Posted: 28 October 2011
WASHINGTON: Some birth control products, including contraceptive pills, rings and patches for women, carry a significantly higher risk of blood clot than low-dose medications, US regulators said Thursday.
The US Food and Drug Administration said in its review of studies that have included more than 800,000 women that the higher risks are posed by products such as the pill Yaz, the transdermal Ortho Evra patch, and the NuvaRing vaginal insert.
All three methods are "associated with an increased risk of VTE (deep venous thrombosis) relative to the standard low-dose" pills, the FDA said.
Featured in the study were pills that contain drospirenone, as opposed to another type of progestin known as levonorgestrel. Some brand names include Yaz, Yasmin, Beyaz, Ocella, Loryna, Gianvi, Safyral, Syeda and Zarah.
Yaz is the second biggest selling product made by the German pharmaceutical giant Bayer, with 1.56 billion in global sales.
NuvaRing is a once-a-month vaginal insert made by Merck pharmaceuticals, and the weekly Ortho Evra patch is made by Janssen Pharmaceuticals.
The finding about clot risk associated with patches and rings are new and need to be replicated, the FDA said. A full discussion on the matter is scheduled for December.
These "continuous exposure" birth control methods "potentially result in higher sustained exposure to estrogen and hence, increased thromboembolic risk," the FDA warned.
The European Medicines Agency concluded on May 27 that such birth control pills carry a higher risk of venous thromboembolism and that warning labels should be updated accordingly.
However it noted the overall risk of blood clot from any birth control method remains small and stopped short of advising women to stop taking pills containing drospirenone.
The pills have been the focus of numerous lawsuits, including one lodged earlier this year on behalf of a teenager who died from a blood clot allegedly linked to the German chemical and pharmaceutical company Bayer's Yaz contraceptive.
Michelle Pfleger, an 18-year-old college student in North Carolina, died of cardiac arrest last September after taking Yaz, also known as Yasmin or Ocella, to treat acne, according to the complaint.
Two studies out this year in the British Medical Journal found that drugs like Yaz and Yasmin increase the risk of serious blood clots three-fold or two-fold compared to earlier-generation oral contraceptives.
The official Yaz website says the drug is associated with "increased risks of several serious side effects, including blood clots, stroke, and heart attack."
According to Glenn Jacobowitz, vice-chair of the division of vascular surgery at New York University, doctors have been aware of the risks of Yaz and similar pills for some time.
"The information on NuvaRing and Ortho Evra would be a new, but similar finding. This is certainly worrisome, particularly for women over age 35 and for smokers," he said.
-AFP/vl
Taken from ChannelNewsAsia.com; source article is below:
Some birth control shows higher clot risk
Now this is really an eye-opener; we've known this for some time, but i think many more don't know this. So how about the iPad? I've heard parents say that it is a 'boost' to their child's learning the alphabets and numbers.
Maybe it is just the videos after all. Think so?
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Posted: 18 October 2011
WASHINGTON: Watching television or videos is discouraged for babies under age two because studies suggest it could harm their development, a US paediatricians' group said on Tuesday.
Instead of allowing infants to watch videos or screens, parents should talk to them and encourage independent play, said the first guidelines issued in more than a decade by the American Academy of Paediatrics.
The advice is the same as that issued in 1999 by United States' largest association of paediatricians, but this time it also warns parents of how their own screen-watching habits may delay their children's ability to talk.
"This updated policy statement provides further evidence that media - both foreground and background - have potentially negative effects and no known positive effects for children younger than two years," it said.
"Thus the AAP reaffirms its recommendation to discourage media use in this age group."
The latest guidelines do not refer to interactive play such as video games on smartphones or other devices, but to media watched passively on any kind of screen, be it phone, computer, television or other.
Paediatrician Ari Brown said the update was needed because of the explosion of baby DVDs targeting the 0-2 age group, and because as many as 90 percent of parents acknowledge that their infants watch some sort of electronic media.
"Clearly, no one is listening to this message," she told AFP. "In this ubiquitous screen world, I think we need to find a way to manage it, and make it a healthy media diet."
The AAP urges paediatricians to discuss media use with new parents, and says adults should be aware of how distracted they become when the television is on.
"I like to call it second-hand TV," said Brown, who is the lead author of the AAP guidelines.
Studies cited in the guidelines say that parents interact less with children when the television is on, and a young child at play will glance at the TV - if it is on, even in the background - three times per minute.
"When the TV is on the parent is talking less," Brown told AFP. "There is some scientific evidence that shows that the less talk time a child has, the poorer their language development is."
Though about 50 studies have been done in the past decade on media viewing by tots, none have followed heavy television watchers into later childhood or adulthood, so any long-term effects are not known. Heavy media use is defined as a household in which the television is on all or most of the time.
Also, the AAP guidelines point out that research to date suggests a "correlation between television viewing and developmental problems, but they cannot show causality."
Even so-called educational videos are not benefiting kids under two because they are too young to be able to understand the images on the screen, said the AAP.
"The educational merit of media for children younger than two years remains unproven despite the fact that three quarters of the top-selling infant videos make explicit or implicit educational claims," it said.
Paediatricians are therefore discouraging any screen viewing for infants, and urging parents to limit media viewing to under two hours per day for children two and over.
"Unstructured playtime is more valuable for the developing brain than any electronic media exposure," the AAP guidelines said.
- AFP/cc
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Taken from ChannelNewsAsia.com; source article is below:
US doctors discourage videos for babies under two
