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 is ok (for most people) over small areas, the recommendations to do this for a mammogram is not such a good idea, says the FDA.

According to reports, two women who used this numbing gel, lidocaine, before laser hair removal died as a result. Use of lidocaine over such large body parts and sealing it in can cause the lidocaine to be absorbed into the blood stream, when it can cause serious problems such as irregular heart beats, seizures, difficulty breathing, coma, and death.

Recently, a study published in the journal Radiology recommended that women who fear pain or discomfort from mammograms use the gel on the breasts and then covering them with plastic. The FDA responded by issuing its second health advisory warning about the practice.

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Tags: pain blog, mammographies, numbing gel, lidocaine

Post from: Blisstree

Numbing gels may *seem* like a good idea but….

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 data from clinical studies involving more than 2,100 patients. The studies, which were presented at the 27th Annual Scientific Meeting of the American Pain Society earlier this year, showed that tapentadol provided significant relief of moderate to severe acute pain compared to placebo.

Following yesterday’s FDA approval, and as per Federal regulation for all controlled substances, tapentadol will be reviewed by the U.S. Drug Enforcement Agency for scheduling, and it cannot be sold until it receives a scheduling classification.

A trade name for tapentadol has not yet been determined.

SOURCE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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Image: Newscom

Tags: FDA drug approval, tapentadol, chronic pain blog, pain blog, acute pain, moderate to severe pain

Post from: Blisstree

FDA approves Tapentadol Immedate Release for moderate to severe pain

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 some debate among researchers as to whether the results were statistically significant – meaning, if it really made a difference.

The FDA announced last week that they were holding back on making a decision regarding an application for the fibromyalgia designation but the report did not say why. As far as we can tell, the FDA didn’t ask for any follow-up information or clarification, something that is often done.

Hopefully, more news will come out as to why they are holding back on their decision.

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Tags: chronic pain blog, pain blog, fibromyalgia, symptoms of fibromyalgia, fibromyalgia symptoms, milnacipran, milnacipran for fibromyalgia

Post from: Blisstree

FDA delays decision on antidepressant milnacipran use for fibromyalgia

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 (PML), with the use of Raptiva (efalizumab). The labeling changes are based on the FDA’s post-market surveillance. The FDA is also requiring the submission of a Risk Evaluation and Mitigation Strategy (REMS), which will include a Medication Guide for patients and a timetable for assessment of the REMS.

Raptiva is a once-weekly injection approved for adults with moderate to severe plaque psoriasis who are candidates for systemic (whole body) therapy or phototherapy to control their psoriasis.

The FDA’s Office of Surveillance and Epidemiology, charged by the Agency with monitoring drugs once approved for the marketplace, has received reports of serious infections leading to hospitalizations, and deaths in some cases, in patients using Raptiva.

Click here to read more.

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Tags: raptiva, psoriasis, chronic pain blog, pain blog, efalizumab, progressive multifocal leukoencephalopathy, PML

Post from: Blisstree

Psoriasis drug, Raptiva, has new FDA warning

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 blog, pain blog, arthritis, tumor necrosis factor alpha blocker, TNF alpha blocker, humira, cimzia, enbrel, remicade, invasive fungal infections, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, Crohn’s disease, TNF

Post from: Blisstree

FDA ALERT: Manufacturers of TNF-Blocker Drugs Must Highlight Risk of Fungal Infections

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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Post from: Blisstree

FDA warning: certain antibiotics can harm tendons

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 tolerated in adolescent subjects, with a safety profile similar to that of adults. The adverse events reported without regard to relationship to Aciphex that occurred in greater than or equal to 2 percent of 111 patients were headache (9.9 percent), diarrhea (4.5 percent), nausea (4.5 percent), vomiting (3.6 percent) and abdominal pain (3.6 percent). Efficacy results demonstrated that once-daily treatment with Aciphex 20 mg for eight weeks reduced the severity and frequency of GERD symptoms compared to symptoms prior to treatment.  

SOURCE: Eisai Corporation of North America

Image: Newscom

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Post from: Blisstree

Press release: FDA Approves Aciphex for Short-Term Treatment of GERD in Teens

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 functioning in this difficult-to-treat disorder,” said Madelaine Wohlreich, M.D., medical advisor and research physician at Lilly.

The cause of fibromyalgia remains unknown; however, scientists believe it may be related to some combination of changes in brain and spinal cord chemistry, genetics and stress. Some researchers believe fibromyalgia is a disorder of increased sensitivity to pain. Although the way Cymbalta works in people is not fully known, medical experts believe it increases the activity of two naturally occurring substances called serotonin and norepinephrine. These substances aid communication in many areas of the brain and spinal cord that affect emotion. Research also suggests that these substances are part of the body’s natural pain-suppressing system. “The FDA approval of Cymbalta for the management of fibromyalgia is another important step in the efforts to ensure that people with fibromyalgia will have the availability of effective medications to help reduce the chronic, widespread pain of this life-altering disorder,” said Lynne Matallana, president of the National Fibromyalgia Association and a fibromyalgia patient.

Fibromyalgia is estimated to affect 2 percent of the U.S. population – approximately 5 million people – the majority of those diagnosed being women. The disorder is characterized by chronic widespread pain and tenderness. Some patients may have additional symptoms. Although there is no known cure for fibromyalgia, some physicians recommend a comprehensive care plan that can include education, medication, and lifestyle changes to help manage the symptoms of the disorder.

