<![CDATA[Jezebel: fda]]> http://tags.gawker.com/assets/base/img/thumbs140x140/jezebel.com.png <![CDATA[Jezebel: fda]]> http://jezebel.com/tag/fda http://jezebel.com/tag/fda <![CDATA[Is Yaz Riskier Than Other Birth Control Pills?]]> In the land of Yaz commercials, everyone has a sassy doctor friend who enjoys casually discussing the possible side effects of oral contraceptives. But in reality, for at least 74 plaintiffs, the side effects can't be brushed aside as easily.

According to Natasha Singer of the New York Times, Yaz, the most popular birth control pill in the country, and its sister brand, Yasmin, are currently facing 74 lawsuits filed in connection with the drugs by those who claim the pills "put women at higher risk for blood clots, strokes and other health problems than some other birth control pills do."

This is not the first time Yaz has run into trouble; in 2008, the FDA ordered Bayer to stop running Yaz ads that claimed the pill was a cure for PMS and acne, leading to a series of "corrective" ads on Bayer's part that attempted to make up for the misleading campaign whilst still pushing Yaz as a sassy alternative to old school birth control. But the misleading campaign fiasco is now the least of the brand's troubles—earlier this month, Bayer was reprimanded once again by the FDA after several batches of drospirenone, an ingredient used in Yaz, failed inspection after being shipped to the US by Bayer from a German manufacturing plant. And now, with several lawsuits on their hands, Bayer is faced with the challenge of keeping their money-maker afloat despite criticisms from former users.

Anne Marie Eakins, a former Yaz user, tells Singer that the pills caused her to develop blood clots in her lungs, and that she "lost partial use of her right lung" as a result. "I didn't think it was going to be worse than any other pill," Eakins admits, noting that she'd used several other birth control pills for a good ten years before switching to Yaz. Bayer, however, claims that the risks of Yaz are no greater than the risks of other leading birth control pills, despite the reports of blood clot troubles and even deaths associated with the drugs, and as the rare side effects are listed in the information provided with the medication, Singer notes, the plaintiffs may have a difficult time in court.

Perhaps the most frightening aspect of all of this is the general lack of information that seems to be given out along side birth control pills; they're advertised like lip gloss or mascara, a fun little accessory to throw in your purse, as opposed to a medication that does carry many risks and should be treated as such. This is a problem that extends to all ads for medication; the consumer is told to go to the doctor and demand a certain brand name, without even knowing, exactly, what the medication really does to the body. Someone always does a voice over about diarrhea and blood clots and death, but all the audience seems to pick up on are the scenes of horses frolicking or women laughing or couples holding hands in the sun.

This is not to say that we should scare the hell out of women when it comes to promoting birth control, but one hopes that the FDA will push to ensure higher standards and safer medications, and that when women do consider birth control pills, they are given all of the information necessary to make an informed choice—from a real doctor, not some actress who just plays one on television.

What do you think, commenters? Do you worry about the side effects of your birth control pills? Or do the benefits outweigh the risks?

FDA Warns Bayer Over German Manufacturing Plant [NYTimes]
Bayer Running Ads To Clarify Benefits Of Birth Control [NYTimes]
Health Concerns Over Popular Contraceptives [NYTimes]
Bayer Contraceptive Probed Over Possible Death Link [Reuters]

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<![CDATA[Yale Murder Suspect "Extremely Controlling" • Study Says: Women Suck At Parking]]> A former girlfriend of Raymond Clark, the lab tech accused in the murder of Annie Le, told Good Morning America that Clark was "extremely controlling." She says dictated what clothes she wore, and who she could see. •

