Dr. Walt's Health Blog

Archives for posts tagged ‘FDA’

Ella Abortion Drug Falsely Called a “Contraceptive Pill”

The ella® abortion drug has been billed by its distributor, the FDA, and abortion advocates as an improved “emergency contraceptive pill.” It is available across the United States via prescription.

Upon its release, Watson Pharmaceuticals, based in New Jersey, announced that ella® (ulipristal acetate) was available for women to obtain and use up to five days following unprotected intercourse or contraceptive failure. While the company maintain the drug works only as a “contraceptive agent,” the fact of the matter is that five days is sufficient time for conception to take place and confer into existence the life of a unique human being who needs only a nine month pregnancy to be born.

Here are the details from LifeNews: “ella® is the first truly new emergency contraceptive option for U.S. women since 1999. It has a unique sustained efficacy profile and offers women an additional therapeutic option for preventing unintended pregnancy,” Wilkinson, Executive Vice President of Watson Global Brands, said in a statement LifeNews.com obtained.

“We are committed to making this innovative prescription-only emergency contraceptive option available to women as soon as possible and supporting the availability of ella® in ways that emphasize education and access,” he said.

The drug company indicated the ella® launch will be phased over the next several months and will include physician educational initiatives, advocacy outreach and educational websites for consumers.

Watson wants the abortion drug to be available immediately and indicates “stocking efforts have ensured the product will be available immediately by prescription at most retail pharmacies, clinics, as well as online via a licensed online pharmacy.”

Kristan Hawkins, the president of Students for Life of America and a national leader against the ella drug, responded to the news in a comment to LifeNews.com.

“The fact that ella is now on sale across the country means that millions of women are at risk for dangerous side effects of this new abortion drug,” she said. “Make no mistake about it, ella, the new abortion drug, will be marketed on college campuses nationwide, and young women across America will be put in serious danger.”

“It is appalling that the U.S. Food and Drug Administration has approved this drug which is dangerous for women and fatal for preborn children. The FDA needs to rescind its approval this new abortion drug before women and children are harmed,” Hawkins added.

Ella has been available in Europe as an emergency contraceptive since October 2009, where it is marketed by its developer,  HRA Pharma, as ellaOne.

But the FDA, when it approved the drug, made its decision based on data from two phase III clinical trails the French drug maker HRA Pharma sponsored.

The studies showed 1.51 percent of women using ella (or ellaOne in Europe) became pregnant when using the drug 72 hours after intercourse while 2.81 percent became pregnant when using the Plan B drug.

However, Wendy Wright, the president of Concerned Women for America, said the ella abortion drug maker could not answer other questions.

“The drug sponsor couldn’t provide information on whether Ella can cause birth defects, or what happens to women who are pregnant who take it. And yet the committee strongly recommended not giving a woman a pregnancy test,” she told LifeNews.com after the hearing.

“In Europe, Ella is contra-indicated (not to be used) in pregnancies. But the FDA committee voted to not to test women to detect if they’re pregnant. They are telling doctors to be willfully blind when giving the drug,” Wright continued.

Americans United for Life and the American Association of Pro Life Obstetricians & Gynecologists told the FDA a study in England confirms the pro-life perspective that ulipristal acts as an abortion drug.

Anna Glasier, of NHS Lothian in Edinburgh, led a study of more than 5,500 women in the UK published online in The Lancet medical journal. It found fewer pregnancies among those women given the ellaOne drug within five days of intercourse.

And for women who took the drug between 3-5 days after having sex, only women taking the traditional morning after pill became pregnant. They’s because all of the women using ulipristal during that time period had abortions.

“AAPLOG has concluded from publicly available information that ulipristal acetate is an abortifacient of the same type as mifepristone (RU 486) and that its approval as an emergency contraceptive raises serious health and ethical issues,” the pro-life physicians group says. “Furthermore, ulipristal’s potential effects on women who used the drug off-label and upon ongoing pregnancies are essentially unexamined and untested.”

