Posts Tagged ‘FDA’

Repeat lead tests are advised for certain children, pregnant women and breastfeeding moms

Wednesday, May 17th, 2017

blood-testsToday, the FDA and CDC issued a notice that some lead tests done by Magellan Diagnostics may be incorrect.

The FDA says “certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in the United States.”

If you have a child age 6 years old or younger, are pregnant or breastfeeding, speak with your healthcare provider or local health department to determine if retesting is needed.

The dangers of lead

Lead is a metal that comes from the ground, but it can be in air, water and food. You can’t see, smell or taste it. High levels of lead in your body can cause serious health problems for you and your family.

Children younger than 6 years of age can be severely affected by lead. It can cause developmental problems, hearing loss, vomiting, irritability, belly pain and weight loss. Very high levels of lead may even cause death.

Lead poisoning (high levels of lead in your body) can cause serious problems during pregnancy, such as premature birth, miscarriage, and high blood pressure. It can also cause fertility problems, mood disorders, headaches, muscle or joint pain, trouble concentrating, belly pain, anemia and fatigue in adults.

Where is lead?

Most lead comes from paint in older homes. When old paint cracks or peels, it makes dust that has lead in it. The dust may be too small to see. You can breathe in the dust and not know it.

Lead may be found in drinking water, at construction sites, in arts and crafts materials used to make stained glass, lead crystal glassware, and some soil.

For more information on lead poisoning, see our web article and the CDC’s information.

Bottom line

If you have a child age 6 or younger, or you are pregnant or breastfeeding, contact your healthcare provider to determine if a lead test should be repeated.

Have questions? Contact our health education specialists at AskUs@marchofdimes.org.

You can find more news on our News Moms Need blog.

 

Fish safety during pregnancy: what to eat or avoid

Monday, February 13th, 2017

Mercury is a metal that can harm your baby. Fish get mercury from the water they swim in and from eating other fish that have mercury in them. By eating fish that contain mercury, the metal can pass to your baby during pregnancy. This can cause brain damage and affect your baby’s hearing and vision. However, it can be difficult to know which fish is safe to eat and which should be limited or avoided. Fortunately, the FDA (US Food and Drug Administration) and EPA (Environmental Protection Agency) have created a chart that classifies fish into three categories:

  • Best choices: eat 2-3 servings a week
  • Good choices: eat 1 serving a week
  • Choices to avoid: high mercury levels, best to avoid completely

Nearly 90 percent of fish eaten in the United States fall into the best choices category, according to the FDA and EPA. So make sure you get the recommended 2-3 servings of fish per week from the “Best choices” category, or 8 to 12 ounces total (12 ounces maximum).

 

FDA

 

FDA bans antibacterial soaps and body washes

Monday, September 12th, 2016

HandwashingFrequent and thorough hand washing is still the best way to ward off germs and to prevent the spread of infections. There is no need to buy antibacterial soaps; regular bar or liquid soap will do the job just fine. In fact, the U.S. Food and Drug Administration (FDA) has banned antibacterial soap products containing certain chemicals.

What makes soap antibacterial?

Antibacterial soaps, also called antimicrobial or antiseptic soaps, contain different ingredients than plain soap. Antibacterial soaps contain one or more of 19 specific active ingredients with the most common ingredients being triclosan (liquid soaps) and triclocarban (bar soaps). These products will have ‘antibacterial’ on the label.

Why the ban?

The FDA asked manufacturers to research and provide evidence that antibacterial soap ingredients, including triclosan and triclocarban, were safe for daily use over a long period of time. The manufacturers failed to prove their safety. Animal studies on triclosan show that this ingredient alters the way some hormones work in the body and raises concerns on its effect on humans. There is also concern that this ingredient contributes to making bacteria resistant to antibiotics. There is not enough research to know how triclocarban affects humans.

The FDA’s new rule applies to all consumer antibacterial soaps and body washes that are used with water. Manufacturers have one year to comply with the FDA’s new rule.

The ban does not include hand sanitizers, hand wipes or antibacterial soaps used in health care settings. The FDA says “Health care antiseptics are being evaluated separately from consumer antiseptics because they have different proposed use settings and target populations, and the risks for infection in the different settings varies.” More scientific research is needed to determine the safety and effectiveness of certain over the counter hand sanitizers.