• A state panel has found that there is probable cause to believe that a suburban Philadelphia swim club, which asked a group of mostly black and Hispanic kids to leave, was guilty of discrimination. One of the girls who was asked to leave reports overhearing a club member asking, "What are all these black kids doing here? I am scared they might do something to my child." • For the low price of $39.95, you can be the proud owner of a Joe Wilson action figure, because nothing says I'm well-versed in politics! quite like a plastic figurine. •  Girls are fast catching up to boys in violent crime, according to new data. Although the increase first began to appear in the 1980s, it was only in the past decade that we saw a true rise in violence among young women. Professor Kerry Carrington will publish her findings in her book, Offending Youth. • The man accused of beating a female soldier outside an Atlanta Cracker Barrel has been indicted on charges of aggravated assault, cruelty to children, and false imprisonment. Federal officials are currently investigating whether he should also be charged with committing a hate crime. • A South African man has been sentenced to life in prison after being found guilty of the "corrective" rape and murder of Eudy Simelane, one of the country's leading female soccer players. Two other men were acquitted due to lack of evidence. • Police have been unable to link Philip and Nancy Garrido to the disappearance of two young girls. Last week, it was reported that police found what could possibly be human remains on the Garrido's land, but it has since been determined that the bones are "far too old to be relevant to our case." • Max Baucus has backed down on his proposed tax on the medical devices industry. The so-called "Q-tip tax" has been amended, so that items under $100 (including tampons, sanitary pads, and Q-tips) would no longer be taxed. •  Researchers have found that providing Mexican women with new, pollution-reducing stoves can dramatically improve their respiratory health. Many Mexican women cook over indoor, wood-burning stoves, which causes them the same damage as smoking a pack of cigarettes every day. • Bad news for breeders: Scientists have linked childbearing to an increased risk for developing metabolic syndrome. • High school science teacher Susan Vincent was disappointed to realize that inner-city girls don't get to spend a lot of time outside, so she introduced a program at her school that brings kids to the Hudson River estuary. She hopes that they will eventually be able to fund a field-trip to the Mississippi River delta. • According to a recent poll, women are twice as likely to ask someone else to park for them than men. Women are also more likely to admit to being flustered while parallel parking, and to becoming self-conscious when watched. This leads the Daily Fail to deduce that "parking is a masculine strength." • Though Justine Henin retired from tennis last year at 25, when she was ranked number one and held two Grand Slam singles titles, she announced yesterday that she's returning to competition, and may even be back for the Australian Open. • A study of 2,000 British children ages 7 to 11 found left-handed kids are more likely to enjoy school and get along with their teachers. • According to another study of 2,000 adult Britons, many people are in denial about their weight problems. Though only 7 percent of those polled thought they were obese, the actual figure was 27 percent. • The FDA has banned the sale of candy, fruit and clove-flavored cigarettes, effective immediately. However, the ban does not apply to flavored cigars, smokeless tobacco products, or most notably, menthol cigarettes. Menthol cigarettes are preferred by 80% of black smokers and 25% of white smokers, and are increasingly popular with teens according to Jonathan Foulds, director of the Tobacco Dependence Program University of Medicine & Dentistry of New Jersey-School of Public Health, but he says banning them too would result in a "pretty major revolt from industry." • Experts say the murder and persecution of women and children accused of being witches is increasing around the world, and may number in the millions. U.N. investigators say the persecution and killing of accused witches, who are often elderly women, is becoming common in South Africa, Nepal, Papua Ne Guinea, India, and other countries. In other areas children accused of witchcraft are abandoned or killed by their families. • Iranian President Mahmoud Ahmadinejad backed off his denial of the Holocaust in an interview with the AP yesterday. He said he isn't interested in debating the past anymore, but that the Holocaust shouldn't be used as a pretext to repress Palestinians today. • Some of the 42 African-American members of Congress who attended the Congressional Black Caucus conference this week said that "tea parties" and the people protesting against Obama's healthcare reform show that racism is on the rise. Democratic Georgia Rep. Hank Johnson, said Joe Wilson shouting "You lie!" could signal the return of "folks putting on white hoods and white uniforms again, riding through the countryside." • In the late '80s, when Glenn Beck hosted a Phoenix, Arizona radio show he used to do a version of Orson Welles' "War of the Worlds" every Halloween. A rival radio host, Bruce Kelly, told a newspaper reported the bit was a stupid rip-off of an old joke. As revenge, Beck called Kelly's wife, Terry, live on the air a few days after she had a miscarriage. According to Brad Miller, one of Beck's former co-workers, he said," We hear you had a miscarriage... When Terry said, 'Yes,' Beck proceeded to joke about how Bruce [Kelly] apparently can't do anything right — about he can't even have a baby." •

