Pros, cons of rheumatoid arthritis drugs—and an FDA alert on Enbrel

Rheumatoid arthritis can be debilitating. So doctors and patients had high hopes a few years ago for TNF blockers, a class of drugs that promised to revolutionize treatment by targeting the inflammation that underlies the disease. But it turns out that the drugs, which interfere with a protein called tumor necrosis factor, can increase the risk of life-threatening infections and certain cancers. Now new evidence helps quantify those risks and provides guidance on when and how to use TNF blockers and other rheumatoid arthritis drugs.

The FDA has issued a new boxed warning about infections, including serious infections leading to hospitalization or death that have been observed in patients treated with etanercept (Enbrel). Infections have included bacterial sepsis and tuberculosis. The warning advises doctors to screen patients for latent tuberculosis infection before beginning Enbrel, and recommends patients educate themselves on the symptoms of infection and be closely monitored for any signs and symptoms of infection during or after treatment with the drug.

FDA reviewing safety of Botox

The Food and Drug Administration is reviewing the safety of Botox and related drugs after receiving reports of respiratory failure and death in a small number of people treated with the medications.

The most serious cases involve off-label uses of the drugs in children. And the maker of Botox is now being investigated by the U.S. Department of Justice for inappropriate promotion of off-label uses. But the FDA says that there have been at least a few reports in adults who got the shots for cosmetic or other approved purposes.

Botox and related drugs use very low doses of botulinum toxin, a powerful natural poison, to paralyze overactive muscles. The shots are approved to treat not only wrinkles but also neck spasms, excessive sweating, crossed eyes, and certain other conditions. Some doctors also use the toxin, without FDA approval, for problems such as spasticity in the legs and arms.

Doctors have long known that in people who have pre-existing neuromuscular disorders the shots can trigger effects far from the injection site, including difficulty swallowing and breathing. The new reports suggest that those effects may occur in other people too. The FDA says that to date only a "small" number of hospitalizations or deaths have been reported to the agency, but there may be unreported cases. The FDA is considering a new warning for all botulinum-containing drugs, including Botox, Botox Cosmetic, and Myobloc.

Here's how to protect yourself:

• People taking or considering Botox for cosmetic reasons should think about the potential risks.


• Those taking or considering Botox or related drugs for medical reasons, especially off-label ones, should make sure that their doctor has considered alternatives. If the shots are necessary, ask your doctor to use the lowest effective dose.


• People taking the drugs for any reason should contact their doctor if they experience any of these warning signs: difficulty breathing, talking, or swallowing; muscle weakness; and shortness of breath.

This article first appeared in the May 2008 issue of Consumer Reports On Health

What’s in your medicine bottle? Your prescription may not be what the doctor ordered!

Just last week, two patients asked me how they could tell if they were getting the right drug. Their pharmacy benefits plan had mailed them their refills, but the drugs looked totally different. In the case of my migraine patient, Leslie, 80 milligrams of Inderal® was now a blue capsule whereas in the past it had always been a yellow tablet. "How do I know if I’m getting the right thing?" she asked.

It's a good question and consumers have a right to be concerned. Years ago when my brother developed bronchitis, he was given a script for the antibiotic Vibrax® (a drug no longer prescribed) by our family physician. By the time he had finished the bottle, his cough was worse and he was even more run down, so the doctor's office phoned in another course of treatment. It wasn't until my brother picked up the pills from the pharmacy and saw that they looked different that he discovered that he had been taking Librax®, a sedating medication, by mistake—the "V" on the original prescription had been mistaken by the pharmacist for an "L."

Thirty years later, more than three-fourths of physicians are still scribbling prescriptions and look-alike and sound-alike errors are still being made. Although digital tools such as handheld prescribing devices and electronic health records are now available, only about 20 percent of us use them, and alas, our handwriting has not improved.

Opioids for relief of chronic pain? Try less risky treatments first

Chronic pain is one of medicine's conundrums. It has a myriad of causes, including injuries that fail to heal properly, nerve damage, and aging joints. And sometimes it seems to arise for no apparent reason. It's notoriously tough to treat.

As a result, people with chronic pain face a host of frustrations and often try many treatments and painkillers before finding relief. A new report from the Consumer Reports Best Buy Drugs project offers fresh guidance on using the strongest of these painkillers—called the opioids—to treat chronic pain.

This 20th Best Buy Drug report compares 12 opioids. We've chosen four generics as Best Buys for people who have chronic pain and whose doctors have concluded that an opioid is necessary. Based on their relative low cost, the evidence for effectiveness, safety, side effects, and dosing convenience and flexibility, the Best Buys are:

• Codeine plus acetaminophen
• Morphine extended release
• Oxycodone extended release
• Oxycodone with acetaminophen

These four medicines have a long track record and provide good value. They range widely in monthly cost, depending on dosing regimen. But most low-dose regimens will run you less than $150 a month or so.

