For Dr. Stephen Borowitz, the most frustrating office visits are with parents of kids suffering from stomachaches and infants prone to spitting up. Often, he says, the parents already know what they want -- adult heartburn drugs such as the "purple pill," Prilosec. "I tell them about nondrug tactics that often help the symptoms," says Borowitz, a professor of pediatric gastroenterology at the University of Virginia. "But they want their kids to have the pills they've seen on TV."
Borowitz and other experts worry about the safety of using potent adult drugs to ease common childhood ailments. But their warnings are unlikely to be heeded by most doctors and parents -- thanks, in large part, to an aggressive marketing campaign by pharmaceutical companies. Nearly a quarter million children took Prilosec in 2000, according to U.S. Food and Drug Administration documents, and nearly 100,000 were prescribed similar "proton pump inhibitor" (PPI) heartburn drugs such as Prevacid, Nexium, Protonix, and Aciphex. None of these PPIs were approved for pediatric use at the time (Prevacid finally secured approval in 2002), and the FDA had warned that children taking Prilosec could face risks of pancreatitis and liver problems. Yet drugmakers have continued to fund medical conference presentations, publications, and tutorials touting PPIs as "highly effective and safe" for children. And this January, tap Pharmaceuticals (which makes a strawberry-flavored version of Prevacid) sponsored a nationwide campaign featuring best-selling baby-book author Dr. Bill Sears to publicize what it calls "one of the most common esophageal disorders in children" -- gastroesophageal reflux disease, or GERD. It's a claim that angers Borowitz, who says there is no evidence of a GERD epidemic. PPIs may be useful in a few "relatively rare" conditions, he says; but too often, "ordinary childhood problems are pathologized into a disease."
The purple pill is just one of hundreds of powerful adult drugs -- many of them not tested for pediatric use -- that are increasingly being given to children. Children's use of prescription drugs has risen by one-third since 1997, according to a recent study by Medco Health Solutions, the nation's largest prescription-management company. Last year, notes Medco public-relations director Ann Smith, prescription spending for children rose faster than spending for any other group, including seniors and baby boomers. Among the fastest-growing categories were asthma and allergy drugs and psychotropic medications such as Prozac; spending on gastrointestinal drugs, mostly PPIs, rose a full 660 percent.
"The survey was a real wake-up call," says Smith. "Children are on more drugs that we think of as adult drugs: Prilosec, anti-depressants, even arthritis drugs like Celebrex and Vioxx, which more kids are taking for sports injuries." Aricept, a drug used for Alzheimer's disease, is now being tested as a treatment for attention deficit hyperactivity disorder (ADHD), and toddlers and grade-schoolers are being given drugs similar to the adult sleeping pills Noctec and Somnos. "Probably a third of the kids I see are on at least two prescription drugs," says Borowitz, "most often a drug for ADHD and an antihistamine."
But perhaps the most remarkable statistic about children's prescriptions is that nearly 3 of 4 are for "off-label" uses -- those not approved by the FDA. Drug salespeople are prohibited from encouraging doctors to prescribe drugs off label, but the practice is widespread, says Dr. Rudolph Mueller, an internist in Jamestown, New York, and author of a book on the health care system. "The reps just say, 'I'm not supposed to be telling you this because it's not approved for this use, but...."
With more children taking more adult drugs, often in combination, dangerous side effects are on the rise. Between 1997 and 2000, the FDA received more than 7,000 reports of adverse reactions to drugs in infants and children under age two, according to a University of Maryland study. Most of the reactions were serious enough to require hospitalization, and 769 of the children died. "Adverse-reaction reports don't prove that the drug being reported caused the reaction," notes Dr. Carol Blaisdell, one of the study's authors. "But what it does show is that we need a lot more studies about drugs commonly used by children." Drugmakers have been so slow to conduct such studies that the FDA now offers an incentive program through which companies can extend a lucrative drug patent -- a benefit often worth hundreds of millions of dollars -- in exchange for agreeing to test the drug on children.
But even as some companies are beginning to fund pediatric studies, off-label uses are multiplying. University of Maryland researcher Julie Magno Zito says she was surprised to discover that anti-psychotics such as Zyprexa and Risperdal are being used to treat kids who "act out." She is also worried about the use of clonidine, a blood pressure medication that is now being given to children with ADHD, and even to "sleep resistant" babies. Clonidine is among the top five psychotropic medications used in children; yet, Zito notes, "no one is tracking what effect it may have on a child's cardiovascular system to take a drug that speeds up the heart, often along with one that slows it down." Poison centers nationwide have received increasing reports of children suffering toxic effects from clonidine, according to a recent University of Maryland School of Pharmacy study. "This is a really potent drug that can have an adverse effect at a dose as small as one pill," says the study's author, Wendy Klein-Schwartz.
Researchers have also documented a rise in adverse effects, including heart problems, in children who take drugs for attention deficit disorder, asthma, and acid reflux. And this past June, the FDA warned doctors against prescribing the anti-depressant Paxil to children because of studies showing that the drug caused an increase in suicidal thoughts.
But the way the pharmaceutical industry sees it, the trend toward increasingly powerful children's prescriptions has just begun. Noting the increase in both obesity and diabetes among children and adolescents, the trade journal Pharmafocus recently called diabetes "an ideal disease for the pharma market," and drug companies are racing to market adult obesity drugs for children. In November, the cholesterol drug Lipitor was approved for use in children from 10 to 17, and more than 1,000 teens have participated in studies for the diet drugs Meridia -- which has been linked to heart problems and deaths in adults -- and Xenical, whose side effects include reduced bowel control.
As competition for the children's prescription market has become more intense, drug companies have also ratcheted up advertising, sometimes with dubious claims: When Schering-Plough ran ads suggesting that the allergy drug Claritin would keep kids more attentive at school, the FDA reprimanded the company for "misleading" consumers. Now that Claritin's patent has expired (and generic competitors are free to make the drug), Schering-Plough is encouraging kids to switch to its new allergy drug, Clarinex, sponsoring soccer tournaments and sports equipment giveaways for inner-city kids -- even as consumer groups and medical experts complain that in many cases it's better to keep children away from allergens than to give them drugs. "People tend to want to have their problem labeled and get an easy treatment to fix it," says the University of Virginia's Borowitz. "I'm afraid our children are absorbing that attitude as well."