Numbing gels may *seem* like a good idea but….
January 17, 2009 by Marijke Durning, RN
Filed under Diseases & Conditions
Hold off on using that numbing gel unless you really need it, say experts.
Numbing gels have become quite popular. They’re used to numb the skin before having an intravenous inserted, to numb areas of the skin before a more thorough anesthetic is injected, or even for procedures like mammographies.
The way to apply these gels is to put some of the gel on the area to be numbed and then cover the gel and area with a plastic wrap to seal the gel in. This wrap is to stay on for a while as the gel is absorbed. While this …read more
FDA approves Tapentadol Immedate Release for moderate to severe pain
November 22, 2008 by Marijke Durning, RN
Filed under Diseases & Conditions
Press Release
FDA Approves Tapentadol Immediate-Release Tablets for Relief of Moderate to Severe Acute Pain
Millions of Americans with moderate to severe acute pain and their health-care providers will soon have a new treatment option. The U.S. Food and Drug Administration (FDA) has approved tapentadol immediate-release tablets for the relief of moderate to severe acute pain in adults 18 years of age or older.
Tapentadol is a new centrally acting oral analgesic. It has two mechanisms of action, combining mu-opioid receptor agonism and norepinephrine reuptake inhibition.
Tapentadol tablets have been approved in 50 mg, 75 mg and 100 mg doses.
The approval was based on …read more
FDA delays decision on antidepressant milnacipran use for fibromyalgia
October 21, 2008 by Marijke Durning, RN
Filed under Diseases & Conditions
Milnacipran is an antidepressant that has been around since the late 1990s. The medication falls under the NSRI group of antidepressants. As with some other types of antidepressants, doctors noticed that milancipran also seemed to help patients who had fibromyalgia so a study was done a few years ago to evaluate its safety and if it was effective in treating pain and fibromyalgia symptoms, like fatigue, depression, and sleep difficulties.
Initially, the results seemed very promising and an application was made to the FDA to allow milnacipran to be used on-label (approved) for treating the symptoms of fibromyalgia. However, there was …read more
Psoriasis drug, Raptiva, has new FDA warning
October 17, 2008 by Marijke Durning, RN
Filed under Diseases & Conditions
While this may sound frightening if you take Raptiva for psoriasis, keep in mind that this is just a warning because the problem has affected some people. If you are worried, please speak with your doctor and/or pharmacist to get a clearer idea of how this may or may not affect you.
This press release was issued yesterday by the United States Food and Drug Administration:
FDA Approves Updated Labeling for Psoriasis Drug Raptiva
Safety concerns drove labeling changes
The U.S. Food and Drug Administration today announced labeling changes, including a Boxed Warning, to highlight the risks of life-threatening infections, including progressive multifocal leukoencephalopathy …read more
FDA ALERT: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections
September 4, 2008 by Marijke Durning, RN
Filed under Diseases & Conditions
FDA ALERT
The U.S. Food and Drug Administration today announced that the manufacturers of Humira, Cimzia, Enbrel, and Remicade must strengthen the existing warnings, in the Warnings and Precaution sections of the drugs’ prescribing information and Medication Guides, on the risk of developing opportunistic fungal infections. Some patients with invasive fungal infections have died.
The four drugs, known as tumor necrosis factor alpha blockers (TNF-alpha blockers), which suppress the immune system, are approved to treat a variety of conditions which may include rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, and Crohn’s disease.
Click here to read more.
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Tags: chronic pain …read more
FDA warning: certain antibiotics can harm tendons
July 8, 2008 by Marijke Durning, RN
Filed under Diseases & Conditions
A certain group of antibiotics, called fluoroquinolones, may increase the risk of tendonitis and ruptured tendons. Examples of antiobiotics in this group are Cipro (sold by generically as ciprofloxacin) and Floxin (sold generically as ofloxacin).
Cipro is most commonly used for urinary tract infections (UTIs).
The risk of tendon injury appears to begreater in patients who are 60 years or older, those who have had certain organ transplants and those who are taking steroid therapy. The FDA says that doctors should restrict use of the drug, only used if absolutely needed.
Image: Newscom
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Press release: FDA Approves Aciphex for Short-Term Treatment of GERD in Teens
July 1, 2008 by Marijke Durning, RN
Filed under Diseases & Conditions
FDA Approves ACIPHEX(R) (rabeprazole sodium) 20 mg for Short-Term Treatment of GERD in Adolescents
WOODCLIFF LAKE, N.J., June 30 /PRNewswire/ — Eisai Corporation of North America, a wholly-owned subsidiary of Tokyo-based Eisai Co., Ltd., announced today that the Food and Drug Administration (FDA) has approved Aciphex (rabeprazole sodium) 20 mg for the short-term (up to eight weeks) treatment of gastroesophageal reflux disease (GERD) in adolescents ages 12 and above.
Included in the submission was a 12-week, multi-center, open-label, randomized, parallel-group study of 111 adolescent GERD patients. In this study, Aciphex was well …read more
Press Release: FDA Approves Cymbalta for Management of Fibromyalgia
June 16, 2008 by Marijke Durning, RN
Filed under Diseases & Conditions
Cymbalta Reduces Pain and Improves Functioning in Fibromyalgia Patients
INDIANAPOLIS, June 16 /PRNewswire-FirstCall/ — The U.S. Food and Drug Administration (FDA) has approved Cymbalta(R) (duloxetine HCl) for the management of fibromyalgia, a chronic widespread pain disorder, Eli Lilly and Company (NYSE: LLY) announced today. Cymbalta is the first serotonin-norepinephrine reuptake inhibitor with proven efficacy for reducing pain inpatients with fibromyalgia. The fibromyalgia indication represents thesecond FDA-approved use for Cymbalta for a pain disorder, demonstrating the medication’s analgesic effect.
“The approval of Cymbalta is important because it provides physicians and patients with a new treatment option shown to help reduce pain and improve …read more
FDA Recall: Morphine Sulfate 60 mg Extended Release Tablets – Recall of a Single Lot
June 10, 2008 by Marijke Durning, RN
Filed under Diseases & Conditions
PRESS RELEASE:
Morphine Sulfate 60 mg Extended Release Tablets – Recall of a Single Lot Due to a Report of a Tablet With Twice the Appropriate Thickness
ETHEX Corporation notified healthcare professionals of a voluntary recall of a single lot of morphine sulfate 60 mg extended release tablets (Lot No. 91762) due to a report of a tablet with twice the appropriate thickness. Oversized tablets may contain as much as two times the labeled level of active morphine sulfate.
The lot was distributed by ETHEX Corporation under an “ETHEX” label between April 16th and April 27th of 2008.
Opioids such as morphine have life-threatening …read more
Press Release: FDA Broadens Indication for Once-Yearly Reclast for Prevention of Fractures After a Hip Fracture
June 10, 2008 by Marijke Durning, RN
Filed under Diseases & Conditions
FDA Broadens US Indication for Once-Yearly Reclast(R) as Only Osteoporosis Treatment Approved for Prevention of Fractures After a Hip Fracture
- Revised label includes data showing 35% reduction in new clinical fractures in patients treated with Reclast following a recent hip fracture
- Few patients currently receive osteoporosis treatment following hip fracture despite high …read more




