Subscribe
to Email Updates on Maturity Health Matters
Issue No. 6 - Summer 2007
Table of Contents
- Magnetic Resonance Imaging (MRI) Detects Cancers in the Opposite Breast of Newly Diagnosed Women
- Colorectal Cancer: Early Detection Saves Lives
- Medical Devices, Aging, and Your Eyes
- Advanced Medical Optics Voluntarily Recalls Complete® MoisturePlus™ Multi-Purpose Contact Lens Solution
- FDA Approves First Bird Flu Vaccine
- FDA Clears First Respirators for Use in Public Health Medical Emergencies
- Incredible Journey Through the Digestive System
- Allergies and Hay Fever
- FDA Offers Produce Safety Tips
- FDA Finalizes Report on 2006 Spinach Outbreak
- Medical Device Recall – HoMedics® Thera-P® Heating Pads
- Weight-Loss Drug for Obese Dogs
- Pet Food Recall of Tainted Animal Feed
- FDA Launches New Web Page, E-newsletter to Enhance Online Consumer Health Information
- My Medicine Record
Editors’ Note: We devoted our previous issue of Maturity Health Matters entirely to female cancers. Since that time, new information has become available about female breast cancer. In our lead article, we provide a summary of a recent study funded by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). The study found that with the use of an MRI (magnetic resonance imaging) scan, breast cancer was detected in the opposite breast of women newly diagnosed with breast cancer.
Magnetic Resonance Imaging (MRI) Detects Cancers in the Opposite Breast of Newly Diagnosed Women
Up to ten percent of women who are diagnosed with breast cancer in one breast are at risk of having cancer in the opposite (contralateral) breast and not having it detected until after the first cancer has been treated. Some of these additional cancers can be found by clinical breast exams or mammograms during a woman’s routine screening, but some breast cancers cannot be found that way. The American College of Radiology Imaging Network, sponsored and funded by the National Cancer Institute, conducted a study to find out if adding magnetic resonance imaging (MRI) could improve the early detection of cancer in the opposite breast.
An MRI scan is a special radiology test that uses radiofrequency waves and a strong magnetic field rather than X-rays to provide clear and detailed pictures of internal organs and tissues. Between April 2003 and June 2004, 969 women participated in the study. The purpose was not to compare mammography with MRI but to determine if additional cancers could be found with MRI. After the year long study, MRI detected cancer in the opposite breast in 30 of the 969 women (3.1%) who were enrolled in the study. Having an MRI to find these breast cancers as early as possible will increase the chance of successful treatment. Although no imaging device is perfect, if the MRI is negative, the chance of cancer in the opposite breast is extremely low.
The article about this study appeared in the March 29, 2007 issue of the New England Journal of Medicine. To read NCI’s questions and answers about MRIs for diagnosis of breast cancer in the opposite breast, please open the Q’s & A’s web address in the source below.
Source: NCI News, March 28, 2007
Colorectal Cancer: Early Detection Saves Lives
Basic Facts:
According to the Centers for Disease Control and Prevention (CDC), in 2003 (the most recent year for which complete statistics are currently available), more than 140,000 men and women were diagnosed with colorectal cancer and almost 56,000 people died of this disease. Cancer is the second leading cause of death in the United States after heart disease. For men, colorectal cancer is the third most common cancer after prostate and lung cancers. For women, colorectal cancer is the third most common cancer after breast and lung cancers. It also affects all racial and ethnic groups.
Colorectal cancer is most often found in people aged 50 years or older. If everyone aged 50 and older had regular screening tests, as many as 60% of deaths from colorectal cancer could be prevented. Screening tests can find colorectal cancer early, when treatment works best and often leads to a cure.
Colon and Rectum
Colorectal cancer is cancer of the large intestine and rectum. Sometimes it is called colon cancer. As the diagram shows, the colon is the large intestine (bowel). It is the last portion of your digestive tract. The colon is a hollow tube that starts at the end of your small intestine and ends at the rectum and anus. The colon is about five feet long, and its main function is to store unabsorbed food waste and to absorb water and other body fluids before the waste is eliminated as stools (solid waste). The rectum is the passageway that connects the colon to the anus where the food waste leaves the body.
