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Avandia and the Heart: A Reminder That Drugs Can Harm

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Diabetes is particularly detrimental to the heart, and heart problems are the eventual cause of death for most patients with diabetes. Given this, it is extremely worrisome that Avandia, a drug marketed to treat diabetes, has been found to harm the heart.

The recognition that drugs can cause harm is nothing new. A recent example is the painkiller Vioxx which was found to harm the heart and taken off the market in 2004.

While many extremely toxic drugs are eventually taken off the market, several drugs that are quite harmful remain available, albeit with a warning from the FDA. An example is acetaminophen, the active ingredient in some over-the-counter painkillers (such as Tylenol) and many cold medications, which can cause severe liver damage.

In theory, any drug can be harmful. Each drug has a therapeutic ratio, which is the dose at which it produces beneficial effects divided by the dose at which it produces toxic effects. The higher the therapeutic ratio, the safer the drug is. However, the therapeutic ratio of a drug can vary in different people depending on their genetic make-up and physical status. For example, some people metabolize drugs more slowly than others. These slow metabolizers experience the toxic effects of drugs at a lower dose. Also, since most drugs are metabolized in the liver and excreted by the kidneys, people with liver and kidney diseases may experience toxic effects at normal therapeutic doses.

The take-home message is that all drugs have the capacity to harm.

If every drug has the potential to cause harm, how can an average person protect himself or herself from the adverse effects of drugs that are approved by the FDA?

The answer is education.

In December 2004, when Vioxx and other painkillers were in the news for their adverse effects, I saw an article in the New York Times stating that the pain killer naproxen, which is sold under the brand name Aleve, had been linked with heart problems. This was alarming to me because my daughter was a regular user of Aleve. When I told her about the article, she did not want to believe that her favorite painkiller could actually cause harm.

Realizing that we need to educate our young people about drug safety, I suggested that we teach it in our schools, the way we teach sex education.

Teaching children that drugs, even those available over-the-counter, can cause harm is a good idea for two reasons. First, these children will become adults who understand the risks and benefits of modern medications. Second, when drug safety is taught in schools, the issue will reach parents, who are the main caretakers of the elderly, a population that often experiences adverse drug effects. In the US, about 40 percent of people over the age of 65 take five or more medications per week. Adverse drugs reactions are common in this population and can lead to unnecessary hospitalization.

While most schools do not yet teach medication safety, several organizations are actively involved in documenting and reporting on the adverse effects of medications. These include:

The FDA's MedWatch

The Institute for Safe Medication Practices

PublicCitizen's worstpills

Not everyone knows about the existence of these organizations. Therefore, we need to find ways to educate people about drug safety. Perhaps the FDA should provide drug safety information on TV during prime time, a time slot heavily used by drug companies to advertise medications.

Educating people that drugs can cause harm is likely to reduce our consumption of drugs and our risk of experiencing adverse drug effects. Currently, Americans consume about 41 percent of all drugs sold worldwide! One wonders -- are we sicker than rest of the world, or are we just using more drugs than we need?

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