From washingtonpost.com

Pharmaceutical companies need to be more responsible in touting products to consumers or else face tighter controls from Congress, a top U.S. Democratic lawmaker said on Thursday.

From  NaturalNews.com

Patients who take the cholesterol drug torcetrapid, intended to increase levels of HDL (”good”) cholesterol and lower LDL (”bad”) cholesterol levels, have a 58 percent higher risk of death than similar patients who do not take the drug, according to a study led by researchers at the Heart Research Institute in Sydney and published in the New England Journal of Medicine.

Researchers studied 15,067 participants, all considered to be at high risk of cardiovascular disease. All the patients were treated with the cholesterol-lowering drug atorvastatin, while half were also treated with torcetrapid.

Torcetrapid is marketed by Pfizer, as is atorvastatin (under the brand name Lipitor).

Patients receiving both drugs had a 58 percent higher chance of dying and a 25 percent higher chance of experiencing cardiovascular events such as heart attacks than those who were treated only with atorvastatin.

Torcetrapid is one of a new class of drugs called cholesteryl ester transfer protein (CETP) inhibitors. Unlike older cholesterol drugs, which only lower LDL levels, CETP inhibitors are intended to raise HDL levels at the same time. The drugs function by blocking the action of a protein that transfers cholesterol from HDL to LDL, thus forcing the cholesterol to remain in HDL form.

In the recent study, torcetrapid was found to raise HDL levels by an average of 72.1 percent, and lower LDL levels by an average of 24.9 percent.

Scientists are still unclear why torcetrapid appears to increase patient death rates and heart attack risk. While the drug is known to raise blood pressure, many of the patients who died in the recent study actually had blood pressure levels below normal.

Researchers have hypothesized that the drug may increase the levels of a hormone involved in regulating blood pressure, and that this may lead to stress on the cardiovascular system.

Merck and Roche Holding have placed the development of their own CETP inhibitors on hold, pending the results of further trials on torcetrapid.

This very helpful web site allows you to research the drugs you may be taking or contemplating and determine potential medication induced nutrient deficiencies induced by that particular product.

DrugWatch side effects and nutritional deficiencies

This is important information and should be a topic of discussion with your treating physician.

   David Perlmutter, MD

   The Renegade Neurologist

From  MedScape

Women who have ever taken alendronate (Fosamax, Merck), the bisphosphonate widely prescribed for preservation of bone density that recently went off patent, have an increased risk of developing atrial fibrillation (AF), according to a population-based, case-control study in the April 28, 2008 Archives of Internal Medicine [1].

In multivariate analyses, the odds ratio (95% CI) for incident AF associated with current or past alendronate use among nearly 1700 women in a clinical practice setting was 1.86 (1.09 - 3.15), with a disproportionate share of the risk concentrated among those who were previously but are no longer on the drug.

“Bisphosphonates have been proven to prevent fractures in people at very high risk of fracture,” lead author Dr Susan R Heckbert (University of Washington, Seattle) observed for heartwire, and for those people, “the benefits in fracture prevention from taking alendronate will outweigh the possible risk of atrial fibrillation.”

For others, including patients “maybe at only moderate risk of fractures or for patients who are at particularly high risk of atrial fibrillation, such as those with coronary disease, heart failure, or diabetes,” she said, “they and their physicians need to do the best they can with the available evidence to weigh the benefits and risks.”

Heckbert et al observe that their work supports two prior studies that had suggested bisphosphonates might promote AF; published last year and reported then by heartwire, they were the Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly (HORIZON) trial of zoledronic acid (Zometa, Novartis) [2] and the Fracture Intervention Trial (FIT) using alendronate [3]. In contrast to those studies, according to the group, the current analysis shows increased risk of AF overall and also specifically in the acute-care setting.

An accompanying editorial [4] lists several notes of caution regarding the group’s findings, including some related to the study’s observational nature (such as the possible presence of uncontrolled confounders, like hyperthyroidism) and the fact that “the association [between alendronate and AF] has not been consistently reported and the biological plausibility of the finding is uncertain.” Conclude the authors, Drs Jane A Cauley and Kristine E Ensrud (University of Pittsburgh, PA), “At this time, it seems that the benefits of bisphosphonate treatment in patients with osteoporosis outweigh the risk of AF.”

