Generic Drug for Enlarged Prostate Approved

By Kathleen Doheny
WebMD Health News

Reviewed By Louise Chang, MD

March 2, 2010 — The first generic version of Flomax, a medication to treat the signs and symptoms of an enlarged prostate gland, has won the approval of the FDA.

The generic version of Flomax, known as tamsulosin, will be made by IMPAX Laboratories of Haywood, Calif. Under FDA regulations, the generic versions must meet the same standards as the brand name drug, says Gary Buehler, director of the FDA Office of Generic Drugs, in a news release.

Enlargement of the prostate gland, a condition known as benign prostatic hyperplasia (BPH), is common among men as they age. More than half of men 60 and older and more than 90% of those 70 and older have BPH symptoms, including a weak urine stream, leaking or dribbling, frequent need to urinate at night, and urinary urgency.

The condition is not cancerous.

The prostate is a walnut-shaped gland located just below the bladder. It produces fluid for semen. But when it grows too big, the prostate puts pressure on the urine-carrying canal or urethra, which passes through the prostate, and this can result in the urinary symptoms.

According to information on the Flomax web site, the drug works by relaxing muscles in the prostate and in the neck of the bladder. Somewhat like releasing a pinched straw, it is then easier for urine to pass out of the body.

Those taking the drug are cautioned to avoid hazardous tasks or driving until they know how the drug affects them. Commonly reported side effects include a runny nose, dizziness, and a decrease in semen, although the drug is not linked with a decrease in sex drive nor impotence.

Avoid red yeast rice products promoted as treatments for high cholesterol, FDA warns

Medicine News Today – The U.S. Food and Drug Administration is warning consumers not to buy or eat three red yeast rice products promoted and sold on web sites. The products may contain an unauthorized drug that could be harmful to health. The products are promoted as dietary supplements for treating high cholesterol.

The potentially harmful products are: Red Yeast Rice and Red Yeast Rice/Policosonal Complex, sold by Swanson Healthcare Products, Inc. and manufactured by Nature’s Value Inc. and Kabco Inc., respectively; and Cholestrix, sold by Sunburst Biorganics. FDA testing revealed the products contain lovastatin, the active pharmaceutical ingredient in Mevacor, a prescription drug approved for marketing in the United States as a treatment for high cholesterol.

“This risk is even more serious because consumers may not know the side effects associated with lovastatin and the fact that it can adversely interact with other medications,” said Steven Galson, M.D., M.P.H., director of FDA’s Center for Drug Evaluation and Research.

These red yeast rice products are a threat to health because the possibility exists that lovastatin can cause severe muscle problems leading to kidney impairment. This risk is greater in patients who take higher doses of lovastatin or who take lovastatin and other medicines that increase the risk of muscle adverse reactions. These medicines include the antidepressant nefazodone, certain antibiotics, drugs used to treat fungal infections and HIV infections, and other cholesterol-lowering medications.

FDA has issued warning letters advising Swanson and Sunburst Biorganics to stop promoting and selling the products. Companies that do not resolve violations in FDA warning letters risk enforcement actions, such as an injunction against continuing violations and a seizure of illegal products.

The FDA warning letters state that the products Red Yeast Rice, Red Yeast Rice/Policosonal Complex, and Cholestrix, sold on the firm’s websites, are unapproved new drugs that are marketed in violation of the Federal Food, Drug, and Cosmetic Act. The warning letters are available on FDA’s web site.

FDA advises consumers who use any red yeast rice product to consult their health care provider if they experience problems that may be due to the product.

Dan shen’s effect for stroke patients lacks strong evidence

Health Behavior News Service, by Bruce Sylvester – The traditional Chinese medicine dan shen (丹参, Salviae miltiorrhizae), a standard treatment for ischemic stroke in China, lacks strong scientific evidence to support such use, according a new review of studies.Nevertheless, based on the available data, dan shen treatment showed a tendency to improve short-term neurological deficits in stroke patients, say researchers at Sichuan University in Chengdu, China.

However, the short-term result “should be interpreted cautiously because of the poor methodological quality of included trials and the small numbers of patients,” said review co-author and neurology professor Ming Liu.

The review appears in the current issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates research in all aspects of health care. Systematic reviews drawevidence-based conclusions about medical practice after considering both the content and quality of existing trials on a topic.

Obstruction of a blood vessel supplying blood to the brain can result in ischemic stroke, which accounts for about 83% of all strokes.

