New safer drug for stroke preventation

London A new drug costing only £2.50 a day may soon be available in Europe to prevent strokes in the over 50s.

Pradaxa, is said to be a safer than warfarin, the blood-thinner also used as a rat poison.

Warfarin has been prescribed to prevent strokes for more than 50 years but patients need to take regular blood tests in case they overdose. In addition some foods – spinach and broccoli stop it working properly and other such as cranberry make it more potent.Many patients refuse the drug because of the risks.


Pradaxa [320x200].jpgPradaxa, on the other hand, taken twice daily, do not affect the diet as much and can be up to 39 per cent better at preventing strokes, the American College of Cardiology was told.

The drug is due to be approved next week by the European drugs regulator for use in atrial fibrillation next week.

The drug was trialled by more than 18,000 men and women suffering from atrial fibrillation, an extremely common heart rhythm disorder that raises the risk of stroke up to five-fold

Pradaxa, also known as dabigatran etexilate, could improve their health – as well as boost the quality of life for many of those who don’t want to take warfarin.

The drug is already licensed to prevent clots after hip, knee and other types of orthopaedic surgery.

Enhanced by Zemanta

New diabetes drug cuts obesity and heart risk


New York: Trials of a Danish-made injectable drug called liraglutide (trademark name Victoza) have revealed that it reduces weight and the prevalence of cardiovascular risk factors in obese people without diabetes.

High doses of liraglutide, were also found to cause greater weight loss than orlistat (marketed over-the-counter as Alli), according to a report in the medical magazine, The Lancet.

In developing countries obesity levels have risen dramtically in the past two decades and in some European countries 30% of the population are overweight. Around 50% of all adults in Europe are classified as overweight.

Obesity increases the risk of degenerative diseases including high blood pressure, diabetes, and atherosclerosis, and all risk factors for heart disease.
Moreover, obesity is associated with a reduced quality of life. Few safe and effective drugs are currently available for the treatment of obesity. Therefore, alternative approaches to weight loss that are safe and well tolerated and that can lower the risks associated with obesity are needed. In this randomised controlled trial, the authors studied the effect of liraglutide on bodyweight and tolerability in obese individuals without type 2 diabetes.

The study, led by Professor Arne Astrup, Department of Human Nutrition, University of Copenhagen, Copenhagen, Denmark, took place in 19 sites in Europe, and analysed 564 people (18-65 years, body-mass index 30-40 kg/m²). Each was assigned to 1 of 4 liraglutide doses (1.2 mg, 1.8 mg, 2.4 mg, or 3.0 mg, n = 90-95) or to placebo (n = 98) administered once a day subcutaneously, or to orlistat 120 mg (n = 95) administered orally 3 times a day. All participants also followed a calorie-restricted diet, which contained approximately 500 calories less than they needed each day. Participants also increased their physical activity throughout the trial, including the 2-week run-in.

Participants on liraglutide lost significantly more weight than did those on placebo and orlistat. Mean weight loss with liraglutide doses 1.2, 1.8, 2.4 and 3.0 mg was 4.8 kg, 5.5 kg, 6.3 kg, and 7.2 kg respectively, compared with 2.8 kg with placebo and 4.1 kg with orlistat. A higher proportion of individuals (76%) lost more than 5% weight with liraglutide 3.0 mg than with placebo (30%) or orlistat (44%).

Liraglutide reduced blood pressure at all doses. At the start of the study, around one-third of patients in each group had pre-diabetes, that is, poor blood glucose control not yet bad enough to qualify as diabetes. Liraglutide reduced the prevalence of pre-diabetes (84%-96% reduction) with 1.8-3.0 mg per day.

Nausea and vomiting occurred more often in individuals on liraglutide than in those on placebo, but adverse events were mainly transient and rarely led to discontinuation of treatment.

The authors say: “Treatment with liraglutide, in addition to an energy-deficit diet and exercise programme, led to a sustained, clinically relevant, dose-dependent weight loss that was significantly greater than that with placebo (all doses) and orlistat (vs liraglutide 2.4 mg and 3.0 mg).”

