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Just say no: Doctors’ drug freebies to kids are risky

Consumer Reports News: November 11, 2008 04:37 PM

Free drug samples for sick kids seem like a deal: You avoid lines at the pharmacy, keep cash in your wallet, and your kid gets to try out the drug right away. Everyone wins, right?

Wrong. There are sobering safety problems with the most popular drug giveaways that doctors hand out to their young patients, a new report from the journal Pediatrics suggests. The greatest potential danger with free drug samples to kids is that there are few safety measures in place to detect abuse, drug interactions, and improper dosing. Plus, doctors get these free samples from manufacturers to promote newer drugs, which are usually more expensive and have shorter safety records than similar medications that are just as effective but are less costly.

The Food and Drug Administration has attached serious safety warnings on 4 of the 15 most common freebie medicines given to kids (click on chart to enlarge). They include Adderall/Adderall XR (amphetamine/dextroamphetamine), Advair Diskus (fluticasone/salmeterol), Elidel (pimecrolimus), and Strattera (atomoxetine). A fifth drug, Singulair (montelukast), is currently under an FDA safety investigation.

The second-most popular drug sample, Singulair, a treatment for asthma, can cause suicidal thinking or actual suicide. It has also been associated with other behavioral changes. The average age of a child given a free sample of Singulair is 5. Advair Diskus, another asthma drug given away frequently, is generally used as a last line of defense for patients—in other words, your doctor should prescribe other medicines first—since it can actually increase the risk of having serious or fatal asthma.

The fourth-most common giveaway drug, Strattera, used to treat attention deficit hyperactivity disorder (ADHD). Formerly a Scheduled II controlled substance, it currently has a warning that children who take it are at high risk for contemplating or committing suicide. Adderall/Adderall XR, another ADHD drug frequently given away, is rated by the FDA as a Schedule II controlled substance, which means it has a high potential for abuse. To put it in perspective, cocaine, morphine, opium, and oxycodone (also known as OxyContin), are also rated as Schedule II drugs. The result? Children on Adderall/Adderall XR and Strattera need close monitoring for changes in mood and behavior, and, with Adderall/Adderall XR, to ensure the drug is not abused, given away to friends, or sold. Misuse of Adderall/Adderall XR can also lead to sudden death and serious cardiovascular events. These kinds of monitoring, combined with an informative patient package insert, are more likely to take place if the drug is obtained from a pharmacy with a prescription from the doctor.

The sixth-most frequently given away drug, Elidel, is a second-choice treatment for eczema when little else will work. It is not approved for children under the age of 2, and yet more than 38,000 children of that age received a drug sample. Some studies have found an association between use of Elidel and skin cancer or lymphoma.

The practice of doling out free medicine to children is widespread. About 1 in every 10 kids in the U.S. already taking a prescription medication was given a free drug sample in 2004, the year of the study. Most samples don't list dosages for kids, or don't have child safety caps. And, since such samples are usually made available for newly-approved drugs, giving them away can encourage regular use before post marketing surveillance determines their long-term safety for kids. Besides that, drug samples bypass the pharmacist, who is considered an important safety checkpoint.

From our perspective, research shows free handouts in a doctor’s office actually can contribute to increases in drug costs, and are less likely to be a first choice for treatment.

Our medical advisers suggest that you be wary of accepting freebies from your child’s pediatrician. Ask if there is a generic alternative that would be just as effective and cost less when the freebie supply runs out. Request a written print out of possible side effects. Free drug samples, enticing as they are for the moment, do increase the overall cost of drugs, tend to hook you on a brand name, and, most important, may not be the best choice for your child’s problem.

CR's take: See our Best Buy Drug recommendations for the safest, most effective and least costly treatments for the most common conditions.

Lisa Gill, producer and writer, Consumer Reports Best Buy Drugs


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