Avoid mercury in skin care products

Thursday, July 28th, 2016

rubbing-nosesMost pregnant women know to avoid mercury from certain fish as it could harm a developing baby. But did you know that some skin care products contain mercury? Mercury may be found in skin creams, lotions and certain soaps. It is also found in some skin-lightening creams made outside of the U.S.

According to the FDA, “Some people – including pregnant women, nursing babies and young children – are especially vulnerable to mercury toxicity…Babies may be particularly sensitive to the harm mercury can cause to their developing brains and nervous systems. Newborns who nurse are vulnerable because mercury is passed into breast milk.”

FDA senior medical advisor Arthur Simone, M.D. says “Your family might breathe mercury vapors released from these products. Your children might touch washcloths or towels that are contaminated with mercury. It could be as simple as touching someone’s cheek or face.”

How do you know if your product contains mercury?

Check the list of ingredients, and do not use the product if any of these words are listed: “mercurous chloride,” “calomel,” “mercuric,” “mercurio,” or “mercury.”

The FDA further warns that if there is no product label or list of ingredients, do not use it. They say “Federal law requires that ingredients be listed on the label of any cosmetic or nonprescription drug, so do not use a product that doesn’t have a label.”

Why is mercury dangerous?

Mercury is a metal which can damage many parts of your body, including your lungs, kidneys and nervous system (brain, spinal cord and nerves). It also can cause hearing and vision problems. How serious the damage is depends on how much mercury you’re exposed to. Babies exposed to mercury in the womb can have brain damage and hearing and vision problems.

Where else is mercury found?

You can be exposed to mercury through your skin (lotions or creams), the air (by breathing it) and eating or drinking food or water that contains mercury. See our article for more details about where mercury may be found and ways to stay safe.

Have questions? Text or email our health education specialists at AskUs@marchofdimes.org.

FDA approves folic acid fortification of corn masa — a great day for babies!

Thursday, April 14th, 2016

Hispanic mom and babyToday the U.S. Food & Drug Administration (FDA) announced that it will allow corn masa flour to be fortified with folic acid. This announcement is a victory for America’s mothers and babies, and caps more than 20 years of work by the March of Dimes to prevent serious birth defects of the brain and spine known as neural tube defects (NTDs).

Scientists have long recognized that folic acid can prevent NTDs.  After wheat flour and related products were required to be fortified with folic acid in 1996, the incidence of neural tube defects dropped by about one-third.  The Centers for Disease Control and Prevention (CDC) estimates folic acid fortification in the U.S. has saved about 1,300 babies each year from these fatal or devastating birth defects – a total of 26,000 babies born healthy since folic acid fortification began in 1998.

But corn masa flour wasn’t part of that rule, and that may be part of the reason that neural tube defect rates have remained higher among Hispanic babies. Foods like tortillas, tamales, pupusas, chips and taco shells can now be fortified. Adding folic acid to corn masa will help to prevent neural tube defects.

The March of Dimes looks forward to the prevention of even more NTDs in the U.S. — giving more babies a chance for a full, happy life, and giving their families the joy of a healthy child.

Please join us in thanking the FDA by tweeting to @US_FDA or posting on their Facebook wall with messages like these:

Join our Advocacy Action Center for updates about how you can make a difference for healthy pregnancies and healthy babies.

You’re pregnant, can you drink eggnog?

Monday, December 14th, 2015

eggnogThe answer is yes and no. It depends. Here’s the scoop:

Store-bought eggnog

Traditionally, eggnog was made with raw eggs, which is not good for pregnant women due to the health concerns of salmonella. Salmonella causes salmonellosis, a kind of food poisoning that can be dangerous during pregnancy . However, currently, the U.S. Food and Drug Administration (FDA) restricts the use of raw eggs to less than 1% in products.

  • If you’re buying eggnog at the store, be sure to check the ingredient label to ensure it is egg-free or contains less than 1% egg product.
  • Also it is important that your eggnog be pasteurized. Pasteurization is a heat process that destroys salmonella that might be in eggs.