They conclude: “The results of this study indicate the potential benefit of liraglutide, in conjunction with an energy-deficit diet, in the treatment of obesity and associated risk factors. Liraglutide offers a new mode of action for the treatment of obesity and improved efficacy compared with currently available therapies. Its effect on pre-diabetes suggests that it might be important for treating obese pre-diabetic individuals.”

They add that further studies, with longer follow-up than 20 weeks, are now needed to establish the long-term risk-benefit profile for liraglutide.

In an editorial accompanying the article, George A Bray, MD, Division of Clinical Obesity and Metabolism, Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, Louisiana, says: “Today’s important report shows a dose-related reduction of food intake and bodyweight in overweight and obese individuals treated with liraglutide.”

Dr Bray adds that one limitation to the use of drugs such as liraglutide is that they require an injection. He says: “Whether long-term use of an injectable drug is palatable as a treatment for obesity is yet to be established.”

Alzheimer’s drug helps patients live longer

London: A new study published in the The Lancet Neurology journal has revealed that the drug, Galantamine, improves the quality of life for sufferers of Alzheimer’s Disease.

The research showed that it improves the condition of patients and extends their life expectancy.

But in the UK, the £2.50 a day treatment, is not available to patients when symptoms become too severe.

Professor Alistair Burns of the University of Manchester, who led the study said: “The results from a very conservative viewpoint do not support withdrawal of such treatment.”

UK health warning over Barbie tan drug


London: UK health watchdogs have joined the US in warning the public about the health dangers of an unlicensed injectable tanning drug, knicknamed the “Barbie Drug.”

The drug, which is known by the names Melanotan and Melanotan II is a synthetically-made hormone that stimulate the body to produce melanin, which gives the body a deep natural tan without the sun.

It is most popular with athletes and fitness enthusiasts who prefer not to expose themselves to sun damage.

As well as protection against burning, Melanotan, is also credited with boosting libido and an appetite depressant which hasled to it being nicknamed the ‘Barbie drug’ or ‘paradise pill’.

Despite its popularity, the American-made drug, has never been licensed for public use either in the US or Europe. But it continues to be sold illegally over the internet and in gyms and beauty salsons for up to £250.

In the UK the Medicine and Healthcare Regulatory Agency (MHRA) has issued a warning over the drug because not enough is known about the possible side-effects.

In addition, people injecting themselves run the risk of contracting HIV or other viruses from dirty needles.

David Carter, head of the MHRA unit for ‘borderline’ drugs, said people should not be fooled into thinking it was safer than the sun and warned anyone who had them not to use them again. Anyone who has used them should see a doctor, he said.

“The safety of these products is unknown and they are unlicensed in the UK. The side effects could be extremely serious,” he said.

New drug relieves rheumatoid arthritis

San Francisco: A new ‘smart drug’ which halts pain and disability for almost half of rheumatoid arthritis patients could go on sale in months.

The drug, called Tocilizumab, has not yet been licensed in Europe, contains a laboratory-made anti-body that blocks interleukin-6, an immune system messenger involved in the inflammation process of the disease. Drug maker Roche hopes to get a licence for sales next year.

The latest results from a trial carried out in 15 countries are to be presented to the American College of Rheumatology meeting in San Francisco.

It looked at the effects of Tocilizumab prescribed with the standard drug treatment, Methotrexate, compared to Methotrexate alone in 1,190 patients with moderate to severe rheumatoid arthritis.

The combination treatment slowed structural damage of joints in patients with rheumatoid arthritis by 85 per cent, compared with 67 per cent in those on standard treatment.

Researchers found 47 per cent of patients on combination treatment achieved remission – where the disease stops advancing – compared with just eight per cent of those treated with methotrexate alone.

Diet pill Acomplia banned in EU


London: The controversial diet pill Acomplia has been banned by European safety chiefs, over concerns that it may be linked to suicide in vulnerable individuals.

The European Medicines Agency (EMA) has ordered doctors to stop prescribing Acomplia now following several deaths, including a suicide and reports of other adverse reactions. It is already banned in the US.

The UK’s, National Institute for Health and Clinical Excellence approved the drug four months ago. At that time there were warnings on the packet about the increased risk of depression, anxiety and other ‘serious’ side effects. The EMA also warned that Acomplia should not be taken by patients with major depression or on antidepressants.

Now the EMA has suspended the medicine’s licence because the ‘benefits no longer outweigh its risks’.