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<![CDATA[FDA Finds More Lead In Lipstick Than Expected, Still Doesn't Set Standards]]> The Campaign for Safe Cosmetics wants the FDA to set standards to reduce the amount of lead in lipstick because the agency found an average lead level in lipstick ten times higher than its standard for lead in candy. [UPI]

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<![CDATA[Food Is The New Old Drug]]> The FDA warned General Mills to either stop advertising that eating Cheerios is "clinically proven to help lower cholesterol" or submit an application to classify them as a drug. (A delicious drug!) [Wall Street Journal]

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<![CDATA[Hydroxycut Pulled From Shelves After Consumer Dies]]> In a not entirely surprising move, the FDA has issued a warning to consumers using Hydroxycut, a dietary supplement that has been linked to severe liver damage and has led to at least one death.

The company that manufactures Hydroxycut, Iovate Health Sciences Inc, has already started recalling the product. According to Linda Katz of the FDA, "The FDA urges consumers to discontinue use of Hydroxycut products in order to avoid any undue risk. Adverse events are rare, but exist." The Hydroxycut website has already been changed to redirect to "Hydroxycut Information," which currently shows information regarding the recall. [Reuters] [Hydroxycut]

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<![CDATA[ In a letter released yesterday, the FDA...]]> In a letter released yesterday, the FDA condemned Bayer AG for misleading TV commercials for the birth control pill Yaz. Two of the ads suggest that Yaz has been approved to relieve common PMS symptoms like "bloating" and "moodiness" when it has only been cleared for a more serious condition called premenstrual dysphoric disorder. The FDA also criticized a suggestion that the pill is approved to treat acne of all types and alleges that ads distract viewers with fast-moving images and background music while information about potential side effects is described. [Reuters]

[Image via Side Salad]

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<![CDATA[Pig Face]]> Mm, pork may be delicious, but is it a wrinkle fighter? The FDA has approved a new porcine collagen filler that is said to last longer than old skool collagen derived from bovines (question: WTF are these people putting in their faces? The entire contents of a butcher shop?). Dermatologists are all abuzz about the filler's potential but also concerned about its appeal to people who keep kosher. Wonder what these rabbis would have to say about the development? [W Magazine]

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<![CDATA[McCain's Buddy And Your Condoms]]> This is Oklahoma Senator (and gynecologist) Tom Coburn who was elected to represent the kind people of Oklahoma in the U.S. Senate. His interpretation of that responsibility is, apparently, to keep everyone else from fucking. The New York Post reported this morning about a GAO report on the FDA's interpretation of the law on labeling condoms, which some would like to see change to reflect both what condoms effectively prevent when used properly (pregnancy and the transmission of HIV, gonorrhea, chlamydia and syphilis) and what they less effectively counter (HPV and herpes). What the Post fails to mention is that the report is in response to Senator Coburn, who has had something up his butt about condom labeling since at least 1999. In Coburn's "never fuck unless you're married and want a kid" mentality, putting scare labels on condoms will keep the people of America and the world from having sex because, as the AIDS rate in the world effectively demonstrates, scaring people about disease transmission keeps them from fucking. (In unrelated notes, he also conducts a sex ed lecture for summer interns every year to keep them from fucking and once said that lesbianism is "so rampant in some of the schools in southeast Oklahoma that they’ll only let one girl go to the bathroom." Oh, he supports John McCain.) [NY Post, GAO, Guttmacher Institute, The Advocate, Washington Post, Alternet]

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<![CDATA[ Lobbyist groups are banging down the FDA's...]]> Lobbyist groups are banging down the FDA's doors, asking the agency to yank the birth-control patch Ortho-Evra off pharmacists' shelves and insisting that it poses high risk of potentially-fatal blood clots and at much higher rates of instance than the drug companies are disclosing. The higher estrogen levels that patch users are exposed to seem to be the source of the problem, though of course Big Pharm begs to differ. One thing is for sure ladies, if you're on hormone-based birth control — of any sort — Do. Not. Smoke. [NYT]

