First, you have to get your hands on one, which isn�t always easy. Your pharmacy should have a current package insert for any drug dispensed; if it doesn�t, ask the pharmacist to get you one. Package inserts are not the same as the abbreviated safety information printouts, often very helpful, that many larger pharmacies offer with your prescription: make sure the pharmacist knows you want both. (Note: Since the printed material on inserts is referred to by the FDA as �labeling� information, �package insert� and �label� are used interchangeably. Neither refers to the label affixed to your pill bottle.)

Some patients know to look in the PDR [Physician�s Desk Reference] which is a compendium of package inserts provided by pharmaceutical companies. What we often forget about the PDR is that older editions often have outdated label information, and because of printing schedules, even the newest edition can easily be a revise behind. Many package insert revises are minor, but not all. Check at the very end of the package insert or the PDR entry to see when it was last updated.

Package insert styles vary from company to company. You can usually tell which companies view them as a useful exercise and which do them grudgingly because they�re forced to. But inserts do generally conform to a basic eleven-point format mandated by the FDA since 1979. Since the print is usually as small as the statute will allow, use a magnifying glass if you need to.

Begin with your drug�s Name: note both its brand name and its generic name. You can then generally skip the Description, as well as the section on Clinical Pharmacology (unless you are very curious about how much of the drug will end up in your urine). Go directly to Indications, which is the diagnosis or diagnoses that the drug has been formally approved to treat. This is a basic piece of information that consumers often don�t know. However, just because you have been given a drug doesn�t mean that you have been diagnosed with one of the illnesses listed under Indications. Bear in mind that a drug can be prescribed for various reasons other than the FDA-approved indications, and many drugs have well-established secondary off-label uses.

If a drug is being prescribed to you for something other than the FDA-labeled indications, you should feel free to ask your doctor why. But make sure you ask in a noncombative way and with the understanding that off-label uses are not only perfectly acceptable but are sometimes more beneficial than the labeled uses. Just say, �I saw this on the label, and can you explain it?� You may learn something and in the process, if you teach the physician something, all the better. You can also ask your pharmacist to ask your doctor.

Next are Contraindications. These contain the strongest warnings about reasons the drug should not be used because the risk clearly outweighs any possible benefit. More often than not, the contraindications consist only of known hypersensitivities to the drug itself or to other drugs in its �therapeutic class� (for example, not just �antibiotics,� but �quinolone antibiotics�). Therefore, in order for you to read the contraindications properly, you need to know the class of the drug as well as any experience you might have had in the past with that specific drug class. (The class can usually be discerned from the contraindication language itself, although if you�re not sure, ask your pharmacist.) Contraindications can be general, or specific to your age, sex or disease state or even to other medications you are taking, either by prescription or over the counter.

Keep in mind that there are some circumstances in which any label caution, even a contraindication, might be reasonably disregarded by your doctor. For example, you may have already tried and failed all the other less risky treatments for an illness that requires treatment. On the other hand, you should never simply assume that your doctor has put a great deal of thought into this kind of a risk/benefit assessment. It is equally possible that he or she forgot about the contraindication, forgot about your previous hypersensitivity to a drug in the same class or forgot the drug was in the same class. Again, it never hurts to ask.

The next two sections, Warnings and Precautions, are meant to be the meat of the label for both doctors and patients. They are supposed to provide as much useful information as possible to assist in handicapping the risk/benefit ratio for the drug in any given situation. They are also a legal minefield, since many product liability cases involve �failure to warn.� Therefore, some of the language of these cautionary guidelines is meant to be more preventive for the drug company than the patient. The decision whether to place this information in Warnings or in Precautions is often subject to drug company idiosyncrasies or legal strategies-as well as FDA advisory committee mandates--so the two sections are best read and digested together. Warnings, by statute, are supposed to be �serious adverse reactions and potential safety hazards,� while Precautions are there to help doctors and patients exercise �special care.�

The strongest warnings are not actually in the Warnings section. They appear in what is called a black box, which is usually placed at the very top of the insert. Technically, a black box warning (which most drugs do not have) is slightly less absolute than a contraindication, but it often has an equal if not stronger impact because of its prominent placement. As with contraindications, there are circumstances in which black box warnings may be reasonably disregarded by your doctor, after a careful assessment of the possible risks and benefits. However, even though the addition of a black box to an insert is often heralded by letters to physicians and coverage in the professional and lay press, don�t assume that the news got to your doctor. If you are being told to take something that contradicts the caution in the black box, ask your doctor why this is so.