It said: “New data from post-marketing experience and ongoing clinical trials indicated that serious psychiatric disorders may be more common than in the clinical trials.”

Patients taking Acomplia are advised to see their doctor or pharmacist

Acomplia, also known as rimonabant, was licensed for the treatment of obesity and overweight patients with type 2 diabetes.

In medical trials. the drug demonstrated that it was helpful to two out five patients in loosing up to 10 per cent of their body body weight.

But a scientific review in The Lancet medical journal found a 40 per cent higher chance of being harmed by ‘adverse events or serious adverse events’.

The pill, made by the French firm Sanofi-Aventis, works by interfering with a system in the body which controls energy levels, reducing the cravings for food and helping to prevent fat from being deposited.

Acomplia costs £44 a month in the UK, and is marketed in 18 European countries.

UK pharmas call for debate on drug access


London: The pharmaceutical industry today called for a public debate on access to modern medicines, and how society determines the value of new treatments.

The Association of the British Pharmaceutical Industry (ABPI) is inviting NICE, patient groups, medical professionals, the NHS and leading healthcare charities to debate the issues amid continuing controversy on the availability and cost of innovative medicines to NHS patients.

“A frank, open and honest debate is clearly in the interests of patients,” said Chris Brinsmead, President of the Association of the British Pharmaceutical Industry (ABPI).

“We are calling for the patient groups, healthcare charities, doctors, Government, NICE and the NHS to join with the pharmaceutical industry to debate these crucial issues to hammer out a lasting solution. The time has come to discuss how we best resolve the issue, and where better than on a public platform?”

The pharmaceutical industry spends approximately £3.9billion a year in the UK researching and developing new medicines for patients. This investment has delivered over 90 per cent of the medicines available today and has led to new treatments for rheumatoid arthritis, cancer, heart disease and HIV to name but a few, Mr Brinsmead added.

He said: “The UK pharmaceutical industry – along with other healthcare professionals and NICE – is committed to developing innovative approaches to pricing, ensuring that patients receive the medicines that they need. Taking the recent example of the four kidney cancer medicines, all these medicines are widely available to patients throughout Europe – where the prices are higher than in the UK.”

Mr Brinsmead said: “We are looking forward to hearing NICE’s response and welcome their contribution to what will be one of the most important debates in the history of modern healthcare.”

Image – Boy and Medicine: courtesy of MedicImage



A powerful drug used to treat Acne.

Arthritis drug banned from sale in UK and Germany


London: The drug Prexige (lumiracoxib), used to treat osteoarthritic pain has been suspended from sale by health regulators in the UK and Germany over liver damage fears.

Manufacturer, Novartis, is informing regulatory agencies around the world of these changes, which come after similar actions in other countries in recent months.

Novartis will also comply with a request from the Austrian health authority to suspend sales pending a final decision by the Committee for Medicinal Products for Human Use (CHMP), which reviews medicines in the European Union.

Patients taking Prexige in the UK, Germany, and Austria are advised to consult their medical practitioner.

Prexige was precribed as 100 mg once-daily treatment for osteoarthritic pain following EU approval through the Mutual Recognition Procedure (MRP) in October 2006. Itis also marketed and sold in Belgium, Cyprus, Hungary, Malta, Portugal, and Sweden.

Other EU countries may decide to independently suspend the marketing authorization or sale of Prexige ahead of a decision by the CHMP, which is expected in December.

Prexige is part of a class of drugs known as a COX-2 inhibitors and liver enzyme changes are a known side effect of these and traditional non-steroidal anti-inflammatory drugs (NSAIDs).

The ban comes The actions in Europe come after an Urgent Safety Restriction was initiated in August 2007 for the Prexige 100 mg dose. Prexige was first withdrawn in August 2007 in Australia where a number of liver side effects were reported, including two deaths, associated with the use of Prexige at doses higher than 100 mg. No deaths have been reported worldwide with the 100 mg dose.

FDA posts heart attack warning on anti-diabetes drug Avandia


Washington: The US Food and Drug Administration has announced that the manufacturer of Avandia (rosiglitazone), a drug used to treat type 2 diabetes, has agreed to add new information to the existing boxed warning in the drug’s labeling about potential increased risk for heart attacks.

