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HIV/AIDS Update – Videx EC/Videx (didanosine) label change reflects potential for serious liver disorder

The Food and Drug Administration (FDA) is alerting healthcare professionals and patients about a rare, but serious, complication in the liver known as non-cirrhotic portal hypertension in patients using Videx or Videx EC (didanosine). Didanosine is a medication used to treat human immunodeficiency virus (HIV) infection.

Non-cirrhotic portal hypertension (portal hypertension that is not caused by cirrhosis of the liver) is rare in the United States. It occurs when blood flow in the major vein in the liver (the portal vein) slows down. This slowed blood flow can lead to the development of severely enlarged esophageal veins (varices) in the gastrointestinal system. Because esophageal varices are thin and portal hypertension increases the pressure of blood flow in these veins, esophageal varices can break open. This can result in serious bleeding and, in some cases, death.

FDA became aware of cases of non-cirrhotic portal hypertension through adverse event reports submitted to FDA’s Adverse Event Reporting System (AERS). Based on these reports, FDA has revised the didanosine drug label to include information about non-cirrhotic portal hypertension to help ensure the safe use of this drug.

FDA believes the clinical benefits of didanosine for certain patients with HIV continue to outweigh its potential risks. The decision to use this drug, however, must be made on an individual basis between the treating physician and the patient.

Additional Information for Patients

  • Didanosine is a prescription medication used along with other drugs to treat patients who are infected with HIV, the virus that causes AIDS.
  • Didanosine works by reducing the growth of HIV.It belongs to a class of medications called nucleoside analogues.
  • Didanosine helps your body maintain its supply of immune cells called CD4 cells. These cells are important for fighting HIV and other infections.
  • Non-cirrhotic portal hypertension is a serious, but rare, side effect that has occurred in patients using didanosine.

Additional Information for Healthcare Professionals

  • Be aware that didanosine use has been associated with the development of non-cirrhotic portal hypertension.
  • Discuss with patients the clinical benefits and potential risks, including the risk of non-cirrhotic portal hypertension, with the use of didanosine.
  • Continue to monitor patients for the development of portal hypertension and esophageal varices.
  • Be aware that didanosine already has a Boxed Warning for lactic acidosis and hepatomegaly with steatosis.
  • Didanosine in combination with other antiretroviral agents as well as hydroxyurea or ribavirin has been associated with the development of liver toxicity.

Data Summary

FDA’s decision to revise the drug label for didanosine is based on post-marketing reports of patients developing non-cirrhotic portal hypertension while using didanosine. Other liver adverse events such as lactic acidosis, hepatomegaly with steatosis, and liver failure have been reported with the use of didanosine alone and in combination with other antiviral drugs.

Of the 42 post-marketing cases of non-cirrhotic portal hypertension in patients using didanosine:

  • Twenty-six were males, 14 were females, and in two no gender was specified.
  • The ages ranged from 10 years to 66 years.
  • Duration of didanosine treatment ranged from months to years before development of non-cirrhotic portal hypertension.
  • Definitive cases of non-cirrhotic portal hypertension were confirmed by biopsy and had no alternative etiology for the diagnosis.

Medical interventions described in the reported cases included:

  • Banding/ligation of esophageal varices in 8 patients.
  • Transjugular intrahepatic portosystemic shunt (TIPSS) procedure in three patients.
  • Liver transplantation in 3 patients.

There were four deaths total in the 42 reported cases. The cause of death in the four patients was due to:

  • Hemorrhage from esophageal varices in two patients.
  • Progressive liver failure in one patient.
  • A combination of multi-organ failure, cerebral hemorrhage, sepsis, and lactic acidosis in one patient.

The only patients who have been reported as fully recovered are the three non-cirrhotic portal hypertension patients who received a liver transplant.

A causal association is difficult to determine from postmarketing reports alone. However, based on the number of well-documented cases and exclusion of other causes of portal hypertension such as alcohol-related cirrhosis or hepatitis C, FDA concludes there is an association between use of didanosine and development of non-cirrhotic portal hypertension. Because of the potential severity of portal hypertension, including death from hemorrhaging esophageal varices, FDA has revised the Warning and Precautions section of the didanosine drug label to assure safe use of the medication.