There's no reason to take the brand-name versions of these drugs—Tylenol #3 or #4, MS Contin, OxyContin, or Percocet—or any opioid for that matter.

Evidence links the long-term use of opioids to some unpleasant side effects, such as loss of interest in sex and impaired sexual function; a decline in immune function; and an increase in the body's sensitivity to pain.  Also, the opioids carry the risk of being addictive and are prone to abuse and misuse. In people who genuinely need them to control moderate to severe pain, addiction is rare, however.

Our report finds that many consumers believe their chronic pain warrants the strongest of pain relievers. But the evidence actually shows that everyday pain relievers, when used in moderate to high doses, can be just as effective as the opioids against many forms of chronic pain—like back pain, osteoarthritis, and recurring muscle pain. And they are a lot safer.

If you suffer from chronic pain we also advise you to talk with your doctor about non-drug measures. Several, including cognitive behavioral therapy, exercise, spinal manipulation, and physical rehab programs, have been shown to ease pain and/or improve quality of life.

The bottom line: don't use opioids until you have tried other, less risky, pain relievers first, and failed to get adequate relief. Those include acetaminophen (Panadol, Tylenol, and generic), non-steroidal anti-inflammatory drugs (the so-called NSAIDs), such as ibuprofen (Advil, Motrin, and generic) and naproxen (Aleve, Naprosyn, and generic), or other non-opioid prescription painkillers.

To find out more about the uses and side effects of the drugs in this class, read our FREE Consumer Reports Best Buy Drugs report.

—Steve Findlay, managing editor, Consumer Reports Best Buy Drugs

5 ways to cut costs while staying healthy

The government may not want to use the "R" word, but there’s no question that the economy is in trouble. It's affecting all of us and causing us to tighten our belts. When it comes to medical care, telltale signs come early. Reports of increasing numbers of elective surgeries have been attributed to fear of potential loss of insurance coverage, similar to when rumors of company cutbacks surface. Routine and preventive care visits decline, and in my practice, I see more patients forgoing referrals to physical therapy because of the frequent co-pays.

Taking care of your health during a recession poses quite a challenge. If you’re healthy, you want to stay that way, and if not, you want to make sure that your treatment is not jeopardized. So what can you trim without sacrificing quality? Consumer Reports has a wealth of information on how to get the best value when it comes to your health.

• Ask your doctor about pill splitting. It can save money because pharmacies often charge the same amount for a particular drug regardless of its dose. There’s no harm in splitting pills as long as your doctor agrees with the idea, you learn how to do it properly, you split only pills that are scored, never split extended- or continued-release tablets, and use a safe pill splitting device, available at most pharmacies for around $5.
• Look into a prescription assistance program. If you need medicines (especially for a chronic condition) and have no health insurance, limited insurance, or lack drug coverage under your current health insurance policy you may qualify for assistance.
• Consider switching to a generic prescription drug. Consumer Reports Best Buy Drugs can help you find the most safe and effective drug for your condition and give you the best value for your health. Not only are generic medications proven and more affordable alternatives, but the newest brand name drugs have less of a track record for safety.
• Put your fancy gym club membership on hold. As the Consumer Reports survey on health clubs showed, you can pay up to $95 per month for name brand chains and still not get a quality experience. Try out your local Y or community center—which got higher marks in our survey than most big chains—or change some habits: take the stairs, park at a distance, walk the dog. As an inexpensive pedometer shows, those steps soon add up.
• Shop smart. Although it’s tempting to reach for inexpensive processed foods on the supermarket shelf, resist the temptation. It’s important to remember to eat healthy foods including fresh fruits and vegetables. Warehouse club supermarkets fared very well in terms of price on the 2005 Consumer Reports Grocery Store Shopper Survey of 24,000 respondents. Those that gave our readers the biggest bang for the buck (subscribers only) were Aldi, WinCo, Trader Joe’s, Market Basket, Cost­co, Shoppers Food Warehouse, Wal-Mart, and Stater Bros. (These chains are a good choice if your top concern is low prices, and service and the quality of meat, produce, and fresh-baked goods are less important.) Use the FDA’s free nutritional label training program to find information that will help you stay healthy by selecting the right foods when you shop.

—Orly Avitzur, M.D., medical adviser to Consumers Union

Poll: Most Americans don’t know they can report bad drug reactions

A new Consumer Reports poll shows that one in six Americans who have ever taken a prescription drug experienced a side effect serious enough to send them to the doctor or hospital, but the majority of consumers don't know they can report these side effects to the FDA, which is responsible for tracking drug safety problems.

To help make the public aware of the FDA's reporting program for drug side effects—known as MedWatch—Consumers Union today gave the FDA a petition signed by nearly 56,000 consumers asking that a toll-free number and website be included in all TV drug ads so people can easily report their serious side effects to the agency.