People with type 2 diabetes who have underlying heart disease or who are at high risk of heart attack should talk with their health care provider about the revised warning as they evaluate treatment options. FDA advises health care providers to closely monitor patients who take Avandia for cardiovascular risks.

Janet Woodcock, MD, the FDA’s deputy commissioner for scientific and medical programmes and acting director of the Center for Drug Evaluation and Research said: “The FDA has moved expeditiously to review the cardiovascular risks of this drug so that we could inform patients and doctors at the earliest possible time of our findings.

“The FDA remains committed to making sure that doctors and patients have the latest information about the risks and benefits of medicines.”

Avandia is manufactured by Philadelphia-based GlaxoSmithKline (GSK) and was approved in 1999 as an adjunct to diet and exercise to improve control of blood sugar levels. Avandia is approved to be used as a single therapy or used in combination with metformin and sulfonylureas, other oral anti-diabetes treatments.

During the past year, FDA has carefully weighed several complex sources of data, some which show conflicting results, related to the risk of chest pain, heart attacks and heart-related deaths, and deaths from any cause in patients treated with Avandia.

At this time, FDA has concluded that there isn’t enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments. Therefore, FDA has requested that GSK conduct a new long-term study to evaluate the potential cardiovascular risk of Avandia, compared to an active control agent. GSK has agreed to conduct the study and FDA will ensure it is initiated promptly.

The revision of Avandia’s existing boxed warning – FDA’s strongest form of warning – includes the following statement:

“A meta-analysis of 42 clinical studies (mean duration 6 months; 14,237 total patients), most of which compared Avandia to placebo, showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction. Three other studies (mean duration 41 months; 14,067 patients), comparing Avandia to some other approved oral antidiabetic agents or placebo, have not confirmed or excluded this risk. In their entirety, the available data on the risk of myocardial ischemia are inconclusive.”

The previous upgraded warning, added to certain diabetes drugs (in class of drugs related to Avandia) on Aug. 14, 2007, emphasized that these types of drugs may worsen heart failure, a condition in which the heart does not adequately pump blood, in some patients.

GSK is also developing a Medication Guide for patients to provide additional information about the benefits and risks and safe use of Avandia.

So far no oral anti-diabetes drug has been conclusively shown to reduce cardiovascular risk. Consequently, the agency also will be requesting that labeling of all approved oral anti-diabetes drugs contain language describing the lack of data showing this benefit.

Today’s action follows recommendations made at the July 2007 joint meeting of FDA’s Endocrine and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees. At the meeting, members voted 22-1 to recommend that Avandia stay on the market, pending a review of additional data. The committee also advised that information warning of the potential for increased risk of heart attacks should be added to the drug labeling.

Company fined $10.5m over fountain of youth drug

Boston: A company that distributed human growth hormone to “well known athletes and entertainers” has agreed to pay a $10.5 million penalty and cooperate with ongoing law enforcement investigations, federal prosecutors said on Tuesday.

Under the terms of the agreement, Specialty Distribution Services Inc., a subsidiary of Express Scripts Inc., will not face prosecution for three years if it fully complies with terms of the agreement.

Steve Littlejohn, a spokesman for St. Louis-based Express Scripts, said the company fully cooperated in the federal investigation and has already implemented procedures to prevent the illegal distribution of human growth hormone.

“Express Scripts does not condone the use of human growth hormone for anti-aging, cosmetic or performance enhancement purposes,” the company said in a news release.

Specialty Distribution Services “knowingly distributed human growth hormone to certain well known athletes and entertainers, including a well known athlete in Massachusetts, knowing that their intended use was athletic performance enhancement, cosmetic or anti-aging,” in violation of federal law, the U.S. attorney’s office said in a news release.

Prosecutors did not mention any names of those believed to have bought HGH from the firm.

The drug in question was approved by the Food and Drug Administration only for specific purposes, including treatment of children with growth failure due to inadequate growth hormones, prosecutors said.

“The public should also realize that human growth hormone has not been shown to be safe and effective for athletic, cosmetic or anti-aging uses, and it must not be promoted or distributed for such uses,” U.S. Attorney Michael Sullivan said in a statement.

The company illegally shipped the drugs five times between October 2000 and December 2005, according to court documents prosecutors filed with the agreement.

