Category Archives: Safety

Republicans say no to CDC gun violence research

Share

Giving the Centers for Disease Control and Prevention money for gun violence research is a “request to fund propaganda,” a Georgia congressman says.

GunBy Lois Beckett
ProPublica, April 21, 2014

After the Sandy Hook school shooting, Rep. Jack Kingston (R-GA) was one of a few congressional Republicans who expressed a willingness to reconsider the need for gun control laws.

“Putgunson thetable, also put video games on thetable, put mental health on the table,” he said less than a week after the Newtown shootings.

He told a local TV station that he wanted to see more research done to understand mass shootings. “Let’s let the data lead rather than our political opinions.”

For nearly 20 years, Congress has pushed the Centers for Disease Control and Prevention (CDC) to steer clear of firearms violence research. Continue reading

Share

Pollution halts Vaughn Bay shellfish harvest: 14 other areas threatened

Share

Pollution to close shellfish harvest in one area; 14 others listed as threatened
Fecal bacteria levels force new restrictions to protect shellfish consumers

From the Washington State Department of health:

Alert Icon with Exclamation Point!OLYMPIA — The state Department of Health has closed harvesting in part of Vaughn Bay in Pierce County due to high levels of fecal bacteria. Health officials also identified 14 more of Washington’s 101 commercial shellfish growing areas that could be closed in the future if fecal pollution continues to get worse.

“The good news is that the pollution problems in almost all these areas can be found and fixed,” said Bob Woolrich, Growing Area section manager. “There have been many successful pollution correction projects using partnerships with local and state agencies, Tribes, and others.”

The agency shellfish program evaluates the state’s shellfish growing areas every year to see if water quality is approaching unsafe limits. If so, areas are listed as “threatened” with closure.

Shellfish harvesting areas threatened with closure include:

Continue reading

Share

Don’t use grills or gas generators in enclosed areas – Department of Health warns

Share

From the Washington State Department of Health

Power outages may raise risk of carbon monoxide poisoning

Charcoal grillDon’t use grills or gas generators in enclosed areas

January 10, 2014 – Barbecue grills and gas generators may seem like they could double as an indoor furnace during a power outage, but that can be downright dangerous.

Neither should be used inside to heat homes, as families could get sick and even die from carbon monoxide poisoning.

Carbon monoxide, or CO, is a poisonous gas that can’t be seen or smelled and can kill a person in minutes. Carbon monoxide is produced whenever any fuel such as gas, oil, kerosene, wood, or charcoal is burned. It can quickly build up to unsafe levels in enclosed or semi-enclosed areas.  Continue reading

Share

Tips for staying safe in cold weather for older adults

Share

Thermometer ThumbHypothermia and older adults

Tips for staying safe in cold weather from the National Institute on Aging

Frigid weather can pose special risks to older adults. The National Institute on Aging (NIA), part of the National Institutes of Health, has some advice for helping older people avoid hypothermia — when the body gets too cold — during cold weather.

Continue reading

Share

Can a dietary supplement treat a concussion? No

Share

Illustration of the skull and brainA Consumer Update from the US Food and Drug Administration

Exploiting the public’s rising concern about concussions, some companies are offering untested, unproven and possibly dangerous products that claim to prevent, treat or cure concussions and other traumatic brain injuries (TBIs).

The Food and Drug Administration (FDA) is monitoring the marketplace and taking enforcement actions where appropriate, issuing warning letters to firms—the usual first step for dealing with claims that products labeled as dietary supplements are intended for use in the cure, mitigation, treatment, or prevention of disease.

The agency is also warning consumers to avoid purported dietary supplements marketed with claims to prevent, treat, or cure concussions and other TBIs because the claims are not backed with scientific evidence that the products are safe or effective for such purposes.

These products are sold on the Internet and at various retail outlets, and marketed to consumers using social media, including Facebook and Twitter.

One common claim: Using a particular dietary supplement promotes faster healing times after a concussion or other TBI.

Even if a particular supplement contains no harmful ingredients, that claim alone can be dangerous, says Gary Coody, FDA’s National Health Fraud Coordinator.

“We’re very concerned that false assurances of faster recovery will convince athletes of all ages, coaches and even parents that someone suffering from a concussion is ready to resume activities before they are really ready,” says Coody. “Also, watch for claims that these products can prevent or lessen the severity of concussions or TBIs.”

A concussion is a brain injury caused by a blow to the head, or by a violent shaking of the head and upper body. Concussions and other TBIs are serious medical conditions that require proper diagnosis, treatment, and monitoring by a health care professional.

The long-term impact of concussions on professional athletes and children who play contact sports has recently been the subject of highly publicized discussions.