Of the consumers polled, eight in 10 (81 percent) said they had seen or heard an advertisement for prescription drugs within the past 30 days. Among them, virtually all—98 percent—viewed an ad on television. When asked if they think prescription drug advertising should include information to report an adverse drug reaction to the FDA, 87 percent of consumers said TV ads should contain the information, and 90 percent said print ads should do the same.

For more information, read the poll and the petition to the FDA, see Adwatch—our video series on the facts behind the drug ads, and watch our animated drug safety video, "The Drugs I Need."

Lipitor: The controversial ad proves highly effective

Don’t feel too sorry for pharmaceutical giant Pfizer, which announced late last month that it would put a halt to a highly publicized ad campaign featuring Robert Jarvik, M.D. as a spokesperson for their bestselling drug, Lipitor.

A new study by the Consumer Reports National Research Center (and reported in our March issue) suggests that the ads were extremely effective while they ran, and probably helped sustain Lipitor’s position as the No. 1 cholesterol-lowering drug -- even though the ads eventually were pulled.

The ads suggested, among other things, that Lipitor—a member of the class of cholesterol-lowering drugs known as statins—is a better choice than less-expensive generic statins that have come on the market. 

The Lipitor ad campaign came under scrutiny in recent weeks by both the media and the U.S. House of Representatives, which launched an investigation into celebrity endorsements of prescription drugs in direct-to-consumer advertising.

The committee is looking into Jarvik’s professional qualifications and his financial arrangement with Pfizer. Among the concerns: Jarvik, known for inventing the Jarvik artificial heart in the 1980s, is not a practicing physician, and it’s been reported that images of him rowing in one widely-aired TV spot turned out to be a body double.

The Consumer Reports survey, however, shows that Dr. Jarvik was a very effective and believable spokesman while the ads were running. In December 2007, we showed the television ad for Lipitor to 978 people who’d been advised by a doctor to lower their cholesterol.  Afterward, we asked viewers for their impressions. Among the key findings:

• Sixty-five percent said the ad conveyed that leading doctors prefer Lipitor.
• Forty-eight percent said Dr. Jarvik’s endorsement made them more confident about Lipitor. More than one-quarter (29 percent) got the impression from the ad that Dr. Jarvik sees patients regularly.
• More than two-thirds of respondents taking Lipitor said they were inclined to stay with it after seeing the ad. One third of those taking a brand-name statin other than Lipitor were likely to speak to their physician about switching.
• Forty-one percent said the ad conveyed that Lipitor is better than generic alternatives. (In fact, the vast majority of people who need to take a statin can get the same protection from a generic, and for less than half the cost.)

What’s more, people just plain liked the ad. Ninety-three percent of respondents found it friendly; 92 percent found it believable; and 91 percent perceived it as factual. No question those types of impressions have helped keep Lipitor the top-selling prescription drug in the United States for six years running.

We believe these findings underscore the need for consumers to view all drug advertising with caution. The ads may not include false information, but they also may not tell the whole story about the drugs they promote. That’s why we’ve launched Consumer Reports’ AdWatch, a series of video critiques that aim to fill in the blanks on direct-to-consumer drug ads. The first two installments critiqued television spots for Requip, the drug approved to treat Restless Legs Syndrome, and the sleep aid Rozerem. Stay tuned for our third AdWatch in the coming weeks.

For more information, see our comprehensive high cholesterol guide and Treatment Ratings (for subscribers) and our free CR Best Buy Drug report on statins.

—Jamie Hirsh, associate editor

Put Vytorin back—way back—on the shelf

Last month, Merck/Schering Plough Pharmaceuticals finally released the disappointing results of a clinical trial, completed nearly two years ago, on the hoped-for ability of Vytorin to halt the progression of thickening in the carotid arteries (the two major blood vessels in the neck). In the interim, with the public totally unaware of those results, Vytorin continued to be heavily advertised to the public and widely prescribed by physicians.

That two-year study of 720 volunteers with inherited very high cholesterol levels, showed no significant differences between the carotid artery scans of those patient who took Vytorin (a combination of Zocor and Zetia) and those who took Zocor alone, despite the finding that the Vytorin takers had lower LDL cholesterol levels.

I think this study has two important implications, over and above the money wasted on purchases of Vytorin:

1. There’s no connection between the lowered LDL cholesterol levels and the lack of change in carotid artery thickening (actually the Vytorin group had more plaque formation which was not, however, statistically significant). This is unlikely in view of the overwhelming evidence that ties LDL cholesterol to cardiovascular disease. Perhaps the study was not long enough.

