FDA Warns About Toxic Effects of Eye Drops and Decongestant Sprays in Young Children

The Food and Drug Adminisration (FDA) is warning parents to keep  over-the-counter (OTC) eye drops used to relieve redness or nasal decongestant sprays away from places where children can get a hold of them.

FDAAccording to the FDA, these products—which contain the active ingredients tetrahydrozoline, oxymetazoline, or naphazoline (known as imidazoline derivatives)—are dangerous, if ingested by children. The products are sold under various brand names such as Visine, Dristan and Mucinex, as well as in generic and store brands.

“In the hands of young children who are apt to swallow them, they can cause serious health consequences,” says pharmacist Yelena Maslov, Pharm.D., at the Food and Drug Administration (FDA).

Maslov explains that one teaspoon of eye drops or nasal spays containing imidazoline derivatives is equal to about 5 mL, and that harm has been reported from swallowing as little as 1 mL to 2 mL. “Children who swallow even miniscule amounts of these products can have serious adverse effects,” she says.

Between 1985 and 2012, FDA identified 96 cases in which children ranging from 1 month to 5 years accidentally swallowed products containing these ingredients. Cases were reported by both consumers and manufacturers to government databases monitored by FDA. According to some case reports, children were chewing or sucking on the bottles or were found with an empty bottle next to them.

The FDA reports there were no deaths reported, but more than half of the cases (53) reported hospitalization because of symptoms that included nausea, vomiting, lethargy (sleepiness), tachycardia (fast heart beat), and coma.

“Under reporting of these types of events is common, so it is possible there are additional cases that we may not be aware of,” says Maslov.

These products are only meant for use in the eyes or nose. In the eyes, the ingredients work by narrowing blood vessels to relieve redness from minor eye irritations. In the nose, they constrict blood vessels to relieve nasal congestion due to the common cold, hay fever, or allergies.

In January, 2012, the U.S. Consumer Product Safety Commission (CPSC) proposed a rule to require child-resistant packaging for all products containing at least 0.08 mg of an imidazoline derivative. However, this rule has not been finalized. In addition, FDA’s Division of Medication Error Prevention and Analysis (DMEPA) is partnering with CPSC to warn consumers about the need to keep these products safely out of the reach of children.

If a child accidentally swallows OTC redness-relief eye drops or nasal decongestant spray, call your local poison control center (1-800-222-1222) immediately. Experts are available all day, every day at these centers. If necessary, poison center staff will immediately help get emergency medical services to your home. Program this number into your home and cell phones so you will have it when you need it. Post it on the fridge so it is in plain sight.

To help avoid a child’s accidental exposure to any medication, parents and other caregivers should:

  • Store medicines in a safe location that is too high for young children to reach or see.
  • Never leave medicines or vitamins out on a kitchen counter or at a sick child’s bedside.
  • If a medicine bottle does have a safety cap, be sure to re-lock it each time you use it.
  • Remind babysitters, house guests, and visitors to keep purses, bags, or coats that have medicines in them away and out of sight when they are in your home.
  • Avoid taking medicines in front of young children because they like to mimic adults.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

 

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After School Food Safety

foodThe kitchen, for food, is often the first place children go when they get home from school, but it’s not always the safest place. Millions of children become ill from the food they eat.

Here are some food safety recommendations from the U.S. Department of Agriculture (USDA) to share with children to help keep them safe after school. When coming home after school, kids can help prevent illnesses by following these recommendations:

  1. Place books, bags, and sporting equipment on the floor, not on eating counters or the kitchen table where germs could be transferred.
  2. Clean out lunch boxes and throw away perishable sandwiches or other “refrigerator type” foods, such as yogurt tubes or cheese sticks, left over from lunch.
  3. Wash your hands before you make or eat a snack. Hands carry lots of germs, and not washing hands is a top cause of foodborne illness.
  4. Always use clean spoons, forks, and plates.
  5. Wash fruits and vegetables with running tap water before you eat them.
  6. Do not eat bread, cheese, or soft fruits or vegetables that are bruised or have spots of mold.
  7. Do not eat unbaked cookie dough because it may contain raw eggs that can have Salmonella bacteria.
  8. Do not leave cold items, like milk, lunchmeat, hard cooked eggs, or yogurt, out on the counter at room temperature. Put these foods back in the refrigerator as soon as you’ve fixed your snack.
  9. Don’t eat any perishable food left out of the refrigerator, such as pizza — even if it isn’t topped with meat. Food should not be left in the temperature “Danger Zone” of 40 to 140 °F for more than 2 hours (1 hour if the temperature is 90 °F or higher).

Heating or cooking foods in microwave ovens can present food safety and personal safety challenges. Some foods do not heat evenly to destroy all bacteria that could be present. Keep these tips in mind:

  1. Read package directions carefully. An adult needs to tell children whether to use the minimum or maximum cooking time on food package directions.
  2. Use only microwave-safe cookware. Don’t put metal or foil-wrapped foods in the microwave. Never microwave food in cold storage containers, such as margarine tubs, cottage cheese cartons, or bowls from frozen whipped topping. The containers can melt and transfer harmful chemicals into the food.
  3. For more even cooking and to better destroy bacteria, cover a dish of food with a lid, plastic wrap, or wax paper. Turn up one corner to let excess steam escape while food is microwaving.
  4. Halfway through cooking, rotate food packages and dishes or stir food during microwaving — even if the oven has a turntable. This helps the food cook more evenly and safely.

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Grapefruit Juice and Your Medications May Not Mix

grapefruit 

The Food and Drug Administration wants you to know that grapefruit juice may be a problem with some medications.