A growing body of scientific evidence indicates that if concussion victims resume strenuous activities—such as football, soccer or hockey—too soon, they risk a greater chance of having a subsequent concussion.

Moreover, repeat concussions can have a cumulative effect on the brain, with devastating consequences that can include brain swelling, permanent brain damage, long-term disability and death.

“As amazing as the marketing claims here are, the science doesn’t support the use of any dietary supplements for the prevention of concussions or the reduction of post-concussion symptoms that would enable one to return to playing a sport faster,” says Daniel Fabricant, Ph.D., director of FDA’s Division of Dietary Supplement Programs.

The Claims

One of the first alarms raised about dietary supplements being promoted to treat TBI came from the U.S. Department of Defense.

“We first learned from the military about a product being marketed to treat TBI, obviously a concern with wounded veterans. We were taken aback that anyone would make a claim that a supplement could treat TBI, a hot-button issue,” says Jason Humbert, a senior regulatory manager with FDA’s Office of Regulatory Affairs. “That sparked our surveillance.”

FDA routinely monitors the marketplace. However, with more than 85,000 dietary supplements on the market and no product registration, products making false claims can slip through, at least for a time.

Typically, products promising relief from TBIs tout the benefits of ingredients such as turmeric and high levels of omega-3 fatty acids derived from fish oil. Turmeric is an Indian spice in the ginger family.

For Omega-3, FDA has recommended a maximum daily level of 3 grams per day from all sources due to possible problems with increased risk of bleeding, increases in cholesterol and problems with controlling blood sugar levels.

In its initial surveillance, FDA identified two companies selling multiple products claiming to prevent and treat concussions and other TBIs. One company claimed to have “the world’s first supplement formulated specifically to assist concussion recovery,” saying “it has the dynamic ability to minimize long-term effects and decrease recovery time.”

A National Football League player testified to its “proven results in my own recovery” from a concussion, and an unnamed “licensed trainer” said he had incorporated it into his “concussion management protocol.”

Similar claims were made by the other company, which was selling four products claiming to protect against and help heal TBIs. FDA sent letters in 2012 warning both companies that their products were not generally recognized as safe and effective for treating TBIs, that the products were misbranded (a legal term meaning, in this case, that the labeling of the products did not have adequate directions for use), and that unless various violations cited in the letters were promptly corrected, the violations could result in legal action taken without further notice, such as seizure or injunction.

Both companies changed their websites and labeling.

In December 2013, FDA issued a warning letter to Star Scientific, Inc., for marketing its product Anatabloc with claims to treat TBIs. FDA continues to monitor the marketplace for products with similar fraudulent claims, and will take appropriate regulatory action to protect the public health.

“As we continue to work on this problem, we can’t guarantee you won’t see a claim about TBIs. But we can promise you this: There is no dietary supplement that has been shown to prevent or treat them,” says Coody. “If someone tells you otherwise, walk away.”

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

Dec. 31, 2013

Share

Keep germs off the guest list at holiday meals

Share

Uncooked turkey in a pot

Keep all your guests healthy by following these food safety tips from the Snohomish Health District.

Proper planning.

Make sure your kitchen has everything you need for safe food handling, including two cutting boards (one for raw meats and seafood and the other for ready-to-eat foods), a food thermometer, shallow containers for cooling and storage, paper towels and soap.

Store foods in the refrigerator at 41°F or below or in the freezer at 0°F or below. Check the temperature of both the refrigerator and freezer with a refrigerator thermometer.

Safe shopping. 

At the grocery store, bag raw meat, poultry and seafood separate from ready-to-eat foods like fruit, vegetables and bread. Don’t buy bruised or damaged produce, or canned goods that are dented, leaking, bulging or rusted, as these may become a breeding ground for harmful bacteria. Buy cold foods last and bring foods directly home from the store.

Always refrigerate perishable foods, such as raw meat or poultry, within two hours. Thaw frozen turkey in the refrigerator or under cold-running water. Never defrost the turkey at room temperature.

Working in the kitchen. 

Got extra helpers in the kitchen? Make sure everyone washes their hands thoroughly with warm water and soap for 20 seconds before and after handling food, visiting the restroom, or changing a baby’s diapers. Keep all work surfaces sanitized, too. Spray or wipe on a solution of 1 tsp of unscented bleach per gallon of cold water.

When baking holiday treats, remember that no one should eat raw cookie dough or brownie batter containing raw eggs. Make eggnog with pasteurized eggs and pasteurized milk, or simply buy it ready-made with those ingredients.

Adding a nip of brandy or whiskey will not kill the germs. When making homemade eggnog, be sure to cook the mixture to 165°F, then refrigerate.

Cook. 

