Friday, January 11th, 2013
The Food and Drug Administration has approved a new intrauterine device (IUD), the first such new approval in 12 years, Reuters is reporting:
The T-shaped polyethylene device is designed to prevent pregnancy for 3 years, during which time it releases a diminishing dosage of progestin, according to Bayer documents.
The proportion of women using long-acting reversible contraceptive methods such as an intrauterine device (IUD) climbed to 7.7 percent in 2009 up from 2.0 percent in 2002, according a 2012 study by the Guttmacher Institute, a reproductive health and rights organization based in New York.
The highest level of use was among women aged 25-39 and those who already had at least one child.
The IUD, called Skyla, is aimed at younger women who have not had children. During a trial of 1,432 women aged 18 to 35 years, the rate of pregnancy over a three-year period was 0.9 per 100 women, and 77 percent of women wishing to become pregnant did so within 12 months of its removal, Bayer documents said.
“Over half of all pregnancies in the U.S. are unintended and there’s just a need out there to have effective birth control,” said Pamela Cyrus, Bayer’s head of medical affairs said in an interview.
Image: Woman talking to her doctor, via Shutterstock
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Wednesday, July 18th, 2012
The chemical compound bisiphenol-A, otherwise known as BPA, can no longer be used to make baby bottles and sippy cups because of health and safety concerns, the Food and Drug Administration has announced. Every major manufacturer of bottles and sippy cups has already stopped using BPA, and parents are familiar with “BPA Free” labels on those and other plastic products.
MSNBC.com reports on the ruling, which was requested by the U.S. chemical industry’s chief association, the American Chemistry Council in October:
The chemical industry’s request may help curb years of negative publicity from consumer groups and head off tougher laws that would ban BPA from other types of packaging because of health worries.
Legislation introduced by some members of Congress would ban BPA nationwide in all canned food, water bottles and food containers. Chemical makers maintain that the plastic-hardening chemical is safe for all food and drink uses.
BPA is found in hundreds of plastic items from water bottles to CDs to dental sealants. Some researchers say ingesting the chemical can interfere with development of the reproductive and nervous systems in babies and young children. They point to dozens of studies showing such an effect from BPA in rodents and other animals.
But the FDA has repeatedly stated that those findings cannot be applied to humans. The federal government is currently spending $30 million on its own studies assessing the chemical’s health effects on humans.
Image: Baby bottle, via Shutterstock.
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Tuesday, June 26th, 2012
Two elementary school girls in Tacoma, Washington have reportedly suffered severe sunburns after their school banned sunscreen, MSNBC.com is reporting. The girls are sisters, and one of them has a skin condition that makes her especially sensitive to the sun. According to MSNBC, the girls’ mother is challenging the ban:
Their mother said seeing her girls walk through the door was a moment she’ll never forget. “It was horrifying to see (Violet’s) bright red face. There were welts, she was swollen and then I saw Zoe’s shoulders. It was absolutely painful and gut-wrenching to look at. I was horrified.” The burns were so severe, [Jesse] Michener whisked her daughters to the local hospital for examinations.
When Michener pressed school officials on the ban, they told her that there is a state-wide policy that does not allow staff to apply sunscreen to students, and students can only apply it themselves if they have a doctor’s note. The law exists because the additives in lotions and sunscreens can cause an allergic reaction in children, and sunscreens are regulated by the FDA as an over-the-counter drug. Michener discovered that the policy exists in 49 states nationwide; California is the only state to allow sunscreen in school without a doctor’s note.
“I did share with the principal that any policy that didn’t allow her to use common sense was something that I had to do something about,” Michener said. “She nodded and shook her head.”
Image: Sunscreen, via Shutterstock
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Monday, June 4th, 2012
The numbing agent in a number of gels designed to ease the pain of teething can be dangerous or even fatal to babies, the Food and Drug Administration has announced. CNN.com has more:
Benzocaine is a local anesthetic that’s in products like Anbesol, Orajel & Baby Orajel, Orabase and Hurricaine. The FDA says using benzocaine products to stop mouth and gum pain can cause a rare and sometimes fatal condition called methemoglobinemia. Methemoglobinemia is a blood disorder where the oxygen that’s carried through the blood to the tissue drops to dangerously low levels. In severe cases it can cause death.
The FDA first sounded the alarm on these products in 2006. Since then there have been 29 reports of benzocaine gel-related cases of methemoglobinemia. FDA pharmacist Kellie Taylor says 19 of those cases were in children, 15 of those 19 were children under the age of 2.
The agency issued another warning in 2011. Some of the symptoms to look for include pale, gray, or blue-colored skin, lips and fingernail beds, shortness of breath, headache, light-headedness and rapid heart rate.
“Symptoms can occur within minutes to hours after benozcaine use,” says FDA Pharmacist Mary Ghods said. “They can occur after using the drug for the first time, as well as after several uses.”
Image: Teething baby, via Shutterstock.
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Wednesday, May 16th, 2012
In a move that critics say will lead to more sun damaged skin this summer, the FDA has announced that sunscreen companies have an extra six months to implement new guidelines on how to label their products. Time.com reports:
Last summer, the FDA told manufacturers they had until this June to revise their sunscreen labels in order to distinguish brands that could be labeled as “broad spectrum,” meaning they protect against both ultraviolet A and ultraviolet B rays, which contribute to skin cancer and early skin aging. The new guidelines also say brands cannot claim to be sweatproof or waterproof on their labels, to alert users that they must reapply the products.
Manufacturers said they were having difficulty meeting the original deadline, which is less than a month away. So in a formal announcement, the FDA said it will give companies six more months, until December, to make the necessary changes. Smaller companies have an even more generous deadline of December 2013.
The agency argues that without the extension, there would be sunscreen shortages. “We asked for the additional time,” Farah Ahmed, chair of the sunscreen task force at the Personal Care Products Council, told USA Today. Ahmed said changing labels on thousands of products “is a huge undertaking” and that unprepared manufacturers wouldn’t be able to ship new products after June 18, resulting in shortages.
“The FDA took a major step backwards today, and as a result, more consumers will likely get burned this summer,” Rhode Island Senator Jack Reed told the Associated Press. Reed has long encouraged the FDA to enforce stricter sunscreen regulations.
Image: Child with sunscreen, via Shutterstock.
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