All drugs have side effects. Even if you don’t take any prescription drugs, you’ve certainly seen the TV ads that spend far more time on the drug’s side effects than on what the medication is designed to treat.
The prescribing information doctors receive has the most serious side effects set off in a “black box” at the very top of the label. The patient information, however, typically lists serious and other side effects. The side effects data is garnered from the research studies submitted to the Food and Drug Administration (FDA) for approval of the drug.
When you pick up your medication from the pharmacy, the education material that comes with the prescription shows side effects information from the pre-approval drug studies, which usually include at the most a few thousand subjects. But what about side effects that are reported after the release of the drug, when it is used by a far greater number of people?
Adverse Event Reports
Accounts of adverse effects are supposed to be reported to the FDA Adverse Event Reporting System by the drug companies within 15 days after their occurrence. However, a recent report in JAMA Internal Medicine (July 27, 2015) noted that of the 1.6 million reports submitted of both fatal and nonfatal events between 2004 and 2014, about 10% were not submitted within the 15-day window.
As a patient, you need to immediately inform your doctor of any suspected adverse side effect you experience. If your doctor feels that what you are experiencing is a result of the drug you are taking, your doctor is supposed to notify the drug company, which then notifies the FDA. The process can be expedited if doctors directly report to the FDA. Then, who knows how long it takes to include that new information in the doctor’s prescribing information and the patient education sheets. If you are taking a drug for a chronic problem, you need to read the patient education material every time you pick up your prescription to see if there have been any side effects added.
Although the listing of potential side effects can go on for a page or more and are usually listed in order of most to less frequent, it is essential that you read to the very end. Be aware that you are most likely to experience the side effects that are related to your weakest systems. For example, if you have weak eyes and a history of eye infections, you might experience visual side effects, although they are among the least common reactions to the drug.
Ignorance Doesn’t Bring Bliss
Some people who are chronically ill and routinely take one or more medications don’t read the side effects information. Their attitude is that they need the drugs, so what does it matter. It does matter. Whether you are taking a drug long- or short-term, if you are having untoward side effects, talk to your doctor. There may be an alternative medication, or you may decide to pursue other methods of treating your condition. Also, be aware that many doctors prescribe other drugs to counter the side effects of the first one. That is why so many people end up taking multiple medications, and, as you know, each one has potential side effects. Going this route can certainly be a slippery slope.
When people are so sick that all they can do is take the drugs prescribed by their doctors, they may be missing a side effect that possibly can be avoided by a change in prescription. That’s why it’s essential to have a vigilant advocate who can review and interpret this information when you’re unable to do so yourself. See the upcoming blog: “Sick or Well, Get Yourself a Healthcare Buddy”.
Learn more? Order Surviving the U.S. Health System: Insurance, Providers, Well Care, Sick Care at https://surviveushealthsystem.com/books-store/and peruse the blog archives.
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