FDA Announces New Warning on Plavix: Avoid Use with Prilosec/Prilosec OTC

February 14th, 2010

Patients should avoid using the stomach acid reducer Prilosec/Prilosec OTC (omeprazole) with the anti-clotting drug Plavix (clopidogrel), the U.S. Food and Drug Administration warned on Nov. 17.

New data suggest that when patients take both Prilosec and Plavix, Plavix’s ability to block platelet aggregation (anti-clotting effect) may be reduced by about half.

“Both of these drugs, when used properly, provide significant benefits to patients.” said Mary Ross Southworth, Pharm.D., of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “However, patients at risk for heart attacks or strokes who use Plavix to prevent platelet aggregation will not get the full effect of this medicine if they are also taking Prilosec.”

Plavix is used to prevent blood clots that could lead to heart attacks or strokes in at-risk patients. Omeprazole, the active ingredient of Prilosec and Prilosec OTC, is a proton pump inhibitor (PPI) used to reduce the production of stomach acid and prevent stomach irritation.

Plavix does not have anti-clotting effects until it is converted or metabolized into its active form with the help of the liver enzyme, CYP2C19. Prilosec blocks this enzyme, thereby reducing the effectiveness of Plavix.

After issuing an Early Communication in January about possible drug interactions involving Plavix, the FDA requested new studies from the drug’s manufacturers, sanofi-aventis and Bristol-Myers-Squibb. These new studies support the existence of a significant interaction that could negatively impact a person’s health. Based on the current scientific information, the Plavix label has been updated with new warnings about the use of Prilosec and other drugs that inhibit the CYP2C19 enzyme and that could interact with Plavix in the same way.

The new studies compared people who took Plavix and Prilosec together with people who took Plavix alone. A reduction in Plavix’s anti-clotting effect was found in those individuals who took the combination. Similar results were seen irrespective of whether the two drugs were taken at the same or different times of day.

It is unknown how other PPIs may interfere with Plavix. Other drugs that should not be used with Plavix because they may have a similar interaction with CYP2C19 include Nexium (esomeprazole), Tagamet and Tagamet HB (cimetidine), Diflucan (fluconazole), Nizoral (ketoconazole), VFEND (voriconazole), Intelence (etravirine), Felbatol (felbamate), Prozac, Serafem, Symbyax (fluoxetine), Luvox (fluvoxamine) and Ticlid (ticlopidine).

Patients who take Plavix and need to take a drug to reduce stomach acid should discuss their therapy with a health care professional. Zantac (ranitidine), Pepcid (famotidine), Axid (nizatidine), and antacids do not inhibit the CYP2C19 enzyme and aren’t expected to interfere with the anti-clotting activity of Plavix.

Plavix’s manufacturers have agreed to continue conducting studies to explore this and other drug interactions. When the FDA has reviewed additional data, the agency will communicate any new recommendations or conclusions.

Diuretics Still Best Treatment for High Blood Pressure

February 7th, 2010

Tried-and-true diuretics maintain their status as the best first-line treatment in older men and women with high blood pressure, new research concludes.

The thiazide-type diuretic chlorthalidone outshone three other treatments — a calcium channel blocker, an ACE inhibitor and an alpha-receptor blocker — in most areas, especially in lowering the incidence of stroke and heart failure, according to the most current data from a large ongoing study known as ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial).

“We believe thiazide-type diuretics should still be preferred,” said study investigator Dr. William Cushman, professor and chief of preventive medicine at the Veterans Affairs Medical Center in Memphis, Tenn., at a news conference on the findings Wednesday at the annual meeting of the American Heart Association (AHA) in Orlando, Fla.

“The message is largely unchanged, and the main message is that treating hypertension [high blood pressure] is very necessary,” added Dr. Clyde Yancy, president of the AHA. “Treating hypertension with chlorthalidone resulted in a significant reduction in heart failure and stroke.”

The original trial, begun in 1994, involved more than 42,000 patients with hypertension and at least one other risk factor for cardiovascular disease. The participants were randomly assigned to take one of the following anti-hypertensive drugs: chlorthalidone (the diuretic), amlodipine besylate (the calcium channel blocker), doxazosin mesylate (the alpha blocker) or lisinopril (an ACE inhibitor).

