FDA Delays Decision on "Morning-After" Pill
The U.S. Food and Drug Administration has delayed for 60 days its long-awaited decision on whether to allow over-the-counter sales of the Plan B contraceptive pill, the Associated Press reported Friday.
Plan B, often called the "morning-after" pill, can lower the risk of pregnancy by up to 89 percent if taken within 72 hours of unprotected sex.
In delaying its decision, the FDA said it was comfortable allowing over-the-counter sales to adults 18 and older, but wanted more time to decide how to keep it out of the hands of young teenagers, the AP said.
Plan B maker Barr Pharmaceuticals criticized the delay, saying scientific evidence supported non-prescription sales, the wire service said.
Merck May Settle Some Vioxx Lawsuits: Report
Pharmaceutical manufacturer Merck may be settling some of the many lawsuits that have been filed over Vioxx, the arthritis painkiller that has been shown to raise the risk of heart attacks and strokes.
In what appears to be a possible reversal of strategy, the company's general counsel, Kenneth C. Frazier, suggested in an interview with The New York Times that Merck would consider settling suits brought by people who took Vioxx for long periods of time and had few risk factors for heart disease.
Almost 5,000 Vioxx suits have already been filed, and in the first one to go to trial, Merck was found liable last week for the death of a Texas man who had taken the drug for eight months. Merck was ordered to pay $253 million to the man's widow.
Merck had previously said it planned to defend every personal-injury lawsuit filed over Vioxx. While Frazier denied that the company had made any change in its position, the Times quoted him as saying, "We would look at the facts of the case and make reasonable decisions."
Cases where settlements might be possible represent only a small fraction of all the lawsuits filed against Merck, Frazier added, noting the company does not plan to offer plaintiffs' lawyers an overall settlement of all the suits.
Last week's award was among the highest ever given to an individual plaintiff, although Texas law will automatically reduce it to about $26 million and Merck has said it will appeal.
Merck stopped selling Vioxx, part of a class of medicines called cox-2 inhibitors, last year after a clinical trial showed that patients taking the drug for more than 18 months had a substantially higher risk of heart attack and stroke than people taking a placebo. Other trials have shown that Vioxx raises heart risks over a shorter period of time compared with a placebo or with naproxen, an older painkiller.
Bextra, another cox-2 drug that is made by Pfizer Inc., has been withdrawn from the market because of cardiovascular risks. The only other cox-2, Pfizer's Celebrex, is still available to consumers but it carries a heightened warning about potential cardiovascular problems.
U.S. Toddlers Don't Have To Occupy Own Airline Seat: Feds
Better for a baby to fly than to ride in a car. At least, that may be the thinking of the Federal Aviation Administration in its most recent ruling concerning small children and where they sit on the plane.
FAA officials have decided not to require toddlers under two years of age to occupy their own airline seats, the Bloomberg news service reports.
The rationale, according to the FAA, is that parents forced to pay for a toddler's plane ticket might decide to drive instead, putting the family at greater risk than if they flew, Bloomberg reported.
"Families are safer traveling in the sky than on the road," FAA chief Marion Blakey said in a statement. "If requiring extra airline tickets forces some families to drive, then we're inadvertently putting too many families at risk."
Airlines allow children under age two to fly in an adult's lap. The FAA estimated that requiring tickets for toddlers would have caused 13 to 42 additional highway deaths over 10 years, Bloomberg reported. Federal statistics show that three toddlers have died in aviation accidents over the last two decades, according to Bloomberg
Breast Milk of Northwest U.S. Women Contaminated
Samples of breast milk of 40 mothers from Montana, Oregon, and Washington state were found to be contaminated with significant levels of a toxic flame retardant called PBDEs (polybrominated diphenyl ethers), the Associated Press reports.
The California Environmental Protection Agency compared the levels of PBDEs found in the women's milk with those of a now-banned chemical cousin, PCBs. According to results released Thursday at a Dioxin conference in Toronto, 30 percent of the mothers tested had higher levels of PBDEs in their milk than PCBs, the .A.P. said.