Food is safely cooked when it reaches a high enough internal temperature to kill the

harmful bacteria that cause illness. Cook your turkey to a minimum of 165°F as measured with a food thermometer, including the stuffing.

The healthiest method is to prepare and cook the stuffing separately – outside the bird. Test the bird’s temp in the thickest part of the thigh, the breast, and the inside. Don’t let the tip of the thermometer rest against bone.

Potluck contributions. 

Remember to keep hot foods hot (135°F or higher) and cold foods cold (41°F or below). To help keep foods hot wrap dishes in foil, cover them in heavy towels, or put them in insulated containers designed to keep food hot.

For cold foods, put them in a cooler with ice or freezer packs, or use an insulated container with a cold pack so they remain at 41°F or lower, especially if traveling for more than half an hour.

Buffet, anyone? 

If you set up food in a buffet line, take care to put spoons in each dish for self-service, and assist children in filling their plates. No fingers allowed!

Wrap it up! 

Throw away all perishable foods, such as meat, poultry, eggs and casseroles, left at room temperature longer than two hours. Refrigerate or freeze other leftovers in shallow, air-tight containers and label with the date it was prepared. Reheat leftovers to 165°F.

Divide large amounts of leftovers into shallow containers for quicker cooling in the refrigerator. Keeping a constant refrigerator temperature of 41°F or below is one of the most effective ways to reduce the risk of an at-home food-borne illness.

Eat cooked turkey and stuffing within 3-4 days and gravy in 1-2 days. Cooked turkey keeps up to 4 months in the freezer. Reheat leftovers to 165°F as measured with a food thermometer, and bring gravy and sauces to a boil before serving. Microwaved leftovers shouldn’t have cold spots (bacteria can survive). Cover food, stir and rotate for even cooking.

Following these food safety steps at your house will make the meal a happy memory for everyone. Happy, healthy holidays from the Snohomish Health District!

Additional resources:

Free kit

The Holiday Food Safety Success Kit at www.holidayfoodsafety.org provides food safety advice and meal planning in one convenient location.

The kit includes information on purchasing, thawing and cooking a turkey; a holiday planner with menus, timelines, and shopping lists; and dozens of delicious (and food-safe) recipes. ]

The kit also has arts and crafts activities and downloads for kids so they can join the holiday fun.

U.S. Food and Drug Administration

1-888-SAFEFOOD: For questions about safe handling of the many foods that go into a delicious holiday meal, including eggs, dairy, fresh produce and seafood.

Escherichia Coli_NIAID E Coli BacteriaNothing can ruin a party quite like food poisoning. According to the Centers for Disease Control and Prevention, there are 31 pathogens known to cause food-borne illness.

Every year there are an estimated 48 million cases of illness, 128,000 hospitalizations, and 3,000 deaths in the United States due to food-borne diseases.

Typical symptoms of food-borne illness are vomiting, diarrhea, and cramps which can start hours to days after contaminated food or drinks are consumed.

The symptoms usually are not long-lasting in healthy people—a few hours or a few days—and usually go away without medical treatment.

But food-borne illness can be severe and even life-threatening to anyone, especially those most at risk such as infants and young children, pregnant women, older adults, people with HIV/AIDS, cancer or any condition or medication that weakens the immune system.

Share

Remembering the Sandy Hook tragedy, protecting kids from gun violence – Seattle Children’s

Share

From Seattle Children’s On the Pulse blog

GunOn Dec. 14 of last year, 20 children and seven adults lost their lives in the senseless tragedy that took place at Sandy Hook Elementary School in Newtown, Conn.

As we approach the anniversary of this horrific event, we remember and mourn the victims and the families who have been affected by this tragedy.

No parent should ever have to suffer through the pain of losing a child to gun violence. And with guns in more than one third of all U.S. households, firearms present a real, everyday danger to children, especially when improper safety techniques are followed.

Frederick Rivara, MD, MPH, division chief of general pediatrics and vice chair of the Department of Pediatrics at Seattle Children’s Hospital, and Dimitri Christakis, MD, MPH, director of the Center for Child Health, Behavior and Development at Seattle Children’s Research Institute, offer the following tips and advice for parents looking to keep kids safe from firearms, and to help reduce their exposure to gun violence in the media.

Gun safety in the home

Less than half of U.S. families with children and guns store their guns unloaded and locked away. Each year just in Washington state, about 25 children are hospitalized and four to five die due to unintentional gun injuries.  Most of these shootings occur in or around the home.

