Drugs Log

Makers of OTC Cough and Cold Medicines Announce Voluntary Withdrawal of Oral Infant Medicines

• Potential misuse of these infant medicines, not product safety, is driving the voluntary withdrawal
• This withdrawal does not affect cough and cold medicines for children age 2 and older
• Further evaluation of these oral cough and cold medicines for infants and children will occur at the October 18 and 19 FDA advisory committee meeting

The Consumer Healthcare Products Association (CHPA) on behalf of the leading makers of over-the-counter cough and cold medicines today announced voluntary market withdrawals of oral cough and cold medicines that refer to “infants.” The voluntary withdrawal affects only these “infant” oral medicines, not those intended and labeled for use in children age two and older.

“It’s important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately,” said Linda A. Suydam, D.P.A, president of CHPA. “The reason the makers of over-the-counter, oral cough and cold medicines for infants are voluntarily withdrawing these medicines is that there have been rare patterns of misuse leading to overdose recently identified, particularly in infants, and safety is our top priority.”

The branded cough and cold medicines that are being voluntarily withdrawn are:
Dimetapp® Decongestant Plus Cough Infant Drops
Dimetapp® Decongestant Infant Drops
Little Colds® Decongestant Plus Cough
Little Colds® Multi-Symptom Cold Formula
PEDIACARE® Infant Drops Decongestant (containing pseudoephedrine)
PEDIACARE® Infant Drops Decongestant & Cough (containing pseudoephedrine)
PEDIACARE® Infant Dropper Decongestant (containing phenylephrine)
PEDIACARE® Infant Dropper Long-Acting Cough
PEDIACARE® Infant Dropper Decongestant & Cough (containing phenylephrine)
Robitussin® Infant Cough DM Drops
Triaminic® Infant & Toddler Thin Strips® Decongestant
Triaminic® Infant & Toddler Thin Strips® Decongestant Plus Cough
TYLENOL® Concentrated Infants’ Drops Plus Cold
TYLENOL® Concentrated Infants’ Drops Plus Cold & Cough

This voluntary withdrawal does not affect medicines intended for children age two and older. CHPA and its member companies have put forth recommendations to the U.S. Food and Drug Administration (FDA) to strengthen the labels on all oral OTC children’s cough and cold medicines from “ask a doctor” before using to “do not use” in children under two years.

CHPA made these recommendations to the FDA in preparation for a joint FDA advisory committee meeting on October 18 and 19. These recommendations, as well as several additional recommendations, including those proposed by FDA review staff, will be explored further at this meeting.

“These medicines are—and always have been—safe at recommended doses,” Suydam said.

“These voluntary actions are being taken out of an abundance of caution. The vast majority of parents and caregivers safely use these medicines to help relieve their children’s symptoms. But as with all medicines, it’s important that parents read over-the-counter medicine labels carefully, use these medicines only as directed, and store them safely out of the reach of children.”

CHPA will be launching a major, multi-year national campaign to educate parents and healthcare providers about the safe use of over-the-counter medicines in children, partnering with major physician, nurse, and pharmacist organizations.

What Parents and Caregivers Need to Know: OTC Cough and Cold Medicines and Children

On October 11, the Consumer Healthcare Products Association (CHPA), on behalf of the leading makers of over-the-counter (OTC) cough and cold medicines, announced the voluntary withdrawal of oral infant medications from store shelves. Here are the facts:

• The voluntary withdrawal of OTC oral infant cough and cold medicines was initiated by the makers of those medications out of an abundance of caution. This is not a mandatory recall or a safety issue.
• Kids’ OTC cough and cold medicines are both safe and effective when used correctly. Rare cases of overdose from misuse, however, have occurred—particularly in infants less than two years of age.
• Infants under the age of two are the most vulnerable to the consequences of this misuse.
• The voluntary withdrawal only affects oral infant cough and cold medications. It does not affect any other children’s medicines.
• OTC pediatric cough and cold medicines affected by this voluntary withdrawal are listed above.

Parents can continue to trust and rely on over-the-counter cough and cold medicines for their children, as they have for generations, because these medicines are safe at recommended doses.

• As with any medicine, it is important for parents to read the labels carefully, use these medicines only as directed, and make sure to safely store them out of the reach of children.
• Labels currently direct parents and caregivers to “ask a doctor” before giving these medicines to children under two. In September 2007, the makers of these medicines recommended to the U.S. Food and Drug Administration that medicine labels have stronger language instructing that parents “do not use” for children under two to prevent incidents of misuse.

Harm from OTC cough and cold medicines is rare and, when it does occur, is almost always the result of misuse (significant overdose or accidental swallowing due to medicine not being properly stored and secured).

• As with all medicines, dosing instructions for all over-the-counter remedies must be read and followed carefully. It is important to remember that any medicine can cause harm if taken or used improperly.
• Safe use and safekeeping are extremely important. Giving medicine according to label directions is part of the solution; storing it out of the sight and reach of children is part of it, as well.

Because children under age two are the most vulnerable to the harm caused by the misuse of oral, over-the-counter cough and cold medicines, the makers of these medicines have recommended strengthening their labels to state “Do Not Use” for children under two.

• This recommendation, as well as others, will be discussed before a U.S. Food and Drug Administration advisory committee on October 18 and 19. FDA asked for the meeting of outside experts to bring the best science to bear on this important issue.
• FDA requested analyses and recommendations from its staff of reviewers, but the agency has not and will not take an official position until after it has the opportunity to discuss and examine all the information.
• FDA has not called for a “ban” on or “recall” of these medicines.

The makers of over-the-counter cough and cold medicines want to ensure that parents and caregivers understand when and how to use these medicines safely.

The safe use of these medicines is our highest priority. We will soon launch a major national educational program to build awareness among parents and other caregivers about how to safely use over-the-counter medicines in children, and, as importantly, when not to use them.