2. There is fallibility in clinical studies that use so-called intermediate end-points (imaging techniques, biochemical changes) instead of real events (heart attack, stroke, death). There are still many unknowns about the causes of heart attacks; fully half of coronary-disease deaths occur in people with no discernable risk factors.

And what about the patients and professionals who believed the TV ads and the hype of the drug reps and spent large sums of money on a drug that was very likely not helping them?
Here’s my advice:

Regard Zetia for what is—excessive and expensive baggage and a relatively weak LDL cholesterol lowerer. It should only be used by those who cannot tolerate statins or by the few patients who are already on high-dose statin therapy and are not achieving desirable LDL cholesterol levels. As for the combination product Vytorin? Put it back—way back—on the shelf and stick to a statin drug, preferably one available as a less-costly generic version. Read our CR Best Buy Drug report on statins to see which ones we recommend.
—Marvin M. Lipman, M.D.

Dr. Lipman has been Consumers Union's chief medical advisor since 1967. He is a diplomate of the American Board of Internal Medicine (certified in endocrinology and metabolism) and is clinical professor of medicine emeritus at New York medical College.

Drugs for nerve pain, bipolar disorder linked to thoughts of suicide

The Food and Drug Administration has warned that a group of drugs called anticonvulsants can cause some people to have thoughts of suicide and to attempt suicide.

This new advice is based on an analysis of 199 studies involving nearly 44,000 patients. The analysis found that the risk of suicidal thinking, behavior, and/or attempts was quite low—less than 1 percent in both people who took one of the drugs and in those who took a placebo pill. However, among those who took one of the drugs, the risk of suicidal thoughts and attempts was twice that of those who took placebos—0.43 percent compared with 0.22 percent. The FDA reported that four people who took one of the drugs died by committing suicide while none of the patients taking a placebo did.

The analysis is the latest to link drugs that affect the brain and nervous system to an increased risk of suicidal thinking and attempts. Most notably, the FDA has also warned of those possibilities for antidepressants.

While stating that patients and doctors should carefully weigh the benefits of the drugs against the risks, the agency is urging doctors to “closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.”

We recommend that patients who start taking any of the drugs in this class also be on the lookout for deepening depression or expressed suicidal thoughts, and immediately consult a physician.

To find out more about the uses and side effects of the drugs in this class, read our full Consumer Reports Best Buy Drugs report.

—Steve Findlay, managing editor, Consumer Reports Best Buy Drugs

Older, cheaper drugs best first choice for high blood pressure in people with pre-diabetes

We’ve long recommended diuretics—the oldest, cheapest class of blood-pressure lowering drugs—for most people with high blood pressure. But one exception has been in people who have type 2 diabetes. In that case, newer and more expensive drugs called ACE inhibitors, such as enalapril (Vasotec and generic) and lisinopril (Prinivil and generic), offer special benefits, since they not only lower blood pressure but protect the kidneys from diabetes-related damage. Many doctors have long assumed those benefits also held true for people with the metabolic syndrome, a precursor to diabetes that multiplies the risk of heart disease. But a new study, published in the January 28 issue of the Archives of Internal Medicine, shows that those individuals should usually start with a diuretic too.

The trial, an influential study sponsored by the National Heart, Lung, and Blood Institute  called the "Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial", found that diuretics were also a better first choice than several other classes of medication, including alpha-blockers and calcium channel blockers. The diuretics were at least as effective as all those drugs in lowering blood pressure and preventing heart attack, and better at preventing heart failure or stroke. The benefits were especially striking in black people.  Generic diuretics can cost less than $5 a month, a fraction of what the other drugs cost.

Most people with high blood pressure—including those with signs of the metabolic syndrome, such as high triglycerides, a low level of HDL (good) cholesterol, and lots of abdominal fat—should now start with a diuretic.

Read more about:

• High blood pressure
• Blood-pressure lowering drugs

Trouble sleeping? Try this ad...

Consumer Reports has just posted the second in our series of CR AdWatch videos that add commentary and context to widely seen pharmaceutical advertisements. You’ll recognize this ad immediately: It’s the one that has Abe Lincoln and a talking beaver offering consolation to an unfortunate insomniac.

The ad—the latest in a series—is memorable not only for its quirky cast of characters, but also because the drug it promotes (Rozerem) does not appear to pose the same risk of chemical dependency as other prescription sleeping pills. Yet as our commentary notes, that doesn’t mean your first move after a sleepless night should be to beg for a prescription. I’ll let the AdWatch crew tell you the rest themselves.

Credit for the video belongs to our host, Associate Editor Jamie Kopf Hirsh, to CRTV News producer Ann Burr Tenthoff, and to the rest of the Consumer Reports Health team. And by the way, here’s a link to their earlier AdWatch video on a remedy for restless legs syndrome. We hope you’ll find them interesting and thought-provoking.—Kevin McKean, Editorial Director

Learn more

• Read about non-drug approaches to insomnia.
  