The best way to protect children from firearms injury in the home is to remove the firearms entirely. However, if this is not an option, Rivara says there are a number of ways that you can minimize the risk:

Store your guns safely:

  • All weapons should be stored in a securely locked case, well out of the reach of children, and make sure children do not have access to the key or combination.
  • Stored firearms should be unloaded and in the uncocked position.
  • Store ammunition separate from the weapon, also in a securely locked location out of the reach of children.
  • Use trigger locks or chamber locks on weapons. Even a padlock can be used to prevent the cylinder of a weapon from locking into place.
  • Remove guns from your home if a family member is depressed, suicidal or is abusing drugs or alcohol.

With the popularity of shooting video games and toy guns, the lines between these weapons and their very real consequences are often blurred. Parents should talk with their children and make them aware that weapons are not toys and that if they ever do come into contact with a weapon, they are not to touch it under any circumstances. The National Rifle Association (NRA) recommends teaching children four things about what to do when finding a gun: stop, don’t touch, leave the area and tell an adult.

Gun violence in the media

Whether or not you keep a weapon in your home, children will be exposed to gun violence in the media at some point, often very early in life. In fact, a recent study found that the rate of violence in movies is increasing, and that this violence is now more predominant in the PG-13 movies your teens are watching than in R-rated movies. And with the medical consensus being that exposure to violent media can increase aggression in children, and that children often imitate what they see on the screen, parents must be mindful of their children’s exposure to gun violence in the media.

While it’s challenging to prevent your child from encountering this violence, you can help to limit it while you talk to them about its real-world consequences. Here are a few tips to help:

Implement a media diet. Christakis recently conducted a study that found that children reproduce what they see on television or in the movies, both bad and good. He suggests staying aware of what your children are watching by keeping a media diary. He also advises to watch more TV and movies with your children so you’re always aware of the content they’re consuming and can discuss it with your kids.

Be available. When events like the Sandy Hook tragedy occur, these stories of violence are plastered all across the news. Each child responds to this in a different way. Many become fearful and have questions about these events. Some end up angry or grief-stricken, while others feel a sense of betrayal. Be sure to talk with your children about these events to reinforce that they are safe and to assuage their fears. Doing this will also show that you are available to talk with them about anything, no matter how difficult it may be.

Keep an eye out for red flags. Pretend gun play, violent video games and movies and other aggressive influences are a part of our lives, and finding the right balance between limiting children’s exposure to these stimuli and not keeping them entirely in the dark can be difficult. However, it can help to look out for potential red flags, such as a child “accidentally” hurting another, aggressive behavior, or a lack of empathy or remorse for their actions. Please discuss these concerns with your child’s doctor.

Resources

Seattle Children's Whale Logo

Share

Seattle Children’s doctor offers tips to keep kids safe this holiday season

Share
Photo courtesy of Jay-Simmons

Photo courtesy of Jay Simmons

From Seattle Children’s On the Pulse blog

Tis the season for mistletoe, gingerbread and carefully strung lights. It’s the most wonderful time of the year, but also a potentially dangerous one for children. And although festivities, candles and garland may make the holiday season more cheerful, with them come some serious safety concerns.

Tony Woodward, MD, MBA, medical director of emergency medicine at Seattle Children’s Hospital, says the most important thing to remember this holiday season is supervision.

“The holidays are a fun and exciting time, but there are a few more things inserted into the environment, like holiday plants, electrical cables, new toys and festive beverages, which are potentially dangerous,” says Woodward.

Holiday safety tips

To keep kids out of the emergency room this year, Woodward recommends some basic safety tips to ensure an injury-free, but still festive holiday season.

Lights, trees and décor. Sparkly ornaments, shiny holiday decorations and small holiday figurines are potential choking hazards for small children. If an object can fit through a toilet paper tube, it can obstruct the airway of a small child and prevent breathing.

“Think like a child,” says Woodward. “Get down on your hands and knees and look around the house. If something looks shiny and enticing, a child may want to put it in their mouth. Keep decorations high and out of reach.”

Make sure trees and decorations are properly secured, either by a sturdy stand or to the wall. Also, talk to children about holiday decorations and explain that they are not toys. Set limits and supervise children.

Poisoning potential. Holiday plants like mistletoe, holly and poinsettias are commonly used as decorations, but they can be hazardous to children. These plants are considered potentially poisonous and should be kept away from children and out of reach. If a child ingests any part of these plants call a pediatrician or the Poison Help Line immediately at (800) 222-1222. Symptoms from poisoning may include vomiting, diarrhea, nausea or rash.

Medicines and vitamins can also be hazardous for children. Keep an eye out for medicine, vitamins and other personal products found in purses or suitcases that guests visiting for the holidays may bring into the home. Also, be aware when visiting other houses this holiday with your family, especially households without young children because the house may not be child proofed.

Be cautious of raw or undercooked foods during the holidays. Wash hands frequently when handling raw meat or eggs, and don’t leave foods out in reach of children.

