Ask these questions to determine whether the benefits of the drug outweigh its risks.
Attention-grabbing headlines such as “Statin Use Tied to Cataracts” and “Patients Taking Antihypertensive Drugs Show Increase in Lip Cancer” can make some readers so fearful that they stop taking their medication. The truth is that these headlines and articles are often misleading. Often, the chance of experiencing the frightening side effect is so small that the benefits of taking the medication far outweigh the risk.
Many times, it’s impossible to prove that the medication caused the problem. “These studies do not give you the full picture,” says Dr. Richard Lee, co-editor in chief of the Harvard Heart Letter.
When you read negative press about a medication, ask these questions:
Did the drug cause the effect? When people who take a drug experience an adverse effect, the drug is not always responsible.”Yellow fingers don’t cause lung cancer. People with lung cancer may have yellow fingers because they smoke. Tobacco causes lung cancer,” says Dr. Lee, citing the classic example of association versus causation taught in medical school. In the articles tying statin use to cataracts and blood pressure medications to lip cancer, the findings were associations. The study design made it impossible to prove that either type of medication caused the adverse effect.
Is the side effect worse than the disease the drug is designed to treat? In clinical trials of cholesterol-lowering statins, some people have developed diabetes. But the statins also lowered the risk of heart attack and stroke. Diabetes can be managed with lifestyle and medication: heart attack and stroke can be deadly. “In people with vascular disease, the chances of developing diabetes on a statin are far less than the chance the statin will prevent a future heart attack or stroke,” says Dr. Lee.
How many people experienced the side effect? Sometimes, the finding touted in the headline is true, but it may affect very few people. For example, a drug may triple the risk of cancer, but if the risk is low to begin with, the benefit of taking the drug may greatly outweigh the risk.
When the side effect is serious
When a clinical trial uncovers a side effect serious enough to compromise the drug’s safety, research usually stops, and the drug is never brought to market.
Some side effects appear after the drug is in use. In these cases, the FDA either removes the drug from the market, or—in the case of a lifesaving drug—warns about the potential risks, so doctors can weigh risks and benefits.
“The FDA works hard to maintain a balance between safety and efficacy and risk and benefit,” says Prabashni Reddy, who directs the Center for Drug Policy at Partners Healthcare in Boston.