Talk to your doctor before deciding to make any changes in your prescription drugs based on information on this web site.
Special Problems in Nursing Homes
All of the problems of dangerous misprescribing of drugs for people living in the community are even worse in many nursing homes. For example, one study found that almost 40% of nursing home residents were being given antipsychotic drugs even though only a small fraction of them actually were psychotic. Another study found that one-third of people in nursing homes were getting seven or more prescription drugs. (See the section on the misprescribing and overprescribing of drugs for more information on the extent of prescription drug use in nursing homes.) Most of the rules below for safer drug use apply in all situations, including the nursing home situation, but there are some differences. The main one is that for patients in nursing homes, the brown-bag session and filling out the Drug Worksheet should be done by the nursing home staff, including the nurse, doctor, and pharmacist. If you are the child, other relative, or friend of a nursing home resident, you have the right, with his or her permission, to demand and receive a completed Drug Worksheet for that person and an explanation of the reasons for each drug being used. You can obtain this information, with the help of your own pharmacist and possibly your own doctor. This will very likely help to reduce the number of drugs being given and, where appropriate, reduce the doses of drugs still judged to be necessary. By taking care of these matters, you will have made a major contribution to the health and well-being of your loved one(s) in nursing homes.
Doctors and pharmacists often blame the adverse effects of prescription drugs on patients, accusing them of improperly taking their medications. The standard solution offered by some health professionals is to get patients to better “comply” with doctors’instructions by using what are called compliance programs or strategies. (Another word for compliance is, of course, obedience.) Occasionally, the blame is also put on doctors for misprescribing and overprescribing, on pharmacists for failing to detect serious drug interactions, and only rarely on the drug industry for overselling drugs to doctors and now directly to patients through direct-to-consumer advertising. Even when it is acknowledged that health professionals are partially responsible for adverse reactions, the proposed solution is based on the assumption that the system of professional education will prepare doctors to better learn about the proper use of drugs and pharmacists to do a better job of learning about and detecting dangerous drug interactions.
While important changes need to be made in the way patients, doctors, and pharmacists perform these important tasks, they are not likely to occur without other, more primary changes. First, improved communication with your doctor is necessary. Second, you must have access to comprehensive objective information about the risks and benefits of prescription drugs written in nontechnical language distributed to you by your pharmacist with each new and refill prescription.
Communication: Activating Yourself and Your Doctor
Patients and their families and friends need to feel comfortable approaching the doctor, with the help of their pharmacist, and to begin working with the doctor to reduce the number of drugs and the dosage of drugs being used, whenever possible. In most cases, this will result not only in fewer adverse reactions, including life-threatening ones, but also in fewer drugs being used, inevitably saving money as well. Equally important, this process will improve patients’ ability to properly take the drugs that are actually needed. Studies show that more drugs lead to poorer patient compliance with instructions, while fewer drugs lead to better compliance.1
This problem is most serious for older patients, who proportionately take a higher number of drugs than their younger counterparts, but it can be a significant problem for younger patients as well. This chapter assumes that most doctors who take care of older patients, and even many doctors who treat younger age groups, have not had adequate training in the problems of drug prescribing and rely too heavily on drug company promotion to make prescribing decisions. For example, too many doctors usually employ the same decision-making process (when to treat and what drug and dose to use) for older adults as for younger people. This too often results in their prescribing too many drugs at doses that are too high. In addition, many older people see multiple doctors—an internist, a gynecologist, and a heart specialist, for example. Communication among these physicians about what drugs are being prescribed is often deficient.
The major reason for making a sharp distinction between drugs that we label “Do Not Use” and other drugs is to inform patients and their physicians about drugs for which there are safer alternatives, also listed herein.
“Do Not Use” Drugs
If a drug already being used or being considered for use is one of the drugs that we list as “Do Not Use” or “Do Not Use for Seven Years After FDA Approval,” ask your doctor about alternative therapy, which could be either nondrug therapy or a safer drug. If the drug you are using is listed as “Limited Use,” it may also be a good idea to discuss the drug with your doctor to see if a better alternative might be found.
“Do Not Use” drugs that have subsequently been taken off the market, usually long after we warned against their use, include the antihistamines Seldane and Hismanal, the heart drugs Posicor and Baycol, the painkillers Duract and Butazolidin, the antibiotics Zagam and Raxar, the antidepressant Serzone, and the weight reduction drugs Redux and ephedra.
