Safety Alert Issued for Off-Label Use of Breast Cancer Drug
The drug letrozole (brand name Femara), which is often prescribed as a fertility aid, may cause birth defects and miscarriages, according to a Health Canada safety alert issued Monday.
The drug is approved to treat breast cancer in post-menopausal women. However, doctors in Canada and the United States often prescribe letrozole "off-label" to promote ovulation as part of fertility treatments, Knight Ridder Newspapers reported.
Health Canada and drug maker Novartis sent letters to doctors in Canada warning them about unapproved off-label use of the drug. Copies of the letter were posted on Health Canada's Web site.
The U.S. Food and Drug Administration hasn't instructed Novartis to alert U.S. doctors but the Swiss drug company plans to send cautionary letters to U.S. fertility specialists. The letters will remind them that the drug is approved only for treatment of breast cancer.
Novartis has received 13 reports of adverse reactions in women who were exposed to letrozole during pregnancy. Of those 13 reports, four involved harm to babies, Knight Ridder reported.
Eye-Drop Maker Required to Sign FDA Consent Order
Eye-drop maker MBI Distributing Inc. has signed a consent decree with the U.S. Food and Drug Administration to stop making and distributing drugs until the company corrects manufacturing problems and other violations at its Benicia, Calif., facility.
Among other problems, MBI lacked manufacturing controls to ensure that its eye drops were sterile, the FDA said. MBI's eye-drop product line includes Oxydrops, Bright Eyes, Bright Eyes II, Clarity Vision for Life, Visitein, and Can-C. The company also makes several over-the-counter pain relievers, the federal agency said.
The FDA also determined that two of MBI's eye-drop brands, Visitein and Clarity Vision for Life, are unapproved drugs. In addition, three of MBI's pain relievers -- Biogesic, Bio-Ice, and Bio-Heat -- don't provide adequate warnings for their safe use, the agency said.
Consumers, health-care providers, and caregivers should dispose of these MBI eye drops and pain relievers, the FDA said. Any adverse events related to these products should be reported to the FDA at 1-800-FDA-1088.
High POP Exposure May Increase Diabetes Risk: Study
Exposure to high levels of toxic persistent organochlorine pollutants (POPs) may increase a person's risk of developing Type 2 diabetes, according to a Swedish study in the journal Environmental Health.
POPs include polychlorinated biphenyls (PCBs) and the insecticide DDT. Eating fatty fish such as salmon is the most likely source of POPs exposure, the study authors said.
The study of 196 fishermen and their wives found significantly higher signs of POPs in the blood of the 6 percent of the men and 5 percent of the women with Type 2 diabetes, BBC News reported.
According to previous research, POPs may impair the ability of the body's cells to take up glucose or may trigger responses that disrupt the body's ability to break down fats, the news service said.
Despite their findings, the study authors said people shouldn't be concerned about eating salmon and other fatty fish. The fishermen and their wives in this study had exceptionally high levels of POP exposure, BBC News reported.
10 Million People in China May Be Infected With HIV by 2010: WHO
Unless more is done to prevent the spread of HIV in China, about 10 million people in that country will be infected with the virus that causes AIDS by 2010, the World Health Organization (WHO) said Tuesday.
The warning accompanied the WHO's call for Asian governments to show stronger political will to stop the spread of HIV/AIDS, The Times of India reported.
Last year, about five million people worldwide were infected with HIV, bringing the global total to 45 million people living with the virus. More than 13,000 people around the world contract HIV every day, the agency said.
In China, HIV has spread to all 31 provinces and autonomous regions. Injected drug use is the main method of HIV transmission in China, the WHO said.
"We know what works and what doesn't. So why has the necessary action to prevent the virus from spreading not been taken? Why is the epidemic still growing and not reversing?" Shigeru Omi, WHO director for the Western Pacific region, said in a statement issued in advance of World AIDS Day on Thursday.
2 New Bird Flu Outbreaks in China
Two new outbreaks of H5N1 bird flu have been reported in China, bringing to 29 the total number of outbreaks in that country so far this year.
