Children's Cough Medicine Recall Update

FDA News Update
List of Children's Drugs Recently Recalled
FDA Public Health Advisory
Ban Sought on Cold Medicine for Very Young

The FDA and American Academy of Pediatrics has recently found that over-the-counter cold and cough medicines may cause serious health problems in young children. Though recalls have been aimed at medicines for children under two years of age, there is further evidence suggesting that such products should not be used by any children under six. If you still have any of the recalled drugs, please discontinue use and discard the items. Consult your pediatrician immediately if you believe your child may be experiencing any complications from any medications. The Corson & Johnson Law Firm will continue to monitor the situation in effort to keep your family safe and informed.

FDA News Update: January 17, 2008
(The following is an excerpt from the official U.S. Food and Drug Administration website)

The U.S. Food and Drug Administration today issued a Public Health Advisory for parents and caregivers, recommending that over-the-counter (OTC) cough and cold products should not be used to treat infants and children less than 2 years of age because serious and potentially life-threatening side effects can occur from such use. OTC cough and cold products include decongestants, expectorants, antihistamines, and antitussives (cough suppressants) for the treatment of colds.

There are a wide variety of rare, serious adverse events reported with cough and cold products. They include death, convulsions, rapid heart rates, and decreased levels of consciousness.

"The FDA strongly recommends to parents and caregivers that OTC cough and cold medicines not be used for children younger than 2," said Charles Ganley, M.D., director of the FDA's Office of Nonprescription Products. "These medicines, which treat symptoms and not the underlying condition, have not been shown to be safe or effective in children under 2."

For complete story, visit the U.S. Food and Drug Administration at: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01778.html

List of Children's Drugs Recently Recalled Due to Possible Overdose Concerns in Children Under Two Years of Age:

Children's Dimetapp Cold & Chest Congestion
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;
PEDIACARE Infant Dropper Decongestant & Cough (PE) products;
Dimetapp Decongestant Plus Cough Infant Drops;
Dimetapp Decongestant Infant Drops;
Little Colds Decongestant Plus Cough;
Little Colds Multi-Symptom Cold Formula;
Robitussin Infant Cough DM Drops;
Robitussin Cough DM;
Robitussin Cough & Cold CF Drops;
Robitussin Cough & Congestion;
Robitussin Chest Congestion;
Robitussin Head & Chest Congestion;
Robitussin Cough Sugar Free DM Drops;
Triaminic Infant & Toddler Thin Strips Decongestant;
Triaminic Infant & Toddler Thin Strips Decongestant Plus Cough.

FDA Public Health Advisory
(The following is an excerpt from the official U.S. Food and Drug Administration website)

Pending completion of FDA’s ongoing review, if parents and caregivers use OTC cough and cold medicines in children 2 years of age and older, FDA recommends:

Checking the “active ingredients” section of the DRUG FACTS label. This will help you understand what “active ingredients” are in the medicine and what symptoms each active ingredient is intended to treat. Cough and cold medicines often have more than one “active ingredient” (such as an antihistamine, a decongestant, a cough suppressant, an expectorant, or a pain reliever/fever reducer).

Being very careful if you are giving more than one OTC cough and cold medicine to a child. Many OTC cough and cold medicines have more than one “active ingredient.” If you use two medicines that have the same or similar “active ingredients” a child could get too much of an ingredient which may hurt your child. For example, do not give a child more than one medicine that has an antihistamine.

Carefully following the directions in the DRUG FACTS part of the label. These directions tell you how much medicine to give and how often you can give it.

Only using the measuring spoons or cups that come with the medicine or those made specially for measuring drugs. Do not use common household spoons to measure medicines for children since household spoons come in different sizes and are not meant for measuring medicines.

Choosing OTC cough and cold medicines with childproof safety caps, when available, and store the medicines out of the reach of children.

Understanding that using OTC cough and cold medicines are intended only to treat your child’s symptom(s). OTC cough and cold medicines do not treat the cause of the symptoms or shorten the length of time your child is sick. They only relieve symptoms and make your child feel more comfortable.

Not using these products to sedate your child or make children sleepy.

Calling a physician, pharmacist, or other healthcare professional if you have any questions about using cough or cold medicines in children 2 years of age and older.

