Archive for May, 2008

FDA Recalls Dietary Supplement

Friday, May 30th, 2008

On May 29, 2008, the U.S. Food and Drug Administration requested that Florida pharmaceutical company, SEI Pharmaceuticals, recall all lots of Xiadafil VIP tablets. The request made by the FDA follows previous actions taken by the state of Florida to prevent distribution of the drug. The FDA is advising consumers not to buy or ingest the product as the FDA may take further actions.

The drugs are being marketed illegally and are being recalled because they have been found to contain an undeclared ingredient that can cause alterations to blood pressure and other dangerous adverse side effects.

Xiadafil VIP Tabs are marketed as a dietary supplement for sexual enhancement and claim they are able to treat erectile dysfunction, or ED. The tabs contain the same ingredient that is used in Viagra. The ingredient is known to cause serious, life-threatening side effects.

Xiadafil VIP Tabs are sold in 8 tablet bottles, labeled Lot # 6K029, or blister cards of 2 tablets, labeled Lot # 6K029-SEI. These lots have an expiration date of September 2009.

Defective drug attorneys are working on cases in which adverse side effects have been caused by dangerous drugs.

FDA and Medicare Work Together to Improve Medical Products

Tuesday, May 27th, 2008

On May 22, it was announced that the U.S. Food and Drug Administration (FDA) will be working in conjunction with the Centers for Medicare & Medicaid Services (CMS).

Both organizations working together will attempt to increase the capacity of the FDA to monitor the effectiveness of medical products. The proposed system is being called the Sentinel Initiative. It will create a new electronic system that will allow the FDA to query information through CMS that will allow them to monitor possible adverse effects of medical products.

The electronic system will maintain strict privacy. The information gathered will only be used to monitor the effectiveness of prescription drugs and medical devices. The intent is to be able to quickly determine if a product is dangerous.

Defective drug attorneys are working on cases in which serious effects of prescription drugs have caused life-long disability or fatality.

Prescription Acne Drug Solodyn Recalled

Friday, May 23rd, 2008

Medicis Pharmaceutical Corporation has voluntarily recalled an antibiotic that is used to treat acne, Solodyn.

All prescriptions filled after April 15th are subject to the recall. This includes lot numbers B080037 and B080038.

The recall is linked to a report that a pharmacist found the prescription drug Azasan in a bottle labeled Solodyn. Azasan is an immuno-suppressant that is used to treat rheumatoid arthritis and to prevent rejection in kidney transplant patients.

Azasan is associated with severe side effects, such as:

• Joint and muscle pain
• Diarrhea
• Chills
• Nausea
• Vomiting
• Infection
• Bleeding
• Decrease in red and white blood cells and platelets

Azasan is a yellow, triangular shaped pill with “75mg” imprinted on the side. Solodyn is a yellow capsule that has “DYN-090” imprinted.

Prescription drug defect attorneys are working on defective drug cases in which serious side effects have resulted from dangerous prescription drugs.