“Do Not Use for Seven Years After FDA Approval” Drugs
Several drugs on this web site are listed as “Do Not Use for Seven Years After FDA Approval.” For many years, we have warned patients not to use newly approved drugs unless they are one of the decided minority of new drugs with evidence that they provide a breakthrough beyond existing treatments. A study, involving Dr. Sidney Wolfe as one of the authors, provides clear evidence why this caution of waiting seven years is well founded. A total of 548 new chemical entities (drugs marketed for the first time in the United States) were approved in 1975–1999. By 1999, 45 drugs (8.2%) acquired one or more black-box warnings and 16 (2.9%) were withdrawn from the market. The estimated probability of acquiring a new black-box warning or being withdrawn from the market over a period of 25 years was 20%. Half of these black-box warning changes occurred within 7 years of drug introduction; half of the withdrawals occurred within 2 years. The article concluded that serious adverse drug reactions commonly emerge after FDA approval. The safety of new agents cannot be known with certainty until a drug has been on the market for many years.2 This study provides the basis for our “Seven-Year Rule” concerning newly marketed drugs that are not therapeutic breakthroughs.
Therefore, one way of protecting yourself without being deprived of new, breakthrough drugs, is to say no to using newly approved drugs unless they are in the small minority of such drugs with a significant therapeutic benefit.
Although most doctors are quite willing to learn to prescribe fewer and safer drugs, this is more likely to occur if you follow the Ten Rules for Safer Drug Use outlined on this web site and have access to objective drug information written specifically for patients. Being more assertive with your doctors or pharmacists is not only appropriate but may be an important factor in better protecting your health. Remember—the doctor is working for you, and with you.
Ten Rules for Safer Drug Use
Rule 1: Have “Brown Bag Sessions” with Your Primary Doctor; Fill Out a Drug Worksheet.
It is impossible to overemphasize the importance of this first and most crucial step in preventing adverse drug reactions. Whenever you go to a doctor you have not previously seen or to one with whom you have never had a brown-bag session, gather all prescription and over-the-counter drugs and dietary supplements in your medicine cabinet or anywhere else and bring them to the doctor so that a list can be made and you can start to fill out a Drug Worksheet.
The purpose of the Drug Worksheet is for you and your doctor (or doctors) to keep an ongoing record of all drugs you are using, the purposes for which they are being used, adverse reactions, whether the drug is working, and other information essential to the safest and most effective use of these products.
Doctors should never prescribe a drug or renew a prescription, nor should you be willing to get a new prescription, without full, up-to-date knowledge of all drugs already being taken or likely to be taken.
Before your brown-bag session with the doctor, your pharmacist may help you to fill out some of the blanks on your Drug Worksheet.
Once you have brought in all the drugs you are taking, ask your doctor to help you fill out the Drug Worksheet. You will probably be able to fill out more of the information concerning over-the-counter drugs yourself, since doctors often do not know that you are taking them or for what purpose. The doctor will be able to help you to fill out most of the information concerning prescription drugs, at least the ones that he or she has prescribed for you.
Explanation of Items on Drug Worksheet
a. Name of drug, of doctor who wrote the prescription, and date drug was started or the dosage changed: Drugs should be listed by both brand and generic names, since both are commonly used. All drugs prescribed by all doctors should be listed. Over-the-counter drugs and the amount of alcohol, tobacco, and caffeine used should also be indicated. There are many dangerous interactions between drugs and between drugs and alcohol, so this information is extremely important in avoiding adverse drug interactions.
b. Purpose of the drug: Identify the reason for which each drug is being taken. Often, because physicians are frustrated at not being able to do anything else for the patient, or sometimes because the doctor believes that the patient will not be satisfied unless a pill is recommended, prescriptions are written without a valid medical reason. In one study, patients reported that one out of every four times (25.4%) they received a prescription, they were not told the purpose of the drug being prescribed.3
c. Dose, frequency of use, and duration of use: It is important to know what the dose is, how often it is supposed to be taken, at what hours, and for how long.
d. When the drug should be stopped or the need for its use reevaluated: For any drug, new or old, you should assume that it should be used for as short a time as possible unless there is evidence that its continued use is necessary. An exception to this is the use, for a prescribed period of time (even if you are feeling better), of antibiotics. Evaluation at least every three to six months of the need for each drug being used will reduce the number of drugs being taken. For some drugs, such as tranquilizers, sleeping pills, anti-depressants, and others, much more frequent reevaluation is necessary.