Pharmacists For Life International, in a statement to LifeNews.com, confirms the abortifacient nature of the Ella drug.

PFLI calls Ella a “chemical cousin analog of mifepristone,” the abortion drug more commonly known by its experimental name, RU 486. “Ulipristal acetate, according to its own developers, can kill embryos,” it confirms.

The organization said it “vehemently denounces and condemns the FDA for this inappropriate use of its drug regulatory power to destroy life rather than approve and regulate medicines which actually are life-saving and preserve health.”

PFLI says it is concerned women will purchase the drug and stockpile it in large doses and sidestep the routine surgical or drug-induced abortion process with dangerous at-home abortions. It also worries the drug will be used by men who want to hide evidence of their crimes of sexual assault.

“This will lead to additional life-endangering problems for the targeted adolescent girls and women, as well as giving continued cover for sexual predators of underage girls and incestuous abusive relationships,” the group worries.

Watson is the exclusive marketer of ella in the U.S.

FDA shifts stance on safety of BPA in plastics

Scientists link BPA in plastics to heart disease
Wow. No sooner do I post a blog in which I say, “The U.S. Food and Drug Administration (FDA) is considering whether any action needs to be taken (about BPA). And I would expect them to express a more cautionary tone in the future. There’s just too much evidence now to not do so,” than the FDA announces a reversal of its position.

In a front-page story, the New York Times reported, “In a shift of position, the Food and Drug Administration is expressing concerns about possible health risks from bisphenol-A, or BPA, a widely used component of plastic bottles and food packaging that it declared safe in 2008.”

The FDA is now saying it has “some concern about the potential effects of BPA on the brain, behavior and prostate gland of fetuses, infants and children.”

While the agency plans to “join other federal health agencies in studying the chemical in both animals and humans,” federal “officials said there was no proof that BPA was dangerous to humans.” FDA principal deputy commissioner Dr. Joshua Sharfstein said, “If we thought it was unsafe, we would be taking strong regulatory action.”

Dr. Sharfstein explained, “We have some concern, which leads us to recommend reasonable steps the public can take to reduce exposure to BPA,” the Washington Post added. “Sharfstein said the agency is conducting ‘targeted’ studies of BPA, part of a two-year, $30 million effort by the administration to answer key questions about the chemical that will help determine what action, if any, is necessary to protect public health.

The Los Angeles Times noted that the “FDA action, which was praised by industry officials and criticized by some food safety and consumer watchdog groups, comes after more than a year of controversy.”

USA Today reported that, along with the increased research, the FDA is “encouraging manufacturers to stop making baby feeding products containing BPA” and “wants to help manufacturers to find safer materials to line metal cans of liquid baby formula.”

The FDA “also is looking into ways to expand its authority to regulate BPA, in case scientists do find definitive evidence of harm, says Joshua Sharfstein.”

The Boston Globe reported that in precautionary recommendations, HHS suggested consumers “throw away scratched cups and bottles with Bisphenol A because small amounts of the chemical can seep out and be ingested by children.” Deputy HHS Secretary William Corr said, “Recent reports show subtle effects of BPA in lab animals that has raised concerns.”

In its report, CBS News correspondent Kelly Wallace asks University of Missouri professor Fred Vom Saal, “How convinced are you that elevated levels of BPA in people’s bodies can lead to cancers, heart disease, obesity and early puberty?”

Vom Saal replied, “I and other colleagues of mine at an NIH (National Institutes of Health) meeting said, with a very high level of confidence, we think Bisphenol A is a threat to human health.”

Here are a couple of my past blogs on BPA:

Scientists link BPA in plastics to heart disease

#mce_temp_url#With disagreement over baby bottle chemical (bisphenol A), what’s a parent to do?

Reuters Health in London is reporting that exposure to a chemical found in plastic containers is linked to heart disease. Scientists researching bisphenol A, known as BPA, have just confirmed earlier findings casting suspicion on BPA and adding to pressure to ban its use in bottles and food packaging — not only for those containers of food or drink for infants and children, but also adults.

