Prescribing guidance for AstraZeneca's 'superstatin' Crestor (rosuvastatin calcium) has been changed across the European Union as a precaution against dangerous side-effects associated with high doses of the drug. The 40mg dose should now only be used under specialist supervision. In addition to the restrictions of Crestor's 40mg dose, all patients will now have to start on the lowest possible dose of 10mg and then wait for four weeks before it is increased, if necessary, to a 20mg dose. The potentially fatal kidney condition can result from the muscle wasting condition myopathy, sometimes seen in patients taking statins. In 2001 the same condition prompted Bayer to withdraw Lipobay/Baycol after the statin was linked to 31 deaths in the US.
Asthma Drug May Actually Boost Risk of Deadly Attacks
One of the most commonly prescribed medicines to treat asthmatics may actually make asthma worse and contribute to heart problems, two studies find. Shelley Salpeter of Stanford University says daily doses of beta-agonists (like Salbutamol and Salmeterol) may increase the risk of a fatal asthma attack and more than doubles the risk of cardiac events such as heart attacks. Beta-agonists help relax muscles in the lungs when they spasm during an asthma attack. They are administered in two ways: as a fast-acting "rescue" drug at the beginning of an attack and in a longer-acting form designed to prevent attacks. The latter is frequently given in combination with inhaled steroids, as both drugs help prevent asthma attacks. Salpeter and her team reviewed studies from 1966 to 2003 of asthmatics taking beta-agonists. They found that patients who took the drug daily developed a tolerance and had more inflammation in their lungs than those not taking the drug at all, making them more susceptible to a potentially deadly attack. Beta-agonists increase heart rate and decrease essential levels of potassium, putting the heart at greater risk of attack or failure, according to the study. Robert Meyer of the Food and Drug Administration's Office of Drug Evaluation, however, disagrees. He says the FDA believes that, taken as directed, beta-agonists are safe and effective
US Patent for Modified Release Formulation Of Amoxycillin
Conley; Creighton and others of Beecham Pharmaceuticals were awarded a patent on modified release formulation of amoxycillin on June 8, 2004. The invention relates to a modified release pharmaceutical formulation comprising amoxycillin and potassium clavulanate in the ratio from 2:1 to 20:1 in which all of the potassium clavulanate and a first part of amoxycillin are formulated with pharmaceutically acceptable excipients which allow for immediate release of the potassium clavulanate and the first part of amoxycillin, to form an immediate release phase, and further comprising a second part of amoxycillin formulated with pharmaceutically acceptable excipients which allow for slow release of the second part of amoxycillin, to form a slow release phase.
New WHO Guidelines To Promote Proper Use Of Alternative Medicines
Up to 80 per cent of developing country populations rely on traditional medicine for their primary health care, due to cultural tradition or lack of alternatives. In wealthy countries, many people seek out various types of natural remedies on the assumption that natural means safe. In China, a country where traditional therapies and products are widely used in parallel with conventional medicine, there were 9 854 known reported cases of adverse drug reactions in 2002 alone, up from 4 000 between 1990 and 1999. As more people use these medicines, governments should have the tools to ensure all stakeholders have the best information about their benefits and their risks.
Empirical and scientific evidence exists to support the benefits of acupuncture, manual therapies and several medicinal plants for chronic or mild conditions. For instance, the effectiveness of acupuncture, a popular treatment for relieving pain, has been demonstrated both through numerous clinical trials and laboratory experiments. As a result, 90 per cent of pain clinics in the United Kingdom and 70 per cent in Germany include acupuncture as a form of treatment. Equally, some medicinal plants have shown efficacy for life-threatening conditions; medicine combinations containing the Chinese herb Artemisia annua are now considered amongst the most effective remedies against malaria. However, there have been many cases of consumers unknowingly using suspect or counterfeit products; choosing inappropriate therapies in self-care; as well as several reports of unintentional overdose.
Canadian Web Pharmacies Best-Behaved
The US General Accounting Office (GAO) report "shows that Canadian pharmacies are a safe source of high-quality prescription drugs and they are cheaper. The probe by the GAO, the investigative arm of Congress, found a multiplicity of problems, including drugs that weren't what they were supposed to be. But Canadian pharmacies were far from the worst offenders, according to its report. And the FDA did not dispute the findings. All 18 Canadian pharmacies contacted required prescriptions before selling drugs, compared to only five of 29 in the United States. The remaining American pharmacies and all 21 other foreign pharmacies contacted sold drugs without a prescription from a doctor. The biggest issue for Canadian pharmacies found was that 16 of 18 samples were not approved for U.S. markets, either because of variations in labeling or facilities that were not FDA-inspected. But for all 16 of those samples, the manufacturer attested that they were chemically comparable. The GAO researchers placed a total of 90 drug orders, each with a different Web pharmacy, and received 68 samples of 13 different drugs. The pharmacies were located in the United States, Canada, and several other countries, including Mexico, Pakistan and Spain. GAO staff checked labeling, shipping, and other information, then forwarded the samples on to the manufacturers to check for authenticity. The list of drugs included narcotics (such as OxyContin and Percocet), some with special safety restrictions (for example, Accutane), and some with special handling requirements (such as Humulin). None of the non-Canadian foreign pharmacies included labels with instructions, and only about one-third had warning information. And while some products were "chemically comparable," the FDA "has concerns about whether that translates into therapeutically equivalent,"
List of First Time Generics Approved By US FDA In May 2004
Propoxyphene napsylate and acetaminophen tablets, usp 100 mg/325 mg, Ofloxacin ophthalmic solution usp 0.3 per cent Fluticasone propionate cream 0.05 per cent, Clarithromycin tablets usp 250 mg and 500 mg, Bupropion hydrochloride extended-release tablets 150 mg, Itraconazole capsules 100 mg, Metronidazole topical cream 0.75 per cent.