• CR Best Buy Drugs assesses drugs by effectiveness and cost. What insomnia drugs are the best overall buy?
  
• Not sure whether you've got insomnia or not? We'll tell you the symptoms, how common it is and how all treatment options compare in our Insomnia Treatment Center.

Q&A: Safe antibiotics for nursing moms?

My doctor recommended I not take an antibiotic for an infection I developed because I’m nursing and it may harm my baby. Are any antibiotics safe when nursing? —Y.Y., Colrain, Mass.

Some appear safer than others, though the risks haven’t been well studied. There’s concern that ingesting antibiotics through breast milk may cause infants to develop diarrhea, nutritional deficiencies, or other problems. But the amount of antibiotic that passes into breast milk varies by drug, so you can limit your baby’s exposure by using the ones least likely to leach.

The safest appear to be the cephalosporins, such as cefaclor (Ceclor and generic), cephalexin (Keflex
and generic), or cefdinir (Omnicef); macrolides, such as clarithromycin (Biaxin and generic), azithromycin (Zithromax and generic), or erythromycin (E-Mycin and generic); and penicillins,
such as amoxicillin, ampicillin, and oxacillin. Antibiotics to avoid include metronidazole (Flagyl and generic); quinolones, such as ciprofloxacin (Cipro and generic); and tetracyclines, such as
doxycycline (Vibramycin and generic) or minocycline (Minocin and generic).

Taking medication right after nursing may also minimize exposure.

Avandia - Our Take on the Controversial Diabetes Drug

The diabetes drug Avandia has been the subject of intense focus and debate - and confusion - in recent months. A study published in a leading medical journal in May 2007 indicated the drug may be associated with a higher risk of heart attack compared to a placebo or other diabetes medicines. Since then, several analyses of existing data on tens of thousands of patients have confirmed this observation.

But none of the studies offered hard proof of Avandia's link to a higher heart attack risk. And Avandia's maker, GlaxoSmithKline, has pointed to several older studies that did not seem to find such a problem. Based largely on this uncertainty and lingering questions about the methodology of the studies finding the link, an expert advisory panel to the Food and Drug Administration voted in July to keep the drug on the market.

After what press accounts characterized as a fierce internal debate - and a very close 8 to 7 vote in favor of Avandia by the agency's Drug Safety Oversight Board - the FDA in November formally concurred with the outside panel's advice to keep Avandia on the market. But the agency announced at the same time that GlaxoSmithKline had agreed to warn doctors and patients about the possible heart attack risk (on the drug's labels and in patient information), and to undertake a new long-term study on its safety.

The agency acted deliberatively and responsibly but should have gone farther. The new patient information material advises people with type 2 diabetes who also have diagnosed heart disease, or risk factors for heart disease, to talk to their doctors about the benefits and risks before taking Avandia.

We believe that people with type 2 diabetes who have been diagnosed with heart disease or have any other risk factors should not take Avandia under any circumstances until future studies, including the one GlaxoSmithKline will now initiate, fully exonerate the drug.

The rationale for this advice is two fold: (a) people with type 2 diabetes are already at considerably higher risk for heart disease and heart attack and taking a drug that possibly elevates that risk simply makes no sense; and (b) there are several alternative diabetes drugs which have quite good, and better known, safety track records. Several of those are low-cost generic drugs. Another is a drug named Actos which is in the same class as Avandia. To date, no studies have suggested Actos elevates heart attack risk and two studies have indicated it is associated with a significantly lower risk.

Since the majority of people with type 2 diabetes have other risk factors for heart disease (such as high blood pressure, high cholesterol, kidney disease, overweight or obesity) in addition to diabetes, we urge people with the condition who are currently taking Avandia to talk with their doctor about switching to another oral diabetes drug.

Our advice is consistent with the recommendations of health authorities in Canada, who urged doctors to use Avandia only in rare circumstances.

For more details, read our detailed report on all the oral diabetes medicines - from Consumer Reports Best Buy Drugs, a Consumers Union public education project.

Finally, an antidote to TV drug ads

If you watch any TV, you've seen the barrage of advertisements for prescription medications. They always start by showing someone in distress—from insomnia, allergies, erectile dysfunction or other medical condition. But after taking the drug, the person is either sleeping soundly or running through the fields, depending on the original ailment,  while the announcer reads a scary list of side effects in a voice so soothing that they almost sound fun.

The problem with such "direct-to-consumer," or DTC, advertisements is that they may generate excessive demand because people go straight to their doctors asking for this or that specific medication. In a 2006 survey by our National Survey Research Center, 78 percent of doctors said that patients asked them at least occasionally to prescribe drugs they had seen advertised on television, and 67 percent said they sometimes did so. And don't expect the ad barrage to let up.  While Congress recently gave the FDA more authority to regulate ads, it rejected a measure that would have allowed the agency to place a moratorium on ads for new drugs that raise safety concerns. The U.S. is one of only two countries in the world (the other is New Zealand) where such ads are legal. 