British and U.S. researchers studied the effects of the chemical bisphenol A using data from a U.S. government national nutrition survey in 2006 and found that high levels of it in urine samples were associated with heart disease.

Bisphenol A, known as BPA, is widely used in plastics and has been a growing concern for scientists in countries such as Britain, Canada and the United States, where food and drug regulators are examining its safety.

David Melzer, professor of epidemiology and public health at the Peninsula Medical School in Exeter, England, who led the study, said the research confirmed earlier findings of a link between BPA and heart problems.

The analysis also confirmed that BPA plays a role in diabetes and some forms of liver disease, said Melzer’s team, who studied data on 1,493 people aged 18 to 74.

“Our latest analysis largely confirms the first analysis, and excludes the possibility that the original report was a statistical blip,” they said in a statement.

BPA, used to stiffen plastic bottles and line cans, belongs to a class of compounds sometimes called endocrine disruptors.

The U.S. Endocrine Society called last June for better studies into BPA and presented research showing the chemical can affect the hearts of women and permanently damage the DNA of mice.

“The risks associated with exposure to BPA may be small, but they are relevant to very large numbers of people. This information is important since it provides a great opportunity for intervention to reduce the risks,” said Exeter’s Tamara Galloway, who worked on the study published by the Public Library of Science online science journal PLoS One.

U.S. environmental health advocacy groups are urging a federal ban on BPA.

“There’s enough research to take definitive action on this chemical to reduce exposures in people and the environment,” Dr. Anila Jacob of the Environmental Working Group, a non-profit organization, said in a telephone interview.

The U.S. Food and Drug Administration is considering whether any action needs to be taken. And I would expect them to express a more cautionary tone in the future. There’s just too much evidence now to not do so.

U.S. government toxicologists at the National Institutes of Health concluded in 2008 that BPA presents concern for harmful effects on development of the prostate and brain and for behavioral changes in fetuses, infants and children.

Canada’s government plans to outlaw plastic baby bottles made with BPA. The charity Breast Cancer UK last month urged the British government to do the same because they said there was “compelling” evidence linking the chemical to breast cancer risk.

Experts estimate BPA is detectable in the bodies of more than 90 percent of U.S. and European populations. It is one of the world’s highest production volume chemicals, with more than 2.2 million tonnes produced annually.

My advice to my patients is to avoid, as much as possible, containers with BPA — and certainly not to heat or microwave items in BPA containers. Also, for parents I advise that they not feed their children using plastics containing BPA.

For now, I think it’s better to be safe than sorry.

Here are a couple of my past blogs on BPA:

Two dietary supplements used by high school athletes contain illegal and dangerous steroids

Two over-the-counter dietary supplements that anti-doping officials say are popular among high school football players contain steroids, according to court papers filed by federal authorities.

More Information:

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Over 90% of online pharmacies may be violating FDA regulations

Buying prescription medications from online pharmacies may seem cheap and easy. But cheap and easy shouldn’t be your top priority when it comes to your health. While there are plenty of legitimate U.S. Internet pharmacies that follow the law and put public safety first, there are many more that don’t.

More Information:

Click to continue reading “Over 90% of online pharmacies may be violating FDA regulations”

Cold medicines and children: a dangerous mix?

As the seasons change and parents reach for over-the-counter cold medicine for their icky-feeling children, they may be baffled by new instructions: Do not give them to kids under 4. Drug companies recently announced they are voluntarily changing the labels for OTC cold and cough medicines in a nod to pediatricians long arguing they do little good and aren’t worth the risks.

So now what?

Click to continue reading “Cold medicines and children: a dangerous mix?”

Tips on giving over-the-counter cold (OTC) medications to children over 4 years old.

Drug companies recently announced they are voluntarily changing the labels for OTC cold and cough medicines in a nod to the arguments from physicians who care for children that these medications may have significant risks, even for children over age 4, if not given correctly. So, what’s a parent to do?