The Videx EC and Videx Pediatric Powder for Oral Solution were revised as follows:

  • In Highlights section of the package insert under Warnings and Precautions, the following was added:
    Non-cirrhotic portal hypertension: Discontinue didanosine in patients with evidence of non-cirrhotic portal hypertension

In section 5 Warnings and Precautions the following new subsection was added:

  • 5.4 Non-cirrhotic Portal Hypertension
    Postmarketing cases of non-cirrhotic portal hypertension have been reported, including cases leading to liver transplantation or death. Cases of didanosine-associated non-cirrhotic portal hypertension were confirmed by liver biopsy in patients with no evidence of viral hepatitis. Onset of signs and symptoms ranged from months to years after start of didanosine therapy. Common presenting features included elevated liver enzymes, esophageal varices, hematemesis, ascites, and splenomegaly. Patients receiving Videx should be monitored for early signs of portal hypertension (eg. Thrombocytopenia and splenomegaly) during routine medical visits. Appropriate laboratory testing including liver enzymes, serum bilirubin, albumin, complete blood count, and international normalized ratio (INR) and ultrasonography should be considered. Videx should be discontinued in patients with evidence of non-cirrhotic portal hypertension

In section 17 Patient Counseling Information the following was added:

  • 17.5 Non-cirrhotic Portal Hypertension
    Patients should be informed that non-cirrhotic portal hypertension has been reported in patients taking Videx, including cases leading to liver transplantation or death.

Videx and VidexEC are Nucleoside Reverse Transcriptase Inhibitors (NRTIs), products of Bristol Myers-Squibb.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

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January 31, 2010 Posted by | 1 | Leave a comment

Loudon Wainwright III – High, Wide and Handsome: The Charlie Poole Project

Loundon Wainwright III - Wide, High and Handsome: The Charlie Poole Project CD Cover

Loundon Wainwright III – Wide, High and Handsome: The Charlie Poole Project CD Cover

© 2nd Story Sound

Charlie Poole, along with his band, the North Carolina Ramblers, was one of the most influential traditional-style folk artists of the 20th Century. His music was a strong early influence on bluegrass pioneers like Bill Monroe and Earl Scruggs, but his career was cut short when he died of heart failure in 1931.This comprehensive two-disc collection breathes new life into Poole’s finest and most influential recordings. Wainwright’s interpretations and arrangements are inspired while staying true to Poole’s legacy and talent.

A Musical History Lesson

Not only are the songs on High, Wide, and Handsome full of historical references to life during the Great Depression, but they’re also full of timeless themes (being broke, in love, trying to kick booze).A good tribute album doesn’t simply address the songs the way they were written, but crawls into the music to deliver interpretations which at once honor their artistry while underscoring their universality. Wainwright doesn’t simply dress up in Poole’s clothes (figuratively speaking, of course), but delivers his musical messages in a manner which spotlights the extent to which they remain culturally relevant.

Highlights

Songs like “Goodbye Booze” and “My Mother and My Sweetheart” have lyrics and themes which will likely never become antiquated. “Awful Hungry Hash House” is an hilarious story about the worst possible boarding house experience ever, mashed up with the chorus of “Keep on the Sunny Side of Life.” It captures that sentiment which is all too often impossible to tap in music: sarcasm (“The butter has red hair”).Then, there are also the songs Wainwright wrote in honor of Poole, and inserted into the lineup. Most notable among them is “Charlie’s Last Song” – a tribute to Poole’s memory and legacy, and also to the drinking habit which saw the death of him.

Throughout the disc, Wainwright is joined by his famously musically gifted offspring – Rufus and Martha Wainwright. The two add tight, intuitive harmonies to the mix, behind their father’s simple and considerate instrumentation. Suzzy Roche delivers a notable vocal performance on “Man on the Moon.” In other words, true to the craft of traditional folk music, this disc is a family and community effort, pulling listeners into songs whose insights are humorous, thoughtful, provocative, and emotionally stirring. Without a doubt, this is one of the finest tribute records of recent memory

January 31, 2010 Posted by | 1 | Leave a comment

Drug Information Update – FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic Pain

FDA/CDER/Division of Drug Information (DDI)

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation byFDA.


