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Add suicide warnings to antidepressant labels, FDA asks

The Food and Drug Administration recently asked drug companies to relabel 10 widely used antidepressants to add strong warnings that patients should be watched for suicidal behavior and anxiety.

"We expect (manufacturers) to be very cooperative," says Russell Katz of the FDA's neuropharmacology division.

The new warnings apply to everyone, but the action follows rising concern over the drugs' effects of children. An advisory panel recommended stronger label warnings Feb. 2 at an FDA hearing after bereaved parents said antidepressants caused their children's suicides. But the FDA doesn't know whether those pills cause suicide, Katz says. "It may be just the natural course of the disease."

The drugs might be safer for adults than for kids, says UCLA psychiatrist James McGough, a member of the FDA's advisory group. Impulse control often isn't as well developed in children as it is in adults, "so parents need to be alerted about hyperactivity. But I hope this doesn't scare doctors away from prescribing antidepressants."

Many mental health experts applauded the FDA action, but some say the agency has gone too far - or not far enough - to protect kids.

"It's a step in the right direction, because the better informed doctors and parents are, the better care kids get," says child and adolescent psychiatrist Harold Koplewicz, director of the New York University Child Study Center.

The FDA has asked Columbia University researchers to review studies on kids who take SSRI antidepressants. SSRIs, a newer class of antidepressants, include popular drugs such as Prozac and Zoloft. Preliminary findings suggested that suicidal thoughts and attempts, though rare, were more common in kids on antidepressants than those on sugar pills. No child in the studies committed suicide.

The report from Columbia is expected at an FDA hearing in September, when the agency is expected to decide whether SSRIs should be prescribed to children. Some say the new warnings could hurt children. Prediatricians and general practitioners, who write most kids' prescriptions, "will be scared off by this," predicts Suzanne Vogel-Scibilia, a Beaver, PA psychiatrist whose two sons use antidepressants. "It's premature, a bad consequence from hasty generalizations. We already know most depressed kids don't get treated, and this will make it worse."

But SSRIs don't work for depressed kids anyway, says University of Connecticut psychologist Irving Kirsch. In Kirsch's analysis of pediatric SSRI studies, the drugs do no better than placebos in six unpublished studies, and "the benefit is so small that it's clinically meaningless" in nine pubished studies.

The FDA must decide whether benefits outweigh risks for children. So far, "studies have been strikingly unsuccessful in showing a benefit" in kids, says the FDA's Tom Laughren. But that doesn't mean they don't work for some, he adds. There's a strong "placebo effect" in depression research, and even drugs proved effective can show no significant benefit in some studies.

Pills often prescribed

In 2002, doctors wrote 157 million outpatient prescriptions for adults for the 10 antidepressants that the FDA says need new warning labels. Doctors wrote 8.1
million prescriptions for kids 12 to 17 and 2.7 million for kids 11 and younger.

by Marilyn Elias, USA Today

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12 Steps to Improve Your Financial Health in 2004!

Interested in some substantial (yet painless!) ways to increase wealth in the coming year? Here are a few suggestions:

1. Give every $20 purchase a second look. If you could save just $20 a week for one year, you would have an additional $1,040 in you wallet. Most of our purchases of $20 or less are for "wants" rather than "needs" anyway; e.g., magazine subscriptions, compact discs, cosmetics.

2. Opt for a new car loan of four years or less. Otherwise you are setting yourself up for eventually owing more than the car is worth.

3. Round off your mortgage payments to the next even hundred dollars. You will save thousands over the long haul and have fewer payments.

4. Pay your bills on time. When you pay only the minimum on your credit card debt, you are electing to pay the highest interest over the longest period.

5. Use the Internet. One bride recently disclosed that the same dress she was thinking of buying at $1,300 retail was available online for $900. Always be sure, however, that your Internet vendor displays the padlock security symbol.

6. Don't expect miracles. Change is hard! So bag your lunch twice a week if you don't think you can do it every day. You can save money in small steps.

7. Don't collect too many store cards. Often, certain stores will offer significant one-time discounts if you apply for one of their cards. However store cards generally carry higher rates and applying for too many cards will actually hurt your overall credit rating.

8. Look for deals. Many credit card companies will invite you to transfer your debt to low rate cards. These can save you money as long as you're moving high-rate debt to low-rate cards. Read the fine print.

9. Don't borrow to the max. Just because someone is willing to lend you the money doesn't mean that you can afford the loan. The more you borrow, the tougher it is to pay back.

10. Take advantage of benefits your employer offers. Yes, a wallet full of cash is nice on payday, but if your employer offers a 401(k) or a flexible spending plan for medical products, you should have a very good reason for not participating!

11. Get help. If you're spending 20% or more of your take-home pay on old credit card debt, you're in trouble. Contact your EAP or a consumer credit counselor at once!

12. Contact Us. Your EAP offers many resources and services to ease your financial stress!

by Employee Services

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