Showing posts with label FDA Alerts. Show all posts
Showing posts with label FDA Alerts. Show all posts

Friday, May 07, 2010

E. coli Tainted Lettuce in the News Again

E. coli tainted lettuce is in the news again... but this time it is E. coli 0145 (not the more common E. coli 0157) and it has been linked to romaine lettuce sold under the Freshway and Imperial Sysco brands with the "best before" date of May 12, 2010.

There are reports of 19 people falling ill owing to the E. coli outbreak, 12 of whom are in hospital. Three of the patients with life-threatening symptoms were diagnosed with hemolytic uremic syndrome, which can cause bleeding in the brain or kidneys:
College students at the University of Michigan in Ann Arbor, Ohio State in Columbus and Daemen College in Amherst, N.Y., are among those affected, according to local health departments in those states. (Associated Press - read more.)

FDA Press Release on the Recall

Wednesday, March 12, 2008

Everything You Read...

There's an old saying that goes something like this: "You can't trust everything you read."

With the proliferation of Big Pharma ads flooding mainstream media these days, it might get a wee bit harder for all of us to sift through the "facts" about various medications and their intended use. And now, the FDA has drafted new guidelines that could make the decision for doctors -- on what pill to give when -- all that more difficult...

You see, back in 2003, a New York Times report came out that detailed a criminal and civil investigation of a drug company.
Court documents showed that company officials hired a marketing firm to write medical journal articles that placed their drug in a positive light. The company paid $12,000 for each article and an additional $1,000 to various doctors who agreed to allow their names to be listed as "authors." Salespeople then distributed the phony articles to doctors to persuade them that the drug was safe and effective for off-label use.

If you're into detail, here's an interesting read.

Just so you know, back in the late 90s a law was passed allowing drug reps to share peer-reviewed articles with doctors.

But back then there were two conditions:
  1. Copies of the articles had to be submitted to the FDA, and
  2. A drug company that submitted an article had to promise to begin the process of seeking FDA approval for the off-label use of the drug.

In other words, before the drug company could send the article out to doctors, they would also have to "prove" their drug could meet the "new use" implied in the peer-reviewed articles by conducting their own efficacy tests for the new use.

That previous law lapsed a couple of years ago, and since then the issue about sharing articles has been in limbo.

But a new draft guidance seeks to establish clear guidelines, AND those two annoying (for Big Pharma) requirements have been dropped. No more bothering with sending copies of articles to the FDA, and no more promises to mount studies to examine little details like efficacy and safety.

According to a New York Times report, one FDA representative confides that "the agency did not really enforce those requirements anyway."

If you read our "Drugs in our Water" article the other day and checked out the AP news release, you might have read this quote:
Over the past five years, the number of U.S. prescriptions rose 12 percent to a record 3.7 billion, while nonprescription drug purchases held steady around 3.3 billion, according to IMS Health and The Nielsen Co.

With this new "guideline" I'm guessing the sales for presecription drugs are going to skyrocket to new and much higher heights.

Monday, April 02, 2007

Pet Food Recall Widens

Del Monte Foods, Nestle Purina PetCare Co., Hills Nutrition and Menu Foods are all part of a growing list of pet food manufacturers who are recalling specific brands of pet food which have been formulated with the contaminated wheat gluten imported from an Asian source.

The latest disturbing news on this is that according to Del Monte (quote):
Del Monte Foods has confirmed that the melamine-tainted wheat gluten used in several of its recalled pet food products was supplied as a "food grade" additive, raising the likelihood that contaminated wheat gluten might have entered the human food supply....

Del Monte issued a voluntary recall Saturday for several products under the Gravy Train, Jerky Treats, Pounce, Ol' Roy, Dollar General and Happy Trails brands.
Wheat gluten is sold in both "food grade" and "feed grade" varieties. Either may be used in pet food, but only "food grade" gluten may be used in the manufacture of products meant for human consumption. Wheat gluten is a common food additive used as a thickener, dough conditioner, and meat substitute. It is widely used as an additive in commercial bakery items and special purpose flours.

Persons suffering from celiac disease must avoid foods containing all forms of gluten. If this particular shipment of gluten has indeed entered the food supply chain, it could have far reaching consequences.
Meanwhile, the FDA now says the contamination in wet pet food that has injured and killed pets across the country may not have been the pesticide aminopterin but possibly a fertilizer and plastics agent called melamine.

...FDA investigators are not certain how melamine would sicken or kill dogs and cats; there is little scientific information available about melamine exposure in animals.
One firm in New York disputes the melamine theory as the source of the many peat deaths and illnesses. They claim the traces of aminopterin discovered are a more likely source owing to its known toxicity as a rat poison and cancer drug treatment.
Earlier in the day, the FDA said its labs found no aminopterin in its tests. Neither did labs at the College of Veterinary Medicine at Cornell University in New York. Cornell has been involved in testing of the Menu Foods since the first indication of the problem, "We have not been able to confirm aminoptrin in the food or body samples," says Donald Smith, dean of the college.
For details on the wide range of pet foods recalled by Menu Foods, vist their pet food recall information website here. You can also find the "Frequently Asked Questions" on the Menu Foods pet food recall this site.

Purina's recalled products include:
13.2-ounce and 22-ounce ALPO Prime Cuts cans and 6-, 8-, 12- and 24-can ALPO Prime Cuts Variety Packs. They have four-digit code dates of 7037 through 7053, followed by the plant code 1159. Those codes follow a "Best Before Feb. 2009" date. This information should be checked on the bottom of the can or the top or side of the multi-pack cartons.

Purina's 5.3-ounce Mighty Dog pouch products, manufactured by Menu Foods, were previously withdrawn from the market as a precaution on March 16 as part of the Menu Foods recall.
Hill's Science Diet Savory Cuts Feline canned cat foods, manufactured by Menu Foods, were previously withdrawn from the market as a precaution. Hills Nutrition products are generally only available through a vetrinarian source. Hills' affected products include:
The affected products:

• Prescription Diet™ m/d™ Feline dry food, 4 pound bag, 52742 42770(all lot numbers)

• Prescription Diet™ m/d™ Feline dry food, ten pound bag, 52742 42790(all lot numbers)

The company advised consumers to stop using the product and return it for a refund. Hill's is reformulating the food so that it will not contain wheat gluten, the company said.
Please don't consider the above the ony products affected. There are more not mentioned above which can be found at the various manufacturers' websites.

And as I mentioned, the recall is widening ...the list is still growing as this story continues to evolve.

Yesterday, the FDA announced that it has traced the contaminated wheat gluten to a single processor, Xuzhou Anying Biological Technology of Peixian, China, but has not released the name of the U.S. distributor who supplied the product to Del Monte, Menu Foods, Nestle Purina, and Hills Nutritional.

In all, more than 70 brands and over 60 million cans and pouches of dog and cat food are now part of this massive recall, as well as at least one brand of dry cat food.

We'll bring you more on the subject as the story unfolds.