Symptoms
Colorectal cancer first develops with few, if any, symptoms. However, if symptoms are present, they may include:
- blood in or on the stool
- frequent gas, pains or indigestion
- change in bowel habits
- unexplained weight loss
- stools that are narrower than usual
- chronic fatigue
- general, unexplained stomach discomfort
Since these symptoms can be associated with many other health conditions, discuss them with your doctor. Only your doctor can determine why you are having these symptoms.
When Screening Should Begin
You should begin regular screening for colorectal cancer soon after turning 50 and then continue getting screened at regular intervals, as recommended by your doctor. You may need to be tested earlier or more often than others if:
- you or a close relative have had colorectal polyps or colorectal cancer
- you have inflammatory bowel disease (a group of disorders that cause the intestines to become red and swollen)
- you have a disorder of the bile ducts
Colorectal Cancer Screening Tests
Screening is used to look for a disease before there are any symptoms. Cancer screening tests, including those for colorectal cancer, are effective when they can detect disease early. Detecting disease early can lead to more effective treatment. Most colon cancers develop over time from polyps, which are abnormal growths on the inner wall of the colon. In some cases, screening tests can detect polyps, before they have a chance to turn into cancer. Removing polyps before they become cancerous can prevent many colon cancers from developing.
The following screening tests, using medical devices, can be used alone or in combination to detect colorectal cancer when it is more easily treatable. When polyps are suspected during any of the tests, you will need a follow-up colonoscopy.
Fecal Occult Blood Test (FOBT)
This test checks for hidden (occult) blood in your stool. At home, you place a small amount of your stool from three bowel movements, one each day, on test cards. You return the cards to your doctor's office or to a lab where they are checked for blood. This test is often recommended yearly. It is not very sensitive for detecting colon cancer or colon polyps on its own. The test, therefore, is often combined with flexible sigmoidoscopy. If blood is found on the FOBT, you will likely need a follow-up colonoscopy.
Flexible Sigmoidoscopy
Before this test, you use a strong drug to make you go to the bathroom (laxative) and/or a liquid placed into the rectum (enema) to clean out the colon. Flexible sigmoidoscopy is performed at the doctor’s office, in a clinic, or at the hospital. The doctor (or another specially trained healthcare professional) uses a narrow, flexible, lighted tube (sigmoidoscope) to look at the inside of the rectum and the lower portion of the colon (sigmoid). During the exam, the doctor removes polyps and collects samples of tissue or cells for closer examination. This test is recommended every five years. Sometimes this test is used along with FOBT.
Colonoscopy
Before this test, you will take a strong laxative and possibly an enema to clean out your colon. Colonoscopy can be performed in a clinic or hospital. You are given medicines that will help make you sleepy and will help relieve your discomfort. The doctor uses a long, narrow, flexible, lighted tube to look at the inside of the rectum and the entire colon. During the exam, the doctor may remove polyps before they become cancerous and collect samples of tissue or cells for closer examination. This test isrecommended every ten years and more often if there is a family history of colon cancer.
Barium Enema
This test is conducted in a radiology center or at a hospital. Before the test, you will take a strong laxative and a regular enema to clean out the colon. Then, you will be given an enema with barium (white, chalky solution that shows up on X-rays), followed by an injection of air. Typically, a double contrast (“air contrast”) barium enema is used for detecting colon cancer. An X-ray of the rectum and colon is then taken. The barium coats the lining of the intestines, so that polyps and other abnormal growths are visible on the X-ray. This test is recommended every five years or as prescribed by your doctor.
Source: CDC Colorectal (Colon) Cancer (March 19, 2007)
Other Resources:
- Food and Drug Administration
- National Institutes of Health
Medical Devices, Aging, and Your Eyes
Is it more difficult to read the newspaper than just a few years ago? If it is, there are many people in the same situation. Aging brings changes to your eyesight. To protect your vision, there are some things that you can do. The most important thing to do is have regular eye exams in order to find problems early.
Steps to Protect Your Eyesight
Eye care professionals rely on medical devices to diagnose problems and to deliver medical care to their patients. Have your eyes checked every one or two years by an ophthalmologist or optometrist to test your vision and look for eye problems. Notify your eye care professional right away if you experience:
- sudden decrease in vision
- double vision
- flashes of light
- redness
- eye pain
- swelling of your eye or eyelid
- constant tearing
- shower of black spots
- pus coming from eye
- blank area in vision
Have regular physical exams to check for diseases like diabetes and high blood pressure that can cause eye problems if not treated.