Too Many Antioxidants May Play Role In Type 2 Diabetes, New Theory
Type 2 diabetes is one of the fastest growing and most costly disorders worldwide. There are currently more than 194 million people with diabetes worldwide, according to the International Diabetes Federation, and this number could reach 333 million by 2025. Dietary factors have been cited as possible factors behind this rise. Obesity is known to impact insulin regulation but there is also research into the impact of different nutrients on insulin function. Many studies have also looked at nutrients that protect against type 2 diabetes, including magnesium and vitamin D. But now researchers at Cornell University report that higher-than-normal amounts of a selenium-containing enzyme could promote type 2 diabetes. The researchers found that mice with elevated levels of the antioxidant enzyme develop the precursors of diabetes at much higher rates than did control mice.
Unmet Needs In Arthritis Treatment
Although there is no cure for rheumatoid arthritis, a wide range of drugs are involved in its treatment. Similar painkilling drugs are used to treat RA as osteoarthritis (OA), such as anti-inflammatory drugs like the new COX-II inhibitors and more traditional, non-steroidal anti-inflammatory drugs (NSAIDs) and steroids. However, RA disease progression can be slowed by the use of disease modifying anti-rheumatic drugs (DMARDs), which target the immune system to slow the immunological attack on the affected joint. New biologic drugs within this class, such as Enbrel (etanercept) and Remicade (infliximab), are offering the most promising route to slowing or even halting this disease. However, these drugs do not fully address all the requirements of an RA patient, leaving areas for pipeline drugs to improve upon. BMS is developing CTLA4-Ig (abatacept), a co-stimulation blocker. The patient potential for CTLA4-Ig is slightly larger than competing biologics due to its relatively low manufacturing cost, as it is produced in the milk of transgenic goats. In addition to its cost advantage, this drug also represents innovation in terms of its mechanism of action. It is the first in a class of drugs known as co-stimulation blockers and is thought to have a great deal of promise in the treatment of RA. Celltech's CDP870: The Anti-TNF antibody fragment is being tested for the treatment of RA Celltech is responsible for the development of the Crohn's disease indication, while Pfizer was responsible for two Phase III trials in RA. Celltech plans to launch CDP870 for the Crohn's disease indication first. Roche's Rituxan (Rituximab): The results show potential for a long-term therapy, as efficacy was good 22 weeks after the treatment. Although dosing appears to be required less often than Enbrel, it is intravenous, and therefore requires administration by a physician. Rituxan is already approved in the US and EU for the treatment of non-Hodgkin's lymphoma. Rituxan is well-positioned for a strong marketing campaign when approved for the RA indication. Rituxan's novel mechanism of action, in terms of targeting the immune system B-cells as opposed to T-cells, represents an innovation in RA therapy. Rituxan has the potential to be an arthritis blockbuster. More than 20 biologic DMARDs are expected to enter the market between 2004 and 2008. Many of these compounds will be similar to Enbrel and Remicade in their price and mechanism of action and are therefore not expected to alter the landscape of the market to a high degree.
Biogenerics Market Presents New Commercial Opportunity
Despite strong opposition from the biotechnology industry, regulatory bodies are expected to establish approval pathways for biogenerics in the next few years, driven by the potential cost savings that would be made by governments and healthcare payers if they had access to lower cost biologics. As yet however, there is no abbreviated pathway for approval of generic versions of biological products. Without such a route, potential biogenerics players will have to undertake the same large-scale clinical development process as the originator companies, thereby preventing a healthy profit margin. Regulators have thus far struggled to introduce a faster approval process for biogeneric drugs because of the difficulty in establishing bioequivalence of a biological product. Biologics are large, complex, heterogeneous molecules, for which the manufacturing process can be a determinant of the end product. For a would be biogenerics manufacturer, demonstrating that its product was as safe and effective as the originators would be a difficult task, since establishing that immunogenicity had not been altered, and that any undetected differences in the product would not impact safety and efficacy, would be problematic without conducting clinical trials. Leading generics companies like Teva and Sandoz are particularly well positioned to target biogenerics as an opportunity to drive revenue and profit growth. Sandoz expects to be the first company to launch a biogeneric product in Europe. The company's generic human growth hormone, Omnitrop, is currently being considered for approval by European regulators, having received a positive opinion from the CPMP in June 2003.
Compiled from WWW by Venkat Appaji Padmanabhuni appajipv@hotmail.com