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Posts Tagged “

Fda

cipro

FDA Warns Of Tendon-Rupturing Antibiotics

The FDA slapped a black box warning on a group of antibiotics known as fluoroquinolones for their link to tendonitis and tendon rupture in patients. Drugs in this group include Cipro, Levaquin, Avelox, Oscient, Factive, Proquin XR, Floxin Noroxin. Ruptures associated with the drug have included the achilles tendon, thumbs, shoulder, bicep and hand. Public interest group Public Citizen has been petitioned the FDA in 1996, 2005 and 2006 to add greater warnings to the drug. Only after Public Citizen sued the FDA for not responding to the petitions were the warnings added. One patient described what happened after he was hospitalized for an infection and treated with Cipro...

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salmonella

FDA: Go Ahead And Eat Tomatoes, We Give Up

Well, the FDA isn't sure what caused that salmonella outbreak, but they're lifting the tomato warning anyway, according to the Associated Press. They'd still appreciate it if you tried not to eat raw jalapeno and serrano peppers, because, well, they have to tell you not to eat something, I guess. More »

salmonella

Health Officials: Did We Say Tomatoes? We Meant Jalapeño Peppers

After causing the tomato industry to lose an estimated $100 million, health investigators have essentially recanted their contaminated tomato theory and have focused their attention on jalapeño peppers. The Baltimore Sun reports that new interviews with salmonella victims have revealed that many of them ate salsa containing jalepeños. Other common Mexican food ingredients such as cilantro are also being investigated, however, no new samples have tested positive for salmonella. Details, inside... More »

food safety

So, We're Probably Never Going To Know Where The Salmonella Came From

The FDA still has no real idea where those salmonella tomatoes came from. They suspect both Mexico and Florida, but as you may have noticed: Florida and Mexico are kind of big. And there's no real evidence aside from a guess by the FDA based on the "time frame" of the outbreak matching up with the harvest in those locations. More »

petco

U.S. Marshals Raid Rat-Infested PETCO Distribution Center

The FDA sent U.S. Marshals to seize "various animal food products" stored at a PETCO distribution center in Joliet, Illinois yesterday, because the storage conditions had been deemed unsanitary twice in a row:

During an FDA inspection of a PETCO distribution center in April, widespread and active rodent and bird infestation was found. The FDA inspected the facility again in May and found continuing and widespread infestation.

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your health

FDA: If You Use The Foot Ulcer Cream Regranex, You May Die From Cancer

Bad news from the FDA: people who treat their foot and leg ulcers with the cream Regranex are five-times more likely to die from cancer. More »

drugs

Drug Maker Develops "Abuse-Resistant" Oxycontin

In response to the epidemic of opiate addiction, Purdue Phrama LP the maker of Oxycontin, has developed a new version of the powerful painkiller that's "harder to abuse." According to an AP article, the government will soon be examining this new incarnation of the drug and evaluating the manufacturer's lofty claims. How could this drug be made "abuse-resistant?" Details, inside... More »

Food and Water Watch is suing the FDA for failure to comply with a Freedom of Information Act request to disclose the plans for how it goes about inspecting various food products. [Food and Water Watch]

inspections

FDA Report Cites 49 Safety Issues At Merck Vaccine Plant

Between November of last year and this past January, the FDA "cited 49 areas of concern, including a failure to follow good manufacturing practices" at Merck & Co. Inc's vaccine plant in Pennsylvania. A Merck spokesman says that most of the incidents were found and reported by Merck's own employees, and that they occurred in the manufacturing process, not the vaccines themselves: "He stressed that no contamination was found in finished vaccines and that Merck was addressing all the problems." More »

food safety

Food Companies Threaten Higher Prices If FDA Increases Safety Oversight

Last week, the Grocery Manufacturers Association told lawmakers that if the FDA doubled its safety oversight budget by increasing fees from food companies, they'd have to raise prices to make up the cost. That's right: affordable food or safe food. Choose one! More »

lasik

Patients Of Botched LASIK Surgery Urge FDA To Step In

Our beloved fatherteacher Ben Popken seems just fine with his newly lasered eyes, but not everyone sees such great results, says Reuters: "Blurred vision, dry eyes, glare and double-vision have led to depression and in some cases suicide, several patients told a U.S. Food and Drug Administration advisory panel." These patients want the FDA to take a more active role in regulating the LASIK industry (currently the FDA regulates the equipment but not the people who use it). More »

health

Recalled Heparin Contaminant Confirmed, And Congress Grills FDA On Inspections

Researchers have identified the chemical in the contaminated blood thinner Heparin that killed 81 people in the U.S. and made patients here and in Europe sick:
The researchers freeze-dried the heparin and used a combination of nuclear magnetic resonance imaging and liquid chromatography-mass spectrometry to analyze its structure. In addition to a known impurity of heparin called dermatan sulfate, they found that contaminated lots contain a molecule that looks similar to heparin and showed it was almost certainly oversulfated chondroitin sulfate.

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big pharma

Pre-Emption Doctrine Would Make FDA Responsible For All Drug Problems, Shield Big Pharma From Lawsuits

Johnson & Johnson is waiting to hear whether or not a judge in Ohio will allow any lawsuits over its Ortho birth control patch to move forward, and the New York Times says lawyers on both sides think there's a good chance he may find in the company's favor based on the doctrine of pre-emption. The argument goes that it's the FDA's responsibility to monitor the safety and labeling of drugs that go to market, and therefore if something goes wrong, it's the agency's fault and not the pharmaceutical company's. More »

singulair

FDA Investigating Possible Increased Risk Of Suicide From Popular Asthma Drug Singulair

ABCNews says that the FDA announced Wednesday that they are investigating a possible connection between suicide and the popular asthma drug Singulair.

Concerns over "behavioral issues" with Singulair developed over the past year. Merck periodically updated the drug's labels to include warnings for tremors, depression and anxiety. FDA spokesperson Susan Cruzan said reports of suicides by "three or four" people who were taking Singulair prompted Merck to clarify suicide warnings on labels and patient information sheets in October 2007.
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food safety

Spinach Facilities Are Unsafe, Disgusting And The FDA Doesn't Care

If you like spinach you might not want to read a new report from the House Committee on Oversight and Government Reform called "FDA and Fresh Spinach Safety." More »

law

Charges Filed Against Importers Of Toxic Toothpaste

On Tuesday, the city of Los Angeles and the FDA charged the heads of two U.S. importing companies with 14 counts each of "receiving, selling and delivering an adulterated drug," for their roles in importing and distributing over 70,000 tubes of toothpaste containing diethylene glycol (DEG) instead of glycerin. "Each count carries a maximum penalty of one year in jail and a $1,000 fine." More »

health

Tainted Heparin May Have Been The Work Of Counterfeiters

The Chicago Tribune is reporting that tainted heparin that killed 19 people may have been the work of counterfeiters:
The U.S. Food and Drug Administration said today drug counterfeiters may have added a foreign ingredient into Chinese shipments of Baxter's blood-thinner heparin which has been linked to 19 deaths and 800 illnesses.
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recalls

Aunt Jemima Pancake Mix Recalled Mysteriously

Here's something sort of weird. The St. Louis Post-Dispatch is saying that two products, "Aunt Jemima Complete Pancake Mix" and "Aunt Jemima Buttermilk Complete Pancake Mix" have been "recalled and are under investigation for a possible health risk, according to a press release given out by Dierbergs grocery stores." More »