The five-year follow-up, which ended in 2002, was intended to see if new differences emerged with long-term use of the medications, especially regarding coronary heart disease, total mortality, heart failure and aggregate cardiovascular disease.

“This is the largest hypertension trial to date,” Cushman said.

Earlier results from ALLHAT had also found that diuretics were as good or better than other blood pressure-lowering drugs for treating hypertension in patients with metabolic syndrome (a collection of factors that put people at risk of heart disease), especially black patients.

“None of the newer drugs were superior to chlorthalidone for reducing death from cardiovascular disease or end-stage renal disease, although the calcium channel blocker was very similar,” Cushman stated.

Strokes were much more common in black study participants taking the newer drugs, and patients on the calcium channel blocker had much higher rates of heart failure.

Cushman also presented some 10-year follow-up data, which were essentially the same as the five-year data. No new adverse events cropped up, he noted.

“Chlorthalidone treatment is superior to each in preventing one or more major cardiovascular events as long as participants continued taking the drug,” he said.

Radiation From Medical Scans Soaring

January 29th, 2010

Americans’ exposure to radiation from medical procedures has exploded over the past few decades, to six times the level of 1980, a new report shows.

In 2006, almost 380 million diagnostic and interventional radiological procedures were performed in the United States, on top of 18 million nuclear medicine examinations.

“Back in about 1980, 15 percent of radiation that the U.S. population got was from medicine and the rest was predominantly from natural background radiation,” noted Dr. Fred Mettler Jr., U.S. Representative to the United Nations Scientific Committee on the Effects of Atomic Radiation and a professor of radiology at the University of New Mexico in Albuquerque. “In the last 20 years, medical exposure has gone up between 600 and 700 percent from what it was, and it is now the biggest source of radiation to the U.S. population.”

“The issue,” Mettler continued, “is that this is a controllable source. We regulate the effluent from nuclear power plants so the public doesn’t get exposure but medical exposure is essentially unregulated. The largest source in the U.S. is essentially unregulated, and it’s up to your family doctor or any other doctor to hand it out.”

Mettler is lead author of a paper appearing in the November issue of Radiology that summarizes the conclusions of two previous reports on radiation sources in the U.S. Those reports were issued by the U.S. National Council on Radiation Protection and Measurements and the United Nations Scientific Committee on Effects of Atomic Radiation.

The findings are in line with previous studies, one of which attributed up to two percent of all cancers to CT scans alone and another which concluded that cumulative exposure to radiation from CT scans increases the risk for malignancy by as much as 12 percent.

The last comprehensive assessment of radiation exposure was conducted in 1980-1982, a veritable eternity by medical and scientific standards.

“We needed to get a grip on how much radiation the U.S. was getting and where it was coming from,” Mettler said.

In the intervening years, the number of procedures performed has risen “by leaps and bounds,” he said. “The biggest chunk of that is CT scanning, which has been growing at better than 10 percent a year while the U.S. population is growing at less than 1 percent.”

Widely used as a diagnostic tool, CT scans provide detailed images of organs, allowing more accurate diagnoses of conditions such as cancer. But CT involves a higher radiation dose than most other imaging tests. According to this paper, CT provides half of the country’s total radiation dose, even though it represents only 17 percent of total procedures.

Emergency room physicians may be at the epicenter of the surge in scan use, Mettler said. “Twenty-five to 40 percent of CT scans are ordered out of the ER,” he noted. “The emergency physicians are in a tough box because they’re worried about getting sued. And they tend to get patients who they haven’t seen before. This is a one-time walk-in and their mantra is, ‘We can’t afford to miss anything.’”

Of course, the trend is not limited to the U.S., although it may be more extreme here. Globally, the per-capita annual dose from medicine has doubled in the past decade or so.

Still the U.S. leads the pack, with 12 percent of all radiologic procedures and half of nuclear medicine procedures performed here.

“We have a little under 5 percent of the world’s population and 25 percent of X-ray studies in the world and double and triple that of other developed countries,” Mettler said. “Nobody thought about how much radiation goes with this.”

But not all of uptick in scans has been unnecessary, said Dr. Robert Zimmerman, executive vice chair of radiology at Weill Cornell Medical Center in New York City.

