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Because my husband snores, he developed severe cataracts that rendered him, for a time, legally blind. That may sound like an odd cause and effect, yet that's exactly what happened after Bill used doctor-prescribed nose drops containing steroids to open up his clogged nasal passages.
At first they worked like a charm and quieted his snoring. But over the course of the following year Bill's sight got so blurry that he was unable to drive or work. The ophthalmologist we saw when his vision first started to decline diagnosed cataracts and told him he didn't need to worry because they take a long time to develop. He never asked Bill which drugs he was taking. Only when Bill's eyes rapidly worsened and our insurance finally gave us the green-light to go to a specialist ophthalmologist did we learn that taking steroids can cause cataracts, a side effect our family doctor never mentioned when he wrote the prescription. In the detailed fine-print information the druggist gave Bill, it said "many people using this medication do not have serious side effects," and among the 20 or so listed it said simply "vision problems."
Cataract surgery restored Bill's vision completely, and our lives are back to normal -- except that he had to endure this trauma simply because he took a drug his doctor prescribed.
Unfortunately, our situation is a snapshot of a troubling trend. While many drug side effects are fleeting and minor, reports to the FDA from doctors, patients and manufacturers about adverse effects and deaths linked to prescription drugs have nearly tripled in seven years, according to a 2007study, which revealed that nearly half a million serious adverse drug reactions were reported to the agency between1998 and 2005. And because reporting is voluntary, the FDA's Office of Drug Safety believes it hears only about 1 percent of all cases of adverse drug reactions -- serious and less so -- according to its own 2004 report.
This spike is not fueled just by recent surprise findings, such as research showing that the diabetes drug Avandia increases heart-attack risk or connecting the anemia medications Procrit, Epogen and Aranespto shortened overall survival in women with breast or cervical cancer. Many long established blockbusters, among them statins and newer antidepressants, have well-known serious side effects. "These potent drugs offer some important advantages but there is often a price to pay," says Curt Furberg, M.D.,Ph.D.,a coauthor of the recent study and professor of public health at Wake Forest University School of Medicine.
A sweeping overhaul of the FDA that became law late last year should help remedy some of the more glaring flaws in the prescripion-drug surveillance system. But it will be two to three years before most changes start making a difference, experts estimate. And nothing in the law speaks to another source of drug-safety problems: deadline-driven drug approvals. Drugs rushed to market had five times the rate of severe side effects requiring recall as those not released this way, according to a Harvard University study in the March 2008 New England Journal of Medicine.
As my husband and I learned, the other safety net consumers count on -- the wisdom and expertise of our own doctors -- also can fail. In a 2006 UCLA study that involved surveys of both doctors and patients, as well as taped transcripts of actual office visits, physicians neglected to mention potential side effects of medications they were prescribing two thirds of the time. When they did, they often downplayed the dangers to the point of trivializing them.
Some side effects are rare and many are undoubtedly worth tolerating to treat, control or cure a serious illness that may be far more dangerous. What's more, doctors have many topics to cover in the short time today's managed care lets them spend with patients. But patients should be warned about known side effects, alerted to how to handle potentially dangerous ones and listened to about their concerns. They should also keep the drug information they're given to show their doctor in case of side effects. This is especially important for women, who take more drugs than men and metabolize some of them differently.
Of course, it's not just a flawed side-effect reporting system that's to blame for the surge of prescription drug problems. The current drug pre-market approval and post-market surveillance systems, for which the FDA is responsible, have serious problems, which the agency itself recognizes and is working to change.
New drugs are tested for safety and effectiveness in large clinical trials that involves several thousand volunteers. If side effects crop up, FDA scientists determine whether the medication's benefits outweigh potential risks. If the drug is approved, any side effects are noted on the information that goes to doctors and patients.
But since 1992 some drugs have been approved under a congressionally mandated "priority review" process requiring the FDA to act on certain new drug applications within six months or lose user fees paid by the drug companies. In 2006 the Institute of Biochemical Medicine concluded that the agency's testing system was "impaired." "Too often the pressure to get drugs approved quickly led to some drugs being approved with less information than was needed to ensure patient safety," says Sheila Weiss Smith, Ph.D., an associate professor of pharmaceutical health services at the University of Maryland School of Pharmacy.
"There is growing scientific evidence that this practice has contributed to the release of drugs that are not as safe as they should be," says Dr. Furberg. Drugs that received priority review include Rezulin, a diabetes drug pulled in 2000 for causing liver problems, Vioxx and its competitor Bextra, pulled in 2004 and 2005, respectively, for increasing the risk of heart attack and stroke, and cholesterol-lowering Baycol, removed in 2001 for its link to muscle damage. There are no plans to change this practice, according to Steven Nissen, M.D., chairman of cardiovascular medicine at the Cleveland Clinic.
