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News
Health questions about ... Prescription safety
March 19, 2008 - Article Courtesy of the Des Moines Register
John Rovers is an associate professor and director of the Community Pharmacy Residency Program at Drake University. He answered questions about drug safety, in the wake of troubling reports about established prescription drugs, such as Vioxx and Vytorin.
Q: All prescription medications must be approved by the Food and Drug Administration. Why do we keep reading about problems that crop up long after that approval?
A: The FDA must serve two groups of stakeholders who are often on different sides of the same issue. Patients who are sick and pharmaceutical companies generally want medications to be approved for sale as soon as possible. But patients or their family members who have suffered from an unexpected adverse drug effect (e.g. Vioxx-related heart attack) want the FDA to slow down and act more deliberately. The FDA is basically in a no-win situation.
You also need to understand the drug approval process.
Prior to approving a drug, the FDA requires three phases of drug testing. Phase 1 is in healthy subjects while Phases 2 and 3 are in populations of patients who have the condition for which the drug company hopes to sell the drug. All subjects in all trials combined usually add up to no more than a few thousand people.
So, if a side effect occurs in every 2,000 patients, you may only see it in a single patient during clinical testing and cannot be certain that it was even caused by the drug being studied until the drug is out for sale and being used in tens of thousands of patients.
Q: What if studies raise questions about a drug I'm on?
A: Talk to your physician and pharmacist. If you don't have a regular pharmacist who knows you and your medications and takes the time to answer your questions, get one. (Don't choose a pharmacist based only on price - if your $4 prescription lands you in the hospital, perhaps it was not really that cheap.) Ask them what they know and what they have read. If you have found information in the media or on the Internet, bring it with you. Much of the information published in the media is over-simplified, so it can be misleading.
Information on the FDA's Web site, www.fda.gov, is dependable, often written for a general readership and accurate, but it may be a few days to a few weeks behind what you see in the daily news reports.
Much medical information takes a certain level of skill to interpret accurately, so if you are not sure you understand what you are reading, ask your pharmacist or physician for help. The concern raised in the media may not even apply to your specific situation. Finally, to quote my statistical colleagues - correlation is not causation. A drug may be related to a kind of problem (i.e. is correlated with it) but that is not the same as saying it caused it. Other medications you may be taking, other conditions you may have, the nature of your illness, your medical history, genetics and a host of other factors are often involved in determining what a drug may do. Just because Vioxx was associated with heart attacks did not mean it caused a heart attack in everybody who took it or that every heart attack in a Vioxx patient was caused by Vioxx. Get help in understanding how the news about a drug problem applies specifically to you.
Q: If I have doubts about my medication, how dangerous is it for me to just stop taking it?
A: It depends a lot on the disease and the drug and your own history. For some medications, abruptly stopping therapy can result in a rapid rebound onset of symptoms. When you start taking a drug, ask your pharmacist and physician if it's safe to stop taking it suddenly. Otherwise, unless you believe you are suffering from a serious side effect, it's probably wise to at least call your pharmacist and ask before just stopping. Then call your doctor and check if he or she wants you to come in for an evaluation.
Q: Does this happen more often with newer drugs? Do older drugs tend to have fewer surprises?
A: Basically, the answer is yes. Older drugs will have been used for long periods of time and in diverse populations of patients. Although older medications still cause side effects, they tend to be more predictable.
Q: How can I tell if the medication I'm on has been tested for the condition I have? How can I tell if a medication has been tested in children?
A: The FDA monograph of a drug will state if the drug is approved for use in children or for your specific condition. These monographs are not consistently available on line, so you may need to check with your pharmacist. Official monographs are published in the Physician's Desk Reference (available at most libraries) but the book is not especially user-friendly. As for children, relatively few medications not specifically used in diseases of childhood have been well-tested in children. If a drug has been adequately tested in kids and is approved for use in children, it will be so stated in the monograph.
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