Always wear sunglasses that block ultraviolet (UV) radiation and a wide brim hat when outside. Did you know that reading glasses, sunglasses, and contact lenses are medical devices?
Common Eye Problems
Some eye problems do not threaten your eyesight. Others are more serious diseases and can lead to blindness. The following common eye complaints can be easily treated, but they can be signs of more serious problems.
Presbyopia is a slow loss of ability to focus on close objects or small print. It is a normal process that happens as you get older. Holding the newspaper at arm’s length, headaches, or tired eyes when you read or do other close work are signs of presbyopia. Your eye care professional may use a medical device called a phoropter to select a prescription for glasses to fix the problem.
Floaters are tiny specks or “cobwebs” that seem to float across your eyes. You might notice them in well-lit rooms or outdoors on a bright day. Floaters can be a normal part of aging. Sometimes they are a sign of a more serious eye problem such as retinal detachment. If you see many new floaters, flashes of light, or both see your eye care professional right away. This is considered a medical emergency.
Excessive tearing can come from sensitivity to light, wind, temperature changes, or foreign matter in the eye. Excessive tearing can be caused by such problems as dry eye, infection, inflammation, or a blocked tear duct. Tearing can also be an allergic response to your environment. You should see an eye care professional to diagnose and treat the cause of excessive tearing.
Eyelid problems can come from different diseases or conditions. Common symptoms of eyelid problems include red and swollen eyelids, itching, tearing, being sensitive to light, and crusting of eyelashes during sleep. Less common problems include benign cancerous tumors and growths. Your eye care professional can diagnose your eyelid problem for you and help you determine if medical or surgical treatment is appropriate.
Dry eye can be caused by a variety of medical conditions. It can also be associated with medicines that you are taking for conditions unrelated to the eye. Besides a feeling of dryness, symptoms of dry eye can include redness, itching, burning and changes in your vision. Dry eye is more common as people get older, especially among women. Your eye care professional may tell you to use a home humidifier, over-the-counter eye drops, or prescription medicines. In more severe cases, tiny plugs may need to be inserted into the tear drainage system. In some cases, the openings of the tear drainage system at the inner corner edges of the eyelids may need to be closed with cautery (lightly burning the tissue to seal the opening).
Cataracts are slow clouding of the eye’s lens causing decreased vision, glare, halos, or double vision. Cataracts sometimes stay small and change eyesight very little. Your eye care professional uses a slit lamp exam to determine when cataracts are affecting your vision and need to be removed surgically. Cataract surgery is very common, but like any surgery, it involves risk. After surgery, you may still need glasses because the artificial lens implanted to replace the cloudy natural lens may not adequately correct your eyesight for all visual needs. Wearing ultraviolet (UV) protective sunglasses can delay the formation and progression of cataracts.
More Serious Eye Diseases and Disorders
The following eye problems can lead to vision loss and blindness. Often there are few or no symptoms. Having regular eye exams is the best way to protect your eyes. For all of the following problems, we recommend that you visit your eye care professional regularly to find problems early.
Glaucoma is a progressive disease of the optic nerve. Elevated intraocluar pressure is one of several risk factors associated with glaucoma. Without treatment, glaucoma can lead to vision loss and blindness. Your eye care professional will use a medical device called a tonometer to measure your intraocular pressure. Most people with glaucoma have no early symptoms or pain from the extra pressure. Treatment may be prescription eye drops, medicines that you take by mouth, laser treatment, or surgery. Retinal disorders are a leading cause of blindness in the United States. The retina is a thin tissue that lines the back of the eye and sends light signals to the brain.
Retinal disorders that affect aging eyes include:
- age-related macular degeneration (see box to the right) • damage to blood vessels of retina (diabetic retinopathy)
- separation of retina from membrane in back of eye (retinal detachment)
- damage to blood vessels of the retina (hypertensive retinopathy )
- closure of the retinal blood vessels (retinal vascular occlusion)
Eye care professionals use a medical device called an ophthalmoscope to check the retina.
Low Vision Impact on Daily Routine
Low vision affects some people as they age. Low vision means that you have significantly decreased vision that cannot be improved with eyeglasses, contact lenses, medicine, or surgery. You may have low vision if you:
- have trouble seeing well enough to do everyday tasks like reading, cooking, or sewing
- cannot recognize the faces of friends or family
- have trouble reading street signs
- find that lights don’t seem as bright as usual
Your eye care provider can determine if you have low vision and refer you to a low vision specialist if necessary.
