Paediatricians Raise Concern Over Off-label Use of Prozac for Children

by Gopalan on Oct 23 2008 4:11 PM

Paediatricians Raise Concern Over Off-label Use of Prozac for Children
Off-label use of psychiatric medicines like Prozac for children are becoming extensive. It could be dangerous when no systematic studies have been done on children with such medicines.
Many treatments applied to children reflect ''off-label'' use of medications specifically approved for adults—but not for kids. When the FDA grants a license to a new prescription medication, it lists its permitted uses (''indications'') and the patients for whom it is intended (including their age range), usually reflecting the population it was tested on—children with strep throat, women with breast cancer. If a drug company even mentions a use not specifically approved, it has violated FDA rules and can be fined or otherwise punished. However, once a drug has received FDA approval, physicians are free to use it for applications or populations for which it was not formally approved.

After (usually adult) FDA approval has been obtained, manufacturers often don't bother with expensive testing that would allow them to request a label extension for use in kids, since they'll have the (off-label) market, anyway. Off-label use accounts for somewhere between half and three-quarters of all medications used in children and is also commonly used for adult treatment.

Pediatricians are often uncomfortable with this practice, but they consider it the lesser of two evils when confronting an illness with effective adult treatment but nothing for children. Most medications behave similarly in children and adults, but that rule has exceptions, as doctors sometimes discover too late.

Aspirin can lead to a horribly dangerous liver and brain disease in children or teens. Tetracycline, a common antibiotic, can damage the teeth of children under 8 years old. The problem is particularly troublesome when it comes to prescribing psychiatric medications to kids, which is increasingly common.

A recent paper in the journal Child and Adolescent Psychiatry and Mental Health critically examined off-label use of medications for children, paying special attention to psychiatric drugs.

It said, “Prior studies suggest that systematic treatment monitoring is warranted so as to both minimize risk of unexpected adverse events and exposures to ineffective treatments. Clinical trials to establish the efficacy and safety of drugs currently being used off-label in the pediatric population are needed. In the meantime, clinicians should consider the existing evidence-base for these drugs and institute close clinical monitoring.”

Some side effects relate to the use of mental-health medications represent special risks for young people, experts warn. For example, a rare but dangerous kind of liver damage associated with the concomitant use of several different medications is much more common in children than in adults. Doctors are now given highlighted warnings to be alert for suicidal behavior that can occur in young people (adults, too) soon after they are started on antidepressants—perhaps because the medicine can energize a patient and stimulate action before the drug acts to decrease the depression and impulse to suicide.

Sydney Spiesel, a US paediatrician, points out such medicines like Prozac are now used a lot because the perceived need is so great and there are so few alternatives. Because of the huge shortage of mental-health workers experienced in working with children, pediatricians and pediatric nurse practitioners are often called on to pick up the slack. Unfortunately, few have the time or the training to use psychotherapy to treat mental-health problems. They are frequently forced to fall back on medication use, often a more familiar and comfortable style of treatment.

Insurance companies too prefer using medication to treat these problems because it is less labor-intensive and, therefore, less expensive than psychotherapy. Anyway, they are inclined to be suspicious of treatments based on talking and thinking.

Most of the drugs used today to treat mental-health conditions have been available for a relatively short time, so doctors don't yet know as much as they ought to about long-term safety profiles for both adults and young people.

These medications include SSRI antidepressants like Prozac as well as drugs targeting severe mental disorders like psychosis. Some medications formerly used to treat seizure disorders have also been found to be helpful for patients with mood disorders, like bipolar illness. An estimated one out of about 20 children suffers from attention deficit disorder, and many, many of these kids are being treated with medications. Even bed-wetting is sometimes treated with medications. And many of the medications used to treat these conditions might have different side-effect profiles in children than in adults.

“We are seeing children with these problems much more than we used to (probably simply because parents and doctors are more sensitive to the symptoms), but, for the most part, we are limited to treating them with off-label medications. Questions have been raised about possible side effects, but the need for treatment seems great, so there is a sense that we must just muddle through, hoping no bad surprises appear,” Sydney Spiesel said, writing in Slate magazine.

The authors of the recent research paper stress the need for closely monitoring children receiving these drugs, especially focusing on questions of safety and effectiveness. For some medicines, this means doing laboratory tests looking for evidence of known side effects. In addition, doctors should be looking at the more subtle signs of effectiveness: Is the patient's school performance improving? Are things better in their social development? Is the child continuing to take the medication? (Non-adherence is sometimes a clue that a treatment is ineffective.) This kind of follow-up is likely to reveal whether a treatment is safe and effective, even for drugs that are prescribed off-label.

Even better would be the kind of organized, thought-out multicenter testing that is applied to drugs used for cancer chemotherapy in children. Alas, that kind of evaluation for mental-health drugs seems very far away, indeed, laments Sydney Spiesel.


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