While Warnings can be about anything and appear in any order, there are more formal rules for Precautions. The General precautions and the Information for Patients tend to be two versions of the same information, one for your doctor, the other for you. Basically, Information for Patients is supposed to list everything your doctor or pharmacist should have told you before letting you take the drug, in order to prevent any of the problems listed elsewhere on the label. After that, often, comes Laboratory Tests, a section that tells the doctor which tests are recommended to assure that the drug is at the proper therapeutic level in your bloodstream. Some tests may also be recommended to check the functioning of organs or body systems that are occasionally affected adversely by certain drugs. Many drugs do not require any lab tests at all. On the other hand, some doctors can be lax about ordering those tests that are required or recommended, assuming they will be able to �tell� if there�s a problem (or presuming that you will �tell� them). If your doctor does not order these tests at the recommended intervals, ask about it.

The Drug Interactions section lists the known interactions of the drug with other drugs and will sometimes also note whether any commonly predicted interactions have been experimentally ruled out. To read this section properly, you must know the generic name and the therapeutic class of all medicines, both prescription and over-the-counter, that you are taking, because the interactions are never listed by brand name. Your doctor, of course, must also have the same information about all the medicines you take, both prescription and over-the-counter. Remember that interactions are not all equally predictable or equally dangerous. Some are listed to keep patients from having certain drugs together in their system at all; others are listed to keep patients from swallowing two drugs together; others are listed to let the doctor know about possible changes in laboratory findings that the patient would never actually feel. (If your doctor should need more information, these interaction listings generally refer to specific studies or case reports available from the drug company.) Either way, if you are prescribed drugs together that have a listed interaction, you may wish to ask your doctor about it.

If you are neither pregnant nor a woman, skip ahead toAdverse Reactions, unless you�re the parent of a small child, in which case stop just before that at Pediatric Use.

If you are pregnant or are considering getting pregnant, the Carcinogenesis, Mutagenesis, Impairment of Fertility section refers only to animal study results in these areas. If there is evidence that the drug causes such problems in humans, that information goes in the Warnings section.

Move on to the Pregnancy precaution, which begins with a letter grade, A, B, C, D or X. Category A drugs have been clinically tested in pregnant women and have failed to show a risk to the fetus even if taken during the first trimester (which is considered a more vulnerable period for drug-related birth defects than the second and third trimesters); they have also failed to cause birth defects in animals. Category B drugs either failed to show a risk in animals and haven�t been tested on humans, or failed to show a risk in human tests but did show some birth defects in animals. (Animal tests for birth defects are not directly predictive of human birth defects.)

Most drugs that carry a rating are category C-in part because it is the default rating for drugs about which little is known but also because, presumably, the benefits of using the drug may acceptably outweigh the risks. Technically, C drugs either haven�t been tested in animals or humans or have been shown to have an adverse effect on the fetus in animals but haven�t yet been tested in humans. Category D drugs have shown evidence of human fetal risk based on individual cases reported during testing or postmarketing, although the potential benefits--in a serious or life-threatening situation--might still outweigh the risks.

Category X drugs are absolutely contraindicated for pregnant women because the risks to the fetus clearly outweigh any possible benefits to the mother. (Teratology experts are lobbying for an end to these categories.--except the X--and a more narrative approach to explaining what is known about pregnancy risks. For an excellent, free consultation on pregnancy risks for the drugs you are taking or thinking of taking, call the Motherisk service in Toronto, 416-813-6780.)

Also listed in this section are Nonteratogenic Effects, which are non-permanent problems the drug can cause the fetus or newborn infant, including such conditions as withdrawal symptoms and hypoglycemia.

The Labor and Delivery section is for drugs that have a recognized use during labor or delivery, regardless of whether it is an FDA-approved use, and it describes anecdotally what effect they have. The Nursing Mothers section explains what is known about whether the drug is excreted in human breast milk and whether it has been associated with serious adverse reactions in infants. If human data are available, you are told either to use the drug with caution while nursing or, if it has more serious risks, to choose between nursing or taking the drug. The same two warnings are used in cases where there is no human data.

