September 19, 2014
The Food and Drug Administration (FDA) has taken a major step towards learning whether levels of arsenic in rice and rice products pose a risk to public health.
The agency has collected a total of more than 1,300 samples of rice and rice products and has tested them for both total arsenic and inorganic arsenic, the more toxic form. FDA scientists have determined that the levels of inorganic arsenic found in the samples are too low to cause immediate health damage.
In the rice grains, the average levels of inorganic arsenic ranged from 2.6 to 7.2 micrograms per serving, with instant rice at the low end of the range and brown rice at the high end. In rice products, the average levels of inorganic arsenic ranged from 0.1 to 6.6 micrograms per serving, with infant formula at the low end of the range and rice pasta at the high end. (A microgram is one-millionth of a gram; serving sizes varied with the product types.)
But what about the long-term impact? After all, rice is a food that people eat over the course of a lifetime.
The next step for FDA will be to conduct a comprehensive risk assessment, explains Suzanne C. Fitzpatrick, Ph.D., the senior advisor for toxicology in FDA’s Center for Food Safety and Applied Nutrition (CFSAN). This analysis of the health risk associated with eating rice and rice products will be the foundation of future FDA actions.
“These are the next steps. To look at exposure levels, to analyze the risk, and determine how to minimize that risk for the overall safety of consumers, including vulnerable groups like children and pregnant women,” says Fitzpatrick.
“We must take one step at a time and stay true to our methodological approach,” says Michael R. Taylor, J.D., deputy commissioner for foods and veterinary medicine. “We can’t get ahead of the science.”
“One of the things we need to emphasize is that arsenic is a naturally occurring contaminant, and because it’s in soil and water, it’s going to get into food,” says Fitzpatrick. “It’s not something that we can just pull off the market.”
Arsenic is a chemical element distributed in the Earth’s crust. Human activities such as fuel burning, mining and the use of arsenic compounds in pesticides have also added arsenic to the environment. But Fitzpatrick says that even if you stripped all human contributions, there would still be arsenic in food.
And rice is particularly vulnerable. “Rice is grown in water and takes in arsenic. You’re going to see greater levels in rice than in other foods,” she says.
FDA has been monitoring arsenic levels in foods for more than 20 years, but Fitzpatrick says there have been advances in testing that allow FDA to get much more detailed information.
FDA consumer safety officers collected samples from retail outlets across the country. In addition to rice itself, these samples cover most types of rice-based foods in the American diet, including cereals, cakes, beverages, snack bars and infant and toddler foods.
These samples were then analyzed in FDA labs, in addition to some labs contracted by the agency to do this work. Fitzpatrick says the laboratory workers were required to undergo training in new chemical testing called “speciation.” This testing enables the labs to look beyond just organic vs. inorganic to all the different species of arsenic present in the samples.
“It’s a very complicated process and it involves a lot of people,” Fitzpatrick says. “We’re working very hard to get the best possible scientific answers.”
Meanwhile, FDA was studying arsenic in other ways. Researchers examined studies of populations exposed to high levels of arsenic in such countries as Chile, Taiwan and Bangladesh. They looked at rates of cancer and diseases such as diabetes and cardiovascular illnesses.
The researchers had to consider how the data about these highly exposed cultures would apply to American consumers.
September 15, 2014
Fatigue can be described as the lack of energy and motivation (both physical and mental). This is different than drowsiness, a term that describes the need to sleep. Often a person complains of feeling tired and it is up to the health care professional to tell fatigue from drowsiness, though both can occur at the same time.
Aside from drowsiness, other symptoms can be confused with fatigue including shortness of breath with activity and muscle weakness. Again, all these symptoms can occur at the same time. Also, fatigue can be a normal response to physical and mental activity; in most normal individuals it is quickly relieved by reducing the activity.
Everyone feels tired now and then. Sometimes you may just want to stay in bed. But, after a good night’s sleep, most people feel refreshed and ready to face a new day. If you continue to feel tired for weeks, it’s time to see your doctor. He or she may be able to help you find out what’s causing your fatigue and recommend ways to relieve it.
September 8, 2014
Acetaminophen, a fever and pain reliever that is one of the most widely used medicines in the U.S., can cause rare but serious skin reactions, warns the Food and Drug Administration (FDA).
Although rare, possible reactions to acetaminophen include three serious skin diseases whose symptoms can include rash, blisters and, in the worst case, widespread damage to the surface of skin. If you are taking acetaminophen and develop a rash or other skin reaction, stop taking the product immediately and seek medical attention right away.
Used for decades by millions of people, acetaminophen is the generic name of a common active ingredient included in numerous prescription and non-prescription medicines. Tylenol is one brand name of the pain reliever sold over the counter, but acetaminophen is also available as a generic under various names. It is also used in combination with other medicines, including opioids for pain and medicines to treat colds, coughs, allergy, headaches and trouble sleeping.
“This new information is not intended to worry consumers or health care professionals, nor is it meant to encourage them to choose other medications,” says Sharon Hertz, M.D., deputy director of FDA’s Division of Anesthesia, Analgesia and Addiction. “However, it is extremely important that people recognize and react quickly to the initial symptoms of these rare but serious, side effects, which are potentially fatal.”
Other drugs used to treat fever and pain, such as nonsteroidal anti-inflammatory drugs including ibuprofen and naproxen, already carry warnings about the risk of serious skin reactions. Advil and Motrin are among the common brand names that include ibuprofen as an active ingredient. Aleve and Midol Extended Relief are among the best-known brand names that include naproxen as an active ingredient.
FDA is requiring that a warning about these skin reactions be added to the labels of all prescription medicines containing acetaminophen. FDA will work with manufacturers to get the warnings added to the labels of over-the-counter (OTC) medicines containing acetaminophen.
On OTC medicines, the word “acetaminophen” appears on the front of the package and on the Drug Facts label’s “active ingredients” section. On prescription medications, the label may spell out the ingredient or use a shortened version such as “APAP,” “acet,” “acetamin” or “acetaminoph.”