Heart-attack prevention: Statins aren’t for everybody

I started getting phone calls from my patients almost as soon as the headlines starting appearing last week. All the media were trumpeting the results of a new study showing that rosuvastatin (Crestor), a powerful cholesterol-lowering statin drug, slashed the risk of heart attack and stroke even in people with normal—that’s right, normal—cholesterol levels who also had high blood levels of a substance called C-reactive protein. CRP rises when the arteries are inflamed, and, as we’ve previously reported, growing research has linked such inflammation with an increased risk of heart attack. All of those callers wanted to know the same thing: Should they start taking the drug?

Here’s my answer to that and two related questions.

Should I immediately start taking a statin?
Probably not, at least based on this study. The trial, released on Nov. 9 by the New England Journal of Medicine, looked at some 18,000 people with an LDL (bad) cholesterol level less than 130 milligrams per deciliter and a CRP level over 2 mg per liter. Half got Crestor and half got a placebo. After about two years the study was halted because there were 44 percent fewer cardiovascular events in one group than in the other. The winner turned out to be the group that took Crestor.

Sounds impressive, right? Well, maybe not very. That’s because cardiovascular disease is relatively uncommon in the group of people enrolled in the study. So the absolute reduction in the rate of heart attack, stroke, and cardiovascular death went from about 2 per 100 patients in the placebo group to 1 per 100 in the treatment group. At that rate, 120 people would have to be treated for nearly two years to prevent one event. A benefit, yes, but is it one that’s worth the treatment’s costs?

Safety Alert: Infant gas relief drops recalled

If you use Mylicon anti-gas drops for your baby, Johnson and Johnson--Merck Consumer Pharmaceuticals Company is urging you to stop using the product because of a recall. The company, in consultation with the U.S. Food and Drug Administration, has announced a voluntary recall of approximately 12,000 units of Infants' Mylicon Gas Relief Dye Free (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed nationwide after October 5, 2008 in retail stores and pharmacies. The recall involves two lot numbers: SMF007 and SMF008. You can find the lot numbers on the bottom of the box containing the product and also on the lower left side of the sticker on the product bottle.

Although the potential for serious injury is low, the company is implementing this recall after determining that some bottles could include metal fragments that were generated during the manufacturing process. If any medical events were to occur, most are expected to be temporary and resolved without medical treatment. Parents who have given the product to their infant and are concerned should contact their health care provider immediately.

For more on this recall and for what to do if you suspect you have the recalled drops, please see the FDA notice. Read more on child safety on our Babies & Kids blog.

Just say no: Doctors’ drug freebies to kids are risky

Free drug samples for sick kids seem like a deal: You avoid lines at the pharmacy, keep cash in your wallet, and your kid gets to try out the drug right away. Everyone wins, right?

Wrong. There are sobering safety problems with the most popular drug giveaways that doctors hand out to their young patients, a new report from the journal Pediatrics suggests. The greatest potential danger with free drug samples to kids is that there are few safety measures in place to detect abuse, drug interactions, and improper dosing. Plus, doctors get these free samples from manufacturers to promote newer drugs, which are usually more expensive and have shorter safety records than similar medications that are just as effective but are less costly.

The Food and Drug Administration has attached serious safety warnings on 4 of the 15 most common freebie medicines given to kids (click on chart to enlarge). They include Adderall/Adderall XR (amphetamine/dextroamphetamine), Advair Diskus (fluticasone/salmeterol), Elidel (pimecrolimus), and Strattera (atomoxetine). A fifth drug, Singulair (montelukast), is currently under an FDA safety investigation.

The second-most popular drug sample, Singulair, a treatment for asthma, can cause suicidal thinking or actual suicide. It has also been associated with other behavioral changes. The average age of a child given a free sample of Singulair is 5. Advair Diskus, another asthma drug given away frequently, is generally used as a last line of defense for patients—in other words, your doctor should prescribe other medicines first—since it can actually increase the risk of having serious or fatal asthma.

Q&A: Do men need extra testosterone?

My husband's doctor prescribed topical testosterone after a blood test showed a low level of the hormone. But we're concerned about possible side effects. Who really needs extra testosterone? —T.L., Hamilton, Ontario, Canada

Most men don't. Even if your husband's testosterone level is below normal, he should consider supplemental doses of the hormone only if he also has signs of deficiency, notably a bothersome decline in libido and potency, a loss of facial or body hair, or osteoporosis before age 65—and only after ruling out or treating possible underlying causes of low testosterone, such as a pituitary or testicular disorder. There's good reason to skip testosterone if he can. Side effects may include blood clots, breast enlargement, decreased sperm production, worsening cholesterol levels, and possibly an increased risk of prostate enlargement or cancer. And the risks of taking testosterone long-term remain largely unknown.

Visit our Men's Health Center for more on conditions and treatments for men.

Safety Alert: ReliOn diabetes syringes recalled

If you have diabetes, the U.S. Food and Drug Administration urges you to check the packaging of your hypodermic needles because of a new recall. Tyco Healthcare Group LP (Covidien) is recalling 4,710 boxes of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.