Holiday parties. Hosting a holiday gathering this year? Plan for a party’s youngest guests first. Take small children into consideration when planning a party’s food and beverage menu, and before adorning the home with festive décor.

“Decorating the home with garland and strung beads may look great for the holidays, but children can mistake the brightly colored beads and floral arrangements for candy or food, which may cause choking or poisoning,” says Woodward.

Alcohol is another common risk for children around the holidays and during holiday gatherings.

“Kids see adults drinking alcohol and become curious. If glasses are left sitting out in reach of children they may ingest the alcohol, which even in small amounts can be dangerous to kids. Use common sense and always keep an eye on children,” says Dr. Woodward.

Also, stay home from parties or gatherings if children aren’t feeling well. Don’t risk spreading germs to others. Talk to children about proper hand washing and coughing techniques. Germs are easily spread, but these techniques can help prevent the transmission of germs from one person to another.

Fire safety. Keep decorations and trees away from heat sources within the home, which includes fireplaces, radiators, space heaters or electrical outlets. Also, avoid using candles if there are small children in the home.

When buying an artificial tree, make sure it is “fire retardant,” and also make sure a child’s sleepwear is labeled “fire retardant” as well. Be sure to also remove dry trees after the holiday season to reduce fire risk.

Use socket covers to baby-proof electrical outlets and make sure extension cords are well hidden and out of reach. Ensure cords are all the way in the outlets so kids don’t get shocked. Also, do not have water around outlets and wires.

Cooking is the leading cause of home fires in the U.S. Try to keep small children out of the kitchen while cooking or preparing food. Turn pot handles in so they can’t be accidently knocked over and stay in the kitchen while frying, grilling and broiling.

Toy safety. Many toys and holiday decorations require button batteries, which can pose fatal risks for young kids. Be sure batteries cannot be removed easily from toys and gadgets. If a battery is swallowed, it can cause life-threatening injuries. Also, avoid magnets. Toys that contain small magnets are especially dangerous for young kids. If swallowed, magnets can attract to one another in a child’s intestine and cause serious complications and even death.

“Make sure toys are appropriate for the age of a child, but also think about other children,” says Woodward. “Think about the worst case scenario. If a 1-year-old or 2-year-old will be in the home visiting for the holidays, ask if there are toys that could potentially be harmful to them.”

Just like checking a food’s ingredient list, parents should read toy and product labels. Avoid toys and products that contain PVC plastic, xylene, toluene or dibutyl phthalate.

Cold weather. With temperatures dropping, make sure children are properly dressed for the weather with hands, feet and heads covered. Dress children in layers and make sure they come in out of the cold periodically. The nose, ears, feet and hands are at the biggest risk of frostbite if temperatures are below freezing.

Supervise children while they play. Activities like sledding can be dangerous without proper supervision and safety gear. Also, be extremely cautious around water. Never allow children to walk across frozen lakes or ponds.

Lastly, wear sunscreen. It may be cold, but children are still at risk for sunburn.

The holidays are a time for celebration and fun. By following these simple safety tips, families can enjoy the holiday season without injury. Happy Holidays!

Photograph courtesy of Jay Simmons

Resources:

Share

‘Lucky 13′ tips for a safe Halloween

Share

Bats across the moon

A Consumer Update from the US Food and Drug Administration

Whether you’re goblin or ghoul, vampire or witch, poor costume choices—including decorative contact lenses and flammable costumes—and face paint allergies can haunt you long after Halloween if they cause injury.

Enjoy a safe and happy Halloween by following the “lucky 13” guidelines from FDA, the Consumer Product Safety Commission, and the Centers for Disease Control and Prevention:

Photo Credit: Lynne Lancaster

  1. Wear costumes made of fire-retardant materials; look for “flame resistant” on the label. If you make your costume, use flame-resistant fabrics such as polyester or nylon
  2. Wear bright, reflective costumes or add strips of reflective tape so you’ll be more visible; make sure the costumes aren’t so long that you’re in danger of tripping.
  3. Wear makeup and hats rather than masks that can obscure your vision.
  4. Test the makeup you plan to use by putting a small amount on the arm of the person who will be wearing it a couple of days in advance. If a rash, redness, swelling, or other signs of irritation develop where the makeup was applied, that’s a sign of a possible allergy.
  5. Check FDA’s list of color additives to see if makeup additives are FDA approved. If they aren’t approved for their intended use, don’t use it.
  6. Don’t wear decorative contact lenses unless you have seen an eye care professional and gotten a proper lens fitting and instructions for using the lenses.