"The comparison with PCBs suggests that toxic flame retardants have emerged as a major environmental health concern," said Clark Williams-Derry, research director for a group called Northwest Environment Watch.
For reasons that weren't specified, the Northwest women had levels of PBDEs 20 to 40 times higher than levels found in women from Europe and Japan, the researchers said.
Diabetes Groups Dispute Metabolic Syndrome Diagnosis
Two top diabetes organizations are challenging the value of labeling patients as having "metabolic syndrome," a diagnosis based on a cluster of risk factors known to be bad for the heart.
The American Diabetes Association (ADA) and the European Association for the Study of Diabetes said in a joint statement that the syndrome is ill defined, built on sketchy evidence and could distract doctors from focusing on more established heart-disease risks, according to a USA Today report.
"We don't believe there's a syndrome," said Dr. Richard Kahn, the ADA's chief scientific and medical officer. "We don't believe that the whole is greater than the sum of the parts. We don't believe that the formula is grounded in scientific evidence."
The statement, in the September issue of Diabetes Care, represents an attack on a concept that has the support of many heart-disease experts. The American Heart Association (AHA) and the National Heart, Lung, and Blood Institute have adopted metabolic syndrome as an important focus of heart-disease research and prevention, the newspaper reported.
The AHA estimates that about 47 million Americans suffer from the array of risk factors that make up the syndrome, including abdominal obesity, high blood pressure, cholesterol abnormalities and a pre-diabetic condition called impaired glucose tolerance.
The diabetes organizations' stance could also affect a potential market for the experimental smoking-cessation and weight-loss drug called rimonabant, which drug maker Sanofi-Aventis is already promoting as "a comprehensive management approach" to metabolic syndrome.
Douglas Greene, a Sanofi-Aventis vice president, said, "The question of whether this group of risk factors has a name is an interesting scientific and semantic debate. From our perspective, (rimonabant) targets all of those risk factors."
Health Tip: When You Start Jogging
If you're new to jogging, the American Physical Therapy Association offers these tips to help you get started:
Alternate between jogging and walking until you build up your endurance.
Use the "talk test" to pace yourself. If you can't talk comfortably while jogging, you're pushing too hard.
Avoid hard surfaces whenever possible. Dirt paths are better than asphalt, and asphalt is better than concrete.
Take care when running over grassy areas. They may hide holes, rocks, and other potential hazards.
Health Tip: Home Safety for Seniors
Elderly people are especially vulnerable to accidents in their homes.
To safeguard your home, the City of Ottawa suggests you make sure that:
Floors are not slippery.
Pathways are clear of extension cords and other objects.
Rugs have no ripples or tears.
Scatter mats are removed or taped to the floor.
Low tables are removed from the middle of the living room floor.
Chairs have armrests and are the right height.
Light fixtures have a minimum of 60-watt bulbs.
Stepladders or step stools are sturdy, and the step surface is not slippery.
Food Fact:
Coffee on the dark side?
If p.m. coffee leaves you too perky to sleep, try cutting it off earlier rather than cutting it out completely. Coffee's stimulatory effects usually take 6 - 8 hours to wear off, so consider your bedtime when you reach for an afternoon or evening cup. The effects -- it can exacerbate insomnia, nervousness, anxiety and even panic attacks -- may last longer in women taking oral contraceptives and in older people. But coffee isn't a demon, either. Short-term studies have found that a cup's worth -- 100mg -- can increase self-confidence, energy and motivation to work.
Fitness Tip of the day:
Carry that weight?
How much should you be lifting? Here's a good rule of thumb. When you can perform 12 to 15 reps using excellent form, it's time to increase the weight used by 5%. In weight training, always use weights you can handle. Remember, we are training our bodies not our egos.
FAQ of the day:
What's the healthiest way to handle garlic and onions?
The way you handle garlic and onions affects their health-protective compounds. The more you cut, chop, smash or otherwise disturb raw onions or garlic, the more compounds they will release. If you're going to cook garlic, for example, it's a good idea to smash or chop it about 10 minutes before.
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