Saturday, December 7, 2013

Sovaldi for chronic hepatitis C

The U.S. Food and Drug Administration today approved Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection.
Sovaldi is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon.

On November 22, FDA had approved Olysio (Simeprevir) for treatment of chronic HCV. 

Aralen (Chloroquine Phosphate) Tablets

US FDA has modified the section of Warnings and adverse reactions of Aralen (Chloroquine Phosphate) Tablets
The warnings section mentions that - retinopathy/maculopathy, as well as macular degeneration have been reported and irreversible retinal damage has been observed in some patients who had received long-term or high-dosage 4-aminoquinoline therapy. Retinopathy has been reported to be dose related. Risk factors for the development of retinopathy include age, duration of treatment, high daily and/or cumulated doses.

The adverse reactions section mentions that maculopathy and macular degeneration have been reported and may be irreversible.

Tuesday, December 3, 2013

Rosiglitazone -Modifications in the prescribing and dispensing restrictions

 Rosiglitazone is a thiazolidinedione, used in the management of type 2 diabetes mellitus, alone or in combination therapy.
The latest drug safety communication by US FDA on rosiglitazone containing diabetes medicines requires the removal of the prescribing and dispensing restrictions for rosiglitazone medicines that were put up in year 2010.
This is based on the recent re-evaluation of the Rosiglitazone Evaluated for Cardiovascular Outcomes and Regulation of Glycemia in Diabetes (RECORD) trial data by Duke Clinical Research Institute (DCRI) which did not show statistically significant differences between the rosiglitazone and the metformin/sulfonylurea groups for the composite end point of CV death, MI, or stroke and the individual components. Still the concerns about the cardiovascular safety remain due to this re-evaluation, but the prescribing information and Risk Evaluation and Mitigation Strategy (REMS), called the Rosiglitazone REMS program will be modified.
Health care professionals, pharmacies, and patients will no longer be required to enroll in the rosiglitazone REMS program to be able to prescribe, dispense, or receive rosiglitazone medicines.   

History of changes in the prescribing information
09/23/2010
US FDA restricted the use of rosiglitazone to patients of type 2 DM who cannot control their diabetes on other medications. This was following the data from a large, combined analysis of mostly short-term, randomized clinical trials of rosiglitazone which had suggested an elevated risk of heart attack.
FDA required a Rosiglitazone REMS program. The Rosiglitazone REMS program restricted the use of rosiglitazone medicines to help ensure that their benefits outweighed the risks. 
02/04/2011
Information on cardiovascular risks added to the physician label and medication guide.
05/18/2011
The new REMS included a restricted access and distribution program for all the three products containing rosiglitazone (Avandia, Avandamet and Avandaryl)
11/04/2011
Healthcare professionals to enroll in the Avandia-Rosiglitazone Medicines Access Program if they wished to prescribe rosiglitazone medicines to outpatients or patients in long-term care facilities.
References
4.      Results of a reevaluation of cardiovascular outcomes in the RECORD trial. http://www.ncbi.nlm.nih.gov/pubmed/23895806


FDA has recommended not to co- administer Aliskiren (Tekturna) with Ramipril in patients with diabetes.


 Safety Labeling Changes Approved By FDA CDER 
Ramipril is an ACE inhibitor indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. The most common adverse reactions include headache, dizziness, fatigue, and cough.
Aliskiren is an orally active renin antagonist given in patients with hypertension with elevated plasma renin levels. 
Physicians are advised not to co-administer Aliskiren with Ramipril in patients with diabetes or in patients with renal impairment (GFR < 60 mL/min/1.73 m2).

Dual blockade of the Renin Angiotensin Aldosterone System (RAAS) with ACE inhibitors and Aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy.

Physicians should closely monitor blood pressure, renal functions and electrolytes in patients on Ramipril and other agents that affect the RAAS.