“We don’t really know how much of it is overuse. We do know some of it is overutilization, but CT is a valuable imaging modality. CT is a great test. There’s no question that in the appropriate cases it’s going to save lives.”

There are things radiologists can do to curb its use, including reducing the doses, while manufacturers are working on new and improved machines, Zimmerman said.

Physicians can also tailor their use, thinking twice about using this type of technology in children, who are more sensitive to radiation and have longer to develop side effects.

“When I get a call for a CT scan, my first question is, ‘How old is the patient?’ If it’s 40 or under my antennas go up and if they’re 70 my antennas don’t get so excited. Mostly my idea is a CT might be a good thing but you would like to think about radiation beforehand,” Mettler said. “There’s a lot of stuff going on now that isn’t justified. Nobody’s ever shown that many of these things we do make a difference in outcome.”

Short-Term, High-Dose Vitamin D2 May Ease Deficiency

January 22nd, 2010

Researchers are reporting that eight weeks of treatment with large doses of vitamin D2 can eliminate vitamin D deficiency, and twice-monthly doses can keep the condition at bay for up to six years.

The dosage — 50,000 international units (IU) every week or two — was large but did not appear to be toxic, according to the study published in the Oct. 26 issue of Archives of Internal Medicine.

Vitamin D is crucial for the body. Among its attributes, it strengthens bones by helping the body absorb calcium and phosphorus from food. Low levels of vitamin D can cause rickets in children and an adult bone disorder called osteomalacia.

A deficiency can also lead to osteoporosis, and research has suggested that it also has something to do with higher risks for such diseases as cancer, heart disease, diabetes, autoimmune diseases and flu, the study’s senior author, Dr. Michael F. Holick, director of the Bone Healthcare Clinic and the Vitamin D, Skin and Bone Research Laboratory at Boston University School of Medicine, said in a university news release.

For their study, the researchers treated 41 people who had low levels of vitamin D with 50,000 IU of the vitamin each week for two months. On average, their vitamin D levels nearly doubled after eight weeks, the study found.

Another 45 people were given 50,000 IU of vitamin D2 every two weeks. The researchers found that their levels also went up, but not quite as much.

“Vitamin D2 is effective in raising [vitamin D] levels when given in physiologic and pharmacologic doses and is a simple method to treat and prevent vitamin D deficiency,” Holick said. “While treating and preventing vitamin D deficiency, these large doses of vitamin D2 do not lead to vitamin D toxicity.”

The U.S. National Institutes of Health Office of Dietary Supplements recommends that you always talk to your health care provider before taking any supplements.

Leg artery disease often goes undetected

January 15th, 2010

Many middle-aged adults may be walking around with a dangerous health problem and not even know it.

The condition called peripheral artery disease, or PAD, occurs when arteries in the legs become narrowed or clogged with fatty deposits, reducing blood flow to the legs. PAD affects about 8 million Americans.

PAD is as serious as heart disease, Dr. Ross Tsuyuki of the University of Alberta in Edmonton noted in a telephone interview with Reuters Health, “but, in general, it is under-recognized by the public and by our health care system.”

In 10 pharmacies in Central and Northern Alberta, Tsuyuki and colleagues had five pharmacy students screen 362 adults over age 50 for PAD. The screening procedure, which is fairly simple, compares the blood pressure in the leg to that of the arm.

Seventeen people who were screened — about 5 percent — had PAD. And, importantly, Tsuyuki said, 80 percent of the people found to have PAD were previously unaware they had the dangerous condition.

“PAD is a very strong risk factor for poor outcome, including heart disease, stroke and lower limb amputation,” Tsuyuki said.

“We informed them of what we found and followed up with them and most of them had gone to see their family physician for treatment,” Tsuyuki said, which may include aspirin or other anti-blooding clotting therapies and aggressive cholesterol-lowering treatments.

While the US Preventive Services Task Force currently does not recommend routine screening for PAD, Tsuyuki thinks it is worthwhile to screen people at high risk for PAD. “That would include people who already have heart disease and people who’ve suffered a stroke. They would be the highest priority,” he told Reuters Health.