The recall applies only to lot number 813900 syringes. This number can be found on the back panel of the 100 count syringe carton, or on the white paper backing of each individual syringe "peel-pack." These syringes are sold only by Walmart or Sam's Club pharmacies under the ReliOn name, and were distributed from Aug. 1, 2008, until Oct. 8, 2008. Walmart has posted recall announcements in stores and on its Web site.

For more on this recall and for what to do if you suspect you have the recalled syringes, please see the FDA notice. And for more on diabetes, see our Treatment Ratings, and our free Best Buy Drugs report on cost-effective drugs for diabetes.

TV ads for birth-control pill Yaz gloss over the risks

If you weren't paying close attention when you saw two recent TV commercials for the birth-control pill Yaz, you might have missed the part where they mention the serious and even life-threatening risks associated with the drug. That's because while a voiceover ran down the potential side effects of the drug, such as heart attack and stroke, pop music played in the background, and what appeared on the screen were images of women jogging, meeting up with their friends, and engaging in other everyday activities.

The ads raised a red flag with the Food and Drug Administration, which said the commercials glossed over the drug's risks and could give viewers the impression that Yaz is safer than has been demonstrated. The agency sent a warning letter in October to Bayer, Yaz's manufacturer, requesting that both commercials be pulled immediately.

In one ad, entitled "Balloons," the voiceover lists the side effects of Yaz while women are shown running in a park, driving, and singing. The FDA said the music and the numerous scene changes distracted viewers from hearing the risk information and made it difficult to process the adverse events associated with Yaz.

Tip of the day: Use drug-free remedies for your child's cold

What's a parent to do when their little one is sniffling, coughing, and sneezing? If your child is under age 6, don't reach for cold and cough medicines. Clinical trials so far have shown no benefit to giving children cough and cold products, except to sedate them. And these drugs pose a high health risk. Take a look at our advice on how to treat your child's cold and cough without drugs.

ADHD drug promotions don't tell you the whole story

Have you seen the recent ads and promotions for ADHD drugs? The ones that claim the drugs can help counter drug or alcohol abuse or help kids who have attention deficit hyperactivity disorder perform better in school?  Some of the promotions even fail to make it clear the drugs can cause dangerous side effects, like sudden death in those with heart abnormalities.

The Food and Drug Administration wants the ads and promotions out of the public eye. In late September the FDA sent warning letters to five drug companies to stop their campaigns: Shire for Adderall XR, Johnson & Johnson for Concerta, Novartis for Focalin XR, Mallinckrodt for Methylin, and Eli Lilly for Strattera.

An estimated 5 to 8 percent of school-aged kids in the US have ADHD. While the drugs used to treat the condition are generally effective and safe, they can in rare cases cause serious side effects, such as death and psychiatric disturbances. But in terms of how effective the drugs are, the ads in question go too far by claiming they can reduce problems that could arise from untreated ADHD, like poor school and job performance, social problems, and drug and alcohol abuse, the FDA said in its letters.

Drug Alert: Treat your child’s cold and cough, but skip the drugs

If you have a child under age 4, what are you supposed to do now that the makers of children's cough and cold medicines are warning parents not to use their products? Actually, all children under age 6 shouldn't be given these medicines. And these drugs should only be used with caution, if at all, for children up to the age of 12, according to our team of medical advisers.

During any given week in the U.S., parents are still doling out these ineffective products to millions of children. Clinical trials so far have shown no benefit to giving children cough and cold products, except to sedate them. At the same time, these drugs pose a high health risk. Particularly dangerous are combination cough and cold medicines (for example, Benadryl Allergy & Cold Fastmelt Children's or Tylenol Cold Multi-Symptom Children's), on which kids can more easily overdose.

Instead, you can do what moms and dads have been doing for generations—using good old home remedies like these:

• Keep your child warm and dry in inclement weather, which can actually cut the chance of catching a cold in the first place.
• Give your child hot chicken soup, which can help with his or her congestion and sore throat, plus lessen the feeling of being sick.
• Ask your child to cough or sneeze into tissues, and dispose of them after using.
• Dole out honey (one-half teaspoon to children ages 2 to 5, 1 teaspoon to children 6 to 11, and 2 teaspoons to those ages 12 to 18), or give your child hard (sugarless) candy to suck on to help reduce coughing.
• Show your child how to gargle with warm, salty water, which can ease a painful throat.
• Remind your child to wash his or her hands often, which can reduce the likelihood of transmitting infections.

To vaccinate or not to vaccinate?

For parents looking for information on vaccines, the Web can be a confusing place. Misinformation abounds about a purported link between childhood vaccines and autism, and anti-vaccination Web sites have been on the rise in recent years. Naturally, that can cause parents anguish about when and whether to vaccinate their children. But the science is clear; there is no concrete evidence of a link between vaccinations and autism. Meanwhile, largely because of the movement by a determined minority against vaccination, long eradicated diseases are gaining a new foothold, making vaccination as important as ever.

