Move comes as U.S. regulators scrutinize safety of products linked to dozens of deaths
THURSDAY, Oct. 11 (HealthDay News) -- Leading drug makers announced a voluntary withdrawal Thursday of oral cough and cold medicines marketed for use in infants.
The move affects only "infant" oral medicines, not those intended and labeled for use in children age 2 and older. And it comes as U.S. regulators review the products' safety, following reports of dozens of deaths since 1969.
"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," Linda A. Suydam, president of the Consumer Healthcare Products Association (CHPA), said in a prepared statement.
According to the CHPA, the cough and cold medicines that are being withdrawn are:
- Dimetapp(R) Decongestant Plus Cough Infant Drops,
- Dimetapp(R) Decongestant Infant Drops,
- Little Colds(R) Decongestant Plus Cough,
- Little Colds(R) Multi-Symptom Cold Formula,
- PEDIACARE(R) Infant Drops Decongestant (containing pseudoephedrine),
- PEDIACARE(R) Infant Drops Decongestant & Cough (containing pseudoephedrine),
- PEDIACARE(R) Infant Dropper Decongestant (containing phenylephrine),
- PEDIACARE(R) Infant Dropper Long-Acting Cough,
- PEDIACARE(R) Infant Dropper Decongestant & Cough (containing phenylephrine),
- Robitussin(R) Infant Cough DM Drops,
- Triaminic(R) Infant & Toddler Thin Strips(R) Decongestant,
- Triaminic(R) Infant & Toddler Thin Strips(R) Decongestant Plus Cough,
- TYLENOL(R) Concentrated Infants' Drops Plus Cold,
- TYLENOL(R) Concentrated Infants' Drops Plus Cold & Cough.
Last month, U.S. health experts urged the federal Food and Drug Administration to consider banning the sale of over-the-counter cough and cold medicines for young children. The recommendation, from FDA safety officials, would apply to decongestant use in children under 2, and antihistamines in those younger than 6, according to FDA documents.
An FDA advisory panel is scheduled to consider the recommendation during a meeting on Oct. 18 and 19, and will then offer an opinion to the full agency. The FDA typically follows the recommendations of its advisory boards but is not required to do so.
In the safety review released Sept. 28, the FDA experts recommended that all infant cough and cold products be removed from the market. They also recommended that the sizes of the droppers, cups and syringes packaged with products be standardized to reduce the possibility of confusion and overdose, The New York Times reported.
An FDA review of records filed with the agency between 1969 and September 2006 found 54 reports of deaths in children associated with decongestant medicines made with pseudoephedrine, phenylephrine or ephedrine. It also found 69 reports of deaths associated with antihistamine medicines containing diphenhydramine, brompheniramine or chlorpheniramine, the Associated Press reported.
Most of the deaths were children younger than 2.
The Consumer Healthcare Products Association, which represents makers of over-the-counter medicines, said it and its member companies have put forth recommendations to the 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 2 years of age.
More information
To learn more about the voluntary withdrawal, visit the Consumer Healthcare Products Association.
SOURCES: Oct. 11, 2007, prepared statement, Consumer Healthcare Products
Association, Washington, D.C.; Sept. 28, 2007, U.S. Department of Health and Human Services report, The Food and Drug Administration's Oversight of Clinical Trials; The New York Times; Associated Press
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