“The second highest priority,” he added, “would be people middle-aged and beyond who are at high risk for heart disease and stroke, such as people with high blood pressure, diabetes and high cholesterol.”

The researcher reported his team’s findings over the weekend at the 2009 Canadian Cardiovascular Congress, co-hosted by the Heart and Stroke Foundation and the Canadian Cardiovascular Society.

In a statement from the meeting, Heart and Stroke Foundation spokesperson Dr. Beth Abramson said: “People don’t recognize that leg cramps while walking may be due to circulation problems that put them at risk for heart disease and stroke.”

While PAD may have no symptoms, there often are some warning signs, such as leg pain during exercise, open leg sores that don’t heal, feeling of coldness or numbness in one or both legs, pain in the toes at night.

Current or ex-smokers are at increased risk for PAD as are people with diabetes, high blood pressure, high cholesterol and heart disease.

Health Tip: Leave Jet Lag Behind

January 8th, 2010

Jet lag is the term for disrupted sleep when you travel between time zones, and your body doesn’t adjust to sleeping on a new schedule.

The U.S. National Library of Medicine offers these suggestions to minimize jet lag:
Stick to a good bed time and sleep schedule before departing. Don’t miss out on sleep in an attempt to beat jet lag.
Adjust your bed time by a few hours before you leave, depending on which time zone to which you’ll be traveling.
If you’re only traveling for a few days, don’t worry about adjusting to a new time zone.
Don’t sleep on the flight, unless the flight includes your usual bed time.
Don’t consume alcohol or caffeine, but do drink plenty of fluids.
Keep up with your exercise routine, just not too close to bed time.

Surgery Best for Carpal Tunnel Syndrome

December 27th, 2009

Surgery is slightly better than non-surgical treatment for patients with carpal tunnel syndrome who don’t have severe nerve damage (denervation), new research has found.

The study included 44 patients who had surgery and 52 patients who had non-surgical treatment, such as hand therapy and ultrasound. A year after treatment, the patients’ hand function was measured using the Carpal Tunnel Syndrome Assessment Questionnaire (CTSAQ).

The patients who had surgery showed an advantage in both function and symptoms — calculated by proportions of patients having at least 30 percent improvement in CTSAQ scores for these indicators, and having minimal interference in daily work or household activities. The study found that 46 percent of surgery patients and 27 percent of non-surgery patients met all three criteria.

“Overall, these data indicate that, in patients with carpal tunnel syndrome without denervation, surgery modestly improves hand function and symptoms by three months compared with a multimodality non-surgical treatment regimen, and this benefit is sustained through one year,” wrote Dr. Jeffrey Jarvik, of Harborview Medical Center at the University of Washington in Seattle, and colleagues.

“However,” they continued, “some patients allocated to surgery reported persistent symptoms, and 61 percent of patients allocated to non-surgical treatment avoided surgery altogether. Our study, together with previous evidence, indicates that surgery is useful for patients with carpal tunnel syndrome.”

The study appears online Sept. 24 in a special surgery issue of The Lancet.

Patient treatment preference is an important factor, two Swedish doctors noted in an accompanying editorial. When patients are “faced with the need to wear a splint each night and during daytime for some weeks, some might prefer early surgery while others may prefer partial recovery to potential surgical risk,” wrote Dr. Isam Atroshi and Christina Gummesson, both of Lund University.

“Nevertheless, patients with carpal tunnel syndrome who do not have satisfactory improvement with non-surgical treatment should be offered surgery,” the editorialists concluded.

Another study in the special surgery issue of The Lancet found that placing a drain in the skull after surgery reduces the risk of death and recurrence among patients with chronic subdural hematoma, in which blood collects under the dura, the outer protective membrane that covers the brain.

After surgery to drain the blood, between 5 percent and 30 percent of patients have recurrence of chronic subdural hematoma and require redrainage, Peter Hutchinson of Addenbrooke’s Hospital in Cambridge, U.K., and colleagues noted.

In the study, the researchers assessed 215 patients, aged 18 years and older, with a chronic subdural hematoma who were treated using the burr-hole surgery technique. Of those patients, 108 had a plastic drain inserted a few centimeters into the subdural space after surgery. The drain was left in for a few days.