Pediatric Use is usually the section where the label says �safety and effectiveness in children has not been established.� This doesn�t mean the drug can�t or shouldn�t be used in children. It just means that the drug company has not submitted studies for specific pediatric indications or dosages for FDA approval. Sometimes this section echoes cautions in the Warnings section about not using the drug in children under certain ages.

Adverse Reactions is the section that your doctor would rather you didn�t read, because it often leads people to overreact. The drug company is legally required to list every adverse reaction to its drug ever reported in this section and to attempt to quantify the risks involved, but the lists often do little but frighten patients. The rules are a little vague on whether the severity of a reaction or its frequency is more important, and the companies are given considerable leeway in how they present the litany of reported reactions. For these reasons, it is almost impossible to compare drugs on the basis of their Adverse Reactions sections. In theory, at least, a drug�s individual safety profile is supposed to be determined by which reactions graduate from this catchall section to Warnings or Precautions.

Reactions from preapproval clinical trials are listed first, beginning with reactions seen in more than one percent of the test subjects. Next come the �less than one percent� reactions, usually broken down by body systems. This is followed by a separate list of adverse reactions that were reported after the drug was on the market but not prior to approval.

Ultimately, the Adverse Reactions section is useful chiefly for one thing. If you are given a new drug and experience what appears to be an adverse reaction and your doctor says, �That�s impossible� or �I never heard of this drug doing that,� you can check and see if the reaction is listed. If it is listed, it doesn�t prove that it is the same reaction you had, but it can move the conversation to a more constructive exchange. If you have a serious reaction or one that isn�t listed, you or your doctor should be reporting it to FDA�s MedWatch system......

A Drug Abuse and Dependence section appears only if the drug is considered a �controlled substance,� because of its potential for abuse or dependence, by the Drug Enforcement Administration (DEA). These drugs, which include amphetamines, narcotic painkillers and some benzodiazepines, are rated by the DEA for abusability on a five-point scale, with �Schedule I� drugs being the most dangerous. The Abuse section includes the type of abuse, adverse reactions caused by the abuse and descriptions of susceptible patients. The Dependence section describes both physical and psychological dependence, the quantities needed to cause dependence and the adverse effects of chronic abuse and withdrawal.

Overdosage describes the symptoms of an overdose of the drug, possible treatments and the amount of a drug likely to be life-threatening.

The sections on Dosage and Administration and How Supplied contain information primarily for your doctor. But if you believe you are being given more or less than the �usual dose,� you might want to ask your doctor why. The How Supplied section may give you a clue to the best values in prescribing costs. (For example, sometimes a dose that is twice as strong is not twice as expensive. If the higher-dose pill can be cut in half, you can save money.)

At the bottom of the label, companies have the option of adding Animal Pharmacology, results of specific Clinical Studies and relevant References.

There are, of course, dozens of reference books geared to consumers that offer more accessible versions of the information on FDA-approved drug labeling, geared to consumers. They include big, thick lay guides by the United States Pharmacopeia and the American Medical Association; substantial, nonconfrontational general-audience books like The Essential Guide to Prescription Drugsand The Pill Book; substantial, confrontational general-audience books like The People�s Pharmacy series and Public Citizen�s Worst Pills, Best Pills and many lesser books masquerading as substantial. There are several things I have noticed about these books over the years.

First, they do not all contain the same information, and the subtle variations in individual entries can either allay or augment fears about specific medications in a way that is more subjective than most readers will realize. Some of these books are simply more party-line-oriented than others. Others appear to update certain drugs more aggressively than they do others. And when they update, they may or may not be persuaded by certain new reports, or they simply may not be as interested in certain kinds of reactions as you are.

Second, these books are not updated as quickly as you would like them to be, and even editions stamped with the current year may be a year or several years behind on the entry for the drug you are about to take. If you are taking a relatively new drug, it is especially important to consult the most up-to-date edition of the most aggressive resources you can find. (You should not assume that information on the Internet is more up-to-date simply because you got it via a newfangled delivery system. Much of the reference information about drugs on the Internet is completely undiscerning, boiled-down package-insert material from two years ago.)

Third, it is important to use all these resources as a guide to conversations with your doctor or pharmacist and not as an excuse to stop taking a medication because it seems too scary. One of the scariest things you can do is stop a medication without telling your doctor.

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