Posts Tagged ‘FDA’
FDA the food and Drugs administration has been seen working on the strict rules for the implementation of security measures for the manufacturers of drugs. The news media have reported that very few drugs have been approved by FDA in the last year and some lucky among them were Novartis’ kidney cancer drug Afinitor and Bausch and Lomb’s pink eye medicine Besivance.
Photo by matchbookromancebang
This might be because of the fact that President Barack Obama tapped Commissioner Margaret Hamburg and Deputy Commissioner Joshua Sharfstein in the last year to restore the credibility of the agency by influencing mainly on the safety of drugs and than in August last year Hamburg announced that the agency would speed up and expand its issuance of warning letters to the companies that don’t follow FDA regulations.
FDA has required black label warning on two colon cleansing drugs used for the colonoscopy. These prescription drugs may cause renal impairment, the U.S. Food and Drug Administration said Thursday.
A black-box warning is know required on the orally administered sodium phosphate products Visicol and OsmoPrep, informing patients about the possible risk of acute phosphate nephropathy, a type of acute kidney injury.
“Twenty distinctive cases of renal injury coupled with the use of OsmoPrep have been reported to FDA,” Dr. Joyce Korvick, deputy director of FDA said. “Among these cases, three were biopsy-proven cases of acute phosphate nephropathy. The initiation of kidney dysfunction in these cases varied, occurring within the several hours of use of these products and in some cases up to 21 days after the use of the drug.”
In routine, patients of constipation take oral sodium phosphate products. These drugs can either be prescribed or OTC (over the counter), to clean the large intestines before a colonoscopy or used as a laxative.
The final rule excluding certain cattle materials from all animal feed even in pet food has been issued by the U.S. Food and Drug Administration. This final rule also guards animals and users against mad cow disease (Bovine spongiform encephalopathy)
“This FDA action serves to further protect the U.S. cattle population from the already low risk of BSE,” stated Dr. Bernadette Dunham, Director of FDA’s Center for Veterinary Medicine. “The new rule strengthens existing safeguards.’’
In these materials, which can not be used in animal feed any more includes those tissues that have mounting risk of shifting the factor that is considered causing BSE. Brains and spinal cords of 30 months and older cattle are some of the major sources of these high risk cattle materials. There is a low risk of BSE among the cattle less than 30 months of age and the risk gradually increases among the cattle that are more than 30 months of age. It has also been banned if the entire dead body of cattle is not examined and supplied for human use.
It is stunning to hear that Food and Drug Administration has declared Singulair as a fatal drug which leads a person to death. Actually it happens that when the patient of asthma is using this drug for a longer period of time; he suddenly changes in his temper and behaviors’. Such patient gets physically and mentally hyper and tries to a suicide.
FDA has clearly reported on the fact that there has been some deaths due to the suicidal attmepts.They have shown these cases which were caused to death by the use of Singulair in last year during the month of October 2007.Therefore FDA has clearly announced that the patients who are involving in asthma and using singulair; they should check to their doctor on a regular basis FDA also reported that it is not to say to the public that the patients of asthma who are using singulair should stop that drug in the tremor and changing behaviors’.
