The food and Drug Administration have approved Abbott Laboratories reintroduction of Abbokinase (urokinase) for the treatment of pulmonary embolism. Manufacturing of the medication was suspended in 1999 after an inspection of Abbott's operational plant by the FDA found issues regarding the manufacture of the product.
15/10/2002
FDA notified healthcare professionals that Cryolife, a human tissue-processing firm, was ordered to recall all distributed human allograft tissues, except allograft heart valves, that have been processed by Cryolife since October 3, 2001. This FDA recall order was issued after FDA discovered regulatory violations related to the processing of human tissue by Cryolife, documented fungal and bacterial contamination of Cryolife tissues, and found that Cryolife had not fully implemented adequate corr
23/08/2002
The US FDA has issued a public-health advisory alerting health care professionals who perform cardiac bypass surgery and their patients to two studies suggesting serious adverse events with aprotinin (Trasylol, Bayer).
21/02/2006
The U.S. Food and Drug Administration has issued a public health Web notification on reports of subacute thromboses and hypersensitivity reactions with the use of the Cordis Cypher coronary stent.
31/10/2003
The US Food and Drug Administration is backing evidence that the monounsaturated fat from olive oil may reduce the risk of coronary heart disease. Because the data remain inconclusive, the FDA says it will exercise its discretion in monitoring the use of this new claim on products that contain olive oil.
08/11/2004
Atorvastatin (Lipitor®, Pfizer) has been approved by the US FDA for the prevention of cardiovascular disease by reducing MI risk in people with normal to mildly elevated cholesterol levels who have other cardiovascular risk factors.
09/08/2004
Bristol-Myers Squibb has announced that it plans to seek approval from the US FDA to sell 20mg of pravastatin (Pravachol®) over the counter.
20/12/2004
The US FDA has called for new boxed warnings and medication guides for most nonsteroidal anti-inflammatory drugs (NSAIDs) to highlight the potential for increased cardiovascular risks and gastrointestinal bleeding.
08/04/2005
Statins do not increase the risk of amyotrophic lateral sclerosis, according to a meta-analysis by the US Food and Drug Administration.
Source: Colman, E. et al. Pharmacoepidemiol DrugSaf 2008; DOI: 10.1002/pds.1643.
10/10/2008
The U.S. FDA is updating the label for warfarin to include information reminding physicians that people with variations in two genes, CYP2C9 or VKORC1, may require a lower initial dose of the drug.
25/08/2007
The FDA has issued a MedWatch alert notifying consumers and healthcare professionals that taking ibuprofen for pain relief may interfere with the benefits of aspirin taken for heart disease. It advises that these two drugs should be taken at different times to avoid such an interaction.
14/09/2006
In response to the launch of an FDA consumer campaign on the safe use of over-the-counter pain relief products, Australian Medical Association president Bill Glasson has said that popular painkillers containing ibuprofen should be taken off supermarket shelves.
30/01/2004
FDA and Aventis strengthened the WARNINGS and PRECAUTIONS sections of the enoxaparin (Lovenox) prescribing information to inform healthcare professionals that the use of enoxaparin injection is not recommended for thromboprophylaxis in patients with prosthetic heart valves. New postmarketing safety information concerning congenital anomalies and non-teratogenic effects on pregnant women and fetuses are described.
26/04/2002
US health officials have approved a new blood test that can help rule out a heart attack in patients with severe chest pain.
18/02/2003
A new warning on the possible interaction between clopidogrel and omeprazole is premature, leading cardiologists say.
24/11/2009
The CypherTM sirolimus-eluting stent has been approved by the US Food and Drug Administration (FDA) for the treatment of restenosis, making it the first drug-eluting stent on the US market.
30/04/2003
The FDA has approved a new bedside test that combines five biomarkers capable of distinguishing between heart failure, acute MI and pulmonary emboli in the emergency setting.
09/07/2004
Expert committees of the United States Food and Drug Administration have recommended that the type 2 diabetes drug rosiglitazone remain on the market but that label warnings and extensive educational efforts about possible adverse cardiovascular effects be instituted immediately. Source: Rosen CJ. New England Journal of Medicine 2007; published online.
10/08/2007
The investment in direct-to-consumer promotion of prescription medications in the United States now exceeds $US4 billion annually and continues to grow, amidst concerns about a low level of FDA scrutiny over advertising standards.Source: Donohue, J. et al. New England Journal of Medicine 2007; 357: 673-681.
16/08/2007
The FDA has raised concerns with the safety of herbal remedies and suggest physicians, particularly cardiologists should become more familiar with the available cardiovascular information on herbs. The Journal of the American College of Cardiology published a review highlighting the data on the efficacy, adverse effects and interactions for herbal therapies that impact on the cardiovascular system. In the United States, 'an estimated 15 million adults are at risk for potential adverse i
24/04/2002