Estrogen Dominance – which means there is too much estrogen and not enough progesterone present in the body. There are many symptoms that result from having low progesterone levels.
The common causes of hormonal imbalance and estrogen dominance include:
taking the pill,
taking HRT (Hormone Replacement Therapy),
exposure to environmental poison,
eating non organic and estrogen pumped animal products,
stress in all its forms and
WHAT YOU CAN DO
When you consider the average lifestyle of most women today, it is not hard to understand why insulin, estrogen and eicosanoids have become imbalanced, setting the stage for increased risk of heart disease, high blood pressure, depression, PMS, arthritis and breast cancer. Here are my suggestions for keeping your blood sugar, eicosanoids and hormones in balance.
Eat at least three meals per day.
Many women skip breakfast or lunch, or even both, “saving” their calories for dinner. The problem with this approach is that the metabolic rate naturally peaks at noon and slows after that. So the food you eat at night is far more likely to be stored as fat. When you eat breakfast, your metabolism gets jump-started for the day. If you skip it, your metabolism will slow down into conservation mode and this can lead to weight gain.
Cut down on refined and high-glycemic index carbohydrates.
Not all carbohydrates are created equal. Whether certain foods with a high-glycemic index, such as baked potatoes or bananas, can be part of a healthy diet for you depends upon your unique metabolism. If you are a true carbohydrate addict, you need to find what foods are healthy for you. I find that eliminating refined carbohydrates, such as sugar, white rice, bread, alcohol, and foods made with white flour, such as muffins, bagels, pasta, pretzels and other snack foods, helps the body burn stored fat and keeps insulin and blood sugar levels normal.
Consume whole grains in moderation.
Even if you have eliminated refined grains, if you are a carbohydrate-sensitive person you may still have problems with whole wheat, whole rye, whole oat, or millet flour. Research shows that the degenerative diseases that currently plague Americans didn’t arrive on the scene until agriculture became widespread. In fact, the ancient Egyptians were fat and had dental disease associated with a grain-based diet.
October 31, 2011
By the CNN Wire Staff
An Alabama pharmaceutical company issued a voluntary nationwide recall Friday for “multiple lots” of birth control pills due to what it described as a systemic “packaging error.”
A spokesman for Qualitest Pharmaceuticals said that “there are no immediate health issues currently” because of the packaging problems. Rather, he said, the chief concern is that women may unintentionally become pregnant after taking the oral contraceptive.
“The unintended consequence of pregnancy is really the issue,” spokesman Kevin Wiggins said. “That’s why the company took a drastic action.”
Wiggins said the recall involves 1.4 million packages that have been distributed to pharmacists and customers since last year.
According to a statement for the Huntsville-based company, “select blisters (found inside the pill box) were rotated 180 degrees within the card, reversing the weekly tablet orientation.” This helped to leave the pills’ lot number, as well as the expiration date, “no longer visible.”
“As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unwanted pregnancy,” the company said.
A pharmacist noticed the issue and contacted the company by phone, Wiggins explained.
Qualitest urged those with such products to begin using a “non-hormonal” form of birth control and consult a health care provider or pharmacist. Pharmacies have been told to contact those who have gotten the faultily packaged pills.
The recall affects these products: Cyclafem 7/7/7, Cyclafem 1/35, Emoquette, Gildess FE 1.5/30, Gildess FE 1/20, Orsythia, Previfem and Tri-Previfem.
October 27, 2011
By Adriel Bettelheim and Naomi Kresge
U.S. regulators warned there may be an increased risk of blood clots connected with birth-control pills made by Bayer AG (BAYN), and said the issue will be further evaluated in a meeting with advisers in December.
Women taking pills containing the hormone drospirenone were 74 percent more likely to experience clots than those on low- estrogen pills, the Food and Drug Administration said in a report released today. An FDA advisory committee will meet Dec. 8 to discuss the findings.
Sales of the Yaz family of birth-control pills fell 13 percent in 2010 to 1.11 billion euros ($1.57 billion), making them the company’s second-biggest drug. North American revenue from the pills has fallen as the German drugmaker, based in Leverkusen, faces competition from generics made by Teva Pharmaceutical Industries Ltd. (TEVA) The company earlier today said the pill’s risks weren’t higher than that of other oral contraceptives.
“We believe that the overall potential risk that Yaz or Beyaz present to patients is absolutely compared with that of other oral contraceptives,” said Joerg Reinhardt, head of Bayer’s HealthCare unit, in a conference call with analysts today before the FDA released the study results.
After the FDA made its statement, Astrid Kranz, a Bayer spokeswoman, said the company will comment further at the agency’s panel in December.
Similar to Progesterone
Drospirenone is similar to the natural female hormone progesterone. The study evaluated data from 835,826 women ranging in age from 10 to 55 taking pills containing the hormone over time, including Bayer’s Yaz, Beyaz and Angeliq, the FDA report said.
The FDA findings come on top of recent studies suggesting newer birth control pills, including those containing drospirenone, carry twice the risk of potentially deadly blood clots than older contraceptives.
Researchers in Denmark used the country’s health-care data base of women between the ages of 15 and 49 from 2001 through 2009 to find dangerous clots known as venous thromboembolism developed in 4,246 women for the first time during the study. The researchers reported their results in the British Medical Journal this week.
September 14th, 2011
The Huffington Post
By: Amanda Chan
The Pill could play a role in how women remember things, according to a new, somewhat small study.