There are special tools and aids to help people with low vision read, write, and manage daily living tasks. Lighting can be changed to suit your needs. You also can try large-print reading materials, magnifying aids, closed-circuit televisions, audiotapes, electronic reading machines, and computers that use large print and speech. Other simple changes also may help:
- Write with bold, black felt-tip markers.
- Use paper with bold lines to help you write in a straight line.
- Put colored tape on the edge of your steps to help you keep from falling.
- Install dark-colored light switches and electrical outlets that you can see easily against light-colored walls.
- Use motion lights that turn on when you enter a room. These may help you avoid accidents caused by poor lighting.
- Use telephones, clocks, and watches with large numbers or audio.
- Put large-print labels on the microwave and stove.
Helpful Eye Websites from FDA
CONTACT LENSES: www.fda.gov/cdrh/contactlenses
This website includes general information on different types of contact lenses, things to consider when buying contact lenses, risks and everyday eye care tips.
LASIK: www.fda.gov/cdrh/lasik
LASIK is a surgical procedure intended to reduce your dependency on glasses or contact lenses. This website gives you information about what you should expect before, during, and after surgery. A checklist to help you determine if you are a good candidate for the surgery, the risks and limitations of LASIK, how to find the right doctor, and surgical expectations.
PHAKIC: www.fda.gov/cdrh/phakic
Phakic intraocular lenses are devices used to correct nearsightedness. These thin lenses are implanted permanently into the eye to help reduce the need for glasses or contact lenses. The website provides general information about phakic lenses, the surgery, risks, and questions for your doctor.
Macular Degeneration Is a Leading Cause of Vision Loss for Americans Sixty Years and Older
Macular degeneration, or age-related macular degeneration (AMD) is a leading cause of vision loss in Americans 60 and older. It is a disease that destroys your sharp, central vision.
You need central vision to see objects clearly and to do tasks such as reading and driving. AMD is a painless disease that affects the macula, the part of the eye that allows you to see fine detail. In some cases, AMD advances so slowly that people notice little change in their vision. In others, the disease progresses faster and may lead to a loss of vision in both eyes. Regular comprehensive eye exams can
detect macular degeneration before the disease causes vision loss. Treatment can slow vision loss, but it does not restore vision.
Source: MedlinePlus
For an excellent graphic of the eye, go to the following website. Moving the magnifying glass around will show a close up picture of the parts of the eye.
www.nei.nih.gov/health/eyediagram
Source: NIH/National Institute on Aging (Updated January 13, 2006)
Other Resources
- FDAConsumer Magazine May/June 2005
- National Institutes of Health
Advanced Medical Optics Voluntarily Recalls Complete®
MoisturePlus™ Multi-Purpose Contact Lens Solution
FDA has learned of a recent increase of a rare but serious infection in soft contact lens wearers called Acanthamoeba keratitis, caused by a parasite that is commonly found in nature. This may lead to a permanent loss of vision that can require a corneal transplant, a surgical procedure to replace the clear outer covering of the eye. Early diagnosis of Acanthamoeba keratitis is important for treatment.
The Centers for Disease Control and Prevention has found an association between Acanthamoeba keratitis and use of the Advanced Medical Optics (AMO) Complete ® MoisturePlus TM Multi-Purpose Solution. At present there is nothing to suggest that the product is contaminated. On May 26, 2007, AMO voluntarily recalled Complete ® MoisturePlus™ Multi-Purpose Solution and is removing this solution from stores.
Recommendations for Complete ® MoisturePlus™ users:
- Remove your lenses and stop using this solution immediately.
- Contact AMO at 1-888-899-9183 for instructions on what to do with unused solution.
- Replace your contact lenses and storage case.
- Ask your eye care professional about choosing another appropriate alternative cleaning/disinfecting product.
- See your eye care professional immediately if you experience symptoms of eye infection such as redness, pain, excessive tearing, increased light sensitivity, blurry vision, and/or sensation of something in the eye.
Source: FDA/CDRH/Medical Device Safety: Advice for Patients
For More Information: FDA News: May 26, 2007
FDA Approves First Bird Flu Vaccine
FDA recently granted a license for the first vaccine in the United States for humans against the H5N1 influenza virus, commonly referred to as the avian influenza or "bird flu." This inactivated influenza virus vaccine has been developed for vaccination of persons 18 through 64 years of age who are at increased risk of exposure to the H5N1 influenza virus. This vaccine will not be available commercially; it will be placed in the U.S. National Stockpile for future use if needed.
