fda | Page 29 of 31 | Health Newstrack

Intelence, etravirine HIV Drug approved in US

The U.S. Food and Drug Administration approved etravirine tablets for the treatment of HIV infection in adults who have failed treatment with other antiretrovirals. Etravirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that helps to block an enzyme which HIV needs to multiply. – US FDA approved Tibotec Therapeutics’ Intelence, etravirine tablets for the treatment of HIV infection, to be used in combination with other anti-HIV medications, in adults who have failed treatment with other antiretrovirals.

Pfizer updated CHANTIX label to quit smoking with more warnings

Pfizer’s CHANTIX label in the U.S. to include a warning for neuropsychiatric symptoms, including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior. – Cigarette smoking is associated with significant morbidity and mortality. Smoking is the leading preventable cause of disease and premature death in the United States, with more than 438,000 U.S. deaths annually attributable to smoking. Patients who smoke cigarettes should be counseled to quit. CHANTIX was approved in May of 2006 in the U.S. as an aid to smoking cessation.

Ortho Evra contraceptive transdermal birth control patch label update

Ortho Women?s Health & Urology, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., has updated the prescribing information for ORTHO EVRA (norelgestromin/ethinyl estradiol transdermal system) to include further epidemiologic data. – The U.S. Food and Drug Administration (FDA) approved additional changes to the Ortho Evra Contraceptive Transdermal (Skin) Patch label to include the results of a new epidemiology study that found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills. VTE can lead to pulmonary embolism.

Sickle cell disease pain occurs daily

In adults with sickle cell disease, pain can occur daily and is much more severe than previously believed. – Sickle cell disease pain can occur daily, and is far more prevalent and severe than previous large studies have indicated. Patients are at home mostly struggling with their pain rather than coming into the hospital or emergency department.

Use OTC cough and cold products with care

US FDA strongly recommends that over-the-counter (OTC) cough and cold products should not be used for infants and children under 2 years of age because serious and potentially life-threatening side effects could occur. – US health agency FDA is recommending that over-the-counter (OTC) cough and cold products should not be used to treat infants and children less than 2 years of age because serious and potentially life-threatening side effects can occur from such use. OTC cough and cold products include decongestants, expectorants, antihistamines, and antitussives (cough suppressants) for the treatment of colds.

Osteoporosis drugs increase bone necrosis risk

FDA is highlighting the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. – A popular class of osteoporosis drugs, bisphosphonates nearly triples the risk of developing bone necrosis, a condition that can lead to disfigurement and incapacitating pain, revealed by researchers in a study. The research conducted by reasearchers at the University of British Columbia and Vancouver Coastal Health Research Institute, Canada.

Selective reporting of antidepressant trials may have adverse consequences

Evidence-based medicine is valuable to the extent that the evidence base is complete and unbiased. Selective publication of clinical trials ? and the outcomes within those trials ? can lead to unrealistic estimates of drug effectiveness and alter the apparent risk?benefit ratio. – Selective publication in reporting results of antidepressant trials exaggerates the effectiveness of the drugs, and may have adverse consequences for researchers, study participants, health care professionals, and patients, revealed in a new study.

Purchasing contact lenses online is risky

Research indicates that Internet lens purchasers typically don’t follow their eye doctor?s recommendations, placing them at greater risk for harmful eye care practices and eye health complications. – Purchasing contact lenses online may save consumers time, but the process could cause more problems in the long run, according to a new study reported in the January issue of Optometry: Journal of the American Optometric Association.

New test to detect and identify 12 respiratory viruses

The U.S. Food and Drug Administration cleared for marketing a test – xTAG Respiratory Viral Panel, manufactured by Luminex Molecular Diagnostics, that simultaneously detects and identifies 12 specific respiratory viruses. – The U.S. Food and Drug Administration has approved a new diagnostic test that detects 12 respiratory viruses, including strains of flu that have triggered epidemics.

Quick Test For Drug-Resistant Staph Infections MRSA

The U.S. Food and Drug Administration (FDA) approved the first rapid blood test for the drug-resistant staph bacterium known as MRSA (methicillin-resistant Staphylococcus aureus). – The U.S. Food and Drug Administration (FDA) announced it has cleared for marketing the first rapid blood test for the drug-resistant staph bacterium known as MRSA (methicillin-resistant Staphylococcus aureus), which can cause potentially deadly infections.