Posts Tagged 'Food and Drug Administration'

$11M in unapproved drugs seized by U.S. Marshals

U.S. Marshals recently seized more than $11 million of unapproved drugs distributed by the Cincinnati-based company Masters Pharmaceuticals Inc, according to the Food and Drug Administration. The unapproved drugs include Pramoxine-HC Otic Drop, Hydrocortisone Acetate Suppositories, as well as Urea Cream 39%, Urea Cream 40% and Urea Lotion 40%.

Read more about the unapproved drugs…

Breast Pump Adapters Recalled

Playtex Manufacturing is voluntarily recalling electric breast pump AC/DC power adapters over concerns of potential electric shock, although there have been no known injuries, the FDA announced Thursday.

Read more about the breast pump recall…

Zithromax side effects make top 10 heart health stories of 2013

The discovery of Zithromax (Z-pak) side effects was the number 3 heart health story of 2013, as chosen by readers of The Food and Drug Administration warned in March 2013 that the popular antibiotic could cause potentially fatal arrhythmias in otherwise healthy patients.

Read more about potential Z-Pak side effects…

Liver failure warning added to Zithromax label

The U.S. Food and Drug Administration’s Warnings and Precautions, Contraindications, and Adverse Reactions sections of the labeling for Zithromax were updated in January 2011, to include liver failure. The drug, commonly referred to as “Z-Pak,” has been on the market since 1998.

Read more about Z-Pak side effects…

FDA takes action against illegal diabetes treatments, supplements

Food and Drug Administration officials are cracking down on companies that sell illegal and fraudulent products that claim to treat, ease or even cure diabetes, which affects 1 in 9 Americans older than 20. The agency posted warning letters on Tuesday that it sent to 15 firms in the U.S. and abroad that market unapproved supplements, creams and other so-called diabetes treatments.

Read more about the unapproved diabetes treatments…



Intuitive Surgical May Not Have Tested Devices Properly

Intuitive Surgical Inc. (ISRG), the maker of the da Vinci Surgical System robots, informed customers that 30 devices may not have been tested properly, according to the U.S. Food and Drug Administration. The FDA, calling it a “class 2 recall,” said the action affects Intuitive’s da Vinci Si Vision System Cart, Si Surgeon Side Cart, Instrument Control Box and Dual Camera Controller, in notices posted on its website yesterday.

Read more about the da Vinci Surgical System recall…


Byetta alternatives may help patients without Byetta cancer risks

Eli Lilly has reported some success in clinical trials with new type II diabetes medication, dulaglutide, which showing decreases risks of diabetes medication side effects. Diabetes drugs such as Amylin Pharmaceuticals Inc.’s Byetta injection have been shown to increase the risks for pancreatitis and cancer.

Read more about the link between Byetta and cancer…

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