In China, post-stroke use of herbal medicine is part of standard care in both Western-style hospitals and in traditional Chinese medicine hospitals. Dan shen, in various pill, tablet and injection formulations, is the herb most commonly given for ischemic stroke; its use in that context spans more than three decades.

However, few researchers have tested the herb’s effectiveness in rigorous clinical trials that approach current international standards.

The reviewers found six studies that met inclusion criteria for the review — randomized or quasi-randomized and controlled — involving 494 acute ischemic stroke patients.

The Cochrane reviewers found that methods of randomly assigning study subjects to dan shen or placebo were unclear, and that this could have led to results exaggerating a positive treatment effect by 30% to 41%. “It is therefore plausible that dan shen is truly ineffective and the apparent benefits are simply due to bias arising from the methodological weaknesses of the studies,” they say.

Since treatment and follow-up in these studies ranged from 14 to 28 days, it was not possible to assess the long-term effects of dan shen.

“We found no evidence to support the routine use of dan shen agents for ischemic stroke,” Liu said. “However, if the apparently beneficial effects on neurological impairment were confirmed in methodologically rigorous trials, it would lead to a useful treatment for stroke being identified,” she added.

Ted Kaptchuck, O.M.D., associate professor of medicine at Harvard Medical School, said, “in Chinese society, at this time, basic science and laboratory evidence seems to be enough to gain widespread acceptance and adoption for the use herbal and other medications. In the West, we think it is a long shot to go from basic laboratoryevidence to demonstrated clinical efficacy in randomized trials. We are not at the point where it is clear that a traditional Chinese herb has a major role in health care.”

Liu agreed: “The designs of these trials need to be improved in the future research, not only in the clinical trials on dan shen agents, but also in trials on other Chinese herbal medicine.”

[Dan Shen agents for acute ischaemic stroke (Review). Cochrane Database of Systematic Reviews 2007, Issue 2.]

The Cochrane Collaboration is an international nonprofit, independent organization that produces and disseminates systematic reviews of health care interventions and promotes the search forevidence in the form of clinical trials and other studies of interventions.

What is the prognosis (outlook) for patients who get swine flu (H1N1)?

The following is speculation on the prognosis for swine flu (H1N1) because this disease has only been recently diagnosed and the data is changing daily. This section is based on currently available information.

In general, the majority (about 90%-95%) of people who get the disease feel terrible (see symptoms) but recover with no problems, as seen in patients in both Mexico and the U.S. Caution must be taken as the swine flu (H1N1) is still spreading and has become a pandemic. So far, young adults have not done well, and in Mexico, this group currently has the highest mortality rate, but this data could quickly change.

People with depressed immune systems historically have worse outcomes than uncompromised individuals; investigators suspect that as swine flu (H1N1) spreads, the mortality rates may rise and be high in this population. Current data suggest that pregnant individuals, children under 2 years of age, young adults, and individuals with any immune compromise or debilitation are likely to have a worse prognosis. Unfortunately, the problem with the prognosis is still unclear. If the mortality is like the conventional flu that causes mortality rates of about 0.1%, the result would be about 36,000 deaths per year because of the huge number of people who get infected. If the Mexico swine flu (H1N1) ends up with a mortality rate of about 6% and infects the same number of millions of people as conventional flu viruses, the projected numbers could be as high as 2 million deaths in the U.S. alone. This is a bad prognosis for about 2 million people and their families; these potential deaths are major reasons that health officials are so concerned about the spread of this new virus. As of September 2009, the current estimates are that about 90,000 deaths will occur in the U.S. from novel H1N1 swine flu (estimated by the president’s advisory committee). As of October, these estimates have not been revised by the advisory committee or the CDC.

Another confounding problem with the prognosis of swine flu (H1N1) is that the disease is occurring and spreading in high numbers at the usual end of the flu season. Most flu outbreaks happen between November to the following April, with peak activity between late December to March. This outbreak is not following the usual flu pattern since novel H1N1 began its outbreak in April and had spread throughout the world by September. Some scientists think that swine flu (H1N1) will die down but return with many more cases in the fall, and still others speculate the current pandemic will eventually resemble the outcomes similar to the 1918 influenza pandemic. Some suggest it may resemble the SARS (severe acute respiratory syndrome caused by a coronavirus strain) outbreak in 2002-2003 in which the disease spread to about 10 countries with over 7,000 cases, over 700 deaths, and had a 10% mortality rate. Effective isolation of patients was done in this case, and many investigators think the outbreak was stopped due to this measure. Because swine flu (H1N1) is a new virus and does not seem to be following the usual flu disease pattern, any prognosis is speculative, although as of October 2009, the numbers of people with flu-like illness are higher than usual and the illness is affecting a much younger population than the conventional flu. As the pandemic progresses, this article will be updated. The best news about this novel H1N1 swine flu is that the majority of people, as of October 2009, who have caught the flu recover without medical treatment and have an excellent prognosis.