  •  Ask your pharmacist or other health care professional if you can have fresh grapefruit or grapefruit juice while using your medication. If you can’t, you may want to ask if you can have other juices with the medicine.
  • Read the Medication Guide or patient information sheet that comes with your prescription medicine to find out if it could interact with grapefruit juice. Some may advise not to take the drug with grapefruit juice. If it’s OK to have grapefruit juice, there will be no mention of it in the guide or information sheet.
  • Read the Drug Facts label on your non-prescription medicine, which will let you know if you shouldn’t have grapefruit or other fruit juices with it.

  • If you must avoid grapefruit juice with your medicine, check the label of bottles of fruit juice or drinks flavored with fruit juice to make sure they don’t contain grapefruit juice.
  • Seville oranges (often used to make orange marmalade) and tangelos (a cross between tangerines and grapefruit) affect the same enzyme as grapefruit juice, so avoid these fruits as well if your medicine interacts with grapefruit juice.

 

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Reasons Not to Give Your Dog Bones

bonesIt’s the holidays and you want your dog to share in the treats of the season. Before you share bones from the holiday roast, please read what the Food an Drug Administration wants you to know why giving your dog bones is a bad idea. Here is what they had to say:

You’ve just finished a big weekend family dinner and you are wondering what to do with the bones from the ham and roast, when in trots your big black Labrador Retriever. It’s hard to resist those longing, puppy-dog eyes.Your veterinarian has told you it’s a bad idea to give bones to your dog, but you’ve done so in the past with no harm done.

“Some people think it’s OK to give dogs large bones to chew on” says Carmela Stamper, a veterinarian in the Center for Veterinary Medicine (CVM) at the Food and Drug Administration (FDA).

“Giving your dog a bone might lead to an unexpected trip to your veterinarian, a possible emergency surgery, or even death for your pet.”FDA has received about 35 reports of pet illnesses related to bone treats and seven reports of product problems, such as bones shattering when pulled from their packaging. The reports, sent in by pet owners and veterinarians, involved about 45 dogs.

A variety of commercially-available bone treats for dogs—including treats described as “Ham Bones,” “Pork Femur Bones,” “Rib Bones,” and “Smokey Knuckle Bones”—were listed in the reports. Many of these products differ from uncooked butcher-type bones because they are processed and packaged for sale as dog treats. The products may be dried through a smoking process or by baking, and may contain other ingredients such as preservatives, seasonings, and smoke flavorings.

Pet owners and veterinarians have reported the following illnesses in dogs that have eaten bone treats:

  • Gastrointestinal obstruction (blockage in the digestive tract)
  • Choking
  • Cuts and wounds in the mouth or on the tonsils
  • Vomiting
  • Diarrhea
  • Bleeding from the rectum, and
  • Death. Approximately eight dogs reportedly died after eating a bone treat.

Remember that your dog can pick up bones while out on a walk. He could also get into the kitchen trash and eat bones that you may have thrown away.

Talk with your veterinarian about other toys or treats that are most appropriate for your dog,” says Stamper. “There are many available products made with different materials for dogs to chew on.”“We recommend supervising your dog with any chew toy or treat, especially one she hasn’t had before,” adds Stamper. “And if she ‘just isn’t acting right,’ call your veterinarian right away!”

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False Prophets of Health Care

Beware of the snake oil sales person; the health health care false prophetscare scam pro who uses the TV, the Internet, the mail and the telephone to peddle fake cures for what ails you.

This is the message the Food and Drug Administration is trying to get out to all of us in their recently released article on the subject of health care scams.

The FDA’s Health Fraud Scams website (www.fda.gov/healthfraud) pulls together videos and articles on how to avoid fraudulent health care schemes, and offers information about products that have been seized, recalled or are the subject of warnings from the agency.

The site also provides links to government resources on health fraud involving FDA-regulated products, such as drugs, dietary supplements, tobacco products, alternative medicines, medical devices, and cosmetics.

Gary Coody, R.Ph., national health fraud coordinator at FDA, calls the site “one-stop shopping” for people who want to learn how to recognize and avoid health care fraud scams. Anyone can search the site to see if FDA has taken an action against a product or company. However, just because a product is not listed does not mean that it is legally marketed or safe to use.

Consumers spend a fortune on health care products that “are either worthless or may cause harm,” says Coody. “Consumers can buy dangerous products on the Internet and in stores that can cause serious injury or death.” The waste of money is bad enough but using one of these unproven treatments can delay getting a potentially life-saving diagnosis and medication that works, he says.

The schemes can take many forms. “Some products billed as “all natural” in fact have prescription drugs and other chemicals not listed on the label that could be dangerous,” Coody says.  The most common categories of these tainted health care products include weight loss, sexual performance, and bodybuilding.

Other health care products claim to be a cure-all for such serious chronic diseases as cancer, arthritis, diabetes, Alzheimer’s disease and multiple sclerosis. Seniors are particularly vulnerable to this kind of deception but consumers of all ages are taken in by fraudulent products, says Coody, adding, “Everyone is vulnerable.”

With every new health threat, phony products appear overnight, Coody says. For example, after the Japan nuclear incident in March, 2011, he says the market was flooded with products that falsely claimed to offer protection from harmful radiation.

“The snake oil salesman is still alive,” says Coody.

Health fraud is more pervasive today, says Coody, because “the Internet has opened up the world market to people from their personal computers.” If you’re tempted to purchase any unproven or little known health care treatment, especially if it’s sold on the Internet, check with your doctor or health care professional first, he advises.

Shady products are also peddled by TV infomercials, radio, direct mail, word-of-mouth marketing and ads in newspapers and magazines.

“There are many ways that consumers are getting these messages,” says Coody, and they should view these ads with a healthy dose of skepticism.”

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