FDA-Approved Medicines Prove to be Risky for Children

Did you know that children’s cough and cold medicines were never tested by the FDA for safety and efficacy, and that the American Academy of Pediatrics considers them ineffective and dangerous?

Did you know that a study by the government’s Centers for Disease Control (CDC) and published in the journal Pediatrics found that doctors commonly hand out free drug samples for parents to give children, even though the drugs are often are not approved by the FDA for use in children?

Try to Avoid Cough and Cold Medicines for Children
Earlier this year the FDA issued a public health advisory that over-the-counter (OTC) cough and cold medicines should not be given to children under two years of age because of the possibility of  “serious and potentially life-threatening side effects.” In its warning letter the FDA included cough suppressants, decongestants, pain relievers and antihistamines. More recently, various health officials, including representatives from the American Academy of Pediatrics, urged the FDA to make the warning even stronger and  recommend that these drugs not be given to children under the age of six.

Children are Not Small Adults
It’s been common knowledge for decades that when it comes to medication you cannot just assume that children are small adults and simply give them a smaller dose. They often respond to a drug in unexpected and unpredictable ways. One of the conundrums of giving any medication to children is that it’s essentially unethical to use children for drug testing. So, the FDA bypassed that thorny moral issue by approving the drugs without testing, and have, in effect, treated American children, and by extension their unwitting parents, as guinea pigs. The result of this massive experiment is that we now know that OTC cough and cold medicines aren’t safe or effective for children.

Be Wary of Drug Samples for Children: No Such Thing as a Free Lunch
The majority of pediatricians give some of their patients drug samples. On the one hand this may be helpful for lower income families and those with no health insurance, but on the other hand many of the free samples are unapproved, untested and/or dangerous for children.

According to the CDC study published in Pediatrics, “Our study showed that, of the 15 medications most frequently distributed as free samples [for use in children] in 2004, 4 (27%) received new or revised black box warnings in the subsequent 2 years.” Black box warnings means these are potentially dangerous and/or deadly drugs.

The CDC study cites the example of the eczema drug Elidel (pimecrolimus), which was given as a free sample to as many as 38,185 children under the age of 2 in 2004. In 2006 a black box warning was added which stated the drug should not be given to children under the age of two due to concerns about cancer, damage to the immune system, and a higher rate of upper respiratory infections in children who used it. (The concerns about cancer also extend to adults.)

The other dangerous drug samples commonly given to children include the ADHD drugs Strattera (atomoxetine) and Adderall (amphetamine/dextroamphetamine), and the asthma medication Advair.

The study concludes that, “Free samples may encourage the use of medications in children before enough is known about potential harm. …significant safety concerns are associated with the use of free drug samples. Giving free samples to children in nonurgent situations is an unproven medical practice that should be undertaken cautiously, if at all.”

As an aside, free drug samples also tend to be newer and thus more expensive, so if you use up the sample and continue on that drug, it will most likely cost you more cash or a higher insurance co-pay than an older or generic drug.

Who Will Protect Your Children?
Will any action be taken? Will cold and cough drugs for children be pulled off the shelves and made prescription-only?

Action is not likely to be taken in the near future. A WebMD article states, “Companies sell an estimated 95 million packages of pediatric cough and cold medications each year, according to Information Resources, a market research firm.” With all that money involved, it’s unlikely that these drugs will be regulated anytime soon. When it comes to FDA regulation, money and drug company pressure almost always wins over public health and safety, even when it comes to children.

Ultimately, Only Parental Caution and Restraint can Protect Children from Dangerous Drugs

It’s completely understandable that parents want to help their children feel more comfortable during an illness, but clearly in most cases, cough and cold medicines and drug samples are not the best choice. The AAP recommends simple and “soothing” solutions such as fluids and humidity for a cough.

The classic book on natural remedies for children is Smart Medicine for a Healthier Child by Janet Zand, Robert Roundtree and Rachel Walton, a naturopathic physician, medical doctor and pediatric nurse. It was updated in 2003 (look for that edition). The authors all have extensive experience treating children with natural remedies, and they intelligently combine natural and conventional medicine approaches. Natural remedies may not have large clinical studies behind them, but they often have an established track record based on centuries of use.

Reference
Cutrona SL, Woolhandler S, Lasser KE et al, “Free Drug Samples in the United States: Characteristics of Pediatric Recipients and Safety Concerns,” Pediatrics Vol. 122 No. 4 October 2008, pp. 736-742.