Well, starting this month, Consumer Reports is introducing an entertaining new online video series that will track and report on such ads. The videos are hosted by Associate Editor, Jamie Hirsh, and produced by the ConsumerReports TV News crew. This first installment concerns an interesting class of medications that are approved to treat something called "restless leg syndrome." That condition may sound fanciful, but it's a real problem. Something like 3 percent of Americans suffer from RLS, which is characterized by an uncontrollable impulse to keep moving your legs even when you are trying to go to sleep—which obviously could make sleep difficult.

Several years ago, doctors discovered that drugs that were originally developed to treat Parkinson's disease could provide meaningful help to people who suffered from moderate to severe forms of this condition.  But the drugs have serious side effects - one of the more bizarre involves a propensity for uncontrolled sexual or gambling impulses, as our video mentions. And while these medications may provide welcome relief to some RLS patients, the ads could leave anyone who ever suffered fidgetiness when trying to go to sleep to wonder whether he or she has RLS and should seek treatment.

We leave the rest to the video to explain, and we urge you to check back next month for the next installment in this fun and informative series!—Kevin McKean, Editorial Director

Learn more
Find more information on drugs commonly used to treat RLS in Consumer Reports' Medical Guide:

• Ropinirole (brand name Requip)
• Pramipexole (brand name Mirapex)

Off label drugs: Why you have to question your doctor

When your doctor prescribes a medication, you assume that the Food and Drug Administration has deemed it safe and effective for what ails you. That's not always the case. More than 20 percent of the drugs prescribed are for "off-label" use — that is, for conditions other than the ones for which they received FDA approval, according to a 2006 study in the Archives of Internal Medicine.

The range of drugs used off-label is far wider than thought, the federally funded study shows. They include medication for allergies, convulsions, heart conditions, indigestion, ulcers, and asthma. In 73 percent of the off-label cases, doctors had little or no scientific evidence to back up their choices.

Drug marketing plays a role, says Randall S. Stafford, M.D., Ph.D., of the Stanford Prevention Research Center in Stanford, Calif., and co-author of the study. "While direct promotion of off-label uses is illegal," he says, "there are several gray areas that provide the industry with an opportunity to increase the off-label use of their products." Over the past few years, some drugmakers have paid millions in fines for promoting off-label uses, said an official at the U.S. Department of Justice.

Physicians are not always aware that a particular use of a drug is not FDA-approved, especially if the off-label use has become commonplace, says Edward Langston, M.D., a spokesman for the American Medical Association. But he says doctors "need the flexibility to prescribe drugs off-label where it seems appropriate and there's peer-reviewed literature to support its use."

Certain off-label uses are appropriate and can even save you a lot of money. For example, some eye specialists use Genentech's cancer drug bevacizumab (Avastin), to inhibit the overgrowth of blood vessels in wet macular degeneration, an eye disorder, says R. Linsy Farris, M.D., M.P.H., a clinical ophthalmologist at the College of Physicians and Surgeons of Columbia University in New York. Published studies on its use, coupled with results in practice, have been so encouraging that Medicare frequently covers the cost despite the lack of formal FDA approval, he says.

In 2006, a similar Genentech drug, ranibizumab (Lucentis), was approved for macular degeneration. One injection costs $1,950, compared with $50 for the off-label drug, according to the April 3, 2007, Annals of Internal Medicine.

CR’s Take:
Ask your doctor whether your medication is FDA-approved for your condition. Or check at the FDA's Web site or our drug reviews. If it wasn't, ask why it was prescribed and if there's scientific support.

Older drugs work best for diabetes

An advisory committee to the Food and Drug Administration concluded in July that the heavily advertised and widely prescribed diabetes drug rosiglitazone (Avandia) posed a greater heart-attack risk than older, cheaper, equally effective medications. That comes on the heels of even stronger evidence that the drug, along with its relative pioglitazone (Actos), increases the risk of heart failure.

Here’s our advice on the best way to safely and effectively treat diabetes.

The FDA initially approved rosiglitazone and pioglitazone because randomized clinical trials found that they helped control blood-sugar levels. But after several years of the drugs’ use outside of that carefully controlled setting, researchers began detecting unexpected heart risks, especially in people taking rosiglitazone.

In contrast, research continues to document the safety and efficacy of older diabetes drugs, especially metformin (Glucophage and generic). That medicine controls blood sugar as effectively as other diabetes drugs, lowers the level of “bad” LDL cholesterol, doesn’t trigger weight gain, and is less likely to cause a dangerously low blood-sugar level (hypoglycemia). Moreover, the generic version of the drug costs just $38 to $60 per month compared with $142 to $262 for each of the glitazones.

