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FDA bans children's cough and cold drugs

Anna Soref

April 24, 2008

3 Min Read
FDA bans children's cough and cold drugs

A Food and Drug Administration advisory panel voted Oct. 19 to ban over-the-counter cold and cough medicines for children under age 6, noting that there is no proof that these medications work for young children and, in rare cases, they can cause serious harm. Fortunately for retailers, a number of natural remedies could help.

The ban could take several years to go into effect because it must first go through an official rulemaking process. In the meantime, the panel is requesting that the drug manufacturers conduct studies on the safety and efficacy of their pediatric cold and cough drugs.

Many manufacturers said they would fight the proposed ban, although some did voluntarily pull their infant formulas from store shelves.

At least 54 young children have died as a result of taking nonprescription cold medications, and 69 have died after taking antihistamines since the drugs were approved for OTC sales in the early 1970s, according to an FDA report. During the past two years, at least 1,500 young children were admitted to emergency rooms for complications from taking cold medications, according to the U.S. Centers for Disease Control and Prevention.

"When you're dealing with medical issues such as these, it's a question of weighing the risks and the benefits. And in this case the risk, which can be death, outweighs the benefit of maybe relieving a stuffy nose," said Dr. Iris Bell, director of research for the program in integrative medicine at the University of Arizona College of Medicine.

According to Dr. Lauren Feder, author of Natural Baby and Childcare (Hather Leigh, 2006), OTC cough and cold drugs for children, which include brands such as PediaCare and Triaminic, can be unsafe for a variety of reasons. For instance, many kids' cough and cold medicines are multipurpose formulas, but parents may not realize this and may combine the formula with a cough medicine, essentially double-dosing their children, she said.

Although death and seizures are rare, other, less severe side effects can occur. "Decongestants can make you more stimulated, which is not so good for the heart or if you are trying to rest," Feder said. "Antihistamines can make you more drowsy, which can interfere with breathing."

Holly Lucille, N.D., who practices in Los Angeles, believes that children are better off without these medications and is happy the FDA is working to ban them. "These symptoms [that the drugs are made to suppress] are actually a way that our bodies work to keep invaders out; a runny nose and fever are fighting off invaders," she said.

To help children older than 2 heal more quickly, Lucille recommended that natural products retailers suggest the following to their customers:

  • Avoid sugar, which depresses the immune system

  • Opt for warm or cold tea instead of juice (which is high in sugar) to hydrate

  • Keep the child home to rest, which allows the immune system to work

  • Take probiotics, which can boost the immune system

  • Give vitamin C and zinc lozenges, which can help reduce length and severity of symptoms

  • For congestion, put several drops of eucalyptus in a warm bath or on a hot washcloth and apply to the face

  • Provide healthy foods rich in antioxidants, such as smoothies with berries

Cold remedies for children younger than 2 are trickier and should be administered under the guidance of a physician, Feder said. She often recommends homeopathy for her younger patients, even infants and toddlers.

Natural Foods Merchandiser volume XXVIII/number 12/p.1,20

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