Another in a long line of studies, this one by researchers from Columbia University's Mailman School of Public Health, and released this month in the Public Library of Science, has also helped dispel the myth of a link between the measles, mumps and rubella (MMR) vaccine, and the development of autism in children.

Another theory, that mercury in thimerosal—a preservative that was once used in many vaccines—causes autism has also been disproved by several reliable studies. Nevertheless, thimerosal has been removed as an ingredient in most vaccines as a precautionary measure to lower children’s exposure to mercury (thimerosal is still used in most flu shots and is considered safe).

Zetia: Down for the count?

For the second time in six months, ezetimibe (Zetia), a featherweight LDL (bad) cholesterol fighter, has taken a hit, and this blow could well end its career. The referee, with the initials FDA emblazoned on his white lab coat, has begun the countdown.

Ezetimibe (made by Schering-Plough and still on patent as the brand name Zetia) was approved in 2002 for use with a statin to achieve additional small reductions in LDL cholesterol, compared to just the statin alone. In 2004, when Merck's brand of simvastatin, known as Zocor, was about to go off patent, Merck teamed up with Schering-Plough to produce a new patented product called Vytorin, a combination of simvastatin and Zetia. A vigorous advertising campaign resulted in billions of dollars in sales.

Then, in February of this year, the first blow landed: A two-year study showed that the combination product was no better than simvastatin alone in decreasing the growth rate of plaque in the carotid arteries. At that time the Consumer Reports Health blog referred to ezetimibe, alone or in combination, as "excess and expensive baggage, to be put back on the shelf and be used only in people who were either intolerant of statins or in conjunction with a generic statin only when LDL cholesterol goals were difficult to achieve."

Fruit juice and medications don't mix

Here's something to contemplate over your morning fruit juice. A few years back, doctors discovered the "grapefruit effect"—the fact that drinking grapefruit juice affects the way certain blood pressure medications work. Doctors have since found that more than 40 different meds can have their effects magnified by grapefruit juice.

Now, the story has gotten a bit more complicated. Orange juice and apple juice could also interfere with some medications. And depending on the drug you're taking, the effects of your treatment could be either be blocked or boosted. This could stop the drug from helping you, or put you at risk of an overdose.

In a new study, researchers looked at healthy volunteers who took a drug called fexofenadine. It's an antihistamine, used to treat allergies.

Some people took the allergy pills with water, and others drank grapefruit, apple or orange juice. The juices stopped people absorbing the drug properly, meaning they got about half the dose they should have done. Grapefruit juice seemed to have the strongest effect.

Q&A: Mixing sleep meds?

I took eszopiclone (Lunesta), then zolpidem (Ambien and generic), for my chronic insomnia, but each stopped working after awhile. Now my doctor is recommending I take both pills together. Is that safe? —B.F., via e-mail

Probably not. While combining those drugs increases the likelihood of falling asleep, it also increases your risk of side effects, including daytime sleepiness, dependency, dizziness, memory problems, rebound insomnia, sleepwalking, and even sleep-driving. And we could find no studies documenting the safety of that regimen. Instead, make sure your doctor has evaluated you for an underlying condition that could hinder sleep, including anxiety, arthritis, depression, heart disease, or sleep apnea. In addition to treating any underlying problems, consider non-drug measures to improve sleep, such as cognitive behavioral therapy, which research has shown to be at least as effective as drugs. For more information, go to www.ConsumerReportsHealth.org and search for "insomnia."

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

Read the latest Best Buy Drugs report on insomnia drugs, and check out our new report and survey on America's sleeping habits.

Cialis AdWatch—deconstructing the ED drug ad

The United States Coast Guard is rightly proud of its longstanding motto, Semper Paratus (Latin for Always Ready). But the term took on a new meaning in January, when the Food and Drug Administration (FDA) approved the new once daily 2.5 mg and 5mg doses of tadalafil (Cialis), one of three oral drugs available for the treatment of erectile dysfunction. The drug, manufactured by pharmaceutical giant Eli Lilly and the third in a new class of drugs known as phosphodiesterase (PDE) inhibitors, was originally approved in 2003 for use on an "as you need it" basis.

In this, our third video in the Consumer Reports AdWatch series, we dissect a recent Cialis ad and tell you some information that the ad doesn't. Our accompanying Web piece also outlines some preventive measures you should consider before asking your doctor for a drug treatment.

Affectionately known as "The Weekender," Cialis differs from its two predecessors, sildenafil (Viagra) and vardenafil (Levitra) by having a chemical structure that prolongs its effect for up to 36 hours. That's more than seven times longer than its brother drugs. The advertising moguls (Eli Lilly spent close to $152 million promoting Cialis to the public in 2007) explain the drug's longer half-life by touting the advantages of sexual spontaneity and avoiding having to plan sexual relations in advance. And now, with the approval of the daily dose, the impotent male can be semper paratus for any opportunity.