The U.S. Food and Drug Administration today approved Morphine Sulfate Oral Solution for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients. This medicine will be available in 100 milligrams per 5 mL or 20 milligrams per 1 mL.

This is the only FDA approved morphine sulfate oral solution available at this concentration. Although the use of this medicine to manage pain has been common practice for many years, this form and concentration of morphine was not FDA approved until now.

Today’s action is part of the FDA’s unapproved drugs initiative. As part of this program, the FDA has worked with the manufacturer of the now-approved product, Roxane Laboratories, to ensure that there is enough drug available for patients. The FDA will also be working with patient organizations and prescribers so that they are aware that an approved product is available, and can notify the FDA if there are any problems with availability.

For more information, please visit: Morphine

January 31, 2010 Posted by | 1 | Leave a comment

Alternative Medicine and Atherosclerosis

What Is Atherosclerosis?

Atherosclerosis (also known as arteriosclerosis) is a disease marked by the buildup of fatty plaques on in the insides of your arteries. This plaque buildup is sometimes referred to as “clogged arteries” or “hardening of the arteries.”

As plaque accumulates and hardens over time, it can narrow your arteries and restrict the blood flow to your heart (as well as other parts of the body). Clogged arteries may result in heart attack, stroke, or even death. Atherosclerosis may also lead to a number of serious diseases, including coronary artery disease, carotid artery disease, and peripheral arterial disease.

Signs and Symptoms of Atherosclerosis

Atherosclerosis often produces no signs or symptoms until blood flow becomes blocked and results in a medical emergency. However, in cases of reduced blood flow to the heart, individuals may experience angina (chest pain that occurs when your heart isn’t receiving enough blood), shortness of breath, and/or irregular heartbeats.

Causes of Atherosclerosis

Atherosclerosis occurs when fat, cholesterol, and other substances accumulate in the walls of the arteries. The following factors may increase your risk for this condition:

Treatment and Prevention of Atherosclerosis

In cases of severe atherosclerosis, certain medical procedures (such as angioplasty and coronary artery bypass grafting) may be necessary. However, in many cases, the following lifestyle changes are recommended as treatment for atherosclerosis:

  • maintaining a healthy weight
  • getting regular exercise
  • keeping your blood pressure and cholesterol levels in check
  • smoking cessation
  • reducing stress

All of these strategies are also considered useful in preventing atherosclerosis.

Alternative Medicine and Atherosclerosis

If you’re seeking to manage atherosclerosis with any type of alternative therapy, make sure to consult your physician before beginning treatment. It’s also important to tell your doctor if you develop any new symptoms, or if your symptoms worsen.

Although little is known about the use of alternative medicine in the treatment of atherosclerosis, studies suggest that the following natural substances and therapies may be helpful for people looking to manage this disease.

1) Yoga

A 2005 review of 70 previously published studies indicates that yoga may fight oxidative stress, a process thought to be involved in the development of atherosclerosis. What’s more, a 2000 study of 42 atherosclerosis patients found that practicing yoga slowed the disease’s progression and improved the participants’ risk factors profiles.

2) Hawthorn

An herbal remedy said to boost heart health, hawthorn was found to reduce levels of blood fats and aid in the prevention of atherosclerosis in an animal study published in 2009.

3) Omega-3 Fatty Acids

In a small study published in 2009, researchers concluded that taking 200 mg of docosahexaenoic acid (a type of omega-3 fatty acid) can help shield the heart from atherosclerosis (as well as aging-related cardiovascular damage and diabetes).

Available in supplement form, docosahexaenoic acid (or DHA) is also found naturally in oily fish like salmon and mackerel.

Sources:

Guillot N, Caillet E, Laville M, Calzada C, Lagarde M, Véricel E. “Increasing intakes of the long-chain omega-3 docosahexaenoic acid: effects on platelet functions and redox status in healthy men.” FASEB J. 2009 23(9):2909-16.