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<![CDATA[ In this Newsweek video, Dr. Susan Wood,...]]> In this Newsweek video, Dr. Susan Wood, the former director of the FDA's Office of Women's Health, comes out for Hillary Clinton. Against an odd background of porny-sounding music, Wood explains how much Hillary did to help Plan B become legal in the United States. "Emergency contraception would not be available without Hillary Clinton," Wood says. Although Wood has come out for Clinton, lots of feminists are still tussling over Hillary vs. Barack. Minnesotan Kim Goodwin invited seven friends to her house to discuss the candidates. Republican Therese Liffrig said of Hillary, "No, I wouldn't vote for her...But if she won, I'd be happy about it," while Barack supporter Stephanie Forsland said, "She just came across as a little bit too slick of a politician." Can't wait to see how it all turns out in Texas and Ohio tonight! [Newsweek, Salon, NPR]

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<![CDATA[U.S. Provider Of Abortion Pills Linked To Contaminated Cancer Drugs]]> The state-owned Chinese pharmaceutical manufacturers Shanghai Hualian, the only suppliers of the abortion pill RU-486 to the United States, have paralyzed or injured over 200 cancer patients in China with tainted leukemia drugs. According to the New York Times, the factory that produced the contaminated drugs has been closed, and the factory that makes RU-486 (aka mifepristone) is an hour away. This is the first time the F.D.A. is publicly announcing the American supplier of the abortion pill; the Times reports that the F.D.A. kept the manufacturers a secret because of security concerns stemming from "sometimes violent opposition to abortion."

Although a FDA spokesman said "[We are] not aware of any evidence to suggest the issue that occurred at the leukemia drug facility is linked in any way with the facility that manufactures the mifepristone", Shanghai Hualian doesn't exactly have the greatest recrod: In 2002, shipments from the company were stopped at the U.S. border because they were unapproved or mislabeled, and pharmaceutical behemoth Pfizer won't import from Hualian at all because of its concerns with quality issues.

What is currently unclear and mildly troubling is why all the mifepristone in the United States is manufactured by a single company at a single factory in a country with a checkered history of drug regulation. Instances of bribery in the Chinese drug industry are so extreme that the top drug safety official was executed last year because he had accepted money to approve drugs. In addition, the same inspector responsible for the factory producing the tainted cancer drug, Gu Yaoming, met with F.D.A. brass in conjunction with the RU-486 factory inspection, all of which makes Tuesday's news that the FDA is the equivalent of 13 years behind in inspecting foreign drug manufacturers all the more inspiring!

Finally we have to wonder whether this news will affect the number of non-surgical abortions in the United States. Since RU-486 was introduced in 2000, the percentage of abortions performed through the pill has risen steadily, and at this point 14% of all abortions are "miffy" induced. Does this new information make you wary of taking RU?

Tainted Drugs Linked to Maker of Abortion Pill [New York Times]
Related: For F.D.A., A Major Backlog Overseas [NY Times]

Earlier: Experts Don't Understand Why Fewer American Women Are Getting Abortions

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<![CDATA[Get in line girls.]]> syringe.jpg

Gardasil, the first ever vaccine against the cervical cancer-causing human papillomavirus (HPV) - that's genital warts to you and me - has been approved by the FDA.

The article is well worth a read, if only for the following fascinating facts:

  • HPV is still the second-most-common malignancy and a leading cancer killer of women worldwide.

  • A quarter of people ages 15 to 24 are infected with HPV.

  • The lifetime risk of becoming infected at least once with a cancer-causing HPV type is more than 80%.

In the Q&A there's an interesting discussion about whether boys should be vaccinated too.

"In men, HPV causes genital warts and has been linked to penile and anal cancer. Plus, of course, men can transmit HPV to women. Merck has tested Gardasil's safety and immune response in 9- to 15-year-old boys and found that they have a slightly better immune response than girls and women, Barr says. "What we don't know yet is whether the vaccine will protect against infection and disease caused by HPV in young men," he says. To answer that question, Merck is conducting a clinical trial in men as old as 26 and expects to complete it in 2008, Barr says."

Color me naive, but I never knew HPV could give men cancer too. Anal cancer.

I'm clenching my buttocks at the mere thought of it.

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