The approval and availability of this vaccine is an important step in enhancing the U.S. readiness against a possible epidemic (pandemic). It improves our ability to protect those at increased risk of exposure to the H5N1 virus.
For more information about the bird flu, please visit:
www.fda.gov/cber/products/h5n1san041707qa.htm
Source: FDA News, Center for Biologics Evaluation and Research, April 17, 2007
Other Resources
FDA Clears First Respirators for Use in Public Health Medical Emergencies
FDA has cleared for marketing two 3M Respirators 8612F and 8670F, the first of their kind. They can be used by the public without special fit and training and can help reduce exposure to airborne infectious particles during a medical public health emergency such as a flu pandemic. The two filtering facepiece respirator models will be available to the public without a prescription. These are often referred to as N95 respirators because they are designed to filter out at least 95 percent of tiny airborne particles.
Source: FDA News, May 8, 2007
Other Resources: pandemicflu.gov
Incredible Journey Through the Digestive System
Tiny Camera to Swallow
People with symptoms of a possible problem in the esophagus or small intestine can now swallow a tiny camera that takes photographs inside the body for a doctor to evaluate. This tiny camera, along with a light, transmitter, and batteries, is in a capsule the size of a large vitamin pill (one inch long and a little less than 1/2 inch wide). The camera takes photographs and relays them to a small recorder attached to the patient’s belt. The capsule, called the PillCam™, is used in a procedure known as capsule endoscopy, a non-invasive and painless way of looking into the esophagus and the small intestine.
The procedure requires no drugs to make you sleepy and no recovery time. In a usual (conventional) endoscopy, the doctor pushes a lighted instrument (endoscope) down the patient's throat to view inside the body. Most patients undergoing conventional endoscopy require drugs given through the veins to make you sleep (sedation). The disposable PillCam™ usually passes out of the body in 8 to 72 hours.
In 2001, FDA cleared the PillCamTM SB for detecting problems in the small bowel (SB), or small intestine, in adults and children at least 10 years old. In November 2004, the FDA cleared the PillCam™ ESO for use in adults to help detect abnormalities in the esophagus (ESO).
Doctors use the PillCam™ ESO to look for abnormalities in the lining of the esophagus which may suggest conditions such as gastroesophageal reflux disease (GERD). The PillCam™ ESO is designed to view only the esophagus--not the stomach or the beginning of the small intestine where peptic ulcers (sores in the lining of the stomach or in the first part of the small intestine) may form. It does not replace conventional endoscopy.
Endoscopy allows the doctor to view these areas and to take a tissue sample (biopsy). If the PillCam™ suggests a serious problem, the patient will likely still need conventional endoscopy to take biopsies and confirm a diagnosis.
Patients who have symptoms may find the capsule more acceptable than having a scope placed down their throat (upper endoscopy) under sedation.
The PillCam™ SB is designed to look at the lining of the small bowel and may be used by a doctor in the evaluation of symptoms including abdominal pain, unexplained rectal bleeding, or diarrhea. Doctors may use it to help detect abnormal growths in the small bowel such as polyps, cancer, and other causes of bleeding and anemia, such as ulcers and Crohn's disease. Crohn’s disease is a chronic inflammation of the digestive tract that can cause abdominal cramps, diarrhea, and anemia.
One advantage of the PillCam™ endoscopy is that it sees areas of the small bowel that are more difficult for conventional endoscopy to reach.
The PillCam™ SB allows doctors to see the entire twenty-foot-long small intestine, but it does not photograph the large intestine--the site of colon cancer. PillCam should not be used in place of a colonoscopy in an attempt to look at the lining of the large intestine (colon). There are not enough data that demonstrate that the capsule can find colon cancer as well as conventional colonoscopy can.
The FDA clearance of the PillCam™ devices was based on their safety and ability to image the lining of the small intestine and esophagus. Some patients may have difficulty swallowing the capsule, but once inside, there is generally no discomfort. However, if a patient has a small blockage or narrowing in their intestine, the device could get hung up, sometimes requiring surgery to remove it. The device is not for use in a person with a known intestinal blockage or a significantly narrowed small intestine.
