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NEW YORK (AP / WCBS 880) -- Drug makers on Thursday voluntarily pulled kids' cold medicines off the market less than two weeks after the government warned of potential health risks to infants.
Products aimed at children under the age of two are being removed from store shelves due to ``rare instantances of misuse'' that could lead to accidental overdose, a trade group that represents over-the-counter drug makers said.
The following medicines are being withdrawn:
McNeil Consumer Healthcare is withdrawing
Concentrated Infants' Tylenol Drops Plus Cold;
Concentrated Infants' Tylenol Drops Plus Cold & Cough;
Pediacare Infant Drops Decongestant (PSE);
Pediacare Infant Drops Decongestant & Cough (PSE);
Pediacare Infant Dropper Decongestant (PE)
Pediacare Infant Dropper Long-Acting Cough;
and Pediacare Infant Dropper Decongestant & Cough (PE)
Cold medicines being withdrawn include:
Johnson & Johnson Pediacare Infant Drops and Tylenol Concentrated Infants Drops,
Wyeth's Dimetapp Decongestant Infant Drops,
Novartis' Triaminic Infant & Toddler Thin Strips and Prestige Brands Holdings' Little Colds Decongestant Plus Cough.
CVS Caremark Corp. said Thursday morning it would remove the affected products as well as CVS-brand equivalents from store shelves.
Late last month the Food and Drug Administration tentatively recommended adding the words ``do not use in children under two years'' to product labeling. Current labeling directs parents to consult a doctor before administering the drugs to infants and toddlers. Government scientists also said there is little evidence that cold medicines actually work in younger children.
FDA will formally consider revising labeling at a meeting scheduled for Oct. 18-19.
After reviewing reports of side effects over the last four decades, FDA found 54 child fatalities [CDC] from over-the-counter decongestant medicines. The agency found 69 reports of children's deaths connected with antihistamines, which are used to treat runny noses.
The Consumer Healthcare Products Association, which represents drug makers, said it will conduct a multiyear campaign to educate parents and physicians on safe use of cold medicines.
The trade group stressed in a statement that the ``medicines are, and have always been, safe at recommended doses.''
However, industry critics challenged this statement.
``When it comes to children under age two there are no recommended doses on these products so it's not reasonable to claim they are safe and effective when used as directed,'' said Dr. Joshua Sharfstein, Baltimore's health commissioner.
FDA is reviewing the safety of cold medicines at the request Sharfstein and other Baltimore city officials, who reported 900 Maryland children under four overdosed on the products in 2004.
Shares of Johnson and Johnson rose 22 cents to $66.05 while shares of Wyeth fell 12 cents to $46.03. Shares of Novartis AG dipped one cent to $54.22 and Prestige Brands Holdings Inc. fell 6 cents to $11.10.
Below is the full press release from the McNeil.
McNeil Consumer Healthcare, a division of McNeil-PPC, Inc., announced today that the company is voluntarily withdrawing certain infants' cough and cold products from the market. When used as directed, these medicines are generally recognized as safe and effective. While most parents use these medicines appropriately and follow dosing directions, an assessment of available data on the use of pediatric cough and cold medicines has identified rare instances of misuse leading to overdose, particularly in infants under two years of age.
McNeil Consumer Healthcare is withdrawing CONCENTRATED INFANTS' TYLENOL® DROPS PLUS COLD; CONCENTRATED INFANTS' TYLENOL® DROPS PLUS COLD & COUGH; PEDIACARE® INFANT DROPS DECONGESTANT (PSE); PEDIACARE® INFANT DROPS DECONGESTANT & COUGH (PSE); PEDIACARE® INFANT DROPPER DECONGESTANT (PE); PEDIACARE® INFANT DROPPER LONG-ACTING COUGH; and PEDIACARE® INFANT DROPPER DECONGESTANT & COUGH (PE) products from the U.S. market.
Cough and cold products for children age two and over and single-ingredient pain reliever/fever reducers expressly labeled for infantsare not included in this voluntary withdrawal and remain available for parents and caregivers.
"This voluntary action by McNeil Consumer Healthcare is based on the company's long-standing commitment to the appropriate use of medications by parents and physicians," said Ashley McEvoy, President, McNeil Consumer Healthcare. "McNeil Consumer Healthcare is committed to providing parents with safe and effective over-the-counter medications that treat their child's cough and cold symptoms. In addition to taking this voluntary action, McNeil Consumer Healthcare, along with our industry partners, supports the Consumer Healthcare Products Association recommendations that were recently submitted to the U.S. Food and Drug Administration (FDA). These recommendations include label changes to OTC cough and cold medicines advising 'do not use' in children under two years of age. Our voluntary action in removing CONCENTRATED INFANTS' TYLENOL® DROPS PLUS COLD; CONCENTRATED INFANTS' TYLENOL® DROPS PLUS COLD & COUGH; and PEDIACARE® INFANT DROPS products from the market is consistent with these recommendations."
The recommendations that were submitted by the Consumer Healthcare Products Association are intended to help reduce misuse leading to overdose by further promoting the appropriate use of OTC cough and cold medicines in children for relief of their symptoms and by further encouraging communication between parents and their doctors. In addition to the label change recommendations for OTC cough and cold medicines, the submission also reinforces the industry’s continued commitment to working with the FDA and pediatric experts to ensure that parents and doctors have appropriate treatment choices for their children through ongoing educational and scientific efforts.
Consumers or retailers who have questions or concerns about the products described in this communication should contact McNeil’s Consumer Relationship Center at 1-877-895-3665 (English) or 1-888-466-8746 (Spanish) or visit www.tylenol.com.
McNeil Consumer Healthcare Division of McNeil-PPC, Inc., markets a broad range of well-known and trusted over-the-counter (OTC) products around the globe. McNeil Consumer Healthcare is most widely recognized for the complete line of TYLENOL® acetaminophen products, the leading pain reliever brand in the adult and pediatric categories. The TYLENOL® product line consists of hundreds of products across a variety of pain categories including: arthritis pain, pain with accompanying sleeplessness and upper respiratory. Other McNeil Consumer Healthcare brands include BENADRYL® allergy medicines; IMODIUM® A-D anti-diarrheal; MOTRIN® IB; PediaCare® upper respiratory medicines for children; ROLAIDS® antacid products; ST. JOSEPH® Adult Regimen Aspirin; and SUDAFED® and SUDAFED PE® nasal decongestants. |