Innes KE, Bourguignon C, Taylor AG. “Risk indices associated with the insulin resistance syndrome, cardiovascular disease, and possible protection with yoga: a systematic review.” The Journal of the American Board of Family Practice 2005 18(6):491-519.

Manchanda SC, Narang R, Reddy KS, Sachdeva U, Prabhakaran D, Dharmanand S, Rajani M, Bijlani R. “Retardation of coronary atherosclerosis with yoga lifestyle intervention.” J Assoc Physicians India. 2000 48(7):687-94.

Xu H, Xu HE, Ryan D. “A study of the comparative effects of hawthorn fruit compound and simvastatin on lowering blood lipid levels.” Am J Chin Med. 2009;37(5):903-8.

January 31, 2010 Posted by | 1 | Leave a comment

Flaxseed and Heart Disease

What Is Flaxseed?

Flax is a plant that grows throughout Canada and the northwestern United States. Its seed, also known as linseed, contains soluble fiber, omega-3 fatty acids, and lignans (naturally occurring chemicals with estrogen-like effects).

Flaxseed is sold whole and in powder form. Derived from flaxseed, flaxseed oil is available in liquid and capsule form. It should be noted that flaxseed oil preparations lack lignans.

Uses for Flaxseed

Flaxseed is purported to offer a number of health benefits, including treatment or prevention of these conditions:

Benefits of Flaxseed

Although research on flaxseed’s health effects is limited, studies suggest that flaxseed products may be beneficial for people with the following health problems:

1) High Cholesterol

A number of human studies have shown that flaxseed can significantly reduce total and LDL (“bad”) cholesterol levels, according to a research review published in 2009. However, flaxseed did not appear to considerably alter levels of HDL (“good”) cholesterol. What’s more, flaxseed’s cholesterol-lowering effects were more apparent in females (especially postmenopausal women) and people with higher cholesterol levels.

2) Hot Flashes

Study results are mixed on whether flaxseed can cool hot flashes. For instance, a pilot study published in 2007 found that six weeks of daily crushed-flaxseed consumption decreased hot flash activity in women not taking estrogen therapy. However, a more recent study concluded that regular intake of flaxseed is no more effective than placebo for reducing hot flashes.

3) Constipation

A 2005 study of 26 healthy young adults found that daily flaxseed intake produced a laxative effect, suggesting that flaxseed may be useful in the treatment of constipation.

Flaxseed and Cancer

Although preliminary research is promising, there is a lack of evidence from human-based studies that flaxseed is effective in preventing or treating cancer.

How to Use Flaxseed

Flaxseed should be taken with plenty of water; otherwise, it could worsen constipation or, in rare cases, even cause intestinal blockage.

Since whole flaxseeds may pass through your intestine undigested, nutrition experts often suggest grinding flaxseed (in a coffee grinder, for instance) before adding it to cereals, smoothies, and other foods.

The fiber in flaxseed may lower the body’s ability to absorb medications that are taken by mouth. Flaxseed should not be taken at the same time as any conventional oral medications or other dietary supplements.

If you’re considering the use of any flaxseed product in the management of a specific health condition, make sure to consult your physician before beginning treatment.

Flaxseed Side Effects

Although flaxseed and flaxseed oil supplements are generally considered safe, their intake may lead to increased bowel movements and/or flatulence.

Sources:

Dahl WJ, Lockert EA, Cammer AL, Whiting SJ. “Effects of flax fiber on laxation and glycemic response in healthy volunteers.” J Med Food. 2005;8(4):508-11.

National Center for Complementary and Alternative Medicine. “Flaxseed and Flaxseed Oil [link: http://nccam.nih.gov/health/flaxseed/%5D.” NCCAM Publication No. D313. Created May 2006.
Updated April 2008.

Pan A, Yu D, Demark-Wahnefried W, Franco OH, Lin X. “Meta-analysis of the effects of flaxseed interventions on blood lipids.” Am J Clin Nutr. 2009 90(2):288-97.

Pruthi S, Thompson SL, Novotny PJ, Barton DL, Kottschade LA, Tan AD, Sloan JA, Loprinzi CL. “Pilot evaluation of flaxseed for the management of hot flashes.” J Soc Integr Oncol. 2007 5(3):106-12.