What's more, the agency lacks the expertise in emerging sciences such as genomics and lipidomics to rigorously evaluate the newer biotech drugs created using these new techniques, according to a 2007 report by the FDA's own Science Board, done at the agency's request. This weakness could possibly allow potentially lethal meds to be approved.
"I was struck by two things: the sincerity and dedication of the FDA staff and how crippled they are by systemic deficiencies within the agency," says Garret A. FitzGerald, M.D., a member of the panel and chair of pharmacology at the University of Pennsylvania School of Medicine. "Here is an agency charged with the safety of the American consumer that uses hand-written reports and has outmoded computer sytems. The infrastructure needs to be brought up to 21st-century standards."
Another problem? Clinical testing doesn't always reveal every side effect a drug has. Relatively rare reactions -- they might hit one in 1,000 users -- may not show up until years after the now approved medication has been taken by millions. That's how scientists found the link between SSRI (selective serotonin reuptake inhibitor) antidepressant such as Prozac and Zoloft and higher risks of suicide or bizarre and violent behavior.
One of the ways the FDA monitors the safety of approved prescription drugs is through its MedWatch program, which relies on drug makers, doctors and consumers to voluntarily report adverse reactions to the agency. These reports may not trigger alarm bells in a timely manner. After Vioxx was approved, in 1999, scientists discovered it carried cardiovascular risks that prompted a labeling change, in 2002. It took another two years of study before the drug was pulled off the market. If the reaction is rare enough, the FDA may never learn about it.
Of course, the person who should be helping you look out for and cope with side effects is your doctor. Some physicians are scrupulous about this, but many are not. It's not just that two -thirds of the time they don't mention side effects from the medicines they prescribe -- or when they do they downplay them.
There's also evidence that when patients do complain of getting symptoms that could be drug side effects, many doctors discount them. Consider what happened to 650 patients in a University of California, San Diego, study published last year. Subjects complained of muscle aches, pain, memory lapses or cognitive impairment after taking cholesterol lowering statin drugs. Researchers found physicians frequently did not connect their patients' symptoms to the statins they were taking. In nine out of 10 cases, it was the patient, not the doctor, who initiated discussions of these muscle-related reactions, which are so common they are listed on package inserts. Slightly more than 60 percent of patients who complained said they felt their doctors did not appreciate the impact the symptoms had on their quality of life. And in roughly 50 percent of cases, doctors insisted the symptoms weren't linked to the statins. They told patients they were just getting old, it was their imagination or that statins don't cause side effects.
Since statins are the best-selling prescription drugs in medical history and their effects are widely recognized, "this may be the best-case scenario," says Beatrice A.Golomb, M.D., Ph.D.,associate professor of medicine at the University of California, San Diego, and lead author of the study.
Physicians point out other complications. "While doctors should, of course, talk about possible side effects," says Columbia University's Dr. Legato, "we also know that hearing about them makes some patients resist taking life saving medications." The average 15.7 minute visit doesn't provide much time to add side effects to all the topics doctors need to cover, such as smoking. Trying to do so much in a routine visit can make physicians feel like "hamsters in a cage," says Howard Brody, M.D., Ph.D.,a family physician and director of the Institute for Medical Humanities at the University of Texas Medical Branch at Galvesto. And, notes G. Caleb Alexander, M.D., assistant professor of medicine at the University of Chicago, "patients may experience side effects simply because the doctor suggested the possibility."
Drug-education expert Michael S. Wolf, Ph.D., disagrees. "Doctors have an obligation to inform patients about potential side effects," says Dr. Wolf, assistant professor of medicine at Northwestern University's Feinberg School of Medicine. Patients go home with little information about how to take a drug properly or about potential side effects because "there's a large health-care system breakdown," says Dr. Wolf, whose research shows that nearly one out of two patients misunderstand common drug instructions. "The information patients get is written at a level that is difficult to comprehend. Physicians are not counseling and assume the pharmacists will; pharmacists don't have the time and patients fall through the cracks." The best way to keep from being one of those patients? Educate yourself about your medicines, be alert to problems and ask questions until you get the answers you need.
Since doctors may not always be forthcoming -- and women are at greater risk than men -- it pays to ask the following four questions the next time your doctor pulls out a prescription pad:
Since it's hard to predict how a new medicine will affect you, your best protection is to assume that any new symptom you develop after starting it could be an adverse reaction, even if it's not listed on the warning label. "Just because the FDA approves a drug doesn't mean it's completely safe," says Michael Negrete, CEO of the Pharmacy Foundation of California. "Patients need to take charge because these are potent chemicals -- and in rare instances, the cure can turn into a killer." Common side effects include loss of appetite, nausea, vomiting, abdominal pain, skin rashes, easy bruising, bleeding, breathing difficulties, diarrhea, muscle and joint aches, depression, dizziness, confusion and memory loss.