On May 7, 2007, FDA cleared a PillCam™ Small Bowel 2 video capsule and Rapid 5 software for use in video imaging. Compared to the original PillCam™ SB, the new video capsule enables the doctor to view a larger area per photograph.
Source: FDA Consumer magazine, March-April 2005 Issue
Allergies and Hay Fever
If you suffer from sneezing, runny noses, or itchy eyes, you might think you have a cold. Instead, it could be an allergy. When you come across something that you are allergic to your body reacts by causing sneezing, runny nose and itchy eyes. People can be allergic to many different things, such as
- pollen
- animal dandruff (scales of dead skin)
- dust mites
- mold
- foods
- drugs
Hay Fever
Hay fever (pollen allergy) is one of the most common kinds of allergies. About 35 million Americans suffer from hay fever. Pollen is made by trees, flowers, grasses, and weeds. During the spring, summer, and fall some plants release pollen into the air you breathe. Your symptoms might change with the season. It all depends on the kinds of plants that grow where you live and what allergies you have.
Symptoms of Hay Fever
- sneezing
- runny or clogged nose
- coughing
- itchy eyes, nose, and throat
- watery eyes
- red, swollen eyes
Causes of Allergies and Hay Fever
No one is sure what causes allergies. You are more likely to have hay fever if your parents have or had it.
Hay Fever vs. Colds
| Hay Fever | Colds | |
|---|---|---|
| Signs | Signs can include runny or stuffed nose, sneezing, wheezing, itchy and watery eyes. | Signs can include fever, aches and pains stuffed nose, sneezing, and watery eyes. |
| Warning Time | Symptoms begin right away after exposure. | Symptoms usually take a few days to start after exposure. |
| Duration | Symptoms last as long as you are around the allergen. | Symptoms should clear up within a week or two. |
Tests that Check for Allergies
Skin tests - Your doctor may put a small amount of many substances that may cause allergic reactions (allergens) under your skin. After a few minutes, the reaction tells your doctor if you have allergies.
Blood tests - Your doctor may use a blood test to look for a protein in your blood called IgE. This protein is made by people with allergies and hay fever. It also helps fight certain types of infection.
Both tests - These two tests look for certain disease-fighting cells (antibodies). Your body makes these cells to match whatever it is fighting. Your antibodies tell doctors what you are allergic to.
Treatments for Allergies and Hay Fever
Your doctor will suggest treatments best suited for your allergy. For example:
- Avoid the things that cause your symptoms whenever possible.
- Use medicines with active ingredients that treat your allergy symptoms (antihistamines). Your doctor will recommend the right one to use.
- Get allergy shots. Allergy shots contain small amounts of what you are allergic to, so your body can build up antibodies. Shots may be given every week to lessen your symptoms. The shots are usually continued for 3 to 5 years.
Source: News from FDA’s Office of Women’s Health
Other Resources:
- FDA/CBER
- NIH/National Library of Medicine MedlinePlus: Allergies
- NIH/Institute of Allergy and Infectious Diseases, Allergies, Fact Sheets and Brochures
FDA Offers Produce Safety Tips
In light of recent contaminated produce outbreaks, such as the spinach E.coli outbreak, FDA asks consumers to use the following tips to make fruits and vegetables safer to eat. In these tips on buying, storage, preparation, and separation, FDA emphasizes ways to reduce the risk of foodborne illnesses from fresh produce.
Buying
- Purchase produce that is not bruised or damaged. Bacteria can enter through damaged sites.
- When selecting fresh-cut produce, such as half a watermelon or bagged mixed salad greens, choose only those items that have been refrigerated or surrounded by ice.
- Bag fresh fruits and vegetables separately from meat, poultry, and seafood products when packing them to take home from the market.
Storage
- Strawberries, lettuce, herbs, mushrooms, and other perishable fruits and vegetables can best be maintained by storing in a clean refrigerator at a temperature of 40 degrees F or below. If you're not sure whether an item should be refrigerated to maintain quality, ask your grocer.
- All produce that is purchased pre-cut or peeled should be refrigerated within two hours to maintain both quality and safety.
- Keep refrigerators set at 40 degrees F or below. Use a refrigerator thermometer to check.
Preparation
- Begin with clean hands. Wash your hands for 20 seconds with warm water and soap before and after preparing fresh produce.
