All Posts Tagged With: "fda"
Contaminated Heparin Seized by the FDA
The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA’s request by U.S. Marshals. These products, which were manufactured from material imported from China, had been found by the agency to be contaminated with over-sulfated chondroitin sulfate (OSCS), a substance that mimics heparin’s anticoagulant [...]
Popularity: 17% [?]
7Nov2008 | PharmaWatchDog | 0 comments | Continued
Increased Cancer Risk Associated with Treatment for Diabetic Leg and Foot Ulcers
The FDA is conducting a safety review based on study data suggesting there may be an increased risk of death from cancer in diabetic patients using Regranex (becaplermin) Gel, a skin product used to heal leg and foot ulcers. While the review is ongoing, the FDA recommends health care professionals discuss the potential risks and [...]
Popularity: 66% [?]
28Mar2008 | PharmaWatchDog | 2 comments | Continued
Cantaloupe from Honduran Grower Tainted with Salmonella
The Food and Drug Administration (FDA) is advising consumers who have recently bought cantaloupes to check with the place of purchase to determine if the fruit came from Agropecuaria Montelibano, a growing and packing company in Honduras. If so, consumers should throw away the cantaloupes.
Based on current information, fruit from this company appears to be [...]
Popularity: 55% [?]
24Mar2008 | PharmaWatchDog | 2 comments | Continued
Bush’s Legacy
Stephanie Mencimer, Mother Jones
When it comes to notorious Bush political appointees, Daniel Troy’s name doesn’t usually make the top-10 list, overshadowed as he is by more high profile cronies such as FEMA’s Michael Brown. But for three years in the president’s first term, Troy served as the chief counsel to the Food and Drug Administration [...]
Popularity: 53% [?]
21Mar2008 | PharmaWatchDog | 0 comments | Continued
Graft use Associated with Increase Risk of Death
FDA issued a Public Health Notification to inform healthcare professionals of an update to earlier FDA safety information on this product. The notification re-emphasizes the need for continued surveillance of patients treated with endovascular grafts, and provides updated information on the mortality risks associated with the use of the AneuRx Stent Graft System to prevent [...]
Popularity: 57% [?]
20Mar2008 | PharmaWatchDog | 0 comments | Continued
Spiriva HandiHaler Associated with Stroke
Boehringer Ingelheim and FDA notified healthcare professionals that ongoing safety monitoring has identified a possible increased risk of stroke in patients who take Spiriva. This product contains tiotropium bromide and is used to treat bronchospasm associated with chronic obstructive pulmonary disease. Boehringer Ingelheim reported to the FDA that it has conducted an analysis of the [...]
Popularity: 58% [?]
20Mar2008 | PharmaWatchDog | 2 comments | Continued
FDA to establish offices in China
In an important development, the U.S. Food and Drug Administration has received approval from the U.S. State Department to establish eight full time permanent FDA positions at U.S. diplomatic posts in the People’s Republic of China, pending authorization from the Chinese government.
This is an important step forward in the FDA’s plans [...]
Popularity: 50% [?]
15Mar2008 | PharmaWatchDog | 0 comments | Continued
Members Call on the Science Board to Assess Resources Needed to Remedy FDA’s Funding Crisis
Reps. Henry A. Waxman, John D. Dingell, Bart Stupak, and Frank Pallone, Jr., called on members of one of FDA’s own advisory committees to provide Congress with its assessment of the resources needed to remedy the crisis at the agency stemming from years of chronic underfunding.
“We are deeply concerned that the budget submitted by the [...]
Popularity: 45% [?]
12Mar2008 | PharmaWatchDog | 1 comment | Continued
Prezista causes Hepatitis
FDA and Tibotec Therapeutics notified healthcare professionals of changes to the WARNINGS section of the prescribing information for Prezista (darunavir) tablets regarding the risk of hepatotoxicity. In clinical trials and postmarketing experience, drug induced hepatitis has been reported in patients receiving combination therapy with Prezista/ritonavir. Appropriate laboratory testing should be conducted prior to initiating therapy [...]
Popularity: 49% [?]
12Mar2008 | PharmaWatchDog | 0 comments | Continued
Guest Authors
Influence Only Money Can Buy
by BRENT HOADLEY
It’s not news that the Federal regulatory agency we the people depend on to provide us with SAFE food and drugs is in shambles. A group of dedicated middle and lower echelon government employees will most likely take the blame for policies that have resulted from the revolving door [...]
Popularity: 17% [?]
2Mar2008 | PharmaWatchDog | 0 comments | Continued
