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Showing posts with label fda. Show all posts
Showing posts with label fda. Show all posts

Friday, 6 February 2015

New FDA Clearance for Ranibizumab for Diabetic Retinopathy with DME

    
     The USFDA has expanded sate use of Ranibizumab for diabetic retinopathy ane Diabetic Macular Edema (DME) treatment. Diabetes is one of the deadly disease that affecting millions of people every year world wide. In this disease the sugar levels of blood will changes time to time with our order. The patient looses body sugars in urine which makes fall down of sugar levels.


    At the time of eating body sugar levels will increases suddenly which damages body organs. Diabetic patients are more prone to organ damages. The main organ is eye. Several diabetic patients are suffering with diabetic retinopathy which impairs vision. So it needs proper treatment. Organ failure chances will increase with age. It is the most common diabetic eye disease and is leading cause of blindness in adults in US.
Diabetic retinopathy

 
   The present drug Ranibizumab is the first significant therapy to treat diabetic retinopathy and diabetic macular edema.

Safety and Efficacy studies of Ranibizumab:
   This profile is obtained by 2 clinical studies involving 759 participants who were treaed and followed for 3 years. In the two studies, treatment with Ranibizumabled to significant improvement in severity of DME and diabetic retinopathy when compared with the patients who does not receiving the drug.

Side effects:
1. Bleeding of conjuctiva
2. Eye pain
3. Floaters
4. Increased IOP(Intra Occular Pressure)
5. Endophthalmitis and retinal detatchment (Serious)

Ranibizumab

    Previously FDA had approved ranibizumab to treat DME and macular edema secondary to retinal vein occlusions, both of which cause fluid to leak into the macula result in blurred vision. Recently FDA granted the Ranibizumab for diabetic retinopathy with DME and reviewed this new use for the drug under the agency's priority review program, which provides for an expedited review of drugs. This drug provides safe and effective treatment in serious condition.

Route of administration:
Ranibizumab is administered by IV injection once monthly.



Other uses of Ranibizumab:
It is also approved for the treatment of neovascular (wet) age related macular degeneratin in US.



    

Friday, 16 January 2015

NSAIDs protects from skin cancer

What are NSAIDs:
Non Steroidal anti Inflammatory Drugs are the agents which are having 3 types of activities
a. Anti pyretic
b. Anti inflammatory and
c. Anti analgesic activity

Non aspirin NSAIDs (Ibuprofen)

Aspirin tablets




Significance of NSAIDs:
1. Used for body aches
2. Used for hyperthermia (Fever)
3. At inflammatory conditions
4. NSAIDs are the choice of drug for arthritis and gout.

Side effects of NSAIDs:
1. Hepatic failure at higher doses for a longer period of time
2. Gastric irritation, gastric bleeding

Contraindications of NSAIDs:
1. NSAIDs are contraindicated for renal impaired patients because NSAIDs are excreted through renal route.
2. NSAIDs are contraindicated for hepatic impaired patients because it is metabolized by glucuronidyl pathway of liver.
3. Contraindicated for gastritis patient as NSAIDs causes gastric bleeding.

Recently it is proved that usage of NSAIDs may protect from skin cancer.
It is already proven that the persons who are using NSAIDs for various health disorders are protective against several cancers like,
1. Prostate cancer
2. Colon cancer
3. Breast cancer and
4. Lung cancer

Now it is evident that NSAIDs also protects from Squamous Cell Carcinoma (SCC), one type of skin cancer. NSAIDs like Aspirin and Non Aspirin usage protects from SSC AND other cancers. 

Mechanism by which NSAIDs protects from SSC:
NSAIDs inhibits Cyclooxigenase (COX-2) enzyme and inhibits prostaglandins (PG's) which are the mediators of inflammation. So, they inhibit the formation of tumors. By this they protects from SCC. But NSAIDs will not protective against all types of cancers but can protect from some types of tumors as we discuss above.