Simbalista RL, Sauerbronn AV, Aldrighi JM, Arêas JA. “Consumption of a Flaxseed-Rich Food Is Not More Effective Than a Placebo in Alleviating the Climacteric Symptoms of Postmenopausal Women.” J Nutr. [Epub ahead of print]

Thompson LU, Chen JM, Li T, Strasser-Weippl K, Goss PE. “Dietary flaxseed alters tumor biological markers in postmenopausal breast cancer.” Clin Cancer Res. 2005 15;11(10):3828-35

January 30, 2010 Posted by | 1 | Leave a comment

NICE PICS FROM NATIONAL GEOGHRAGHIC

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January 30, 2010 Posted by | 1 | 4 Comments

Drug Information Update – Serious Liver Disorder Associated with the Use of Videx/Videx EC (didanosine)

FDA/CDER/Division of Drug Information (DDI)

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation byFDA.


The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals and patients about a rare, but serious, complication in the liver known as non-cirrhotic portal hypertension in patients using Videx or Videx EC (didanosine). Didanosine is a medication used to treat human immunodeficiency virus (HIV) infection. Videx was the first approved didanosine medication. Videx EC is a delayed-release version of Videx.

Non-cirrhotic portal hypertension (portal hypertension that is not caused by cirrhosis of the liver) is rare in the United States. It occurs when blood flow in the major vein in the liver (theportal vein) slows down. This slowed blood flow can lead to the development of severely enlarged esophageal veins (varices) in the gastrointestinal system. Because esophageal varices are thin and portal hypertension increases the pressure of blood flow in these veins, esophageal varices can break open. This can result in serious bleeding and, in some cases, death.

FDA became aware of cases of non-cirrhotic portal hypertension through adverse event reports submitted to FDA’s Adverse Event Reporting System (AERS). Based on these reports, FDA has revised the didanosine drug label to include information about non-cirrhotic portal hypertension to help ensure the safe use of this drug.

For more information, please visit: Videx

January 30, 2010 Posted by | 1 | Leave a comment

HIV/AIDS Update – Kaletra (lopinavir/ritonavir) package insert revision regarding drug-drug interaction information

On January 29, 2009, FDA approved revisions to the Kaletra (lopinavir/ritonavir) package insert to include drug-drug interaction information for concurrent Kaletra administration with inhaled medicines such as salmeterol or salmeterol in combination with fluticasone propionate (Serevent, Advair) and sildenafil (Revatio).

Specifically, sildenafil (Revatio) when used for the treatment of pulmonary arterial hypertension is listed under Contraindications (Section 4, Table 3) because a safe and effective dose has not been established when used with Kaletra. There is an increased potential for sildenafil-associated adverse events, including visual abnormalities, hypotension, prolonged erections andsyncope. Additionally, in Section 7 Drug Interactions, Table 9 was revised to include this information and differentiate use of PDE5 inhibitors for pulmonary arterial hypertension and for erectile dysfunction

Section 7 Drug Interactions Table 9 was revised to include the following information on salmeterol.

Concurrent administration of salmeterol and Kaletra is not recommended. The combination may result in increased risk of cardiovascular adverse events associated with salmeterol, includingQT prolongation, palpitations and sinus tachycardia.

Section 17 Patient Counseling Information was revised to state:

If they are receiving sildenafil, tadalafil, or vardenafil they may be at increased risk of associated adverse reactions including hypotension, visual changes, and sustained erection, and should promptly report any symptoms to their doctor

If they are taking or before they begin using Serevent (salmeterol) and Kaletra, they should talk with their doctor about problems these two medicines may cause when taken together. The doctor may choose not to keep someone on Serevent (salmeterol)

If they are taking or before they begin using Advair (salmeterol in combination with fluticasone propionate) and Kaletra, they should talk to their doctor about problems these two medicines may cause when taken together. The doctor may choose not to keep someone on Advair (salmeterol in combination with fluticasone propionate).

Similar changes were made to the Medication Guide.

Kaletra is a product of Abbott Laboratories.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

January 30, 2010 Posted by | 1 | Leave a comment

Mind-Body Sleep Solutions

What is Insomnia?

