Navigation Links
Drugmakers to End Infant Formulas of Products With Acetaminophen
Date:5/5/2011

THURSDAY, May 5 (HealthDay News) -- The makers of cold and fever medications that contain the painkiller acetaminophen said Wednesday night that they will discontinue infant-drops versions of the products to avoid confusion that might lead to overdoses, the Associated Press reported.

Once production ends, later this year, the companies will sell just one formula for all children under the age of 12. Companies such as Johnson & Johnson currently sell infant versions of the drugs (80 milligrams) that contain half the amount of acetaminophen found in regular children's formulas, the news service said.

Acetaminophen is a widely used drug found in a variety of products that helps to ease pain and reduce fever. Although it's usually safe if used according to directions, too much can damage the liver. Acetaminophen overdose is the leading cause of liver failure in the United States, with more than 50,000 people requiring emergency-room treatment each year, the AP said.

The manufacturers' announcement preceded a U.S. Food and Drug Administration meeting scheduled for later this month, at which time agency advisers will consider whether clearer instructions and safety labeling are needed for products containing acetaminophen that are marketed for children younger than 2 years of age, the news service said.

Earlier Wednesday, the FDA issued final guidance for the production, marketing and distribution of liquid over-the-counter drug products that are measured and dispensed with provided devices such as spoons, cups and droppers.

The agency developed the guidance in response to concerns about the risk of overdoses when using liquid over-the-counter (OTC) pain relievers, cold medicines, cough syrups and digestion aids if the dispensing devices included with the products have markings that are confusing, unclear or inconsistent with the dosage directions on the label.

Among the main recommendations in the guidance:

  • Dosage dispensing devices should be included with all OTC liquid drug products that are taken by mouth.
  • The dispensing devices should be marked with calibrated units of liquid measurement (such as teaspoon, tablespoon, or milliliter) that match the units of measurement specified on the label directions. The devices should not have any unnecessary markings.
  • Companies should ensure that dispensing devices are used only with the intended products.
  • The measure markings on dispensing devices should be clearly visible when the liquid product is added to the device.

"Accidental medication overdose in young children is an increasingly common, but preventable, public health problem," Dr. Karen Weiss, program director for the Center for Drug Evaluation and Research's Safe Use Initiative, said in an FDA news release.

The FDA also outlined 10 tips that should be followed by parents and caregivers when giving medicine to an infant or child:

  • Read and follow the Drug Facts label on OTC medicines.
  • Know the active ingredient in the medicine.
  • Use the dosing tool that comes with the medicine.
  • Know the difference between a tablespoon and a teaspoon.
  • Know your child's weight.
  • Give the right medicine, in the right amount.
  • Check the medicine three times.
  • Ask your doctor, pharmacist or nurse which medicines can or can't be used at the same time.
  • Always use child-resistant caps on medicines.
  • Store all medicines in a safe place.

More information

The FDA has more about buying and using medicines safely.

-- Robert Preidt

SOURCE: U.S. Food and Drug Administration, news release, May 4, 2011; Associated Press


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Extra Sleep in Infants Seems to Signal Growth Spurts
2. Study is the first to link sleep duration to infant growth spurts
3. Errors put infants, children at risk for overdose of painkillers
4. Antibiotic may prove beneficial to preterm infant lung health
5. Sanofi Pasteur announces FDA approval of menactra meningococcal conjugate vaccine indication for infants
6. How can we measure infants pain after an operation?
7. 2 physicians from Women & Infants honored by APGO
8. Abusive Head Trauma in Infants Doubled During Recession: Study
9. Internet program reduces infant and toddler sleep problems, helps moms sleep better too
10. Decline in CP diagnoses in premature infants suggests improvements in perinatal care
11. 6-month drug regimen cuts HIV risk for breastfeeding infants, NIH study finds
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2016)... ... May 24, 2016 , ... The old expression “a ... problem. A common injury that’s often misunderstood, whiplash should be swiftly diagnosed and treated ... orthopedic spine surgeon at Atlantic Spine Center . , So named because ...
(Date:5/24/2016)... ... 24, 2016 , ... Researchers from Catholic Health Initiatives (CHI) ... bleeding complications from percutaneous coronary intervention (PCI). The data, presented at the annual ... document a 40% reduction in risk-adjusted bleeding event rates over a two-year period ...
(Date:5/24/2016)... ... May 24, 2016 , ... ... web-based software module. The cutting-edge feature provides end users with an embedded, ... self-service business intelligence solution and its analytics engine. , This powerful ...
(Date:5/23/2016)... Akron, Ohio (PRWEB) , ... May 23, 2016 ... ... not-for-profit continuing care retirement community, dedicated its new $11.5 million, 64-room assisted living ... an invitation-only ceremony and ribbon cutting. , The new building provides the ...
(Date:5/23/2016)... ... May 23, 2016 , ... According to an article ... than 1% of United Kingdom residents who could benefit from bariatric surgery are actually ... increases the number of bariatric procedures it offers to obese patients from 6,000 to ...
Breaking Medicine News(10 mins):
(Date:5/19/2016)... 19, 2016 A new report ... Market -Opportunities and Forecasts, 2015 -2022, projects that the ... 2022, registering a CAGR of 5.1% from 2015 to ... be the highest revenue-generating segment throughout the forecast period. ... one-third of the market share in 2015, and is ...
(Date:5/19/2016)... -- The equities market is never short of ... is without doubt the Healthcare space. ActiveWallSt.com has uncovered four ... Alkermes PLC (NASDAQ: ALKS ), AMAG Pharmaceuticals Inc. ... IDXX ), and Atossa Genetics Inc. (NASDAQ: ... http://www.activewallst.com/ On Wednesday, Alkermes PLC,s ...
(Date:5/19/2016)... 19, 2016 MGB Biopharma, ... of Anti-infectives, Welcomes the Final Instalment of Lord ... Today   Lord Jim O,Neill,s ... final recommendations, providing a comprehensive action plan for ... the rising threat of superbugs - something that ...
Breaking Medicine Technology: