Policy Watch
healthalerts.com.au article posted on: Wednesday 22nd August 2007
The U.S. Food and Drug Administration today announced manufacturers of certain drugs approved to treat Type 2 diabetes have agreed to add a stronger warning on the risk of heart failure, a condition that occurs when the heart does not adequately pump blood.
The information will be included in the form of a "boxed" warning—FDA's strongest form of a warning. The upgraded warning emphasizes that the drugs may cause or worsen heart failure in certain patients.
After a review of postmarketing adverse event reports, FDA determined that an updated label with a boxed warning on the risks of heart failure was needed for the entire thiazolidinedione class of antidiabetic drugs.
This class includes Avandia (rosiglitazone), Actos (pioglitazone) Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepride). These drugs are used in conjunction with diet and exercise, to improve blood sugar control in adults with type 2 (non-insulin-dependent) diabetes. FDA had asked the drug's manufacturers, GlaxoSmithKline and Takeda, to address these concerns.
"Under FDA's postmarketing surveillance program, we carefully monitor new safety information for marketed drugs and take appropriate action when necessary to inform patients and health care providers of new information," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research.
"This new boxed warning addresses FDA's concerns that despite the warnings and information already listed in the drug labels, these drugs are still being prescribed to patients without careful monitoring for signs of heart failure."
FDA's review of adverse event reports found cases of significant weight gain and edema—warning signs of heart failure. In some reports, FDA noted, continuation of therapy has been associated with poor outcomes, including death.
The strengthened warning advises health care professionals to observe patients carefully for the signs and symptoms of heart failure, including excessive, rapid weight gain, shortness of breath, and edema after starting drug therapy.
Patients with these symptoms who then develop heart failure should receive appropriate management of the heart failure and use of the drug should be reconsidered. People who have questions should contact their health care providers to discuss alternative treatments.
The warning also states that these drugs should not be used by people with serious or severe heart failure who have marked limits on their activity and who are comfortable only at rest or who are confined to bed or a chair.
FDA's review of Avandia and possible increased risk of heart attacks is ongoing. On July 30, 2007, FDA's Endocrine and Metabolic Advisory Committee and the Drug Safety and Risk Management Advisory Committee recommended that Avandia continue to be marketed, and further recommended that information be added to the labeling for risk of heart attacks (ischemic risks).
Source: United States Food and Drug Administration, 17th August 2007
healthalerts.com.au article posted on: Thursday 17th May 2007
The National Joint Replacement Registry is being expanded to include data collection on ankle, shoulder, wrist and spinal disc replacements.
About one in four hip and knee replacements fail and there is no reason not to expect that the statistics collected under the expanded registry will reflect those already available on hip and knee prostheses.
More than 70,000 Australians undergo joint replacement procedures every year.
The Australian Health Insurance Association will continue to lobby on behalf of health consumers for appropriate clinical testing for all prostheses used in Australia.
Federal Budget 2007: National Joint Replacement Registry - increased data collection (762 KB)
healthalerts.com.au article posted on: Thursday 17th May 2007
The expansion of the current Medicare item for Bone Mineral Density testing to allow people aged 70 years and over to have their bone density tested without the need for other medical indications, such as fractures, is great news for Australia’s ageing population.
This test, when combined with Fosamax therapy is an excellent preventative health measure and will reduce fracture risk in older Australians. An extension of the listing of Fosamax on the PBS was announced in the recent Federal Budget.
The AHIA advises all Australians over 70 years of age to discuss having tests done on their Bone Mineral Density with their General Practitioner.
Federal Budget 2007: Pharmaceutical Benefits Scheme - extension to the listings of Fosamax (633 KB)
healthalerts.com.au article posted on: Friday 13th October 2006
The Australian Orthopaedic Association's national conference has today heard that new types of artificial hips have a higher failure rate than previous technology.
Surgeons have been asked to consider abandoning the newer, more expensive products in favour of their cheaper and more effective predecessors.
The Australian Health Insurance Association has backed the calls, saying more rigorous clinical testing should be undertaken on the new products
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(Source: ABC Local Radio - The World Today)
healthalerts.com.au article posted on: Friday 6th October 2006
After years of complaints that they don't offer value for money, Australia's private health insurance funds are preparing to deliver some big changes to their members.
From April next year private health funds will be allowed to offer rebates for a range of services designed to prevent disease as well as coverage for out-of care hospital costs, as Samantha Donovan reports.
The nation's health insurers are busy developing new policies, which will see them not only able to cover diet advice and exercise classes, but also more medical treatment outside hospital. More cancer patients, for example, may be able to have chemotherapy at home and dialysis and palliative care is expected to be covered by many.
Health Economist Paul Gross is an enthusiastic supporter of the changes, which he says many other Western countries introduced five to ten years ago. FULL TRANSCRIPT
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(Source: ABC Local Radio - The World Today)
healthalerts.com.au article posted on: Friday 1st September 2006
The Pan Pharmaceutical "problem" two years ago exposed weakness in the regulation of herbal and natural remedies. The massive recall of Pan products prompted the Federal Government to commission a review of the burgeoning alternative therapies industry. That review found that the sometimes dangerous side-effects of complementary medicines were being widely under-reported and the Federal Government has since agreed to overhaul its reporting system and to develop a public information campaign. More(Source: ABC 7:30 Report)