My Take?

Click to continue reading “Tips on giving over-the-counter cold (OTC) medications to children over 4 years old.”

With disagreement over baby bottle chemical (bisphenol A), what’s a parent to do?

USA Today is reporting on the confusion that consumers, in general, and parents, in particular, are having about the safety of chemicals in plastic. Even federal government agencies don’t agree about the hazards posed by bisphenol A, or BPA, an estrogen-like chemical used in plastic that has been detected in the bodies of 93% of Americans tested. The FDA says it’s safe, but new studies question its safety.

My Take?

Click to continue reading “With disagreement over baby bottle chemical (bisphenol A), what’s a parent to do?”

Study Links Herbal Medicines to Lead Poisoning. How can you find safe herbs?

Fox News is commenting on a study published in the August 27 issue of JAMA in which medical researchers say that one-fifth of Ayurvedic herbal medicines sold on the Internet contain dangerously high levels of lead, arsenic and mercury. How’s a consumer to protect themselves?

My Take?

Click to continue reading “Study Links Herbal Medicines to Lead Poisoning. How can you find safe herbs?”

Secret Drug Test Takes Center Stage at Tour de France

MedPage is reporting that a secret test nabbed three riders for using a banned new form of erythropoietin. The drug is CERA (Mircera), a pegylated EPO developed by Roche that reached the European market earlier this year. It was approved by the FDA last November, but U.S. distribution has been stalled by a patent dispute with Amgen, another firm that markets EPO. 

My Take?

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Antibiotics can harm tendons, FDA warns

Reuters is reporting that a class of antibiotic drugs, known as fluoroquinolones, will be getting a black box warning from the FDA about the risk of tendonitis and ruptured tendons. Drugs in this class include Cipro, Avelox, Proquin XR, Levaquin, Floxin, and Noroxin. Cipro is sold by various generic makers as ciprofloxacin and Floxin is sold generically as ofloxacin.

My Take?

Click to continue reading “Antibiotics can harm tendons, FDA warns”

Controversial HPV Vaccine Causing One Death Per Month: FDA Report

LifeSiteNews.com is reporting a shocking revelation – that one death per month is the average loss of life associated with the cervical cancer vaccine Gardasil. The data comes from an FDA report obtained by a government watchdog agency.

My Take?

Click to continue reading “Controversial HPV Vaccine Causing One Death Per Month: FDA Report”

Report Suggests 85% of Sunscreens May Not Live Up to Marketing Claims

In its new report, the nonprofit Environmental Working Group says that 85 percent of sunscreens either inadequately protect from the sun’s rays or contain ingredients that may be unsafe. They say that the problem is worsened by the fact that the Food and Drug Administration has not passed standards for testing and labeling sunscreens — meaning that makers often have carte blanche when it comes to making claims about their products.

My Take?

Click to continue reading “Report Suggests 85% of Sunscreens May Not Live Up to Marketing Claims”

FDA Cracks Down On Unproved Cancer Cures

The AP is reporting that the Food and Drug Administration (FDA) is cracking down on teas, supplements, creams, and other products that falsely claim to cure, treat, or prevent cancer, even though they are not agency-approved drugs. All are available for sale on the Internet. 

The agency has sent 25 warning letters to companies and individuals marketing these products, FDA officials said Tuesday. Twenty-three of the letters went to domestic companies and two to foreign individuals.

Click to continue reading “FDA Cracks Down On Unproved Cancer Cures”

Another Study Suggests Planned Parenthood at Fault in Abortion Drug Deaths

LifeNews is reporting a study that suggests Planned Parenthood is at fault in the deaths of women in the United States from the abortion drug RU 486. The abortion business had been telling women to use the drug in a different way than the FDA guidelines suggested and the study shows it contributed to the deaths.

