Thursday, February 15, 2007

Antibiotic Ketek more dangerous than thought

The Food and Drug Administration (FDA) today announced its new decision to restrict use of antibiotic Ketek (Telithromycin) based on reports of severe adverse effects associated with this drug.

The antibiotic Ketek was originally approved in 2004 and is manufactured by Sanofi Aventis. From now on, the drug is no long indicated for use in patients with acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis. However, Ketek will remain on the market for the treatment of community acquired pneumonia of mild to moderate severity, which is acquired outside of hospitals or long-term care facilities. In addition, the FDA requires that the drug maker put on the label a "boxed warning", FDA's strongest form of warning to indicate that Ketek is contraindicated (should not be used) in patients with myasthenia gravis, a disease that causes muscle weakness.

The federal agency also worked with the manufacturer to develop a Patient Medication Guide, which is to be distributed along with each prescription, to inform patients of the risk of the drug and advise them how to use it safely. "Today's action is the result of comprehensive scientific analysis and thoughtful public discussion of the data available for Ketek, and includes important changes in the labeling designed to improve the safe use of Ketek by patients and give healthcare providers the most up-to-date prescribing information," said Steven Galson, M.D., Director, Center for Drug Evaluation and Research.

Specific drug-related adverse events including visual disturbances and loss of consciousness are to be strengthened on the label. Warnings for hepatic toxicity (rare but severe symptoms of liver disease) were already strengthened in June 2006, according to the FDA. A joint advisory committee comprised of FDA's Anti-Infective Drugs and Drug Safety and Risk Management Advisory committees advised that the benefits of the drug outweigh its risk for patients with community acquired pneumonia. But they said for patients with acute bacterial sinusitis or acute bacterial exacerbation of chronic bronchitis, the risk is too great to allow the antibiotic for these conditions. The committee also recommended a boxed warning as well as Medication Guide for the drug.

On January 20, 2006, the FDA advised the public that the Annals of Internal Medicine had published an article reporting three patients who experienced serious liver toxicity following administration of Ketek (telithromycin). These cases had also been reported to FDA MedWatch. Telithromycin is marketed and used extensively in many other countries, including countries in Europe and Japan..... There have been reports of side effects on the liver, including severe liver disease. In some cases, liver damage worsened rapidly and happened after just a few doses of Ketek. If you develop signs or symptoms of hepatitis (liver disease), such as tiredness, body aches, loss of appetite, nausea, jaundice (yellow color of the skin and/or eyes), dark urine, light-colored stools, itchy skin, or belly pains, stop your medication and immediately contact your healthcare provider.


Note: You can't win. The above drug may be bad for your liver but if you switch to the less powerful and more common Keflex (cephalexin) you endanger your kidneys!


As a confirmed afternoon napper, I am not going to criticize this study, weak as it is:

Men who take siestas can lower their risk of death from coronary heart disease by as much as 64 per cent, even when other factors such as diet, age and exercise are taken into account. The findings, from American and Greek scientists, suggest that dozing off after lunch could play an important role in fighting stress, with benefits for cardiovascular health.

The study of Greek adults showed that the effects were strongest among working men. It remains unknown whether working women get similar benefits from siestas because only six of those involved in the research died during the study period. Researchers have long noted that death rates from heart disease appear to be lower in countries where taking a siesta is common practice - typically the Mediterranean region of Europe and parts of South and Central America. It was not known, however, whether this reflected a health benefit from the naps themselves, or because people in these regions tend to follow a Mediterranean diet.

In the new research, a team from the Harvard School of Public Health and the University of Athens studied 23,681 Greek men and women aged between 20 and 86, who did not have a history of heart disease or serious medical condition when they enrolled. Their siesta habits, diet and exercise were then monitored between 1994 and 1999, and the subjects' long-term health was followed up for an average of six years and four months. During this period 792 participants died, of whom 133 died of heart disease. Once the influence of diet and exercise was taken into account, there was still a big benefit to napping.

Among working men, the risk of dying of heart disease was 64 per cent lower in those who took regular or even occasional naps. Retired and non-working men had a smaller but still significant benefit: they had a 36 per cent reduced risk. "We interpret our findings as indicating that among healthy adults, siesta, possibly on account of stress-releasing consequences, may reduce coronary mortality," said Androniki Naska, who led the study. "The fact that the association was stronger in working men, who likely face job-related stress, than non-working men is compatible with this hypothesis," the report said. "This is an important finding because the siesta habit is common in many parts of the world, including the Mediterranean region and Central America."



Just some problems with the "Obesity" war:

1). It tries to impose behavior change on everybody -- when most of those targeted are not obese and hence have no reason to change their behaviour. It is a form of punishing the innocent and the guilty alike. (It is also typical of Leftist thinking: Scorning the individual and capable of dealing with large groups only).

2). The longevity research all leads to the conclusion that it is people of MIDDLING weight who live longest -- not slim people. So the "epidemic" of obesity is in fact largely an "epidemic" of living longer.

3). It is total calorie intake that makes you fat -- not where you get your calories. Policies that attack only the source of the calories (e.g. "junk food") without addressing total calorie intake are hence pissing into the wind. People involuntarily deprived of their preferred calorie intake from one source are highly likely to seek and find their calories elsewhere.

4). So-called junk food is perfectly nutritious. A big Mac meal comprises meat, bread, salad and potatoes -- which is a mainstream Western diet. If that is bad then we are all in big trouble.

5). Food warriors demonize salt and fat. But we need a daily salt intake to counter salt-loss through perspiration and the research shows that people on salt-restricted diets die SOONER. And Eskimos eat huge amounts of fat with no apparent ill-effects. And the average home-cooked roast dinner has LOTS of fat. Will we ban roast dinners?

6). The foods restricted are often no more calorific than those permitted -- such as milk and fruit-juice drinks.

7). Tendency to weight is mostly genetic and is therefore not readily susceptible to voluntary behaviour change.

8). And when are we going to ban cheese? Cheese is a concentrated calorie bomb and has lots of that wicked animal fat in it too. Wouldn't we all be better off without it? And what about butter and margarine? They are just about pure fat. Surely they should be treated as contraband in kids' lunchboxes! [/sarcasm].

Trans fats:

For one summary of the weak science behind the "trans-fat" hysteria, see here. Trans fats have only a temporary effect on blood chemistry and the evidence of lasting harm from them is dubious. By taking extreme groups in trans fats intake, some weak association with coronary heart disease has at times been shown in some sub-populations but extreme group studies are inherently at risk of confounding with other factors and are intrinsically of little interest to the average person.


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