Study: Deaths, Severe Complications More Than Doubled From 1998-2005

(CBS) A new study paints an alarming picture of reactions Americans are having to medications.

As The Early Show medical correspondent Dr. Emily Senay explained Tuesday, the study, in the Archives of Internal Medicine, drew from official Food and Drug Administration statistics, and found that "adverse drug events" more than doubled from 1998 to 2005.

Those events include deaths, birth defects, disabilities, hospitalizations, and other life-threatening incidents.

Of the many drugs documented by the study, Senay points out, drugs that work primarily on the immune system and pain relievers were disproportionately represented. Many pain relievers are bought over the counter, without prescriptions.

Senay stresses that people need be more cautious when using those and all drugs. It's easy to overdose these medications, and the numbers in this study suggest there are real consequences.

In 1998, Senay notes, the FDA began what it calls the "adverse event reporting system," which requires both health providers and drug manufacturers to report apparent reactions that people have to drugs.

The researchers report that the number of drug-related fatalities rose more than two-and-a-half times over the eight years from 1998-2005, to more than 15,000 in 2005, and other adverse drug events increased by a similar amount, to nearly 19,000 in the last reporting year.

And, Senay observed, 87 percent of the events were linked to just 20 percent of the medications tracked, meaning a small number of medications had a disproportionate impact on the overall situation.

The study's authors singled out two categories in particular. One includes drugs that alter the function of a patient's immune system, such as those used for autoimmune diseases like rheumatoid arthritis and Crohn's disease. Since a weakened immune system can open the door to infection, that's no surprise -- and it's not uncommon for patients to be aware of this risk.

But the second category they singled out may surprise some people: pain relievers. Senay says prescription medications used for arthritis, such as Vioxx and Celebrex, which studies have famously linked to increased heart risk, were responsible for a certain amount of that. So were very powerful narcotic drugs, including Fentanyl and morphine.

But another pain reliever believed responsible for many deaths is acetaminophen, the active ingredient in many products, including Tylenol. On the list of drugs linked most closely to deaths, acetaminophen is No. 5. People can buy this medication over-the-counter, and therefore might assume that it's safe, but if they use too much of it, they can sustain liver damage, especially if they also consume alcohol.

What's more, Senay adds, it's common for people to take too much acetaminophen. One reason is that it's in numerous products, and you might not even realize it. You might take the recommended dose of each product -- one for menstrual cramps, another for coughs, another for cold or flu, not to mention extra-strength acetaminophen tablets for fever or headache. The label on a bottle of Extra Strength Tylenol says you should take no more than eight tablets every 24 hours. That's all the acetaminophen you should have. So, if you take that dose, and also use any of those other products, you've overdosed on acetaminophen. And this new study confirms that can have serious consequences.

In fact, continued Senay, late last year, the FDA recommended new labeling for products containing acetaminophen, with that ingredient highlighted prominently in color on the drug facts panel, so people could keep better track of just how much they're taking. Through labels like those, the FDA hopes people will keep better track of the acetaminophen they're taking, and avoid the sorts of overdoses that have generated the deaths and adverse health effects documented in the new study.

What other resources to consumers have at their disposal, to avoid the adverse reactions described in this study?

One of the study's authors reminds us how useful pharmacists can be, Senay says. Whenever you get a prescription drug, especially for the first time, quiz your pharmacist about whether he or she thinks the drug and dosage are right for the condition you want to treat, and ask about interactions with other medications you take. If the pharmacist has doubts, double check everything with your doctor. That's especially true for the drugs in that upper 20 percent that produce the greatest number of adverse events.