If you think your medication is making you sick, "Don't just live with it or stop taking your medication without telling your doctor," says Curt Furberg, M.D., Ph.d., professor of public health at Wake Forest University School of Medicine. Alert your doctor immediately. She may take you off the drug, at least temporarily, to see if it's the source of the problem. Even foods and beverages such as grapefruit, grapefruit juice and alcohol can affect how drugs work, producing side effects. If you're taking more than one drug, you could be having a bad reaction from the combination. To help figure out which is the culprit, compare the possible side effects of every drug you're taking. You may even need to go off each one temporarily to see if symptoms stop. Don't forget to tell your doctor about nutritional supplements you're taking, as these may interact with drugs.
"Some side effects become apparent immediately," says Dr. Legato, "but others can take weeks or months to appear." Occasionally they can emerge years after you start taking a drug owing to changes in body chemistry or the cumulative negative effects of years of ingesting it. Using inhaled steroids for asthma or allergies, for example, may contribute to bone loss, and lithium that controls bipolar disorder (manic depression) can lead to kidney damage. If you become ill, be sure to tell your doctor about any medicine you're taking in case your new illness is associated with those drugs.
Be Sure to Always:
Inventory your meds. Periodically take all prescription, OTC and dietary supplements you're currently taking to your doctor's office and review them for possible drug interactions.
Review the doses of your prescription pills once a year with your doctor. Body chemistry changes and kidney and liver function slow over time, making us metabolize drugs differently. You may need to change how much you're taking or switch to another medication.
Ask your doctor about taking fewer drugs. You may be able to stop taking some medications that aren't essential. If you're taking a combination product that delivers several medicines at once, maybe you can take a single drug instead.
Use the same Pharmacy to fill all your prescriptions and make sure that your computerized record contains all your current prescriptions. Whenever you get a new drug, ask the pharmacist to check for drug interactions. Also find out whether there are any non-prescription drugs, foods or supplements that you should avoid with this medication or if adverse reactions have emerged since the drug was originally approved. "Pharmacists are often underutilized by patients," says Howard Brody, M.D., of the University of Texas Medical Branch at Galveston. "But they have multiple sources of information, including access to databases doctors don't see."
Can you trust the package insert? Tthat depends. When you picked up your prescription, you probably received a patient information leaflet (PIL) written in what attempts to be everyday language by the manufacturer or pharmacy. For side-effect issues, focus on the sections called "contraindications" (which means: who shouldn't take this drug) and "side effects."
The problem with PILs is that they're not always comprehensive -- some side effects may not be mentioned. You'll find the most complete list of proven side effects on the "full prescribing information" list that the FDA requires makers to provide to doctors and pharmacists, and which is available to you on the Internet. The easiest way to find it: type the medicine's name into your computer browser. (for example: www.ambien.com.) Look for a link that takes you to the doctor, health-care provider or "full prescribing information" section. You can also get it by calling the FDA's consumer information line at 888-463-6332 or go to www.fda.gov, move your mouse to "drugs" in the left-hand column and click on "index to drug-specific information."
Less comprehensive but easier to understand: drug information from the U.S. National Library of Medicine and the National Institutes of Health. It's well laid out, concise and presented in a question-and-answer format. (Visit www.medlineplus.gov. Click on "Drugs and Supplements" to reach the home page. then click on the first letter of your medication's name. Scroll until you find your drug.)
Our advice? Start with the NLH Web site for an overview, then read the PIL. If you want to drill deeper -- or have a symptom not on the other two lists -- read the prescribing information. Below, the surprising differences we found listed for zolpidem (Ambien). -- Catherine Winters
Name of drug
Patient info leaflet (PIL)
-6 common side effects
-6 "unlikely but serious"
-1 "rare" side effect
-5 reactions, including sleep-driving
-5 symptoms of serious allergic reaction
Grand total: 23
Medline, Web site of the NLH
-22 side effects that warrant a call to the doctor if they persist or become severe
-13 serious side effects
-1 caution that patient should alert the doctor if changes in mental health occur
Grand total: 36
Full prescribing information
-35 side effects seen in long-term clinical trials
-177 symptoms experienced at least once by patients who were taking the medicine (but not necessarily caused by it)
Grand total: 212
To find out why women suffer from worse drug-related side effects, and to learn about what the FDA is doing to address the problem, pick up a copy of the July issue of Ladies' Home Journal, on newsstands now.
Originally published in Ladies' Home Journal, July 2008.