Laboratory tests confirmed that H5N1 was responsible for a Nov. 18 outbreak in Yongzhou city in central Hunan province and a Nov. 22 outbreak in Shanshan County in western Xinjiang province, Bloomberg news reported.
In the Hunan outbreak, 13,481 birds were culled within a three-kilometer radius of the infection site and 52,162 birds were culled in Xinjiang.
As of Nov. 25, China had reported three human cases of bird flu and two deaths. The virus has infected a total of 132 people in Cambodia, Indonesia, Thailand, Vietnam and China and killed 68 people in those countries, Bloomberg reported.
Studies Offer Evidence of 'Placebo Effect'
If your mind truly believes your medicines will work, they may actually have more of an effect in your body, according to numerous studies examining this so-called "placebo effect."
"Your expectations can have profound impacts on your brain and your health," Columbia University neuroscientist Tor Wager told the Associated Press.
It has long been believed that the placebo effect was psychological. However, new studies are offering direct evidence that the placebo effect is physical and that expectations of benefiting from treatment actually activate the same neurological healing pathways that are triggered by drugs.
One example is new research that suggests that a proven painkiller doesn't work as well once Alzheimer's disease robs people of the ability to expect that the painkiller will help them, the AP reported.
Another example involves Parkinson's disease patients who were given a placebo while researchers measured electrical activity of individual nerve cells in an area of the brain that controls movement.
After the Parkinson's patients received the placebo, there was a 40 percent decrease in the firing of these nerve cells that correlated with improvement in the patients' ability to move, the AP reported.
Health Tip: Don't Be Shocked
Injuries stemming from electric shock can lead to muscle, nerve and tissue damage, burns, and even cardiac arrest. Such injuries often are serious because the human body is an excellent conductor of electricity.
Duke University Medical Center says about 1,000 people die each year in the United States as a result of electric shock.
Here's a list of preventive tips:
Use child safety plugs in all outlets.
Keep electrical cords out of the reach of children.
Teach children about the dangers of electricity.
Follow manufacturer safety instructions when using electrical appliances.
Avoid using electrical appliances when wet.
Never touch electrical appliances while touching faucets or cold water pipes.
Health Tip: Keep That Cast Intact
Plaster or fiberglass casts protect injured bone and soft tissue while reducing pain, swelling and muscle spasms. But in order to work properly, it is important to keep the cast in good condition.
The American Academy of Orthopaedic Surgeons recommends keeping the cast dry, because moisture weakens the plaster and can cause skin irritation. Patients should also keep dirt, sand and powder away from the inside of the cast.
Although itchy skin is a common side effect of a cast, try not to scratch. Also avoid objects or powders to stop itching. Call your doctor if the itching persists, or the cast becomes cracked or soft in spots.
Food Fact:
Soymilky way.
A splash of soy milk on your breakfast cereal may help lower your cholesterol. According to the FDA, 25 grams of soy protein, or about four daily servings, is a good part of a dietary plan for a healthy heart. One cup of soymilk has 6.25 grams. Calcium-fortified soymilk is sold in supermarkets and whole foods stores. It's available in plain, vanilla, chocolate or strawberry flavors. Not all soymilk is calcium-fortified, however, so check labels. You can also use soymilk in custards, baked goods and other desserts -- just as you would with regular dairy milk.
Fitness Tip of the day:
Don't just stand -- stretch!
It's easy to fit stretching into your day; try these 3 tips. Practice some stretches while waiting in shopping lines. Simple neck and shoulder rolls are a great way to release stress and relax tight muscles. And make use of the stairs -- a great tool for stretching out your calves. How important is it to stretch? The American College of Sports Medicine has added stretching to its fitness recommendations.
FAQ of the day:
What's a Daily Value?
The Recommended Dietary Allowances (RDAs) and a related number, the Dietary Reference Intakes (DRIs), are suggested intakes of nutrients based on age and sex. They do not appear on food labels, but they were used to develop the Daily Values you see on a label. The Daily Value is a single number for everyone that is set high enough to ensure that the vast majority of people get enough of each nutrient. It's the best general guide for the public.
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