Entries in OTC (5)


FDA Panel Recommends Dosing Changes for Children's Acetaminophen

Comstock/Thinkstock(WASHINGTON) -- When children have a fever or pain, the first over-the-counter medicine many parents reach for is acetaminophen, more commonly known as Tylenol.

A U.S. Food and Drug Administration advisory panel is recommending changes in determining how much of the medicine children should get, and adding dosage instructions for children under 2 years of age.

Currently, liquid formulas give instructions for children ages 2 to 12.  But the advisory panel unanimously agreed the dosage should be based on weight, not age.  While some product labels provide dosing information with both age and weight tables, the panelists emphasize weight is a more accurate measure and the preferred approach.

For children younger than 2, parents are advised to ask a doctor to avoid an overdose and rule out dangerous infections, which could be the cause of fevers.

Although safe when used as directed, children's acetaminophen accounted for 7,500, or nearly three percent, of emergencies reported to poison control centers last year.

Overdoses of the drug, most common among children under age 2, have increased in the last ten years.

While not obligated to do so, the FDA is expected to adopt the panel's recommendations.

Copyright 2011 ABC News Radio


OTC Drug Makers to Stop Producing Infant Doses of Acetaminophen

Comstock/Thinkstoc(WASHINGTON) -- The Consumer Healthcare Products Association (CHPA) announced Thursday on behalf of over-the-counter (OTC) drug manufacturers that parents will no longer find acetaminophen in concentrated infant drops at their local drugstores. Pediatric liquid acetaminophen for children 12 and under will only be sold in a 160 mg/5L concentration.

"CHPA member companies are voluntarily making this conversion to one concentration to make it easier for parents and caregivers to appropriately use single-ingredient liquid acetaminophen," said the CHPA President Scott Melville in a statement Thursday.

Melville added that the association is committed to educating parents and caregivers about the proper amounts and methods for giving these medications to their children.

While OTC manufacturers will continue to include cups with these medications for older children, they will also provide syringes with dose restrictors in products for infants.  Earlier this week, the FDA release guidelines recommending manufacturers to such devices.

Recent studies report that parents and caregivers often give children incorrect doses of OTC liquid medications due to poorly marked packaging and because they often use household spoons, according to MedPage Today.

The change will take place in mid-2011 after a transition period during which the concentrated products may still appear on store shelves for a time.

Copyright 2011 ABC News Radio


The FDA Weighs In on Over-the Counter Genetic Tests

Photodisc/Thinkstock(WASHINGTON) -- Scientific advances now let us buy genetic testing kits over-the-counter, but the results may be confusing without professional advice.  Now the government is taking a closer look.

The U.S. Food and Drug Administration wants to know what the risks are when consumers use genetic tests they buy over-the-counter.  They include tests that look for inherited disease, predict the risk of future disease, and predict a patient's response to specific drugs.

The test results are typically sent directly to the customer without being evaluated by a clinician.

The government is asking a panel of outside experts:

-- What are the risks and benefits of direct public access to such tests?

-- What do you do about test results that are false, incomplete, misleading or too complicated for a lay person to understand?

-- The FDA requires scientific evidence to determine whether home-use tests are safe and effective.  Since results of home genetic tests may be used in many ways, should evidence requirements vary with the claims made for the various tests?

The study will not involve tests that make no medical claims, such as genealogical or forensic tests.

Copyright 2011 ABC News Radio 


How to Choose the Right Over-the-Counter Painkiller

Jupiterimages/Thinkstock(NEW YORK) -- Consumer Reports Health has released its "Best Buy Drugs" -- a 22-page report that compares the effectiveness, safety and price of some of the top brands (and generics) for pain killing.

The report focuses on non-steroidal anti-inflammatories (NSAIDs), which commonly are used to treat pain associated with arthritis.

But NSAIDs are only one type of painkiller. Depending on the ache, another type might be better. And depending on the sufferer, some drugs can be dangerous.

ABC News asked pain experts to weigh in on what drugs to take for various aches and pains, and when to avoid the drugs.

