Helpful Videos From the FDA

These are good quick (about 2.5 minutes, or less) consumer update videos from the FDA. For more information, go to www.fda.gov/consumer.

FDA 101: Product Recalls (video) - This explains why products get recalled by the FDA.

Avoiding Drug Interactions (video) - Foods are ok to mix, but medications and herbs may not be.

Avoiding Medication Mistakes (video) - Wonderful tips on how to avoid medication mistakes.

Food Allergies: Reducing the Risks (video) - Great information about food allergies.

Don't forget:

1) Keep a list of all the medications, herbal supplements, allergies, vaccinations received, and contact information about your doctors and keep the list handy.

2) Learn as much about your medications by asking the pharmacist or doctor.

3) Take medications the way they are prescribed or are recommended on the label for over-the-counter products. Use the correct measuring devices for liquid medicines.

Recall of Certain Lots of Infants' and Children's TYLENOL Products

Did you buy TYLENOL brand infant's or children's products between April 2008 and June 2008? Certain lots are being recalled by the company, McNeil, because when they examined the bulk raw material, they found that one of the inactive ingredients did not meet internal testing requirements. A type of gram-negative bacteria, B. cepacia, was found and isolated in this portion of raw material. NOTE: no bacteria were detected in any of the finished products, but, as a precaution, the company has volunteered to recall all product made when that particular batch of raw material was present in the factory. Again, no need to panic because the bottle you have at home does not contain bacteria and it was not made from that specific batch of raw material. No side effects have been reported to the company or FDA from these products. Also, one cannot get an infection from this bacteria by taking the medicine. If your child has an underlying lung disease, cystic fibrosis, or a weaker immune system, the bacteria could cause adverse effects. To check to see if the bottle you have at home is being recalled, look for the lot number at the bottom of the box that came with the bottle, or on the sticker that surrounds the bottle. Below is the complete list of recalled lots. If you determine that you have the affected product, please call McNeil's Customer Care Center at 1-800-962-5357 to be sent a coupon for a new bottle. Please contact your child's doctor if you have specific concerns or if you have recently given your child Tylenol purchased during April and June 2008.

Recalled Products - Full List

Lot #	Product Description
SBM041, SBM067, SCM037, SDM027, SEM109	Children's Tylenol Plus Cold MS Suspension 4 oz. Grape
SBM042, SCM015, SCM036, SDM034	Children's Tylenol Suspension 4oz. Grape
SBM043, SBM044, SCM029	Children's Tylenol Suspension 4oz. Bubble Gum
SBM045, SCM011, SCM030, SDM035	Children's Tylenol Suspension 4oz. Strawberry
SBM064, SCM033, SDM020	Infant’s Tylenol Grape Suspension Drops 1/4oz.
SBM065, SCM005, SCM006, SDM032	Infant's Tylenol Suspension 1/2oz. Cherry
SBM066, SCM068	Children's Dye Free Suspension 4oz. Cherry
SBM068, SCM035, SCM070, SCM080, SDM005	Children's Tylenol Suspension 4oz. Cherry
SBM069, SBM070, SCM081, SDM006	Children's Tylenol Plus Cough & Runny Nose 4oz. Cherry
SCM012, SCM067, SDM007, SDM068	Infant's Tylenol Suspension Drops 1/2oz. Grape
SCM013, SCM014, SCM069	Children's Tylenol Plus Flu 4oz. Bubble Gum
SCM016, SFM024	Children's Tylenol Plus Cold Suspension 4oz. Grape
SCM017	Children's Tylenol Plus Cough/ST Suspension 4oz. Cherry
SCM082, SDM039, SDM040	Infant's Tylenol Suspension Drops 1oz. Grape
SCM083, SCM084, SDM008	Infant's Tylenol Dye Free Suspension 1oz. Cherry
SDM064	Children’s Tylenol Pediatric Suspension 1oz. Cherry
SDM038, SDM009	Infant's Tylenol Suspension Drops 1oz. Cherry
SDM033	Children's Tylenol Plus Cold/Allergy 4oz. Bubble Gum
SDM078	Infant's Tylenol Drops 1oz. Grape
SCM034	Infant’s Tylenol Grape Suspension Drops H/G 1/2oz.
SDM028	Children's Tylenol Suspension 4oz. Cherry, Hospital Govt.