If you can’t take metformin or if it doesn’t adequately control your bloodsugar level, talk with your doctor about glimepiride (Amaryl and generic), glipizide (Glucotrol and generic), or glyburide (Diabeta, Micronase, and generic). Those drugs, called sulfonylureas,pose fewer heart risks than the glitazones, and their generic versions cost less as well.

If none of those options works for you and you’re at low risk of heart failure, you could consider pioglitazone. Or ask your doctor about exenatide (Byetta) and sitagliptin (Januvia), new drugs that might be safer than the glitazones.

For more information, see our free Best Buy Drug report on diabetes.

This article first appeared in the November 2007 issue of Consumer Reports onHealth.

‘Behind the counter’ cold meds

“Cold medicine so strong you have to ask your pharmacist for it,” boomed an ad I heard recently over the loudspeaker in my drugstore. While consumers are long used to the distinction between prescription and over-the-counter medicines, many are still unaware of a federal law that went into effect in September 2006. It requires customers to show identification and sign a log when they purchase cold medicines, such as Comtrex Day/Night Flu Therapy and Sudafed, and other products that include the common decongestant pseudoephedrine. Drugstores are keeping the medicines either in the pharmacy
section or behind the cash register counter so they can collect the mandated information.

The reason pseudoephedrine is now sold in a controlled fashion is that it can be used to make the illegal and very dangerous drug methamphetamine, or crystal meth. Keeping tabs on who is buying large quantities of medicines with pseudoephedrine is a lawenforcement—not a consumer-protection—measure, despite what the ads may imply.

Several manufacturers have substituted phenylephrine for pseudoephedrine so their product can be sold on open store shelves. But the evidence, including a thorough review published in The Annals of Pharmacotherapy in March, shows that oral phenylephrine doesn’t work. So if you need an oral decongestant, ask your pharmacist for pseudoephedrine. Check with your doctor before taking cold medicine with either ingredient if you have anxiety, diabetes, heart disease, hypertension, hyperthyroidism, or take other drugs. Children under age 2 should not be given any cough or cold medication at all. —Ronni Sandroff, Director of Health Information

Find out more about the common cold and find out which treatments are most likely to work for you in our Treatment Ratings (available to subscribers of ConsumerReportsMedicalGuide.org).

Don't be taken by drug ads

Overheard recently on the radio: The pediatrician was about to conclude 6-year-old Michael's annual checkup and asked if his mother had any further questions. "No," she replied, and then felt a forceful tug on her arm as Michael blurted out, "Yes, we do, Mom. Ask the doctor if Viagra is right for me."

No, Michael was not precocious. He was merely following instructions given by a gray-haired person in a white coat in a TV ad. He might have thought that the drug ad was somehow similar to those for sugared cereals and junk food that interrupt his favorite cartoons on Saturday mornings. After all, they are both aimed at consumers who need an intermediary to get their hands on the advertised product: For one, a parent with the money to buy the "kid-friendly" food, and for the other, a doctor with a prescription pad.

Caveat prescriber

Recently, a 76-year-old retired journalist, a long-term patient, called me about an ad he saw for ropinirole (Requip), a drug previously approved for Parkinson's disease that now had been approved—the first drug ever to be so honored--for the treatment of restless legs syndrome, an uncomfortable urge to move one's legs, which can interfere with sleep. The journalist had been wrestling with that problem for years but had been coping lately with the help of a small dose of diazepam. He had seen the satisfied consumers in the Requip ad and wanted to try it. I resisted. He insisted. Against my better judgment, I gave in. At 3 a.m. I received a call from the emergency room, where he had been taken by ambulance because of a fainting episode due to a drop in his blood pressure just an hour or two after taking his first (and most likely his last) dose.

Truth in advertising?

In one survey, half of the respondents believed that drug ads had to be approved by the government before they were aired or printed, and nearly half thought that only "entirely safe" drugs were allowed to be promoted. Nothing could be further from the truth. The Food and Drug Administration (FDA), the government agency that has jurisdiction over drug promotion, rarely gets a chance to review ad copy before the public sees it. Months can go by before the agency catches up with any misrepresentation, puffery, or inaccuracies. Those months inevitably see burgeoning sales of the drug.

Direct-to-consumer (DTC) drug ads not only permeate the TV screen, but they also fill the radio waves, print media, and, more recently, the Internet. The pharmaceutical industry in 2005 spent the staggering sum of $4.86 billion on consumer advertising—more than the Gross Domestic Product of 53 countries, according to the latest World Bank data. It is a productive investment. As spending on DTC advertising has risen, so have the number of prescriptions written and drugs sold. For each dollar spent on advertising, the pharmaceutical industry recoups $4.25.