Safe Treats

Eating sweet treats is also a big part of the fun on Halloween. If you’re trick-or-treating, health and safety experts say you should remember these tips:

  1. Don’t eat candy until it has been inspected at home.
  2. Trick-or-treaters should eat a snack before heading out, so they won’t be tempted to nibble on treats that haven’t been inspected.
  3. Tell children not to accept—or eat—anything that isn’t commercially wrapped.
  4. Parents of very young children should remove any choking hazards such as gum, peanuts, hard candies, or small toys.
  5. Inspect commercially wrapped treats for signs of tampering, such as an unusual appearance or discoloration, tiny pinholes, or tears in wrappers. Throw away anything that looks suspicious.

For partygoers and party throwers, FDA recommends the following tips for two seasonal favorites:

  1. Look for the warning label to avoid juice that hasn’t been pasteurized or otherwise processed, especially packaged juice products that may have been made on site. When in doubt, ask! Always ask if you are unsure if a juice product is pasteurized or not. Normally, the juice found in your grocer’s frozen food case, refrigerated section, or on the shelf in boxes, bottles, or cans is pasteurized.
  2. Before bobbing for apples—a favorite Halloween game—reduce the amount of bacteria that might be on apples by thoroughly rinsing them under cool running water. As an added precaution, use a produce brush to remove surface dirt.

Eye Safety

FDA joins eye care professionals—including the American Academy of Ophthalmology, the American Association for Pediatric Ophthalmology and Strabismus, the Contact Lens Association of Ophthalmologists and the American Optometric Association—in discouraging consumers from using decorative contact lenses.

These experts warn that buying any kind of contact lenses without an examination and a prescription from an eye care professional can cause serious eye disorders and infections, which may lead to permanent vision loss. Despite the fact that it’s illegal to sell decorative contact lenses without a valid prescription, FDA says the lenses are sold on the Internet and in retail shops and salons—particularly around Halloween.

The decorative lenses make the wearer’s eyes appear to glow in the dark, create the illusion of vertical “cat eyes,” or change the wearer’s eye color.

“Although unauthorized use of decorative contact lenses is a concern year-round, Halloween is the time when people may be inclined to use them, perhaps as costume accessories,” says FDA eye expert Bernard Lepri, O.D., M.S., M.Ed.. “What troubles us is when they are bought and used without a valid prescription, without the involvement of a qualified eye care professional, or without appropriate follow-up care. This can lead to significant risks of eye injuries, including blindness.”

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

Posted October 19, 2011; reviewed October 24, 2013

Share
Stairs steps small

King County offers free fall safety prevention program for seniors

Share

Stairs steps smallWith over 20,000 admissions every year, falls are the leading cause of injury-related hospitalizations in Washington state, and seniors account for over two thirds of these cases.

To help prevent these painful and costly events, King County Emergency Medical Services is offering free home safety assistance.

Called One Step Ahead, the service is available for residents 65 years and older who are at highest risk for falls and live in King County outside of the City of Seattle. It includes:

  • a home safety walk through
  • education about staying safe in your home
  • information about local resources
  • installation of fall safety devices for low income residents who qualify

“One Step Ahead provides a great opportunity for older adults in our community to reduce their fall risks, avoid injury and keep their independence longer,” said King County Emergency Medical Services Director Jim Fogarty.

For more information about the One Step Ahead fall prevention program and how to qualify, please call 206-263-8544. September 22 -28, 2013 has been declared Fall Safety Prevention Week in Washington state by Governor Jay Inslee.

Ways to stay steady

Alan Abe, Injury Prevention Program Manager for King County Emergency Medical Services, offers these four key tips for seniors to reduce their risk of falls:

  • Do exercises that improve mobility, strength and balance and that are taught by trained professionals. Examples of exercise programs include Tai Chi, Matter of Balance, Enhanced Fitness or other individual or group exercise programs. King County Emergency Medical Services helps sponsor exercise classes at several local senior centers.
  • Have your medication reviewed to identify possible side effects or drug interactions that may contribute to falls.
  • Have your eyes examined by an optometrist or ophthalmologist.
  • Improve your home environment, such as providing proper access to bathtub or showers, sufficient lighting, clear walkways and installing handrails.

Key statistics

  • Each year in the United States, nearly one-third of older adults (65 year or older) experience a fall.
  • One in five older adults report having fallen in the previous three months.
  • About one out of ten falls among older adults result in a serious injury, such as a hip fracture or head injury that requires hospitalization.
  • In 2010, adults age 65 and older had over two thirds of the hospitalized falls in Washington state and 83% of fall-related deaths.

 

Share
Tablet Thumb Blue

FDA moves to reduce use of long-acting opioid pain drugs

Share

The US Food and Drug Administration has changed the labeling on long-acting opioids, such as OxyContin, in an effort to limit the use of these drugs to patients with severe refractory pain. Here’s is the Consumer Update from the FDA released today.

