Tag: FDA (Page 6 of 6)

FDA Expected to Revise Tylenol Labels to Eliminate Dosage Mistakes for Children

Tylenol labels will now instruct that dosage be given by weight rather than by age.

New dosing tools will also be included in products going forward.

Acetaminophen, the effective ingredient used to lower fever in children is among the most frequent cause of unintentional poisonings seen in emergency departments.

Complications include acute liver failure.

According to The Mayo Clinic, an acetaminophen overdose is serious and it can occur all too easily. For example, a parent might unwittingly give a child too much acetaminophen if they don’t take the time to carefully measure the medication or if you don’t realize that another caregiver has already given your child a dose of medication.

Government Crack-Down on Hand Sanitizer Claims

Labeling and marketing materials for hand sanitizers claim that they can prevent infection from disease-causing germs and viruses, and some claim to protect against E. coli and the H1N1 swine flu virus.

There is no proof to support these claims and the companies are marketing them in violation of federal law.

Federal regulators are warning companies that make over-the-counter hand sanitizers to stop exaggerating the bacteria-killing benefits of their products

Hand sanitizer and other over-the-counter products can’t prevent dangerous staph infections no matter what they claim, federal officials warned Wednesday.

The Food and Drug Administration ordered four companies that make such promises to change their marketing practices, arguing there is no proof the store-bought products prevent H1N1, MRSA or E. coli – as they suggest.

The products include Staphaseptic First Aid Antiseptic/Pain Relieving Gel, Safe4Hours Hand Sanitizing Lotion, Dr. Tichenor’s Antiseptic Gel and CleanWell All-Natural Hand Sanitizing Wipes.

The manufacturers were given 15 days to change labeling and marketing material or face seizure of products.

Government to Regulate Electronic Cigarettes as Tobacco

The FDA wants to regulate electronic cigarettes as drug devices, just as nicotine gum and smoking cessation products are regulated. Electronic cigarettes are battery-powered tubes that turn nicotine-laced liquid into a vapor.

The U.S. Food and Drug Administration’s announcement came after the U.S. Court of Appeals for the D.C. Circuit issued a decision that electronic cigarettes are not drugs or devices unless they are marketed for therapeutic purposes.

In 2009, the FDA was given the authority to regulate tobacco products that are not drugs or devices.

Electronic cigarettes, marketed under names such as NJOY, mimic the act of smoking and include nicotine, but do not emit the same type of odor or ash.

It Might Surprise You to Know What a “Portion” is!

You have a bowl and you fill it to the brim and you think that you’re having a “serving”.

It may surprise you to know that most recommended “serving” sizes are much smaller than you think.

Not to mention the fact that everything from plates to cups are super-sized these days, we are misled into believing that we are eating a portion when in fact we are eating 2,3,or 6 times what we need!

Cereal 1 cup = a baseball
Salad Dressing 2 Tbsp. = a shot glass
Cheese 1 oz. = a golf ball
Nuts 1 oz. = 1 cupped palm
Hamburger 3 oz = mayo jar lid
Beef 3 oz. = deck of cards
Rice 1/2 c = ice cream scoop
Sweet Potato = computer mouse
Butter 1 tsp = a waterbottle cap
Pasta 1/2 cup = a tennis ball

Good News on Preventing Early Deliveries

For patients and for doctors everything came together to benefit pregnant woman fearing preterm pregnancy

The FDA approved the preterm prevention drug which subsequently was priced out of reach for most patients.

As soon as FDA allowed ccompounding pharmacies to produce their own version of the drug the price dropped enabling more women access.

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