Drugmakers eliminate infant drops of key medicine

May 5, 2011 By MATTHEW PERRONE , AP Health Writer

(AP) -- Johnson & Johnson and other makers of cold and fever medications said Wednesday that they will discontinue infant drops of medicines containing acetaminophen in an effort to avoid confusion that can lead to dangerous overdoses.

The industry association for over-the-counter medicine companies said its members will begin phasing out the liquid drops later this year.

After the transition is complete, companies will only sell a single formula for all children under the age of 12. Currently, J&J and other companies market infant formulations that contain half the amount of as that found in regular children's formula.

Acetaminophen is a ubiquitous pain reliever and fever reducer found in Tylenol, Nyquil and thousands of other medicines used to treat flu, headache and sore throat. While generally safe when used as directed, acetaminophen is the leading cause of liver failure in the U.S. and overdoses send more than 50,000 people to emergency rooms each year.

The announcement late Wednesday appeared timed to head off debate about the products at a Food and Drug Administration meeting scheduled for later this month. The FDA has called the meeting to discuss whether additional instructions and safety labeling are needed when acetaminophen products are used in children younger than 2.

The infant products now on the market usually come with a dropper and are designed to deliver 80 milligrams of acetaminophen per 0.8 milliliter of liquid.

Beginning mid-year, drugmakers will stop producing those formulas and only the standard children's formula, which contains 160 milligrams per 5 milliliter. Parents can accidentally give too much of the ingredient if they do not read the instructions carefully or use the dropper with a different formulation of the drug.

"We are committed to providing parents and caregivers with the tools and information they need to help give their children the right amount of these medicines," said Scott Melville, president of the Consumer Healthcare Products Association. Member companies include J&J, Novartis, Procter & Gamble and makers of generic cold medicines.

The elimination of acetaminophen-based infant formula marks the second time the drug industry has pulled its products off the market ahead of federal action. In 2007, the same industry group announced it would discontinue all infant decongestant medicines, ahead of an FDA meeting to look into deaths with the products.

shares

Related Stories

Recommended for you

In most surgery patients, length of opioid prescription, number of refills spell highest risk for misuse

January 17, 2018
The possible link between physicians' opioid prescription patterns and subsequent abuse has occupied the attention of a nation in the throes of an opioid crisis looking for ways to stem what experts have dubbed an epidemic. ...

Patients receive most opioids at the doctor's office, not the ER

January 16, 2018
Around the country, state legislatures and hospitals have tightened emergency room prescribing guidelines for opioids to curb the addiction epidemic, but a new USC study shows that approach diverts attention from the main ...

FDA bans use of opioid-containing cough meds by kids

January 12, 2018
(HealthDay)—Trying to put a dent in the ongoing opioid addiction crisis, the U.S. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

Taking ibuprofen for long periods found to alter human testicular physiology

January 9, 2018
A team of researchers from Denmark and France has found that taking regular doses of the pain reliever ibuprofen over a long period of time can lead to a disorder in men called compensated hypogonadism. In their paper published ...

Nearly one-third of Canadians have used opioids: study

January 9, 2018
Nearly one in three Canadians (29 percent) have used "some form of opioids" in the past five years, according to data released Tuesday as widespread fentanyl overdoses continue to kill.

Growing opioid epidemic forcing more children into foster care

January 8, 2018
The opioid epidemic has become so severe it's considered a national public health emergency. Addiction to prescription painkillers, such as oxycodone and morphine, has contributed to a dramatic rise in overdose deaths and ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.