Homemade eggnog

Many families make a batch of home-made (and alcohol-free!) eggnog as part of their holiday traditions, but homemade eggnog causes many cases of salmonella each year due to raw or undercooked eggs. If you’re going to make your own eggnog, here are some tips:

  • Use egg substitute products or pasteurized eggs.
  • If you are using pasteurized eggs, the FDA recommends starting with a cooked egg base to ensure your safety.
    • To make a cooked egg base, combine eggs and half the milk as indicated in the recipe. (Other ingredients, such as sugar may be added at this step.) Cook the mixture gently to a temperature of 160°F, stirring constantly. The cooking will destroy Salmonella, if present. At this temperature, the mixture will firmly coat a metal spoon. After cooking, chill the mixture before adding the rest of the milk and other ingredients.

You can keep your eggnog holiday traditions, but remember to read all the labels on eggnog containers or carefully prepare your homemade eggnog.

Thalidomide and Dr. Frances Kelsey

Friday, August 21st, 2015

Dr. Frances Kelsey & President KennedyThere aren’t many people who can singlehandedly claim that they prevented thousands of children from being born with serious birth defects. Yet, Dr. Frances Oldham Kelsey is one woman who is famous for that reason.

You may have heard of thalidomide. It is a drug that is used to treat a skin disease caused by leprosy, but in the 1950’s and 60’s it was given to pregnant women to lessen morning sickness. Unfortunately, thalidomide caused serious limb (arms and legs) defects in thousands of children around the world. But, due to the vigilance of Dr. Kelsey, medical officer at the FDA (Food and Drug Administration) thalidomide was never allowed to be licensed in the U.S.

On August 7th, Frances Oldham Kelsey, MD, PhD, passed away at the age of 101. She was a wife, mother, and a highly educated woman. She earned a doctorate degree (PhD) in pharmacology and was one of seven women in her class of 100 to graduate from the University of Chicago Medical School in 1950. She joined the FDA in 1960.

In her autobiography, she writes “I had been hired as a medical officer and this meant that I would review the medical part rather than the pharmacology of new drug applications.” Despite considerable pressure to allow thalidomide to be available in the U.S., Dr. Kelsey followed her instinct (aided by her excellent education and training) to not allow the drug to be licensed. She says it was particularly important to investigate this drug because “When you give a drug to a pregnant woman you are exposing, in fact, two people to the drug, the mother and the child.” Dr. Kelsey felt that until it was established that the drug was safe for pregnant women, it should not be given to them. “Our objections… were really on theoretical grounds, largely based on the fact that there was no evidence that it was safe. Until we had such evidence we had to question the safety.”

Dr. Kelsey recalls that this near-miss disaster “caught the eye of the persons who were pressing for drug reform… In next to no time, the fighting over the new drug laws that had been going on for five or six years suddenly melted away, and the 1962 amendments were passed almost immediately, and unanimously.”

Later, an important amendment to the law provided that patients must know about and consent to taking a new, unapproved drug in a clinical trial – a very important aspect in drug testing that continues to this day.

Dr. Kelsey notes that “Nowadays we know exactly what is being tested and who is testing it and we get results back as soon as possible. Then if we get reported adverse reactions, we may stop the studies…”

Dr. Kelsey received the President’s Award for Distinguished Federal Civilian Service in August 1962, from President John F. Kennedy. She received numerous other awards, commendations and honorary degrees. According to the FDA, “in October 2000 Dr. Kelsey was inducted into the National Women’s Hall of Fame, and in 2010 Commissioner Hamburg conferred the first Dr. Frances O. Kelsey Award for Excellence and Courage in Protecting Public Health on Dr. Kelsey herself.”

We are grateful for Dr. Kelsey’s vigilance and tireless efforts in protecting babies, women and all individuals in the United States. Her honorable legacy will never be forgotten.

 

Photo: Courtesy of US National Library of Medicine. Frances O. Kelsey receives the President’s Award for Distinguished Federal Civilian Service from President John F. Kennedy, 1962.

Questions?  Text or email them to AskUs@marchofdimes.org.

