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U.S. News & World Report – Is the Label for the Prescription You’re Taking Outdated?

U.S. News & World Report – Is the Label for the Prescription You’re Taking Outdated?

What exactly do you know about the prescription medication you’re taking?


If you read the pill bottle itself, besides the drug name, you’ll see things like the medication strength and instructions for taking it properly. And the drug labeling information approved by the Food and Drug Administration, which regulates medications, extends beyond what’s on the bottle. A lot of the information about a prescription actually comes in a leaflet, or information that is printed and given to patients when they pick the prescription up, explains Sunny Linnebur, a clinical pharmacist for the University of Colorado Hospital Seniors Clinic in Aurora, Colorado, and a professor of pharmacy at the university. “I would encourage patients to read the leaflets that accompany the prescription medications in order to find out more about the drug,” Linnebur says. That includes everything from what the medication is approved to treat and drug side effects to specific dosing instructions, like how much to give a child, if it’s approved for kids.


But what’s known about a drug when it hits the market is only part of the picture. In fact, frequently, doctors will prescribe drugs “off-label” to treat conditions for which the medication hasn’t been approved by the FDA specifically to address. Though certain off-label uses are heavily debated, the general practice of prescribing drugs for new uses beyond what they were approved to treat based on emerging research is widely accepted in medicine.


“Of course, it’s impossible to know everything about a drug when it’s first approved for marketing,” says Jeff Allen, president and CEO of Friends of Cancer Research, a nonprofit organization that advocates for policies to support safe and effective use of new drugs. “So information about modifications to dose, different conditions of use that could be associated with the drug – that can all evolve over time.”


So can safety information; in the most serious cases, the FDA will update prescription labeling to account for so-called adverse events reported when people took the drug. In some cases, the FDA requires a black box warning – it’s most serious warning – to the label to flag a hazard that’s been associated with the drug. That happened recently with the popular diabetes drug Invokana after industry-sponsored research found it increased the risk for amputations of the leg, foot and toe compared with placebo. Other black box warnings caution that a drug may increase the risk of death.


But frequently, adverse events that are less common or milder by comparison don’t trigger a requirement by the FDA that the drug maker change the prescription’s labeling.


Given the speed at which new information emerges today, Allen says drug labeling commonly fails to keep pace.


Allen is advocating for Congress to broaden the FDA’s authority so that it can more quickly update drug labeling information. “Having a label that is more up to date, including safety information, would just improve the accuracy of the information that’s available to consumers,” he says. Allen adds this would help patients make more informed decisions about drugs prescribed off-label, as is common – for example – in cancer treatment, where a drug approved to treat one type of cancer is shown effective in treating other cancers.


While one off-label use of a drug may be backed by peer-reviewed research and broadly accepted within a specialty, other off-label uses may be based on far less. “With the high prevalence of off-label use … it becomes difficult to really understand the strength of the evidence that supports its use,” Allen says. He hopes the FDA will be able to play a bigger role in helping make that determination – beyond its current drug approval process. “Obviously we believe that the current approach has worked in some circumstances,” he says. “But with the availability of so much more information about patients’ experience with a drug, it’s worth revisiting whether the FDA could have a growing role in adjudicating the claims that are being made and ensure the most up-to-date information is available in all venues for physicians and patients.”


To keep drug labels as up to date as possible, Allen advocates expanding the agency’s ability to work with drug companies and analyze data after a drug is on the market by taking advantage of advances in information technology. “With the state of health information technology, I think we do have a real opportunity to improve the understanding of the use of different drugs in the post-market space,” Allen says. “Things like electronic health records will allow the collection of data that never before has been able to be aggregated and analyzed.”

Learn More About What’s Not on the Drug Label

In the meantime, experts say patients can take proactive steps to get information about the medications they’re taking that isn’t on the label. Of course, the place to start is with the doctor who prescribed it. Health providers should be able to discuss reasons and evidence for prescribing a drug as well as risks and side effects based on the latest research.


Pharmacists, too, can provide more information that’s not found in drug labeling. “Pharmacists have access to drug information resources that are very extensive,” Linnebur says, including on off-label use of drugs and side effects, which they can share with patients.


You can also check out the FDA’s website for the latest safety information on a drug you’re taking. “If it’s a very serious risk, the FDA will see that evidence and require a labeling change,” she reiterates. If it’s not as serious – like maybe the headache risk is a lot higher than first anticipated based on the clinical studies – she adds the FDA won’t require such a labeling change. “But they may send out a safety announcement, and those go to health care practitioners, and they also have a patient version typically,” Linnebur says.


If you don’t have your pill bottles handy, but do have access to an electronic medical record, you should be able to get an updated list of what you’ve been prescribed, including recommended dosing – which you can use if you plan to go online for more information. Dr. Sorina Madison, an assistant professor of health informatics and coordinator of a health informatics internship at George Mason University in Fairfax, Virginia, recommends checking out drug information provided online by MedlinePlus, which is affiliated with the National Library of Medicine, in addition to the FDA.


She also recommends talking to others with the same condition in online communities, such as PatientsLikeMe or Inspire, to compare notes on drug treatment, especially if you have a condition that’s rare or are prescribed medication off-label. “Beyond support, you get information,” Madison says.


She and other clinicians emphasize it’s important to guard against misinformation and ultimately to consult with a doctor. But sharing experiences with others can raise questions that help you to be more thoughtful in considering treatment options with a provider. All things considered, experts say, it’s most important to stay engaged in your care to get all the information you need about the drugs you’re taking – whether that’s on the label or not.…