Human growth hormone was sent to a “well known professional athlete in Massachusetts” in January 2002 and again in October 2003 following a doctor’s request, the documents said.

Drugs were sent to an entertainer in March 2002 at the request of a doctor who said he was filling the prescription at the patient’s request and that the drugs were “not medically necessary,” according to the documents. The doctor identified his practice as an “anti-aging clinic.”

The company shipped the drugs to a 6-foot-5, 276-pound “entertainer/athlete” in January 2003 after a doctor said it was “medically necessary,” even though the dosage was typically used for performance enhancement, the documents said.

Specialty Distribution Services had pharmacists and other employees who should have recognized the prescriptions as illegitimate, prosecutors said. Under the agreement, it will better train employees to recognize fake prescriptions.

Human growth hormone is produced naturally by the body throughout life, but can cause complications when taken in excessive amounts, said Dr. Linn Goldberg, professor of medicine at Oregon Health and Science University in Portland.

“When you are a fully grown adult who takes HGH in excess, it thickens your bones and skin, puts you at risk for diabetes and other conditions, and causes fluid retention, joint pain and nerve damage,” he said.

Goldberg said he is not surprised that entertainers and athletes are using it, because it can cost $100 per day. Prosecutors said HGH treatment can cost up to $20,000 per year.

“Athletes are looking for the fountain of youth, and the fountain of youth is not to be found in a bottle,” he said.

New diet drug works on metabolism

London: A new fatbusting drug that makes the body loose 12 percent of weight in a year – faster than any other drug on the market – could soon be available to UK patients.

The one-a-day tablet called Excalia which has been developed by US scientists works by tricking the metabolism into running faster.

The number of NHS prescriptions for obesity drugs has jumped almost 600 per cent since 1999. Already available in the UK are Xenical, which blocks absorption of fat, Reductil, which makes the stomach feel full, and Acomplia, which reduces cravings and stops the body storing abdominal fat.

Britain’s National Health Service spends around £1bn a year on obesity-related illness such as diabetes and the UK the worst problem with overweight adults.

The American scientists say the pill also helps weight to come off for longer. It works on the hypothalamus in the brain to boost the body’s metabolism and uses two drugs which are already widely used, against epilepsy and smoking. It also boost levels of a hormone that stops us getting hungry.

Drug may reverse liver damage even in alcoholics

Newcastle: Scientists have discovered a drug that could prevent liver disease, even in alcoholics.

Tests on the drug, Sulphasalazine, which is currently used to treat inflammatory bowel disease, found that it also prevented scarring of the liver and even reversed liver damage.

Professor Christopher Day, a liver specialist from Newcastle University in Britain who led the research, said Sulphasalazine could provide an alternative to liver transplants.

“This drug is not a finite resource. You are not stealing it from someone else, which is always a worry in public opinion,” said Professor Day said. “People are dying on the transplant list.”

Until now, cirrhosis of the liver, usually caused by alcohol abuse, is considered incurable and the only option for patients in the final stages of liver disease is a liver transplant.

Many patients die waiting for a transplant and there is a lack of desire to give organs to those who are ill through self abuse.

The researchers have tested the drug on animals and human trials are expected to begin in Britain next year.

The drug will initially be given to heavy drinkers who have given up alcohol too late for their liver to recover naturally.

If this proves successful, the medicine will also be prescribed to alcoholics who continue to drink but show a determination to fight their addiction by reducing intake.

Sulphasalazine may also relieve the ethical dilemma of giving donated livers to people whose illness was self-inflicted through excessive consumption of alcohol or poor diet and obesity.

Professor Jones said 10 to 15 per cent of people on the waiting list for a liver transplant were heavy drinkers.

“It’s a very tough decision for the doctors, if, for example they are faced with a 45-year-old man with a young family who’s a heavy drinker. If you say no to the transplant, they will die.

“It would be revolutionary if this drug could reverse the liver damage so you wouldn’t need to do a transplant or, better yet, prevent the damage in the first place.”

New clot-busting drug offers hope to stroke victims

London: Trials of a new clot-busting drug for stroke victims are taking place in the US and Canada.

If successful, the drug, by UK company Vernalis and codenamed V10153, could go into the final phase of clinical trials next year.