Heckbert studied 719 patients with AF, classifying them according to duration of the arrhythmia and whether the diagnosis had been made in an outpatient or acute-care setting. They were matched with 966 non-AF controls according to age, treated hypertension, and calendar year of diagnosis.

Hazard ratio* for atrial fibrillation for users of alendronate compared to those who had never used alendronate

*Adjusted for age, treated hypertension, and calendar year of diagnosis (all matching variables) and for the diagnosis of osteoporosis and any cardiovascular disease

The AF risk didn’t vary by history of cardiovascular disease, treated hypertension, or age. Significantly increased AF risks were observed among patients who used statins and among diabetics, but there were so few patients involved, little can be made of the observations, according to Heckbert.

The bisphosphonate-AF link observed in the current analysis and the HORIZON and FIT studies, she said, “was and still is a completely unexpected effect,” whose mechanism, if the effect is real, remains undefined. Speculating, Heckbert said infusions of the drugs could cause an inflammatory response, “and inflammation is known to be related to the development of atrial fibrillation.” Or, she said, the treatment may affect the metabolism of calcium or other ions to which the atrium may be sensitive.

Heckbert said she knows no reason why their findings wouldn’t apply to men. “We would have liked to study this in men,” she said, but in their database, “you could count on one hand the number of men who had atrial fibrillation and were taking a bisphosphonate.”

From USATODAY.com

The osteoporosis drug Fosamax appears to double a woman’s odds of developing atrial fibrillation, a chronic irregular heartbeat, a study reported Monday.

The study raises fresh concerns about a popular drug taken by millions of postmenopausal women and puts patients and their doctors in a bind: Fosamax is the only drug known to build bone in women who are prone to osteoporosis. Research has shown that it reduces hip fractures by 63%.

Even lead author Susan Heckbert of the University of Washington cautioned women not to stop taking Fosamax without talking to their doctors. “For women at high risk, the drug’s benefit will vastly outweigh the risk of atrial fibrillation,” she says.

BETTER LIFE: Health news and wellness tips

Heckbert and colleagues decided to study the link between Fosamax and atrial fibrillation after a report last year linking an intravenous drug from the same class, Reclast, with a high risk of the abnormality. Atrial fibrillation causes fatigue, dizziness and fainting, but it isn’t life-threatening.

The Reclast study, called Horizon, was published last year along with novel analysis from a study of 6,459 patients called FIT (Fracture Intervention Trial) that first appeared in 1997. The new analysis found that patients who took Fosamax were more prone to severe atrial fibrillation than those taking a placebo, though the link wasn’t conclusive.

The drug’s maker, Merck & Co., and independent experts reviewed the evidence from FIT and results from 28 Fosamax trials and concluded that a link with atrial fibrillation was “unlikely.”

Arthur Santora, Merck’s director of clinical research, says: “In FIT, we did look pretty specifically at atrial fibrillation.” Researchers who carried out the study held all the data and published the study without interference from Merck, he says.

Heckbert, a cardiovascular epidemiologist, says she hoped to resolve the uncertainty using data from a long-term study of atrial fibrillation at Group Health, a statewide health care provider in Washington. The study, which involved more than 1,700 women, found that 6.5% of 719 patients with atrial fibrillation took Fosamax, compared with 4.1% of more than 900 women who did not take the drug, according to the study in Archives of Internal Medicine.

Women who had taken the drug had an 86% higher risk of atrial fibrillation than those who never took Fosamax, the study found. But these results too were far from conclusive, doctors say. Fosamax accounted for 3% of the atrial fibrillation cases, and 97% were the result of other causes.

“We need more data to know if this is coincidence or if it’s real,” says Ethel Siris, president of the National Osteoporosis Foundation. “You should certainly treat women who need to be treated, because fractures are serious. And if you’ve ever taken the drug, you’re already at risk, so stopping it won’t help you.”