FDA Consumer Update

FDA logojpgConsumers and health care professionals will soon find updated labeling for extended-release and long-acting opioid pain relievers to help ensure their safe and appropriate use.

In addition to requiring new labeling on these prescription medications, the Food and Drug Administration (FDA) is also requiring manufacturers to study certain known serious risks when these drugs are used long-term.

“The new labeling requirements and other actions are intended to help prescribers and patients make better decisions about who benefits from the use of these medications. They also are meant to reduce problems associated with their use,” says Douglas Throckmorton, M.D., deputy director of regulatory programs in FDA’s Center for Drug Evaluation and Research.

“Altogether, the actions we’re now announcing are part of FDA’s efforts to make opioids as safe as possible for those who need them,” Throckmorton adds.

He noted that the actions come after careful analysis of new safety information, including reviews of medical literature, and consideration of input from patients, experts and many other interested parties.

How Labeling Will Change

Opioids work by changing the way the brain perceives pain. They are available by prescription as pills, liquids, and skin patches.

Extended-release and long-acting (ER/LA) forms pose a greater safety concern because—as their names suggest—they produce their effects for a longer period, and many contain higher doses compared with immediate release or opioid/non-opioid combination products.

They include, to name a few, long acting versions of opioids such as morphine, oxycodone, and fentanyl.

Currently, labeling on these ER/LA opioids indicate they are for “the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.”

However, the updated indication for when to prescribe and take these medicines will, when finalized, emphasize that other, less potentially addictive, treatment options should be considered first.

FDA is requiring labeling that says the drugs are “indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.”

The “limitations of use” portion of the new labeling retains language indicating that the drugs are not intended for use as an “as-needed” pain reliever.

Furthermore, the new labeling adds: “Because of the risks of addiction, abuse and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve [Tradename] for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.”

This new labeling language emphasizes that patients in pain should be assessed not only by their rating on a pain intensity scale, but also based on a more thoughtful determination that their pain—however it may be defined—is severe enough to require daily, around-the-clock, long-term opioid treatment, and for which alternative treatment options are inadequate.

This framework better enables prescribers to make decisions based on a patient’s individual needs, given the serious risks associated with ER/LA opioids, against a backdrop of alternatives such as immediate release (IR) opioids and non-opioid pain relievers.

It allows prescribers to make an assessment of pain relative to a patient’s ability to perform daily activities or enjoy a reasonable quality of life.

FDA-approved labeling of these pain relievers already describes the effects on newborns of exposure to these drugs while in the mother’s womb and warns against use by women during pregnancy and labor and while nursing.

The new labeling, however, will provide more detail and will elevate the risk of neonatal opioid withdrawal syndrome (NOWS) to the most prominent position in labeling—a boxed warning. Symptoms of NOWS may include poor feeding, rapid breathing, trembling, and excessive or high-pitched crying.

Postmarket Studies

Recognizing the need for more scientific data about the benefits and risks of ER/LA opioids when used over long periods, FDA also decided to require drug companies to conduct longer term studies and trials of ER/LA opioid pain relievers on the market.

The companies must evaluate long-term use, with the goal of assessing a variety of known serious risks, including misuse, abuse, addiction, overdose, and death, as well as the risks of developing increasing sensitivity to pain.

Education to Reduce Risk

Following implementation of the safety labeling changes, certain educational materials for patients and health care professionals will be modified to reflect the new labeling for the ER/LA opioid pain relievers.

As part of the new labeling changes, opioid manufacturers also must revise a paper handout patients receive with their prescription.

The ER/LA Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) will also be updated after the labeling changes are finalized.

The ER/LA Opioid Analgesics REMS requires manufacturers to make available continuing education courses for health care professionals who prescribe these drugs.

The courses, from accredited sources, teach about risks and safe prescribing and safe use practices of these medications.

“By improving information about the risks of ER/LA opioid pain relievers and by clarifying the populations for whom the benefits outweigh the risks, we aim to improve the safe and appropriate use of these products,” says Throckmorton.

He adds: “This is not the first or last initiative, and we will continue supporting broader efforts to solve the serious public health problems associated with the misuse and abuse of opioids.”

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

Sept 10, 2013

Share
Thumbnail

FDA warns of rare acetaminophen risk

Share

A Consumer Update from the US Food and Drug Administration

ucm363013Acetaminophen, 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.”

Ingredient Linked to Several Conditions

Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) are the two most serious skin reactions linked in rare cases to acetaminophen. They usually require hospitalization and can cause death.

Problems usually begin with flu-like symptoms followed by rash, blistering and extensive damage to the surfaces of the skin. Recovery can take weeks or months, and possible complications include scarring, changes in skin pigmentation, blindness and damage to internal organs.

