How safe is your medicine? To answer that question you might ask your physician when she prescribes a new pill what side effects it causes. But how reliable is the information she depends on to answer your question?
Most doctors assume that the official prescribing information approved by the FDA is reliable. Even though there may be a long list of side effects, this information can be misleading.
Take sex, for example. When antidepressants like Prozac and Paxil were first introduced, sexual side effects like lower libido or difficulty achieving orgasm were not perceived as important or common complaints. The original clinical trials did not highlight such symptoms.
But patients knew that there was a problem. We heard from people who said that such medications threw a monkey wrench into their love lives. Eventually, physicians figured out that many popular antidepressants interfered with sexual function in up to two-thirds of their patients.
How did this happen? First, nobody thought to ask the question during the early clinical trials. Second, studies aimed at testing new medicines are not very good at uncovering unexpected side effects.
A Perspective in The New England Journal of Medicine (March 11, 2010) questions the common assumption that health professionals are good at detecting and reporting side effects. Ethan Basch, MD, writes: “Yet a substantial body of evidence contradicts this assumption, showing that clinicians systematically downgrade the severity of patients’ symptoms, that patients’ self-reports frequently capture side effects that clinicians miss, and that clinicians’ failure to note these symptoms results in the occurrence of preventable adverse events.”
When the doctor does not mention a side effect of a drug, the patient can suffer: “The VA gave me lisinopril for blood pressure without any warnings. I developed a cough so bad I passed out twice and went to the ER once. I have since have learned the cough is a common side effect, and yet lisinopril is handed out like candy.”
We have heard from scores of patients who have developed a severe cough while taking an ACE inhibitor (benazepril, captopril, enalapril, lisinopril, ramipril). In some cases they have undergone extensive workups including blood tests, x-rays and trials of antibiotics to treat a cough caused by a blood pressure pill.
A patient may become annoyed if a doctor denies that a medication can cause the symptoms he is experiencing: “I took Zocor for high cholesterol and developed neuropathy, joint pain and extreme fatigue. I went to at least four physicians and none of them said it could be the Zocor. The cardiologist who prescribed it said it was a coincidence that I developed these symptoms. He told me to go back on the drug, as these were not side effects of Zocor.”
Zocor (simvastatin), like other statin-type medications, can cause nerve and joint pain, fatigue, muscle aches and weakness. Such symptoms may be more common than most physicians realize (American Journal of Cardiovascular Drugs, Nov. 1, 2008).
Pharmacists, physicians and pharmaceutical companies would all know more about possible side effects if they listened to patients. This would benefit everyone.
The People's Perspective on Medicine