This Is How Much Attention You Should Pay to Side Effect Warnings
Turn on your TV or open a magazine, and chances are you’ll come across at least one ad for a drug promising to fix a very specific illness — followed by a long list of side effects ranging from the annoying to the terrifying. It’s tempting to tune it all out and hope for the best. But how seriously should we consider these potential side effects, and are some more likely than others? How do we know if the cure is worse than the disease? Get ready for a dose of insight.
What are side effects?
When you take a medication to treat a certain condition, any other outcomes — good or bad — caused by that medicine are considered side effects. There are two types, Type A and Type B, explains registered nurse and Army Nurse Corps. Veteran Donique Jones: “Type A is related to the drug itself and are expected side effects. Type B is related to an allergy or intolerance. If you experience a Type B reaction, that could be serious enough to stop a medication. If there is a tolerance issue, your prescribing health care provider may decrease your dosage.”
Medical professionals also distinguish between mild and severe outcomes, says Craig K. Svensson, PharmD, PhD, Professor of Medicinal Chemistry, and Molecular Pharmacology at Purdue University College of Pharmacy. “Side effects are symptoms expected from the pharmacology of the drug that may be annoying, but do not usually put a patient’s health at risk. Examples would include dry mouth and mild diarrhea.” These aren’t inherently dangerous to your health, but they can be uncomfortable, and can make certain activities unsafe — like driving after taking a drug that can cause drowsiness — or unwise — like getting on a long flight. In contrast, Dr. Svensson continues, “Serious adverse effects are effects that can meaningfully impair your health and should be of greatest concern to patients.” These are usually rare, he says, and aren’t necessarily an expected effect of the drug. “There are a limited number of drugs that cannot be used without some serious adverse effects,” he cautions. “These are most commonly drugs used to treat cancer. Essentially, everyone receiving these drugs will experience significant adverse effects.”
How seriously should we take side effect warnings?
Don’t be tempted to skip the leaflet that comes with your medication. “All drugs can potentially cause side effects, so it is important to pay attention to the side effects listed in these commercials — or more specifically, on the actual drug labeling,” warns Caitlin Hoff, a CDC-certified consumer advocate with ConsumerSafety.org, an online legal and educational resource on drugs and medical devices. “Knowing the potential side effects of a drug can help you spot adverse reactions that your body might experience while taking a medication.”
But how much information are drug companies required to give us? “All side effects observed during clinical trials must be reported to the US Food and Drug Administration (FDA) as part of the filing process requesting approval to market a drug,” Dr. Svensson explains. “The FDA is ultimately the arbitrator in terms of what gets included in the formal package insert. I am unaware of any minimal percentage of frequency required to be included. After a medication is approved and marketed, the manufacturer is required to report any new adverse effects they become aware of within 15 days.” Once the FDA has had their say, it’s up to the drug companies whether they include just what the FDA told them to, or absolutely every single side effect. Most err on the side of caution, says Hoff: “It is certainly in the company’s best interest to warn consumers about all side effects. There are numerous consumer lawsuits right now against drug and medical device manufacturers claiming that these companies failed to warn patients and healthcare providers about the more dangerous side effects.”
While you should read the whole list and be aware of it, not all those side effects are equally likely. Sharon Orrange, MD, Clinical Associate Professor of Medicine at the Keck School of Medicine of USC, and medical expert for drug price comparison website GoodRx, explains, “A side effect that occurs less than 10 percent of the time is roughly the same as the placebo group — those taking an inactive pill — so an adverse reaction reported in more than 10 percent of folks taking it is worth paying attention to.”
What about over-the-counter medications?
As Hoff noted, all medicines can have side effects, but over-the-counter (OTC) medications — drugs you can legally buy without a doctor’s prescription — have been deemed by the FDA as less risky when used by a patient without medical supervision. That said, you should still get up to speed about possible side effects by reading the packaging and any extra materials that come with your medicine. Dr. Orrange notes that some common OTC drugs that have side effects you might not expect include nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen, “which can cause gastrointestinal bleeding” and “roughly double the risk of heart failure;” proton pump inhibitors (PPI) which are used for acid reflux and heartburn, “but can contribute to bone loss, Vitamin B12 deficiency, and potentially cognitive decline when used for longer periods of time;” and sedating allergy medications and sleep medications, which “may lead to confusion and increase fall risk, particularly in the elderly.”
It’s especially important to consult a doctor or pharmacists before taking an OTC drug if you’re taking prescription medication, Jones advises. And always tell your doctor which OTC medications you’re taking, she adds, as “you may have an underlying disease or prescribed medications that interact with the OTC medication. OTC medications should be used only as directed on the label to decrease your chance of experiencing drug-related interactions.”
How do we know if the side effects are worth the risk?
When you’re sick and you just want to get better, you’re probably not in the right headspace to be making what could be life and death decisions about medication. Which is why the FDA has done it for you. “When the FDA approves a drug, it does so with the understanding that the risks involved do not outweigh the overall benefits of the drug,” Hoff reassures us. “So following that logic, if the most severe side effects of a drug affect a majority of the trial patients, ideally, it won’t be approved.”
There are some drugs, as Dr. Svensson mentioned, that necessarily come with extreme adverse effects. The FDA marks prescription labels for these drugs with what’s known as a black box warning. “Although rare, any black box warning needs to be considered, because recognizing those rare serious effects early is key, as they are often reversible when you discontinue the medication,” Dr. Orrange explains. “For some folks, the potential of a serious side effect may steer you away from the medication.” For example, she points to Accutane (a brand of isotretinoin) which is used to treat severe acne but can also cause congenital birth defects, meaning that anyone who can get pregnant and isn’t using birth control may not see the risk as worth taking.
Ultimately, if you’re concerned about side effects, says Hoff, “Talk to your doctor! While doing your own consumer research is a good thing, there is a lot of misinformation available online. The best thing you can do is bring up any concerns you have regarding a certain medication to your doctor, pharmacist, or trusted healthcare professional. They will be able to answer any questions you might have to help you make a safe choice when it comes to medications.” You don’t have to be paranoid, but definitely get informed.
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