Insomnia is a common condition marked by difficulty falling asleep or staying asleep. People with chronic insomnia experience such difficulties at least three nights a week for more than a month.

In addition to leaving you low in energy during the daytime, insomnia may lead to anxiety, irritability, lack of focus, and memory problems.

The most common sleep complaint in the U.S., insomnia is estimated to affect about 30 to 40 percent of adults each year.

Natural Remedies for Insomnia

A number of natural substances (such as valerianand melatonin) have been found to fight insomnia.

Learn more about natural sleep aids.

Additionally, certain lifestyle changes (such as exercising regularly and managing stress) may help keep insomnia in check. Improving your sleep hygiene (by limiting your caffeine intake, establishing a regular bedtime, and keeping your bedroom as dark as possible at night, for example) may also help you achieve quality sleep, according to the National Sleep Foundation.

Mind-Body Solutions for Insomnia

In recent years, a number of studies have explored the use of mind-body therapies in treatment of insomnia. Here’s a look at some key findings.

1) Yoga and Sleep

For a preliminary study published in 2004, people with chronic insomnia practiced yogaeach day for eight weeks. Among the 20 participants completing the study, researchers observed significant improvements in several sleep-related factors (including total sleep time).

In a 2005 study of older adults, scientists discovered that those practicing yoga had a significant decrease in the time taken to fall asleep, an increase in the total number of hours slept, and an improvement in the feeling of being rested in the morning.

2) Tai Chi and Sleep

Tai chi (an ancient Chinese martial art that combines slow, graceful movements with deep breathing and meditation) may help enhance sleep quality and protect against insomnia in older adults.

In a 2008 study of 112 healthy older adults, researchers found that 25 weeks of tai chi practice improved sleep quality among those with moderate sleep complaints. An earlier study, published in 2004, showed that older adults who practiced tai chi for 60 minutes three times a week for six months increased their sleep duration and decreased the time it took to fall asleep at night.

3) Meditation and Sleep

Combining mindfulness meditation with cognitive behavioral therapy may have long-term benefits for people with chronic insomnia, according to a 2008 study. Analyzing sleep and meditation diaries provided by 21 participants, researchers observed that several sleep-related benefits were maintained throughout a 12-month period following treatment with mindfulness meditation and cognitive behavioral therapy (a form of psychotherapy that emphasizes the role of your own thoughts in how you feel and behave).

Mindfulness meditation is a form of meditation that involves focusing on your mind on the present. Here’s how to practice mindfulness meditation.

Sources:

Irwin MR, Olmstead R, Motivala SJ. “Improving sleep quality in older adults with moderate sleep complaints: A randomized controlled trial of Tai Chi Chih.” Sleep. 2008 1;31(7):1001-8.

Khalsa SB. “Treatment of chronic insomnia with yoga: a preliminary study with sleep-wake diaries.” Appl Psychophysiol Biofeedback. 2004 29(4):269-78.

Li F, Fisher KJ, Harmer P, Irbe D, Tearse RG, Weimer C. “Tai chi and self-rated quality of sleep and daytime sleepiness in older adults: a randomized controlled trial.” J Am Geriatr Soc. 2004 52(6):892-900.

Manjunath NK, Telles S. “Influence of Yoga and Ayurveda on self-rated sleep in a geriatric population.” Indian J Med Res. 2005 121(5):683-90.

Ong JC, Shapiro SL, Manber R. “Mindfulness meditation and cognitive behavioral therapy for insomnia: a naturalistic 12-month follow-up.” Explore (NY). 2009 5(1):30-6.

January 29, 2010 Posted by | 1 | Leave a comment

Drug Information Update – FDA approves Victoza (liraglutide) to treat type 2 diabetes mellitus in adults

FDA/CDER/Division of Drug Information (DDI)

The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation byFDA.


 

FDA approved Victoza (liraglutide) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Victoza is not recommended as first-line therapy for patients who have inadequate glycemic control on diet and exercise. Additionally, Victoza is not a substitute for insulin and should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.

For more information, please visit: Victoza

January 29, 2010 Posted by | 1 | Leave a comment