e. Important possible adverse effects of the drug: Because many of the most serious perceptible adverse effects of drugs are often wrongly attributed to such things as “growing old” (such as falling, memory loss, depression, and many more), it is important for patients to know about the adverse effects of the drugs they take so they can recognize them and report them to the doctor. In one study, researchers found that 37% of documented adverse drug reactions had not been recognized by patients and reported to their doctors, and that the majority of these patients had not been informed about possible adverse drug reactions by their doctors.3
f. Important possible drug and food interactions, especially with over-the-counter drugs, and diet recommendations: Ask your doctor which foods and other drugs taken along with your drug can interact and cause adverse effects, and ask for dietary recommendations.
g. How you are actually taking the drug: Always be straightforward with your doctor about whether or not you are taking your medicine and how often. Do this even if you had no defined reason for stopping. This is important because not giving your doctor this information can lead to mistaken conclusions about what dosage or drugs work.
h. New problems or complaints noticed by the patient, friends, or family since any of the drugs listed on the worksheet have been started: As mentioned above, patients themselves often do not notice a change, especially older adults who are inclined to blame many of their problems on aging. Friends and relatives are often the first to notice adverse drug reactions, especially ones that affect thinking or mood. An additional difficulty is that patients are often reluctant to tell their doctors that something the doctor did to try to make them better actually made them worse. The safest assumption is that any worsening of a patient’s condition or any new symptom that develops after a drug is started is an adverse drug reaction until proven otherwise.
i. In the judgment of you, your family, and your doctor, is the drug working? Have the purposes for which the drug is being prescribed (as in [b]) been achieved?
Rule 2: Make Sure Drug Therapy Is Really Needed.
Often, drugs are prescribed to treat situational problems such as loneliness, isolation, and confusion. Whenever possible, nondrug approaches to these problems should be tried. These include hobbies, socializing with others, and getting out of the house. When a person is suffering from an understandable depression after losing a loved one, for example, support from friends, relatives, or a psychotherapist is often preferable to drugs such as antidepressants. (See discussion on the proper use of antidepressant drugs for depression.)
Nondrug therapy, such as weight loss and exercise, is preferable to drug therapy for such problems as mild high blood pressure and mild adult-onset diabetes. (See discussions of high blood pressure and diabetes.) Increasing fiber and liquid in the diet is preferable to using laxatives (see discussion of diarrhea). For swollen legs due to “bad” veins in the legs (not due to heart disease), wearing support hose is less expensive, safer, and probably more effective than taking heart pills or water pills.
Drugs should rarely be prescribed for anxiety or difficulty sleeping, particularly in older adults. See our discussion of this problem and nondrug solutions.
A last category of “disease” for which drug therapy is rarely, if ever, appropriate is drug-induced disease or adverse drug reactions. The proper treatment for drug-induced parkinsonism is not a second drug to treat the problem caused by the first drug, but, rather, stopping the use of the first drug.
For any condition, always talk to your doctor about whether the selected drug may cause problems (adverse effects) worse than the disease being treated. A common example of this is the extraordinary overtreatment of older people with slightly high blood pressure but without any symptoms of or problems caused by high blood pressure. (See guidelines for treatment of high blood pressure.) In most cases, treatment will make the person feel worse, with no evidence of any benefit. Always consider the seriousness of the condition that your doctor is considering treating, and try to make sure that the treatment is not worse than the disease.
The guiding principle is to use as few drugs as possible, in order to reduce adverse reactions and increase the odds of properly taking the drugs that are really necessary.
Rule 3: If Drug Therapy Is Indicated, in Most Cases, Especially in Older Adults, It Is Safer to Start with a Dose That Is Lower Than the Usual Adult Dose.
More generally, start with as low a dose as possible. In other words, “Start low, go slow.” A lower dose will cause fewer adverse effects, which are almost always related to dose. In the elderly, some experts suggest starting with one-third to one-half the usual adult dose for most drugs and watching for side effects, increasing the dose slowly and only if necessary to get the desired effect.
Rule 4: When Adding a New Drug, See If It Is Possible to Discontinue Another Drug.
If your doctor is considering adding a new drug, this is an opportunity to reevaluate existing drugs and eliminate those that are not absolutely essential. The possibility of an adverse drug interaction between the new drug and one of the old ones may lead to discontinuing or changing the use of a drug.
Rule 5: Stopping a Drug Is as Important as Starting It.
