A long-awaited universal definition of myocardial infarction (MI) has been released. A global task force with expertise in biomarkers, electrocardiographic (ECG) criteria, imaging, interventions, clinical trials, and public policy has updated the consensus document from the year 2000. The revised definition is being published simultaneously in European Heart Journal, Journal of American College of Cardiology, and Circulation.
Labeling changes have been approved for erectile dysfunction drugs such as Generic Cialis, Generic Levitra, and Generic Viagra, to display the potential risk of sudden hearing loss in a more prominent fashion. The FDA plans to require the same changes for Revatio, which is used to treat pulmonary arterial hypertension (PAH).
The FDA asked for the label revisions after a small number of patients taking these drugs reported sudden hearing loss, sometimes accompanied by ringing in the ears and dizziness.
Patients taking Cialis drug, Levitra drug, or Viagra drug who experience sudden hearing loss should immediately stop taking the drug and should seek prompt medical attention.
The Centers for Disease Control and Prevention (CDC) reports that nearly 19,000 people died in the U.S. in 2005 after being infected a virulent drug resistant bacterium, methicillin-resistant Staphylococcus aureus (MRSA). The number of deaths associated with MRSA exceeds those attributed to AIDS, Parkinson’s disease, emphysema, and homicide each year.
Sanofi-Aventis and Bristol-Myers Squibb have announced the approval of a supplemental New Drug Application (sNDA) for a 300mg tablet of clopidogrel bisulfate (Generic Plavix) for acute coronary syndrome (ACS) patients as soon as possible after hospital admission. Currently available as a 75-mg tablet taken once a day, generic clopidogrel helps to prevent platelets from sticking together and forming clots. It was initially approved in 1997.
Diclofenac sodium topical gel 1% (Voltaren Gel, Novartis) has been approved as the first topical prescription treatment that patients can apply directly to sites of pain associated with osteoarthritis, a condition in which the cartilage in the joint breaks down.
Voltaren Gel is a nonsteroidal anti-inflammatory drug (NSAID) that can be used to treat pain associated with osteoarthritis in joints amenable to topical treatment (e.g., the knees and hands).
The FDA has approved oral topotecan (Hycamtin capsules) for patients with relapsed small cell lung cancer (SCLC).
This agent is indicated for patients who have had a complete or partial response to first-line chemotherapy and who are at least 45 days from the end of that treatment.
Terbinafine HCl (Lamisil drug Oral Granules, Novartis) has been approved for the treatment of tinea capitis, a fungal infection of the scalp, in children four years of age and older. Tinea capitis most commonly affects children and is often characterized by severe itching, dandruff, and bald patches. This contagious infection does not usually respond to topical treatment.
The granules can be sprinkled on food and are administered once a day for six weeks. The actual dosage is based on the child’s weight.
(Source: FDA, October 1, 2007.)