Subdural hematoma recurred in 10 of 108 people (9.3 percent) with the drain and in 26 of 107 (24 percent) of patients without the drain. After six months, 8.6 percent of patients in the drain group and 18.1 of those in the non-drain group had died, the researchers reported.

Early form of breast cancer may need new name

December 20th, 2009

A common, nonmalignant tumor of the breast called ductal carcinoma in-situ or DCIS may need a name change because the word “carcinoma” scares so many women, a U.S. panel of experts said on Thursday.

They said the term carcinoma creates a lot of worry in women who fear they will develop cancer, even though long-term survival rates for DCIS are excellent, approaching 100 percent. “We’ve had long discussions about this,” Dr. Susan Reed of the University of Washington School of Medicine told a briefing.

She was one of several independent panelists asked by the National Institutes of Health to look into whether too many women are being treated too aggressively for a condition that is poorly understood.

“If you use a word that evokes fear, as the word carcinoma may, I think we need to consider is that appropriate,” said Reed, who favors changing the name to something less scary.

DCIS is a condition in which abnormal cells accumulate in the breast duct, but have not spread to other tissues in the breast.

Since the start of widespread mammography screening in the 1980s, rates of DCIS diagnoses have increased sevenfold. By 2020, an estimated 1 million U.S. women will be living with a DCIS diagnosis.

And because most women diagnosed with DCIS get treated for it — with surgery to remove the cells and sometimes radiation — little is known about how much of a risk it presents, or whether some women might do well with less or no treatment.

“Despite having had a century of knowledge of the disease, we do not understand the natural history of DCIS, and probably never will,” Dr. Carmen Allegra of the University of Florida, who chaired the panel, told the briefing.

After two days of scientific presentations and many discussions, the panel is urging scientists to come up with better ways to determine which women with DCIS might develop invasive breast cancer.

“Given that this diagnosis has significant emotional impact for the women diagnosed with it, we felt it was critical to develop methods that would allow a very precise determination of exactly which patients would ultimately be at risk for developing invasive disease,” Allegra said.

And he said the medical community needs to at least consider whether the name of the condition, which raises the specter of cancer, may need to be changed.

Not all panel members think that is a good idea.

Dr. Arnold Schwartz, a surgical pathologist at George Washington University Hospital, said the cells that eventually replace the duct are identical to the cells in invasive cancer, suggesting that DCIS is a precursor to cancer.

“We have many other cancers in the body and precursor cancers that are also called carcinoma in-situ. Cancers of the skin, head and neck, esophagus and bladder also have the term carcinoma without any emotional impact,” he said.

More than 400,000 women in the world die from breast cancer each year.

Health Tip: Choosing a Nursing Home

December 13th, 2009

If you’re evaluating nursing homes for a loved one, there are many things to consider and a lot of questions to ask.

The U.S. National Institute on Aging offers these guidelines:
Consider proximity to family and friends.
Note the resources offered by each home that may apply to your loved one, such as whether it provides dementia care.
Question family, friends and nearby residents to get a feel for each home and its quality of care.
Take a tour of each home and ask many questions of the staff. Evaluate whether each home is certified by Medicare/Medicaid and offers handicap access.
Also pay attention to whether the residents look happy and well-cared for, and if there seems to be enough staff on hand to care for all residents.
Meet with each home’s director, social worker, or chief of nursing. Ask about staff turnover, particularly in management positions.
Stop by unannounced to have another look; see what’s going on when the staff isn’t expecting a visitor.
Make sure you fully understand the details of the contract, costs and any waiting lists.

Health Tip: Crib Mattress Safety

December 6th, 2009

When picking out baby’s crib, you must make sure you’ve chosen a mattress that’s safe.

The mattress must fit snugly inside the crib, says the U.S. National Safety Council. If two adult fingers can fit between the sides of the crib and the mattress, the mattress is too small for the crib.

Never attempt to protect baby’s mattress with plastic, such as with a mattress cover or plastic bag of any type. Those materials can stick to an infant’s face and pose a suffocation hazard.

Make sure that the mattress is flat and firm, and not too soft. Also, to further reduce the risk of suffocation, don’t place soft blankets or pillows beneath your child, the council advises.