The drug contains a protein that activates when it comes into contact with a clot and breaks it up. It is thought that the drug will be particularly helpful to those who have ischemic strokes, the most common form of stroke triggered by a blood clot in the brain. It can be given up to nine hours after a stroke and still be viable, unlike most current medications.

Vernalis medical director Dr John Hutchison said that clotbusting drugs should be administered as quickly as possible after a stroke, but that it was often difficult to get a patient scanned and treated within three hours.


Doctors at the Mayo Clinic have discovered that the popular over-the-counter dietary supplement 5-Hydroxy-L-Tryptophan (5-HTP) may have the same contaminant found in a similar supplement banned nearly a decade ago after being associated with a rare and occasionally deadly blood disease. So far, there are no known cases of anyone becoming ill from taking contaminated supplements, Mayo researchers said, but they’re warning people to avoid taking high doses of it for fear of triggering an outbreak of a possible fatal illness.

The contaminant is similar to one found in tainted batches of a related amino acid dietary supplement, L-tryptophan, which killed 30 people and sickened more than 1,500 in 1989, said Dr. Stephen Naylor, one of the Mayo researchers. It had been used by an estimated 15 million Americans as a remedy for depression, premenstrual syndrome and insomnia.

Since then, the supplement has been replaced by a version called 5-HTP or sometimes 5-OH-Trp, which is derived from a plant, sold over the counter and promoted for variety of problems by several manufacturers. Now Naylor and his colleague, Dr. Gerald Gleich, found the contaminant, known as “peak x,” in all six batches of 5-HTP that they sampled from health and nutrition stores in New York and Rochester, Minn. The same contaminant was linked to a small outbreak of a disease known as eosinophilia-myalgia syndrome (EMS), in 1991, and is chemically similar to – but not the same as – the contaminants discovered in the fatal outbreak in 1989.

“I don’t believe the present environment requires that these things are pulled off the shelves,” said Naylor, whose findings were published today in the journal Nature Medicine. “But on the other hand, based on our fairly extensive experience with this disease . . . we have cause for concern.”

Gleich, however, said that in his opinion, people should stop taking the supplements. Naylor added that they don’t even know what a safe level would be. The Mayo researchers notified the U.S. Food and Drug Administration (FDA) about their findings, but the FDA declined to say what action, if any, it is taking. Michael Osterholm, the Minnesota state epidemiologist, said it would be up to the FDA to decide if the supplements should be pulled from the market. But, he said, “if this is a product that has the potential to cause {EMS}, that is a very serious illness and people need to be aware of that.”

The researchers found that the new supplements have anywhere from 3 to 15 percent of the levels of contaminant that were linked to a 1991 case, in which a Canadian family became ill after taking 5-HTP.

Even with small levels of contaminants, Naylor said, people could get a potentially toxic dose if they take too much. Because the supplements aren’t regulated, there’s no control over how much people take. At least one new book is recommending doses of 300 to 900 milligrams a day, which the doctors say could bring the contaminants to dangerous levels. “We would just like to let the public know that there is a concern, that they should be cautious, and they should certainly forgo taking high doses of 5-HTP,” said Naylor.

The symptoms of EMS, a blood disorder, include fatigue, muscle aches, soreness, numbness, tingling and other nerve problems. Gleich said anyone who has been taking the supplements and is experiencing those symptoms, should call a doctor and have a blood test. “The potential, we believe, is there, and we think a warning is appropriate,” said Gleich, Naylor’s co-author.

The Mayo researchers started testing 5-HTP in April at the request of a TV news show, “Dateline NBC,” which was preparing a story on contaminated food supplements. The Mayo doctors also said their discovery underscores the potential dangers of so-called natural products. Said Naylor, “Some of the most potent toxins known to the human race are derived from plant species, so natural does not necessarily mean safe.”

Gleich noted that there have been no reports of illness so far. “Had we seen cases then this would have quickly evolved very differently. There may be cases, we’re simply not aware of it.”

The Mayo clinic played a key role, along with the Minnesota Department of Health, in tracing the cause of the 1989 outbreak to the tainted batches of L-tryptophan. The manufacturer, a Japanese company, reportedly paid $2 billion to settle claims from the outbreak.