A side effect is a symptom that appears within minutes, hours or a day or two of taking a drug. Nausea, a rash, even an allergic reaction is a side effect. Other side effects take time to manifest. For example, new research shows that taking baby aspirin for as little as three months can double the risk of macular degeneration ten years after taking aspirin. Those are what we are calling “long-term effects.”
MedShadow Foundation is concerned that patients are not always warned about the long-term effects some drugs have. Worse, patients may not be informed that long-term effects aren’t known for many common drugs.
Our goal is for the patient and the health care provider to include the question of long-term effects, whether they are known or unknown, into the decision-making process in order to choose the right care and treatment for an individual.
Every time your health care provider suggests taking a drug, please include in your risk/benefit discussion questions about the long-term effects: How long can I safely take this drug? Do side effects change over time? Does the efficacy of the drug change over time? Might the changes the drug makes in my body/mind today result in something else years later?
After consideration of the benefits and alternatives, it may be reasonable to move ahead with a medicine choice even if the long-term effects are unknown. Some medicines are the only choice, or the best choice by a wide margin, or the choice needed to stay alive today. All medicine comes with a level of risk. MedShadow Foundation totally supports modern medicine and the patient’s right to have all the information before making a decision.
There is no official medical definition of long-term effects of medicine. It can be difficult to identify a long-term effect because often the symptom doesn’t appear for months or years after starting or stopping use of the medicine.
We define a long-term effect as one that appears months or years after starting or stopping the medicine. The medicine might have been taken for a short period of time yet several years later an unanticipated outcome might emerge. A medicine might be taken for a long time and the cumulative effect of long-term exposure might have consequences.
Both long-term effects and side effects can be beneficial, harmful or negligible. Individual responses to medicines may result in differing effects among users. The combination of medicines or interactions with food all lead to possible short or long-term symptoms.
Some people ask, aren’t all drugs in America approved by the FDA and, therefore, are safe? Long-term testing takes, well, a long time. The FDA and the pharmaceutical companies don’t want to wait 20 years to find out the long-term effects in the lab. Neither do patients, many of whom have life-threatening diseases. For those and other reasons, the FDA generally does not require testing for long-term effects on drugs before approval for use. When reviewing the research before approval, if the FDA feels more research in needed for side- and long-term effects, the FDA can require the pharmaceutical company to test further and still approve the drug for immediate use. A drug may have a different effect in the general population than it had in trials.