At least every three to six months, regularly review with your doctor the need to continue each drug being taken. For many mind-affecting drugs, such as sleeping pills, tranquilizers, and antidepressants, and for antibiotics, this reevaluation should be more frequent and sooner. The prevailing principle for doctors and patients should be to discontinue any drug unless it is essential. Many adverse drug reactions have been caused by continuing to use drugs long after they are needed. Many drugs such as antidepressants, sleeping pills, tranquilizers, and others that are prescribed for an acute problem are not needed beyond a short period and cause risks without providing benefits. Slow and careful weaning off these drugs may significantly improve the user’s health. In addition to considering whether to stop the drug, you and your doctor should discuss the possibility of lowering the dose. As mentioned above, an exception to this is the use of antibiotics for the prescribed period of time, even if you are feeling better before having finished the prescribed dosage.
Rule 6: Find Out If You Are Having Any Adverse Drug Reactions.
If you develop any of the following reactions after beginning to use any drug, contact your doctor. Ask if you really need a drug in the first place and, if you do, whether a safer drug can be substituted or whether a lower dose could be used to reduce or eliminate the adverse effect. This web site lists widely used drugs that can cause each of these adverse effects.
• mental adverse drug reactions: depression, hallucinations, confusion, delirium, memory loss, impaired thinking, and insomnia
• nervous system adverse drug reactions: parkinsonism, involuntary movements of the face, arms, and legs (tardive dyskinesia), dizziness on standing, falls (which can sometimes result in hip fractures), automobile accidents that result in injury because of sedation, and sexual dysfunction
• gastrointestinal adverse drug reactions: loss of appetite, nausea, vomiting, abdominal pain, bleeding, constipation, and diarrhea
• urinary tract adverse drug reactions: difficulty urinating or loss of bladder control (incontinence)
If you or a relative or friend have any of the above problems or develop other problems after starting a new drug and are taking any of the drugs listed under the respective problem, notify your doctor or tell your friend or relative to notify his or hers.
Another way to identify possible adverse drug reactions you may be having is to look up the name of your drug using the search function on this site. Then scroll doown to the section in the drug profile containing details on adverse reactions caused by the drug.
The remaining rules for safer drug use (or nonuse) were compiled from a number of lists, but particularly from the World Health Organization’s General Prescribing Principles for the Elderly.4, 5, 6 These rules, however, apply to all ages. All doctors and patients involved in drug therapy should know them.
Rule 7: Assume That Any New Symptom You Develop After Starting a New Drug May Be Caused by the Drug.
If you have a new symptom, report it to your doctor.
Rule 8: Before Leaving Your Doctor’s Office or Pharmacy, Make Sure the Instructions for Taking Your Medicine Are Clear to You and a Family Member or Friend.
Regardless of how old someone is, the chance of adverse reactions is high enough that at least one other person—a spouse, child, or friend—should know about these possibilities. In the presence of such adverse reactions as confusion and memory loss, this is especially critical. For older adults, the complexities of drug use may be greater, especially for people taking more than one drug and people with physical or mental disabilities. In these cases, it is even more important to inform another person about possible adverse drug reactions.
Ask your doctor to make sure that the label on the drug states, if at all possible, the purpose for which the drug is being used. This is especially important when you are using multiple drugs but is always important as a way of increasing your and your family’s or friend’s participation. All information concerning the proper use of the drug should also be on the label. In addition to the label, you should get a separate instruction sheet and have it explained to you.
Rule 9: Discard All Old Drugs Carefully.
Many people are tempted to keep and reuse drugs obtained in the past, even though their condition has changed. Additional drugs used may make the earlier drugs much more dangerous. In addition, you may be tempted to give drugs, such as antibiotics, to a friend or relative who you believe may benefit from them. Resist these temptations and avoid further problems caused by using outdated drugs by throwing them away when you are done with your course of therapy.
Rule 10: Ask Your Primary Doctor to Coordinate Your Care and Drug Use.
If you see a specialist and he or she wants to start you on new medicines in addition to the ones you are on, check with your primary doctor first—usually an internist or general or family practitioner. It is equally important to use one pharmacist, if possible.