 

Ice cream and listeria

Thursday, April 30th, 2015

Jeni’s Splendid Ice Cream® is recalling all of its ice creams, frozen yogurts, sorbets and ice cream sandwiches because the products may have listeria. Listeria is a kind of bacteria that can cause the food poisoning, listeriosis. This recall follows the Blue Bell ice cream recall from a couple weeks ago, also due to listeria.

You can get listeriosis and other kinds of food poisoning from harmful germs in something you eat or drink. Listeriosis can cause nausea, vomiting, diarrhea, fever and headache. Most healthy people don’t get sick from listeriosis. It mostly affects people with a weak immune system, including pregnant women, newborns, elderly people and people with health conditions, like diabetes or HIV. If you get listeriosis during pregnancy, it can cause serious and even life-threatening health problems for your growing baby.

If you have the recalled ice cream, throw it out. You also can return or exchange the recalled ice cream at the same store where you bought it. Contact Jeni’s Splendid Ice Cream at (614) 360-3905 or at jenis.com/recall if you have any questions.

For more information about this ice cream recall, visit the Food and Drug Administration’s (FDA) website. Learn more about listeriosis and pregnancy.

Prescription drugs: new FDA labeling rules will help pregnant women

Friday, December 5th, 2014

prescription medsCurrent FDA guidelines about medication safety during pregnancy can be very confusing for women and their health care providers. Soon, however, doctors will have access to more information about the safety of prescription drugs during pregnancy.

When you are pregnant, you try to avoid anything that may harm your baby. But sometimes, you need to take medications for your own health. Managing chronic conditions like diabetes, asthma, and high blood pressure is very important, especially during pregnancy. But it is often difficult to know what medications are safe. And current FDA safety categories can be very confusing and difficult to understand.

However, in the summer of 2015, drug manufacturers will need to start providing additional details about medication safety in pregnant and breastfeeding women. The new labels will have to state how the safety information was obtained and whether the data was the result of scientific studies in people, or if it was obtained through study of animal models. The manufacturers must also include how much of the drug is excreted in breast milk and whether it affects the nursing baby, as well as how the drug may affect future fertility for both men and women of reproductive age.

These changes in labeling will provide doctors with more information about a medication’s safety during pregnancy. The information will not be on the actual medication bottle. It will be included in the official drug labeling information that doctors use when prescribing medications. It may also be included in the printed materials that pharmacies often include when filling prescriptions. This change in labeling does not apply to over-the-counter medications, though.

The new guidelines will allow doctors and patients to weigh the pros and cons of which medication is best to take during pregnancy for a given condition based on scientific evidence. And it will provide doctors and patients with more safety data than has previously been readily available.

The March of Dimes hails the release of the FDA’s final rule on pregnancy and lactation drug labeling information for prescription drugs. According to Dr. Jennifer Howse, president of the March of Dimes the new rules “will drive critical improvement to prescription drug labels regarding known effects on pregnancy, breastfeeding, and fertility.  The rule takes vital steps to improve the organization, readability, and usefulness of this information, which will enable women and their providers to find it and use it more readily….It is important to note, however, that this rule is only a first step, and it does not address other crucial issues related to pregnancy, lactation, and prescription drugs. The March of Dimes looks forward to working with the FDA and other interested stakeholders to ensure that appropriate research is performed and data generated to allow women and their health providers to make fully informed decisions about medication and its expected impact on pregnancy, lactation and childbearing.”

New nutrition labels may be coming

Thursday, February 27th, 2014

When I’m grocery shopping, I often find myself looking at the nutrition labels on food packages and trying to make sense of all the information I’m reading. Once I’m home, I end up trying to figure out if the serving size on the label is the actual size of the serving I have on my plate. Thankfully, it looks like things might get a little easier when it comes to eating healthy.

The Food and Drug Administration (FDA) is proposing changes to nutrition labels to make it easier for you to know exactly what and how much it is you’re eating. Some of these changes include more emphasis on total calories, added sugars and nutrients such as Vitamin D and potassium. The FDA may also be changing serving sizes to some foods so the nutrition label more accurately shows what most people usually eat. Who drinks half of that 16oz bottled iced tea?

Below is an image of a nutrition label as they are now (on the left), and an image of the new label. What do you think? The FDA says the new label is open to the public for comment for the next 90 days. Share your thoughts!Nutrition labels