Posts Tagged ‘ baby medicine ’

FDA Warning: Beware of Teething Medication with Benzocaine

Tuesday, May 10th, 2011

Teething babyThe ingredient (benzocaine), used in medications that soothe a baby’s teething pain, can cause a rare but serious condition known as methemoglobinemia.  Methemoglobinemia reduces oxygen in the bloodstream,  which can lead to death. 

According to the FDA, which issued a warning in early April, the symptoms of methemoglobinemia include pale, gray, or blue-colored skin, lips, and nail beds; shortness of breath; confusion; headache; lightheadedness; and rapid heart rate.  The condition is caused by gels and liquids containing benzocaine, with concentrations as low as 7.5% and symptoms can appear within minutes or hours of application.

So far, children 2 years and younger have been affected by benzocaine.  The FDA warns against giving children under 2 any medication containing benzocaine, unless directed by a pediatrician.  Naural ways to soothe baby’s pain include giving your child a chilled teething ring or rubbing/massaging  the gums with your fingers, suggests the American Academy of Pediatrics.  Otherwise, seek advice from a healthcare professional.

Name-brand medications that include benzocaine are Baby Orajel, Orajel, Anbesol, Hurricaine, and Orabase.  However, there are still benzocaine-free OTC teething medicines available.  Church & Dwight, the makers of Orajel, have released Baby Orajel Naturals, which contains clove oil instead of benzocaine, alcohol, and dye to relieve teething symptoms.  They are also working with the FDA to determine the best actions for using benzocaine in children under 2 years old.  Boiron has also released a homeopathic teething medicine called Camilia that comes in pre-measured, individual doses and is free of benzocaine, preservatives, flavors, dyes, and sugar/artificial sweeteners.

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Over-the-Counter Infant Medicine with Acetaminophen Will No Longer Be Produced

Thursday, May 5th, 2011

Consumer Healthcare Products AssociationStarting as early as June, over-the-counter drug manufacturers will no longer produce acetaminophen in concentrated liquid drops for infants.  Acetaminophen, a common ingredient in various OTC medications for children, is included to reduce symptoms of pain and fever.

The Consumer Healthcare Products Association (CHPA), a non-for-profit group that represents OTC drug manufacturers, decided on this step to reduce dosing errors and prevent accidental poisonings in infants.  Currently, liquid acetaminophen is sold in two concentrations: 80 mg/0.8 mL or 80 mg/1.0 mL, with droppers for infants; 160 mg/5 mL, with cups for children ages 2-11.  The two different concentrations have often caused confusion, leading parents to give kids incorrect doses due to badly-marked droppers or cups. 

Johnson & Johnson and other drug manufacturers will cease production of the 80 mg/0.8 mL and the 80 mg/1.0 mL concentrations through 2012.  Instead, 160 mg/5 mL will become the standard concentration for all ages, along with cups for older kids and new syringes with flow restrictors for infants, which will provide accurate dosing and reduce spills.  Most medications with acetaminophen do not have proper dosing instructions for kids under 2 years; instead, the labels instruct parents to contact pediatricians.  Tylenol, produced by Johnson & Johnson, will be working on a case to urge the Food and Drug Administration (FDA) to include correct acetaminophen dosing information for children 6 months and up on labels.

For now, both concentrations will still be on shelves until CHPA can work with retailers to remove the infant concentrations.  Parents can keep acetominophen medications they already have or purchase them in stores, but read labels and dosing directions carefully.  Always consult a trusted pediatrician to clarify the concentration of your child’s dose, especially if you have any questions or concerns.

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