The Personal Health Navigator is available to all Canadian patients. Questions about your doctor, hospital or how to navigate the health care system can be sent to AskPaul@Sunnybrook.ca
The Question: I have diabetes and my doctor has prescribed a relatively new drug to treat my condition. I trust my doctor, but I’m still worried about taking a new medication. I remember all those news reports about Avandia – another diabetes drug that turned out to have serious side effects. Should I be worried?
The Answer: I wouldn’t want you to lose sleep from worry, but your concerns do have some merit. The full effects of a drug – the benefits and potential harms – became known only when it has been used for an extended period by many patients.
“The way in which a drug is used in the real world is often very different from how it is used in a clinical trial,” says Dr. David Juurlink, a physician and drug-safety researcher at Sunnybrook Health Sciences Centre.
Before a new drug ends up on the market, a pharmaceutical company must conduct a series of studies as part of the government approval process. Usually these tests are carried out on a few thousand patients under near-ideal circumstances. “The manufacturer purposefully selects people who they think might benefit from their drug, and they exclude people who are particularly likely to be harmed,” explains Dr. Juurlink. The patients are then closely monitored for results, including potential side effects of treatment.
This pre-market research provides a best-case scenario of a drug’s safety and effectiveness picture, because “real-world” patients are often very different from those in the clinical trials. Once a drug enters the market, it may end up being used by millions of patients worldwide. Rare side effects that weren’t apparent in pre-market studies may then come to light. Furthermore, “because patients in clinical practice may be on more medications and less closely monitored, the risk of drug interactions is higher,” he adds.
As a general rule, physicians are trying to act in the best interest of patients when they prescribe a new drug, says Dr. Juurlink. “Doctors want patients to feel better or live longer because of our treatments.”
A new drug may be promoted as having some novel mechanism that works differently than older medications, suggesting it may be particularly helpful for certain patients.
“There is a tendency to believe that new and approved is new and improved. But that is not always the case,” he says. And physicians, like everyone else, can succumb to the pharmaceutical sales pitch.
It’s clear from your question you have some confidence in your doctor’s judgment. But how can your doctor protect you from what’s currently unknown – such as side effects that could emerge over time?
Dr. Juurlink says it’s important to keep your physician informed about how you feel while taking the medication. “If you don’t feel better, the doctor needs to know because that might warrant reconsideration of the drug or the dose prescribed.”
Still, some side effects may not be obvious. In other words, you might not feel them. They may be revealed only through a blood test or another medical procedure.
Dr. Juurlink says patients may be able to help themselves by paying attention to any reports that suggest there could be a problem with their medication.
For instance, you could set up a Google alert to automatically notify you of news about the drug you’ve been prescribed. “The internet is actually a useful resource for patients,” he says. Of course “you have got to be careful because there is all kinds of misinformation on the internet, particularly from people with axes to grind.”
If the news comes from a credible source, such as a medical journal, the U.S. Food and Drug Administration or Health Canada, you should mention it to your physician. In fact, with an alert system, you may learn of a potential problem sooner than your doctor. But your doctor will be well positioned to help interpret that information.
Taking a new drug “is not necessarily a bad thing, it might turn out to be good thing in the long run,” says Dr. Juurlink. “We often just don’t know up front.”
But playing an active role in your health – paying attention to how you feel and being alert to news about your medication – should give you a greater sense of control.
Paul Taylor is Sunnybrook’s Patient Navigation Advisor. His column Personal Health Navigator provides advice and answers questions from patients and their families, relying heavily on medical and health experts. His blog is reprinted on healthydebate.ca with the kind permission of Sunnybrook Health Sciences Centre. Email your questions to AskPaul@sunnybrook.ca