So far, eight women have died from the use of the abortion drug, including women going to Planned Parenthood abortion centers in California. Planned Parenthood had been telling women to use the abortion drug vaginally, even though the FDA indicated oral use is safer for women.

Click to continue reading “Another Study Suggests Planned Parenthood at Fault in Abortion Drug Deaths”

FDA Approves Another Drug for Fibromyalgia

MedPage Today reports that the FDA has approved duloxetine (Cymbalta), an SNRI (serotonin-norepinphrine reuptake inhibitor), for fibromyalgia (FMS).

This is only the second drug to be approved for FMS. Last year the the FDA approved the anti-seizure drug pregabalin (Lyrica) for FMS.

Click to continue reading “FDA Approves Another Drug for Fibromyalgia”

British Teenager Becomes 14th Woman to Die From Dangerous Abortion Drug

 

LifeNews is reporting another death of a woman from an abortion drug. Eight women in the United States have died from the Mifepristone abortion drug, one in Canada, now three in the UK, one in Sweden, and one in France.

My Take?

Click to continue reading “British Teenager Becomes 14th Woman to Die From Dangerous Abortion Drug”

Consumers Urged to Avoid Raw Milk and Raw Milk Products

A report in Health on the Net reminds us that, according to the CDC, from 1998 to May 2005, raw milk or raw milk products were implicated in 45 food-borne illness outbreaks that resulted in more than 1,000 cases of illness in the United States.

Click to continue reading “Consumers Urged to Avoid Raw Milk and Raw Milk Products”

St. John’s Wort No Help in ADHD

ABC News reports a new study suggesting that St. John’s wort is not a useful treatment for attention deficit hyperactivity disorder, or ADHD. Although the researchers only studied 54 children between 6 and 17 years old who have ADHD for eight weeks, the study design was the gold standard randomized controlled trial. And, they found that St. John’s wort was no better than placebo when it came to improving the children’s attentiveness or hyperactivity.

Click to continue reading “St. John’s Wort No Help in ADHD”

FDA Official Says Baby Bottles With Bisphenol A Safe

According to the Associated Press, the FDA is declaring that “Plastic baby bottles and water bottles are safe.” Thus, the FDA is seeking to ease public concerns about the health hazards of a chemical used in the products.

Click to continue reading “FDA Official Says Baby Bottles With Bisphenol A Safe”

Red Yeast Rice (Chinese Supplement) May Cut Heart Risk

ABC News is reporting a study showing Chinese red yeast rice extract reduced the risk of repeat heart attacks by nearly one half. The researchers tested red yeast rice extract pills versus a placebo on nearly 5000 Chinese heart attack patients who were followed for 5 years.

Click to continue reading “Red Yeast Rice (Chinese Supplement) May Cut Heart Risk”

Dr. Walt’s Take on the Health Headlines – June 6, 2008

Here are my takes on some of today’s health headlines, including one that is, in my opinion, being blown way out of perspective:

Mercury teeth fillings may harm some: FDA

Silver-colored metal dental fillings contain mercury that may cause health problems in pregnant women, children and fetuses, the Food and Drug Administration said on Wednesday after settling a related lawsuit.

Click to continue reading “Dr. Walt’s Take on the Health Headlines – June 6, 2008″

Vaccine Myth #8: A Preservative Contained in Many Vaccines Harms Children

In 1999, a study revealed that the preservative thimerosal, a mercury-containing compound present in many vaccines, caused several infants to have levels of mercury in their blood that exceeded guidelines recommended by the Environmental Protection Agency (EPA). Preservatives are used in vaccines to reduce the risk of contamination by bacteria once the vial is opened. Exposure to high levels of mercury, especially in the developing child before birth, is associated with neurological disturbances. Therefore, parents began to fear that thimerosal may cause neurological difficulties, like autism. When this study was first described, physicians, scientists, and public health officials quickly assessed the situation and found that:

Click to continue reading “Vaccine Myth #8: A Preservative Contained in Many Vaccines Harms Children”

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