What treatment is available for swine flu (H1N1)?

The best treatment for influenza infections in humans is prevention by vaccination. Work by several laboratories has recently produced vaccines. The first vaccine released in early October 2009 was a nasal spray vaccine. It is approved for use in healthy individuals ages 2 through 49. This vaccine consists of a live attenuated H1N1 virus and should not be used in anyone who is pregnant or immunocompromised. The injectable vaccine, made from killed H1N1, became available in the second week of October. This vaccine is approved for use in ages 6 months to the elderly, including pregnant females. Both of these vaccines have been approved by the CDC only after they had conducted clinical trials to prove that the vaccines were safe and effective. However, caregivers should be aware of the vaccine guidelines that come with the vaccines, as occasionally, the guidelines change. Please see the sections below titled “Can novel H1N1 swine flu be prevented with a vaccine?” and the timeline update for the current information on the vaccines.

Two antiviral agents have been reported to help prevent or reduce the effects of swine flu. They are zanamivir (Relenza) and oseltamivir (Tamiflu), both of which are also used to prevent or reduce influenza A and B symptoms. These drugs should not be used indiscriminately, because viral resistance to them can and has occurred. Also, they are not recommended if the flu symptoms already have been present for 48 hours or more, although hospitalized patients may still be treated past the 48-hour guideline. Severe infections in some patients may require additional supportive measures such as ventilation support and treatment of other infections like pneumonia that can occur in patients with a severe flu infection. The CDC has suggested in their interim guidelines that pregnant females can be treated with the two antiviral agents.

€1 million EU funding for Chinese medicine research

King’s College London – King’s College London successfully led a consortium bid for €995,100 of EU funding for a ground-breaking research project that will play an important role in the unification of Western and Chinese approaches to medicine.

The project entitled ‘Good Practice in Traditional Chinese Medicine Research in the Post-genomic Era’ (GP-TCM) will review the current status of Traditional Chinese Medicine (TCM) research, identify problems and propose solutions by applying modern methods of investigation, as well as providing a forum for the exchange of opinions, experience and expertise among scientists in the EU and China.

The three-year project aims to propose guidelines and priority areas for future research, and will lead to the formation of a new academic society, the European Society of TCM Research, which is to facilitate and foster sustainable EU-China collaboration in this area.

The research consortium consists of 29 beneficiary partner institutions and small-and-medium-sized enterprises from the EU and China. Partnerships with more than 20 additional non-beneficiary institutions, companies and independent experts are further strengthening its research.

Holistic approach

Dr Qihe Xu, Lecturer in the Department of Renal Medicine, Division of Gene and Cell Based Therapy, and coordinator of the project, explains: ‘In contrast to the reductionist approach of Western medicine that is based on modern anatomy and cell and molecular biology, TCM uses a unique theory system and an individualised holistic approach to describe health and disease, which is based on the philosophy of Yin-Yang balance. These two medicine systems disagree with each other in many situations since they observe health from their own limited perspective. GP-TCM aims to inform best practice and harmonise research of the safety and efficacy of TCM, especially Chinese herbal medicines and acupuncture, in the EU.’

‘The project will be divided into ten parts, which will review aspects of quality control, extraction and analysis of Chinese herbal medicines. Discussion fora that explore the role of functional genomics methodology in researching the safety, efficacy and mechanisms of action of Chinese herbal medicines and acupuncture are at the core of this project. New guidelines about good practice and agreed protocols in related research areas will harmonise future TCM research in the EU, and online tools and research resources will be made available to all EU member states. As an open-start and open-ending consortium, we will invite more organisations to become involved in the work.’

Professor Peter Hylands, Head of the Department of Pharmacy and Director of the Centre for Natural Medicines Research, continues: ‘We are delighted to be part of this unique group. In the Centre for Natural Medicines Research at King’s we are examining the application of emerging technologies to the solution of difficult problems in the use of traditional medicines. This forum provides an unparalleled opportunity to share our experiences with Chinese and European colleagues and together to develop a 21st-century road map for the global development of traditional medicines.’

Professor Bruce Hendry, Professor of Renal Medicine, concludes: ‘This programme grant is an excellent opportunity for King’s College London to play a leading role in the unification of Western and Chinese approaches to medicinal therapeutics.’