- Many pre-cut, bagged produce items like lettuce are pre-washed. If so, it will be stated on the packaging. This pre-washed, bagged produce can be used without further washing.
- Pre-cut or pre-washed produce in open bags should be washed before using.
- Cut away any damaged or bruised areas on fresh fruits and vegetables before preparing or eating. Produce that looks rotten should be thrown away.
- All unpackaged fruits and vegetables, as well as those packaged and not marked pre-washed, should be thoroughly washed before eating. This suggestion includes produce grown conventionally or organically at home, or produce that is purchased from a grocery store or farmer's market. Wash fruits and vegetables under running water just before eating, cutting, or cooking.
- Even if you plan to peel the produce before eating, it is still important to wash it first.
- Washing fruits and vegetables with soap or detergent or using commercial produce washes is not recommended.
- Scrub firm produce, such as melons and cucumbers, with a clean produce brush.
- Drying produce with a clean cloth towel or paper towel may further reduce bacteria that may be present.
Separation
- Keep fruits and vegetables that will be eaten raw separate from other foods, such as raw meat, poultry, or seafood, and from kitchen utensils used for those products.
- Wash cutting boards, dishes, utensils, and countertops with hot water and soap between the preparation of raw meat, poultry, and seafood products and the preparation of produce that will not be cooked.
- For added protection, kitchen sanitizers can be used on cutting boards and countertops periodically. Try a solution of one teaspoon of chlorine bleach to one quart of water.
- If you use plastic or other nonporous cutting boards, run them through the dishwasher after use.
Source: FDA Consumer March/April 2007
FDA Finalizes Report on 2006 Spinach Outbreak
The Food and Drug Administration and California's Department of Health Services (CDHS) recently released a joint report on an extensive investigation into the causes of an Escherichia coli (E.coli) strain O157:H7 outbreak last fall that was associated with contaminated Dole brand Baby Spinach and resulted in 205 confirmed illnesses and three deaths. The inquiry was conducted by the California Food Emergency Response Team, FDA's district office in San Francisco, CDHS, experts from the Centers for Disease Control and Prevention, and the Animal and Plant Health Inspection Service of the U.S. Department of Agriculture (USDA). The investigators successfully identified the environmental risk factors and the areas that were most likely involved in the outbreak, but they were unable to definitely determine how the contamination originated. The strain of E.coli, O157:H7 can be transferred in many ways including by animals, humans, and water. While washing produce would not have prevented the recent E-coli outbreaks in spinach, washing can reduce the overall risk of foodborne illness.
The report on the probe of the Dole spinach contamination, titled: Investigation of an Escherichia coli O157:H7 Outbreak Associated with Dole Pre-Packaged Spinach is posted at www.dhs.ca.gov.
Source: FDA News, March 23, 2007
Medical Device Recall – HoMedics® Thera-P® Heating Pads
HoMedics Inc. is voluntarily recalling several models of heating pads. Some heating pads may contain a loose connection which may cause the unit to short circuit. This problem may pose a risk of burn injuries or fire as well as damage to the heating pad itself or to materials (like bedding and furniture) that may be in contact with the pad.
Consumers should discontinue the use of these heating pads immediately and return them to the place of purchase for a full refund.
For more information about this recall, please visit:
Weight-Loss Drug for Obese Dogs
The FDA has recently approved Slentrol™, a prescription drug, for the management of obesity in dogs. Slentrol™ reduces appetite and fat absorption to produce weight loss. A veterinarian will need to determine whether the dog should be treated, based on the dog's weight and general health.
Overweight pets, like humans, are at a higher risk of developing various health problems, from cardiovascular conditions to diabetes to joint problems. Veterinarians generally define a dog that weighs twenty percent more than its ideal weight as obese. Surveys have found that approximately five percent of dogs in the United States are obese, and another 20 to 30 percent are overweight.
The way in which Slentrol™ produces weight loss is not completely understood. It seems to result from reduced fat absorption and a feeling of fullness signal from certain cells lining the intestine.
The dog is given an initial dose for the first fourteen days. After that, the veterinarian will assess the dog's progress at monthly intervals, adjusting the dose depending on the dog's weight loss. After the dog has achieved the goal weight, the drug's manufacturer recommends continued use of the drug during a three-month period. During this time, the veterinarian and dog owner establish the best level of food intake and physical activity needed to maintain the dog's weight.