The Hunt for Gentian Violet

What's that white stuff on his tongue? Looks like cottage cheese. I can't brush it off. Wait, he's bleeding somewhere. Did he bite his tongue? His lip? Ah, the telltale signs of oral thrush (yeast infection in the mouth). He has no other symptoms and his eating habits have not changed. Breastfed babies commonly acquire oral thrush. Other risk factors include breastfeeding, use of antibiotics or inhaled corticosteroids, a weakened immune system, and diabetes. No, he is not taking inhaled corticosteroids, but I was on a course of antibiotics a month ago for 10 days. I'm not rushing to the pediatrician just yet because his daily activities do not indicate that he is in pain or that the thrush is bothering him. I am, however, increasing his yogurt intake to restore the balance of normal gut bacterial flora to minimize the overgrowth of the fungus. A trip to the pediatrician will buy him a prescription for nystatin suspension, which will have to be swished and swallowed for a couple of weeks. Gentian violet 1% is an over-the-counter remedy that I am considering a brief trial of 3 days before taking him in.

Growing up, my mother used gentian violet on my cuts, scrapes, and mouth sores. I remember taking a class picture with a purple scab on my upper lip. As a pharmacy intern, I ordered and stocked the shelf with this product. This past weekend, I could not find it in any pharmacy, chain or independent. Some pharmacists thought it was an herbal supplement and sent me to GNC. Another pharmacist tried to order it for me for $17 when it used to be $1.69 (or something like that 10+ years ago). Walgreen's ordered it for $2.09. Interestingly, gentian violet is not made of gentian or violet, but is named after the deep purple color. It is used in laboratories as a stain to identify bacteria via the Gram stain test. If you read the label, it is an antiseptic for minor cuts and burns. When used sparingly, it can treat oral thrush [1]. It is generally safe, as long as it is not doused on the lesions repeatedly (just 2-3 times a day) and it is not drunk like medicine. The most common side effect is staining of the skin and clothes. Other concerns that have not been soundly supported are the risk of ulceration and oral cancer (probably due to the 10% alcohol the product contains). In the breastfeeding community, gentian violet has been used frequently with good results. Here is a guide on how to administer the gentian violet, that is, after you locate it in your local pharmacy. Actually, just call and ask them to order gentian violet 1% in a 1 ounce bottle. Make sure it's kept out of reach when you get it.

[1] Weisse ME and Aronoff SC. Chapter 231. Kliegman: Nelson's Textbook of Pediatrics. 2007. Accessed via MDConsult.

Don't let the flu get to you or your children

Everyone is at risk for getting seasonal (aka regular) influenza (flu), but some people (including parents and children, working adults, those aged 50 and up, and those with chronic illnesses) have a greater risk and should try to get the seasonal “flu shot” every year. Vaccination typically starts in the fall and continues until spring; I already got mine when I was at my doctor’s last week. If a doctor’s appointment is not in your foreseeable future, then below is a list of placesthat will be offering the seasonal vaccine for a small fee. Your children should still visit their pediatrician(s) as many of these “flu clinics” do not offer the vaccine to children, or only to children 9 years and older. My children's pediatrician has not opened the schedule for vaccination, yet.

The American Lung Association can help you locate the nearest flu clinicanywhere in the U.S.. You may even have seen signs at the community pharmacies. To learn more about the seasonal flu, visit the CDC’s web site. Here are also their tips on how to fight the flu, or just to stay generally healthy. Consider the flu shot for you and members of your family. Although it will not prevent your child from being sick from all of possible flu viruses, it will minimize the chances of getting the most common ones, reduce the severity of the infection if your child should acquire it, and prevent spread to others.