The team of researchers reported observing that women who take birth control pills were better able to remember the “gist” of an emotional event, while women not on birth control were able to better recall the details of that event.
It’s important to note that birth control pills were not shown in the study to damage memory — rather, “it’s a change in the type of information they remember, not a deficit,” study researcher Shawn Nielsen, of the University of California, Irvine, said in a statement.
The change in memory could occur because birth control pills prevent pregnancy by altering women’s sex hormone levels. Those hormones have also been associated with “left brain” memory, researchers said.
In the Neurobiology of Learning and Memory study, 34 women on birth control and 32 women who were naturally cycling looked at pictures of a mother and son and a car accident. Some women were told that the car hit a curb, while the others were told the car hit the boy and left him critically injured.
A week later, all the women were asked about how much they recalled from the pictures and the details of what happened. Women on birth control — even when they were on the Pill for just a month — better remembered the main events that happened (for instance, that the boy went to the hospital and then the doctors performed surgery on him to reattach his feet), the study reported.
But the women not on birth control better remembered the smaller details, like that there was a fire hydrant by the car, researchers said.
The Telegraph reported that birth control’s effect on the brain has been researched before, and that studies have even suggested that it could enlarge part of the brain to increase a woman’s “emotional skills.”
However, this is the first study to show the effects of hormonal contraception use on emotional memory, Nielsen said.
And even though the number of people in the study was relatively small, researchers conducted a statistical analysis to find that the size of the effect was “relatively large for a human behavioral study,” Nielsen told HuffPost. Researchers plan to continue investigating the effects that hormonal contraception could have on emotional memory.
Birth control pills are 99.9 percent effective when taken correctly and work by preventing a woman’s ovary from releasing an egg, thereby making it impossible to join with the sperm, WebMD reported. Side effects can include lighter periods, changes in mood, sore breasts, nausea, weight gain and spotting between periods. More severe side effects include stomach and chest pain, aching legs and severe headaches.
Today, LIVE from a Top Secret location, Kevin gives you the history behind the CIA’s rise to power and proof that they run America. Plus, find out the real benefits of doing a cleanse and why men have such low levels of testosterone these days.
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December 8, 2009
By Dana Chivvis
Charles Duhigg of The New York Times today delivered the latest unsettling news about the nation’s water supply: It’s not as clean as you might think. An analysis of federal data from the last five years revealed that more than 20 percent of the nation’s water-treatment systems have broken provisions of the Safe Drinking Water Act, the standards enforced by the Environmental Protection Agency. The result? As many as 19 million Americans are sickened each year.
Over the years, the EPA has identified many substances in water supplies far and wide. Here are nine unexpected things that they’ve spotted.
Arsenic A naturally occurring element found in soil and minerals, arsenic is used as a pesticide and wood sealant. Ingesting high levels of arsenic, Madame Bovary can tell you, is deadly. At lower levels, over longer periods of time, it can darken skin and spur corns and warts. A carcinogen, arsenic can increase the risk of skin, liver, bladder and lung cancers.
The EPA has said that more than 3 million Americans have been exposed to water with illegal concentrations of arsenic since 2005.
Uranium The element Iran insists on enriching despite howls from the U.S. and other Western nations, it is also used in helicopters, airplanes, armor, fertilizer and household items like certain microwaves. After it’s mined and processed, some of it is released back into the environment in waste material, called mill tailings. Large amounts of uranium can lead to kidney disease and cancer, though naturally occurring uranium is much less radioactive.
The EPA says levels of uranium in drinking water are usually low and safe, according to the Agency for Toxic Substances and Disease Registry. However, the 3 million Americans exposed to illegal amounts of arsenic were also exposed to illegal amounts of radioactive substances.
Radium This radioactive metal has been used to treat cancer, for scientific research and in instrument calibration. Everyone is exposed to low levels of the substance, but higher levels are found near uranium mines, coal-burning industries and sometimes in drinking water that comes from wells. Radium can cause anemia and cataracts. At high levels, it is a carcinogen, causing increased bone, liver and breast cancer.
The EPA has reported that levels of radium were 2,000 times the legal limit in water flowing in some areas.
Tetrachloroethylene Used in dry cleaning and for metal degreasing, this chemical usually evaporates when it meets water, soil or air, but high exposure can cause headaches, dizziness, confusion, nausea and unconsciousness. Women who are exposed to high levels of tetrachloroethylene may have menstrual problems and even spontaneous abortions. It is also believed to be a carcinogen.
The New York Times found that the drinking water in Ramsey, N.J., located 35 miles outside of New York City, has had illegal concentrations of tetrachloroethylene since 2004.
Lead Houses built before 1986 are more likely to have lead pipes than newer ones. Because hot water dissolves lead more easily, people who live with older plumbing should never drink hot water from the tap. Kids who drink lead-tainted water above the legal limits are at risk for physical and mental development problems. In adults, lead can lead to high blood pressure and kidney trouble.
The EPA’s threshold for lead is 0.015 parts per million. If you are concerned about the levels of lead in your water, you can have it tested at a certified laboratory.
Prozac, Birth Control, Makeup, Shampoo Along with deceased goldfish and incriminating evidence, it turns out Americans like to flush their drugs and personal care products down the toilet, too. These substances leave the toilet (or bathtub and shower) and end up in our waterways. In fact, most of the waterways the EPA tested had pharmaceuticals and personal care products (PPCPs) in them.
While there is evidence that ecological harm can come from PPCPs in the water, scientists are not yet sure of the threat to humans.
You can find reports on the drinking water in your area at the EPA Web site.