What You Can Do: Finding Information About New Drugs
Information on commonly used drugs can be found on this web site and in our book, Worst Pills, Best Pills. For monthly updates on new drugs and newly reported adverse drug reactions, you can turn to the Public Citizen’s Health Research Group newsletter, Worst Pills, Best Pills News (available from this web site or in hard copy). But what if you are prescribed one of the flood of new drugs that are now coming on the market? In 1994 and 1995, for example, 50 new drugs were marketed in the United States, while in the following two-year period, 1996 and 1997, this number almost doubled to 92 new drugs. Although fewer drugs have been approved in recent years (an average of 22 per year have been approved from 2000 to 2003), they include many big-sellers, like rosuvastatin (CRESTOR), that should never have been approved. Where else can you go for objective drug information? Until the FDA requires the distribution of objective information written in nontechnical language, placing the risks and benefits of prescription drugs in a context meaningful for patients with each new and refill prescription, you have two choices—the nearest pharmacy or the local library. You should not turn to most sites on the Internet. Drug companies and marketing firms working for drug companies maintain Internet sites that are nothing more than a new platform for drug advertising, and as with all advertising for drugs, the benefits are overemphasized while the risks are understated. Public Citizen's Health Research Group is able to offer you independent, unbiased information because we do not accept any money from corporations, professional associations or government agencies.
Reading Package Inserts
For every bottle of a prescription drug delivered to the pharmacy—these usually contain a very large number of pills—the FDA requires drug companies to attach detailed written information for doctors and pharmacists about the drug’s uses, adverse effects, drug interactions, and dosage recommendations. This piece of paper goes by several names; the most common is simply the package insert. Only information that has first been approved by the FDA can be included in a package insert, and it is usually the best picture we have of the risks, at the time of approval, of a new drug. FDA-approved package inserts are not routinely given out by pharmacists, but it’s easy for you to get one for either a new or an old drug—just ask your pharmacist. If your pharmacist tells you that she or he can’t give you the package insert because it is against the law or regulation, get a new pharmacist. For many brand-name drugs, FDA-approved inserts are available online. Simply type in the brand name of the drug followed by .com.
The package insert is written in technical language, in very small print, and you may need some help with the jargon. Despite what some paternalistic doctors and pharmacists think, there is little in the package insert about a drug’s risks that can’t be understood by a motivated patient.
For the elderly or others with substandard vision, reading the small print may be a bigger problem than understanding the contents of the package insert. Help on this score is available in the form of the PDR—Physicians’ Desk Reference—a dictionary-sized, annual compilation of FDA-approved package inserts that often can be found on public library reference shelves and in bookstores. Helped along by Dorland’s Illustrated Medical Dictionary or some other medical dictionary (also available in many public libraries and on the Internet; you can search on Google, for example, for “medical dictionary”), the average reader can usually get a general idea of the drug’s indications (approved uses), contraindications (no-no’s), and other potential hazards. Even if you don’t fully understand the complex medical language, the PDR will often flash a warning that tells the prudent reader to ask the doctor some pertinent questions. One big advantage of the book over the actual package inserts is that the print is a lot easier on the eyes. Because the PDR is published only once a year, however, information about the very newest drugs may be absent. Also, not all older drugs are included, and the main edition of the PDR does not include OTC (over-the-counter, or nonprescription) drugs, although they do publish a separate book of this information.
The information in package inserts is divided into a number of sections. Those sections of greatest importance to patients include the following:
Indications and Usage
“Indication” is the term used for a drug’s FDA-approved use. The FDA has approved the drug only for the specific uses, or indications, listed in the package insert. Clinical studies and a rigorous FDA review are required to establish a drug’s safety and effectiveness for a particular use. Doctors are not bound by law or regulation to prescribe drugs only for FDA-approved uses, and there may or may not be adequate scientific evidence supporting the safety and effectiveness of a drug when it is prescribed for a use not approved by the FDA.
These include other drugs or medical conditions with which the drug should not be used because of serious safety concerns. They may include some serious drug interactions between the drug about to be prescribed and a drug already being taken by the patient.
The adverse drug effects listed in this section of the package insert have usually come from the clinical studies that were done before the drug was approved for sale. This is a good source of information about the adverse effects of a new drug and may be as much as we know about these risks when a drug is first marketed. However, this risk information must be placed in its proper context. The number of patients receiving a drug in clinical trials is relatively small—typically only a few thousand individuals at the most. Rare but serious adverse reactions to a drug may not be detected until years later, after large numbers of people have been exposed to the drug.
This is why we recommend that you do not take a new drug until it has been released for at least seven years (see the section of Frequently Asked Questions for more information about this designation), unless it is one of the rare “breakthrough” drugs that offer some important documented advantage over older proven drugs. Remember, most new drugs are not breakthrough drugs.