Acetylsalicylic Acid

The drug commonly referred to as aspirin has been around since 400 B.C., when people used salicin-containing willow tree bark to treat pain and inflammation.

"Aspirin was the 'original' headache medication," said Dr. Timothy Collins, assistant professor of medicine and neurology at Duke University Medical Center's Pain and Palliative Care Clinic.

But ASA's anti-inflammatory properties make it good for other types of pain, too, including muscle pain, joint pain from arthritis and toothaches. It's also relatively cheap. The drug is an NSAID that works by suppressing the production of prostaglandins -- hormone-like molecules that play an important role in inflammation. Unfortunately, the same molecules help to protect the stomach lining.


Another NSAID, ibuprofen, has pain relieving effects similar to those of acetylsalicylic acid. But it tends to work better even at a lower dose and have milder side effects.

"It is a very good anti-inflammatory medication, originally developed to treat arthritis," said Duke's Collins. "It also lowers fever, and helps with symptoms from the common cold."

The brand name version of ibuprofen is Advil. But only the generic form of ibuprofen was named a "best buy" NSAID by Consumer Reports Health.


A relative newcomer to the pharmacy shelves, naproxen (Aleve) only was approved by the Food and Drug Administration for over-the-counter use in 1994.

Naproxen is an NSAID with a pain-killing mechanism similar to that of ibuprofen. The drugs have comparable effects and side effects, so the choice comes down to personal preference.

"The anti-inflammatory medications like ibuprofen and naproxen are very good for the common muscle aches from 'overdoing it' (like at the gym or working in the yard) and also help with common arthritis pain," said Collins.


The drug known by most people as Tylenol is another mild pain reliever. It is not an NSAID, so it won't quell inflammation. However, it won't irritate the stomach, either.

"Acetaminophen is better for people who have stomach troubles," said Dr. Mike Schmitz, director of pediatric pain medicine at Arkansas Children's Hospital in Little Rock. "It has been a good drug for children as well."

The drug is good for treating aches and pains not related to injury or inflammation. But because it's metabolized in the liver, it can have serious side effects if taken at high doses or with alcohol.

Acetaminophen use should be avoided in people who have consumed alcohol or are dehydrated, or who have kidney or liver problems.

Combination Drugs

Over-the-counter medications designed to treat multiple symptoms often contain painkillers in combination with other drugs. Cold and flu medications often contain painkillers as well as decongestants. And menstrual pain relievers often provide diuretics, too.

When in doubt, ask a doctor or pharmacist for a recommendation or an explanation of a particular drug's ingredients. And during pregnancy, it's important to talk to a doctor before taking any over-the-counter medication.

Copyright 2011 ABC News Radio 


Dangerous Dose? Kids' Meds Are Hard to Measure

Photo Courtesy - Getty Images(NEW YORK) -- Dosing directions for children's over-the-counter medications are misleading and hard for parents to understand, according to a study from the New York University School of Medicine.

Researchers sampled 200 of the top-selling cough/cold, allergy, analgesic and gastrointestinal over-the-counter (OTC) liquid medication for children and found that inconsistencies between labeled dosage and the provided measuring device could increase the likelihood of mis-dose when medicine is administered by caretakers in the home.

One-in-four OTC medications didn't even include a measuring device, despite guidelines from the Food and Drug Administration that recommend all children's medications to include them.

In response to growing concerns over accidental drug overdose in OTC children's medications, the FDA released new guidelines on how to create clear and easy-to-use dosing directions in November 2009.

The study examined over-the-counter products around the time the guidelines were released and documents the widespread inconsistencies in dosing directions and packaging that spurred the action by both the FDA and the Consumer Healthcare Products Association, which represents the makers of 95 percent of all OTC consumer medications.

"This study is intended to establish baselines.  The plan is to take another look in a year or so to see if changes have been made," says Dr. H. Shonna Yin, lead author on the study and assistant professor of pediatrics at NYU School of Medicine.

According to the CHPA, all member manufacturers are voluntarily participating in revisions to bring pediatric medications up to the new guidelines, though the results of these changes will not be reflected in the products immediately.

Copyright 2010 ABC News Radio

ABC News Radio