A third skin reaction, acute generalized exanthematous pustulosis (AGEP), usually resolves within two weeks of stopping the medication that caused the problem.

A serious skin reaction can occur at any time, even if you’ve taken acetaminophen previously without a problem. There is currently no way of predicting who might be at higher risk.

If you’ve ever had a skin reaction when taking acetaminophen, don’t take the drug again and discuss alternate pain relievers/fever reducers with your health care professional.

Evidence of Link

Prior to deciding to add a warning about skin reactions to products containing acetaminophen, FDA reviewed medical literature and its own database, the FDA Adverse Event Reporting System (FAERS).

A search of FAERS uncovered 107 cases from 1969 to 2012, resulting in 67 hospitalizations and 12 deaths. Most cases involved single-ingredient acetaminophen products; the cases were categorized as either probable or possible cases associated with acetaminophen.

A small number of cases, just over two dozen, are documented in medical literature, with cases involving people of various ages.

FDA has examined—and continues to examine—acetaminophen for safety issues, just as it does with all approved drugs. The warning comes two years after FDA took new steps to reduce the risk of liver injury from acetaminophen.

In that case, FDA asked all makers of prescription products to limit acetaminophen to 325 milligrams per tablet or capsule. FDA also required all prescription acetaminophen products to include a Boxed Warning—FDA’s strongest warning, used for calling attention to serious risks.

The agency continues to consider the benefits of this medication to outweigh the risks.

“FDA’s actions should be viewed within the context of the millions who, over generations, have benefited from acetaminophen,” says Hertz. “Nonetheless, given the severity of the risk, it is important for patients and health care providers to be aware of it.”

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

August 1, 2013

Share
Blue sky and white clouds (Panorama)

Hot weather: How to stay cool and safe

Share

Blue sky and white clouds (Panorama)

Hot weather tips from Public Health – Seattle & King County

When outside temperatures are very high, the danger for heat-related illnesses rises. People’s bodies are not able to cool themselves quickly enough, and they overheat.

In severe instances, people can suffer heat stroke, which can cause death or permanent disability if emergency treatment is not provided.

Older adults, young children, and people with mental illness and chronic diseases are at highest risk for heat-related illness. But even young and healthy individuals can suffer in heat if they participate in strenuous physical activities during hot weather.

You can protect yourself and loved ones against very hot temperatures by following these recommendations:

Stay cool

  • Spend more time in air conditioned places. If you don’t have air conditioning, consider visiting a mall, movie theater or other cool public places.
  • Cover windows that receive morning or afternoon sun.
  • Dress in lightweight clothing.
  • Take a cool shower or bath, or place cool washcloths on your skin.
  • Check up on your elderly neighbors and relatives to take these precautions too.

Drink liquids:

  • Drink plenty of water. Avoid drinks with caffeine, alcohol and large amounts of sugar because they can actually de-hydrate your body.
  • Have a beverage with you at all times, and sip or drink frequently. Don’t wait until you’re thirsty to drink.

If you go outside:

  • Limit the time you’re in direct sunlight.
  • Do not leave infants, children, people with mobility challenges and pets in a parked car, even with the window rolled down.
  • Avoid or reduce doing activities that are tiring, or take a lot of energy.
  • Do outdoor activities in the cooler morning and evening hours.
  • Avoid sunburn. Use a sunscreen lotion with a high SPF (sun protection factor) rating.

Water safety:

Some people turn to local rivers to cool off, but drowning is a real concern. Please use caution and wear a personal flotation device (PFD) on the water. Find deals on affordable lifejackets. And if you want to swim, choose a safer location – visit a local pool or lifeguarded beach instead.

Certain medications may increase sensitivity to the heat. If you are concerned about the heat and the medications you are taking, check with your doctor. Do not take salt tablets unless your doctor tells you to.

Hot Weather fact sheets in other languages by the Washington State Dept. of Health:

Recognizing heat exhaustion and heat stroke

When people’s bodies can’t cool themselves quickly enough it can cause heat exhaustion. Symptoms of heat exhaustion include muscle cramps, weakness, dizziness, headache, nausea and vomiting.

If you see someone with signs of overheating, move the person to a cooler location, have them rest for a few minutes and then slowly drink a cool beverage. Get medical attention for them immediately if they do not feel better.

Heat exhaustion can lead to heat stroke, which can cause death or permanent disability unless treated immediately. Symptoms of heat stroke include:

  • An extremely high body temperature (above 103°F)
  • Red, hot, and dry skin
  • Rapid, strong pulse
  • Nausea, confusion and unconsciousness

For more information, visit these websites:

Share