For complete story, visit the U.S. Food and Drug Administration at: http://www.fda.gov/cder/drug/advisory/cough_cold_2008.htm

Ban Sought on Cold Medicine for Very Young

"Safety experts for the Food and Drug Administration urged the agency on Friday to consider an outright ban on over-the-counter, multisymptom cough and cold medicines for children under 6." -New York Times

For complete story, visit the New York Times at: http://www.nytimes.com/2007/09/29/health/29fda.html

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	Children's Cough Medicine Recall Update FDA News Update List of Children's Drugs Recently Recalled FDA Public Health Advisory Ban Sought on Cold Medicine for Very Young The FDA and American Academy of Pediatrics has recently found that over-the-counter cold and cough medicines may cause serious health problems in young children. Though recalls have been aimed at medicines for children under two years of age, there is further evidence suggesting that such products should not be used by any children under six. If you still have any of the recalled drugs, please discontinue use and discard the items. Consult your pediatrician immediately if you believe your child may be experiencing any complications from any medications. The Corson & Johnson Law Firm will continue to monitor the situation in effort to keep your family safe and informed. FDA News Update: January 17, 2008 (The following is an excerpt from the official U.S. Food and Drug Administration website) The U.S. Food and Drug Administration today issued a Public Health Advisory for parents and caregivers, recommending that over-the-counter (OTC) cough and cold products should not be used to treat infants and children less than 2 years of age because serious and potentially life-threatening side effects can occur from such use. OTC cough and cold products include decongestants, expectorants, antihistamines, and antitussives (cough suppressants) for the treatment of colds. There are a wide variety of rare, serious adverse events reported with cough and cold products. They include death, convulsions, rapid heart rates, and decreased levels of consciousness. "The FDA strongly recommends to parents and caregivers that OTC cough and cold medicines not be used for children younger than 2," said Charles Ganley, M.D., director of the FDA's Office of Nonprescription Products. "These medicines, which treat symptoms and not the underlying condition, have not been shown to be safe or effective in children under 2." For complete story, visit the U.S. Food and Drug Administration at: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01778.html List of Children's Drugs Recently Recalled Due to Possible Overdose Concerns in Children Under Two Years of Age: Children's Dimetapp Cold & Chest Congestion 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; PEDIACARE Infant Dropper Decongestant & Cough (PE) products; Dimetapp Decongestant Plus Cough Infant Drops; Dimetapp Decongestant Infant Drops; Little Colds Decongestant Plus Cough; Little Colds Multi-Symptom Cold Formula; Robitussin Infant Cough DM Drops; Robitussin Cough DM; Robitussin Cough & Cold CF Drops; Robitussin Cough & Congestion; Robitussin Chest Congestion; Robitussin Head & Chest Congestion; Robitussin Cough Sugar Free DM Drops; Triaminic Infant & Toddler Thin Strips Decongestant; Triaminic Infant & Toddler Thin Strips Decongestant Plus Cough. FDA Public Health Advisory (The following is an excerpt from the official U.S. Food and Drug Administration website) Pending completion of FDA’s ongoing review, if parents and caregivers use OTC cough and cold medicines in children 2 years of age and older, FDA recommends: Checking the “active ingredients” section of the DRUG FACTS label. This will help you understand what “active ingredients” are in the medicine and what symptoms each active ingredient is intended to treat. Cough and cold medicines often have more than one “active ingredient” (such as an antihistamine, a decongestant, a cough suppressant, an expectorant, or a pain reliever/fever reducer). Being very careful if you are giving more than one OTC cough and cold medicine to a child. Many OTC cough and cold medicines have more than one “active ingredient.” If you use two medicines that have the same or similar “active ingredients” a child could get too much of an ingredient which may hurt your child. For example, do not give a child more than one medicine that has an antihistamine. Carefully following the directions in the DRUG FACTS part of the label. These directions tell you how much medicine to give and how often you can give it. Only using the measuring spoons or cups that come with the medicine or those made specially for measuring drugs. Do not use common household spoons to measure medicines for children since household spoons come in different sizes and are not meant for measuring medicines. Choosing OTC cough and cold medicines with childproof safety caps, when available, and store the medicines out of the reach of children. Understanding that using OTC cough and cold medicines are intended only to treat your child’s symptom(s). OTC cough and cold medicines do not treat the cause of the symptoms or shorten the length of time your child is sick. They only relieve symptoms and make your child feel more comfortable. Not using these products to sedate your child or make children sleepy. Calling a physician, pharmacist, or other healthcare professional if you have any questions about using cough or cold medicines in children 2 years of age and older. For complete story, visit the U.S. Food and Drug Administration at: http://www.fda.gov/cder/drug/advisory/cough_cold_2008.htm Ban Sought on Cold Medicine for Very Young "Safety experts for the Food and Drug Administration urged the agency on Friday to consider an outright ban on over-the-counter, multisymptom cough and cold medicines for children under 6." -New York Times For complete story, visit the New York Times at: http://www.nytimes.com/2007/09/29/health/29fda.html The Law and You is a community service provided by The Corson & Johnson Law Firm to help people better understand the law and enable them to ask questions they might have about civil law
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