The FDA approved four new vaccines against the H1N1 virus yesterday. They will be available for adults next month. Studies are still under way to find the optimal dose for children. The vaccines have been tolerated well by the patients.

A Salty Lesson

We have been to the beach multiple times this summer. The kids love to make their own mud, so I thought it might be useful to prefill a water bottle with sea water so that they could play while I set up the blankets. Unfortunately, the bottle fell out of the beach bag and into the trunk. Of course, I had forgotten about it. I was so thirsty yesterday that I just took a guzzle and sprayed it right out, not realizing it was: (1) an opened bottle and (2) sea water not spring water. It was a great teaching moment for my preschooler, though!

The lessons to be learned here: (1) not all clear fluids are water, (2) parents should not refill bottles with any substance without labeling them (if the substance is toxic, please keep out of reach of children), and (3) remind your children to check with an adult before putting anything in their mouth. I was quick to drink sea water from an unsuspecting water bottle, but imagine your little one taking a mouthful of chlorine or some other cleaning liquid, especially if it's colorful and has a sweet smell! Just as a reminder, the Poison Control Center's number is 1-800-222-1222.

Get ready for flu season 2009-2010

This week, the CDC released a new guidance to help minimize the spread of any flu virus in child care and early childhood programs during the 2009 and 2010 season. This toolkit contains resources for providers and parents, including action steps for parents to protect your child from the flu, action steps for parents of children at higher risk for flu complications; action steps for parents if children are sick, or if the child care/early childhood programs are closed, and must stay home; and action steps for providers regarding daily health checks for children, staff recommendations, and decision-making about closures. These can be found at the CDC website.

General tips from the CDC to protect you and your child include:

1. Get you and your child vaccinated for seasonal flu AND H1N1 flu (when available); caregivers for children under 6 months should consider vaccination
2. Stay home if you or your child is sick for at least 24 hours until after a fever breaks (temperature is < 100 degrees Fahrenheit or < 37.8 degrees Celsius) or there are no more feeling of chills, feeling warm, flushed appearance, or sweating
3. Practice good hand hygiene with proper handwashing using soap and water or an alcohol-based hand sanitizer
4. Cover the mouth and nose with a tissue when sneezing or cough/sneeze into elbow or shoulder, not hands
5. If someone at home is sick with the flu, children in the household should stay home for at least 5 days from the time the first person got sick
6. Keep your child home for at least 7 days if your child is sick, even if they are ready to run and play before that. If your child is still sick after 7 days, keep him/her home until 24 hours after the symptoms have completely gone away.
7. Seek urgent medical attention if one or more of the following signs are noticed:

fast breathing, trouble breathing, shortness of breath, or stopping breathing;

bluish, purplish, or gray skin color especially around the lips and the inside of the mouth, or around the nails;

not drinking enough fluids, refusing to drink;

not urinating, decreased number of wet diapers, or no tears when crying;

severe or persistent vomiting;

not waking up or not interacting (e.g., unusually quiet and inactive, no interest in playing, no interest in favorite toy);

being so irritable that the child does not want to be held, or cannot be consoled;

pain or pressure in the chest or stomach;

sudden dizziness;

confusion; and

flu-like symptoms improve but then return with fever and worse cough.

Quick Guide to Childhood Vaccines From the FDA

There is some good information in this Parent's Guide to Kids' Vaccines, including benefits and risks, types of vaccines, steps to take when your child is vaccinated, and some commonly used vaccines. Adverse reactions, or other problems, suspected to be caused by vaccines should be discussed with your child's health care provider and reported to the Vaccine Adverse Reaction Reporting System (VAERS). Yes, you can file a report anonymously as a consumer. Also, it is ok to ask your health care provider questions about the vaccines if you have concerns. Vaccine information sheets (VIS) are required by federal law to be given to the caregiver prior to vaccination of each vaccine. They are available in languages other than English. Be sure to ask your child's health care provider for a copy of the VIS in your native language, if you prefer.