“In fibromyalgia, there is no one-size-fits-all approach to managing the disorder,” said Dan Clauw, M.D., professor of medicine in the University of Michigan’s Division of Rheumatology and director of the Chronic Pain and Fatigue Research Center at the University of Michigan.

The approval marks the fourth disorder that the FDA has approved for Cymbalta. In addition to fibromyalgia, Cymbalta is approved for the management of diabetic peripheral neuropathic pain (DPNP) and the treatment of major depressive disorder and generalized anxiety disorder, all in adults age 18 years and older.

Additional important changes have been made to the Cymbalta prescribing information, including updates to the Warnings and Precautions section. Full prescribing information can be found at http://www.cymbalta.com.

SOURCE Eli Lilly and Company

Post from: Blisstree

Press Release: FDA Approves Cymbalta for Management of Fibromyalgia

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 consequences if overdosed. Consequences can include respiratory depression (difficulty or lack of breathing), and low blood pressure. Many patients for whom this product is prescribed are likely to be highly debilitated with reduced strength or energy as a result of illness, and may be less likely to determine that a tablet is overweight or oversized than an unimpaired individual. If consumers have any questions about the recall, they should call their physician, pharmacist, or other health care provider.

Read the MedWatch 2008 safety summary, including a link to the firm’s press release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Morphine

SOURCE: MEDWATCH

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Post from: Blisstree

FDA Recall: Morphine Sulfate 60 mg Extended Release Tablets – Recall of a Single Lot

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 risk of morbidity and mortality

- Safety and efficacy profile of Reclast, already approved for treatment of postmenopausal osteoporosis, reinforced in revised label

EAST HANOVER, N.J., June 5 /PRNewswire/ — The US Food and Drug Administration (FDA) has broadened the US indication for once-yearly Reclast(R) (zoledronic acid) Injection to include the prevention of new clinical fractures in patients who have recently had a low-trauma hip fracture.

No other osteoporosis treatment has demonstrated a reduction of new clinical fractures in patients who have recently had a low-trauma hip fracture (e.g., due to a fall from standing height or less). A clinical fracture is defined as a composite endpoint of skeletal sites excluding finger, face and toe.

The FDA decision is based on safety and efficacy data from the landmark Recurrent Fracture Trial, published in The New England Journal of Medicine, showing a significant 35% reduction in the risk of new clinical fractures in patients treated with Reclast.

“The consequences of osteoporosis can be devastating, particularly hip fractures. However, few patients actually receive treatment for the prevention of additional fractures after a hip fracture,” said Kenneth G. Saag, MD, MSc, Professor of Medicine and Epidemiology, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham. “In the first large scale clinical trial of its kind, these data support an efficacious therapeutic option for patients after a hip fracture.”

Osteoporosis is a condition in which the bones become weak and can break more easily. Around 10 million people in the US are affected by osteoporosis, which caused an estimated 297,000 hip fractures in the US in 2005. Of those patients who experience a hip fracture, almost a quarter of people over the age of 50 die from complications within one year.

Among those who experience a hip fracture, 85% need help walking at six months, nearly 20% who could walk before their hip fracture require long-term nursing care, and all remain at high risk of further fracture. Yet, currently few patients are treated for osteoporosis following a hip fracture.

The Recurrent Fracture Trial involved more than 2,100 men and women aged 50 and older with osteoporosis who had experienced a recent low-trauma hip fracture. Results showed that Reclast increased bone mineral density (BMD) and reduced the risk of new clinical fractures by 35% compared to patients treated with placebo. The risk of new spine fractures was reduced by 46%. The incidence of all-cause mortality was 9.6% in the Reclast group and 13.3% in the placebo group.

The updated US label further reinforces the safety and efficacy of Reclast, the only once-yearly treatment for postmenopausal osteoporosis approved in the US and European Union (EU) (under the name Aclasta(R)) for the reduction in the incidence of fractures in all key areas of the body typically affected by this disease, including the hip, spine and non-spine. Regulatory approval is also being sought for Aclasta in the EU for this broadened indication.

Reclast is given as a once-yearly 15-minute intravenous infusion. This means a single treatment, along with daily calcium and vitamin D supplements, helps protect against fracture for a full year.

“The new label reinforces the potential of Reclast for treating a range of osteoporosis patients,” said Trevor Mundel, MD, Head of Global Development Functions at Novartis Pharma AG. “These data support the clear need to treat patients after hip fracture who are at risk of the potentially devastating and life-threatening consequences of osteoporosis.”

The most common side effects are flu-like symptoms, fever, muscle or joint pain and headache. Patients should tell their doctor if they have dental problems because rarely, problems with the jaw have been reported with Reclast. Patients should tell their doctor if they have low blood calcium or cannot take calcium and vitamin D, had surgery involving the neck or intestines. In patients with Paget’s disease of bone, it is especially important for them to take 1500 mg of calcium and 800 IU of vitamin D daily, particularly during the first 2 weeks after getting Reclast. Patients should discuss all medicines they’re taking, including prescription and non-prescription, vitamins and herbal supplements. Patients should contact their doctor if they develop severe bone, joint or muscle pain, numbness, tingling or muscle spasms. For more information about Reclast, visit http://www.reclast.com or call 866-RECLAST (866-732-5278).

Image: Newscom

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Post from: Blisstree

Press Release: FDA Broadens Indication for Once-Yearly Reclast for Prevention of Fractures After a Hip Fracture