Side effects associated with Slentrol™ include vomiting, loose stools, diarrhea, fatigue, and loss of appetite. To discourage human use, the label of Slentrol™ includes the warning: "Not for use in humans. Keep this and all drugs out of reach of children." The label also cites adverse reactions associated with human use, including abdominal swelling, abdominal pain, diarrhea, stomach gas, headache, nausea, and vomiting.
Source: FDA Consumer, March/April 2007
Pet Food Recall of Tainted Animal Feed
On March 15, FDA learned from Menu Foods, Inc. that certain pet foods were sickening and killing cats and dogs. During the subsequent investigation, FDA discovered the contaminant, melamine, in vegetable proteins (wheat gluten, rice gluten, etc.) imported into the United States from China and used as ingredients in pet food.
A portion of the tainted pet food was used to produce farm animal feed and fish feed. FDA and the United States Department of Agriculture (USDA) discovered that some animals that ate the tainted feed had been processed into human food. Government scientists have determined that there is very low risk to human health from consuming food from animals that ate tainted feed.
FDA and USDA continue their comprehensive investigation to protect the nation's food supply.
For more information, visit:
www.fda.gov/oc/opacom/hottopics/petfood.html
FDA Launches New Web Page, E-newsletter to Enhance Online Consumer Health Information
Keeping up with the latest consumer health information from the FDA just got easier. FDA announced two new initiatives to enhance online communications. A Web page, "Consumer Health Information for You and Your Family" (www.fda.gov/consumer), provides comprehensive and timely consumer information. A monthly e-newsletter, "FDA Consumer Health Information" replaces the agency’s print publication, FDA Consumer, (www.fda.gov/consumer/consumerenews.html) and will alert consumers to content contained on the page. Both the web page and the e-newsletter are free of charge.
"The Web page and e-newsletter are important new
consumer resources that will feature timely stories on
pressing FDA topics, provide links to our most requested
information, and include interactive content," says Andrew
C. von Eschenbach, M.D., FDA Commissioner.
The new consumer Web page will present important public
health developments clearly and accurately in easy-toread
language. One article describes FDA's ongoing
investigation of the recent recall of more than 100 brands of
pet food due to potential contamination. Other articles
discuss the benefits and risks of pain relievers, facts about
generic drugs, and what FDA is doing to keep produce safe.
The page also provides links to useful information about
the various products that FDA regulates, including food, human and animal drugs, medical devices, and vaccines and other biologics. The page also links to health information available from other U.S. government sources and provides essential health information in
Spanish.
The e-newsletter is expected to reach far more people. Subscribers will receive notice of product approvals, safety warnings, and other health news.
FDA invites feedback on the new Web page and the e-newsletter. Comments and questions may be sent via email to fdaconsumerlist@oc.fda.gov or mailed to FDA Consumer Health Information, Food and Drug Administration, HFI-40, Room 15-A29, Fishers Lane, Rockville, MD 20857.
Source: FDA News, May 3, 2007
My Medicine Record
FDA has a website that can help you keep track of your medicines. Once you make your personal medicine record, you can save it to your personal computer and print it. That way, you can easily make changes to your list of prescription medicines, over-the-counter medicines, and dietary supplements. It is a good idea to keep a printed copy with you at all times and share the record with your doctors, pharmacists, or other health professionals at all visits.
My Medicine Record can be found at:
www.fda.gov/cder/consumerinfo/my_medicine_record.htm
Maturity Health MattersMaturity Health Matters is an FDA publication for older adults, their families and caregivers. We provide our readers with current information on FDA-regulated medical products. This publication can be reproduced. If you have comments about our publication, please send them to the editors. Editors: Harriet Albersheim and Mary Ann Wollerton
Department of Health and Human Services - Food
and Drug Administration Special thanks to: CDER, CBER, CFSAN, CVM, and FDA Consumer for contributing to this issue. If you wish to receive email notification of new issues, go here to subscribe. Links to non-Federal organizations are provided solely as a service to our readers. Links do not constitute an endorsement of any organization by FDA or the Federal Government, and none should be inferred. FDA is not responsible for the content of the individual organizations' web pages found at these links. |
Visit Us at AARP!
Come meet the editors of Maturity Health Matters at AARP’s Life @50+ National Event & Expo that will be held at the Boston Convention & Exhibition Center, September 6-8, 2007. Our booth number is 570.
Looking forward to meeting you there.