The precautions section of the package insert contains information about other drugs and medical conditions for which the drug should be used only if its potential benefits outweigh the risks. These situations often require special monitoring for toxicity by the doctor. In addition, this section contains information about the known drug interactions when a new drug is approved. The drug interaction information in the package insert can be lifesaving.
Dosage and Administration
Not only are the specific uses for a drug approved by the FDA, but also the dosage range and sometimes even the duration of treatment. Dosages or durations of treatment not listed in this section may or may not be safe or effective. Frequently, most of the patients studied in clinical trials are younger or middle-aged men, and information may not be available on the proper dosage of a drug for women, the elderly, or children. If special dosage information is known, it will appear in this section of the package insert.
You can ask your pharmacist for a package insert; in fact, you can do this even before you have a prescription filled. Read it over, and if you think it describes a drug you should not be taking or if you have questions about it, talk with your doctor.
You have a right to all of the information in the package insert. Assert this right; it could save your life.
Beware of Patient Information Leaflets (PILs) Routinely Distributed by Pharmacists
Ask the pharmacist for the full professional labeling instead. Remember, for many brand-name drugs, FDA-approved inserts are available online by typing in the brand name of the drug followed by .com. Many pharmacists are distributing patient information leaflets (PILs). Do not confuse these with FDA-approved package inserts for the drugs you are taking. Pharmacists’ PILs are produced by commercial information vendors and printed out on pharmacists’ computer systems, but there is little or no evidence supporting the completeness or quality of information contained in these leaflets. In fact, guidelines for the quality of information contained in PILs distributed by pharmacists were not established until 1996.7 However, these guidelines are only voluntary and patients have no way of knowing if a particular PIL meets them.
The most recent, nationwide study on PILs was commissioned by the FDA and done by researchers from the University of Wisconsin.8 From a random sample of 384 community pharmacies, a total of 1,367 PILs for four drugs were evaluated: (1) atenolol (TENORMIN), a high blood pressure drug; (2) the popular cholesterol-lowering agent atorvastatin (LIPITOR); (3) glyburide (DIABETA), used in the treatment of type-2 diabetes; and (4) nitroglycerin (NITROSTAT), used under the tongue for chest pain (angina).
Not a single one of these 1,367 PILs met all of the nationally accepted guidelines. In fact, the highest mark in the survey went to a drug that contained 80% of the information that patients should be receiving, and the average leaflet provided only 50% of the minimum amount of information needed to enable a patient to use a drug. Incomplete drug information is misleading and thus potentially dangerous.
One of the very discouraging results were in two very important areas of PIL evaluation: Contraindications and Precautions. This information is contained in the professional product labeling. Only about one-fifth of the atenolol PILs contained 80% or more of the required information about Contraindications. None of the PILs for glyburide or nitroglycerin reached this level of information content. The results for Precautions were similar. Approximately one-fourth of the atorvastatin PILs reached the 80 to 100% level of information. The PILs for the other three drugs totally failed.
Focusing on the scientific accuracy of the PILs evaluated for the cholesterol-lowering drug atorvastatin, the findings were alarming. There were more than 53 million prescriptions dispensed for this drug in 2001. Fewer than 1% of atorvastatin PILs (0.6%) cautioned about the drug’s interaction with gemfibrozil (LOPID). By contrast, atorvastatin’s professional product labeling warns of increased risk of a serious adverse reaction (rhabdomyolysis) that can lead to kidney failure when the drug is used in combination with drugs like gemfibrozil.
Only one-quarter of the atorvastatin leaflets warned consumers that blood tests are needed to monitor for possible liver failure. The drug’s professional product labeling recommends that function tests be performed prior to starting the drug, at 12 weeks following initiation of treatment, and after any elevation of dose, and semiannually thereafter.
These PILs currently being distributed by pharmacists are misleading and potentially dangerous because of the amount of important safety information that is omitted. In addition, some PILs have been found that contain indications, or uses for drugs, that are not FDA-approved and are also FDA-disapproved (because there is no evidence of a benefit for that particular use but there are serious safety concerns). Pharmacists’ PILs should not be considered as a reliable source of information for the safe and effective use of prescription drugs.
BEWARE OF DIRECT-TO-CONSUMER ADVERTISING
Whether on television, radio, or in print ads, the main purpose of advertising is not to educate but to sell drugs. The falseness of these ads, often understating the risks and overstating the benefits, has increased because of dangerously lax FDA enforcement over prescription drug advertising. Between 1998 and 2003, there was an 85% decrease in FDA actions to stop such misleading advertisements.
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