Add to that $7 billion spent on advertising to doctors and other professionals, and it's obvious why drug costs are so high in this country. Spending on drugs is only part of the overall increase in health-care costs that have now risen to the point that the U.S. is the world leader at $5,200 per capita per year. Yet we rank lower than several similar industrialized and even some less-developed countries on such public-health benchmarks as life expectancy, infant mortality, and rates of obesity and chronic disease. And people in those countries pay much less for drugs than we do here in the U.S. Is it a coincidence that DTC ads are not allowed anywhere except here and in New Zealand (where a ban is being strongly considered)?

What you can do

To be a savvy consumer, pay little or no attention to prescription drug ads. Those ads usually promote the newest and most expensive drugs. Many older drugs are available in generic form—and they can be every bit as effective as the newer brand-name drugs. Ask your doctor whether there's an older drug that has stood the test of time and can do the job as well as the newer product. Consult a nonbiased source, such as the Consumer Reports Consumer Drug Reference or the National Institutes of Health's Medline Plus, to learn about your alternatives, drug interactions, side effects, warnings, and how to take prescription medicines safely. 

And don't let the ads convince you that every personality quirk, such as shyness, fear of heights, or performance jitters, requires a pill. If you're bothered by such problems, open a discussion about them with your physician. —Marvin M. Lipman, M.D.

Dr. Lipman has been Consumers Union's chief medical advisor since 1967. He is a diplomate of the American Board of Internal Medicine (certified in endocrinology and metabolism) and is clinical professor of medicine emeritus at New York medical College.

Beware of drug soundalikes

The name of the sleeping pill Lunesta sounds a lot like Neulasta, the name of a drug used in cancer therapy. A pharmacist confused the two in a case reported in the journal Hospital Pharmacy. Fortunately, another pharmacist corrected the mistake before the wrong drug reached the patient.

Up to 25 percent of the reported medication errors are caused by confusing drug names that sound alike, according to a recent report from the National Academy of Sciences’ Institute of Medicine. Such potentially dangerous mix-ups are compounded by labels that look alike, poor physician penmanship, and sloppy pronunciation when phoning in drug orders. When mix-ups occur, patients not only fail to receive adequate treatment for their problem but might also suffer adverse events. Here’s how to protect yourself:

When your doctor prescribes a drug, ask him or her to print the name and dosage for you, then spell it back aloud. If it’s a brand-name drug, make note of the generic name as well.

Ask your doctor to briefly note the drug’s intended purpose on the prescription form. That will enable the pharmacist to make sure the drug is for the right purpose.

Don’t leave the pharmacy until you’ve checked the label on your prescription. If a refill doesn’t look the same as your usual medication, ask the pharmacist to double-check.

Over-the-counter heartburn drug could save you thousands

The over-the-counter drug omeprazole (Prilosec OTC) is just as effective in easing heartburn and acid reflux as costlier prescription medicines--and could save consumers up to $2,000 a year, according to an updated report from Consumer Reports' Best Buy Drugs initiative.

Prilosec OTC and prescription versions of similar drugs, such as lansoprazole (Prevacid) and esomeprazole (Nexium), belong to a class of drugs called proton-pump inhibitors (PPIs). They are among the most widely prescribed drugs in the country, and manufacturers have put a great deal of marketing muscle into steering consumers to their brands. Nexium, for example, was the second-most advertised drug in 2005, with a $205 million direct-to-consumer ad campaign.

But according to the Consumer Reports' Best Buy Drugs report, none of the PPIs are significantly more effective than the others, with the only real difference being price.

Nexium, depending on the dose, costs $181 to $193 a month, while Prevacid costs $131 to $186 a month. But Prilosec OTC, which was chosen as the Best Buy PPI, costs just $19 to $26 a month on average, and may even be cheaper at discount stores. Switching to the pill could save consumers $100 to $200 a month. Still, the report cautions that not everyone with heartburn needs a PPI, and says the drugs are overused in large part because of heavy advertising. In a recent Consumer Reports survey, physicians said PPIs were high on the list of drugs that patients requested because they had seen a TV commercial . In addition, the drugs do come with some potential risks, including a higher chance of pneumonia and infection with a bacterium called C. difficile. In December 2006 a study also suggested that taking PPIs for a year or more may increase the risk of hip fractures in adults over 50 years old.

If you only experience occasional heartburn and haven't been diagnosed with gastroesophageal reflux disease (GERD), try nonprescription antacids, such as Maalox or Tums, or acid-reducing drugs, such as famotidine (Pepcid, Pepcid AC, and generic) or nizatidine (Axid, Axid AR, and generic). People 65 and over and people with chronic medical conditions who take a PPI should get vaccinated against pneumonia and be sure to get a flu shot every year. For more information, read the Best Buy Drugs Report.