The FDA yanked the heart surgery drug Trasylol off the market last November, but a medical researcher now claims that 22,000 lives could have been saved if Bayer AG hadn’t withheld the results of an earlier internal study proving the drug’s danger. An FDA committee held hearings in September 2006 to determine Trasylol’s safety, but three of the committee members had a financial interest in Bayer, and the drug maker had underwritten the committee chairman’s research.
fda
This Is Your Brain On Chantix?
By 2.15.08
NY Magazine has published a interesting personal account from a patient who was taking the smoking-cessation drug Chantix. The FDA has reported 37 suicides and more than 400 reports of suicidal behavior in connection with Chantix, a pleasure blocking drug that sits in the nicotine receptors and prevents the smoker from properly experiencing their nicotine high. The FDA recently issued a patient advisory about the drug, requesting that patients carefully monitor their moods. The possible side-effects of Chantix now include “anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide.”
Icy Hot Heat Therapy Products Recalled For Too Much Hot, Not Enough Icy
By 2.11.08
Chattem, Inc., the manufacturer of Icy Hot products has issued a recall of their “heat therapy” products due to reports of skin irritation and first, second and third degree burns. Ouch!
Don't Eat The Botulism Tainted Asiago Cheese Dip, Please
By 2.6.08
There are some jars of Olivier brand Parmesan & Asiago Dip with Garlic & Basil floating around that are possibly tainted with botulism, so you’ll want to check your cupboards.
Tainted Puerto Rico Pills Hit U.S. Mainland
By 2.6.08
A review of FDA reports shows that Puerto Rico’s pharma industry has exported pills with metal in them, pills with incorrect dosages, and pills with paint from the factory doors embedded in the finishing, among other defects. One company, responding to the findings, said “some metallic material was to be expected because the manufacturing equipment is made of metal.” The FDA says the problems in Puerto Rico, which makes 13 of the top 20 best-selling drugs, are proportional to those found on the mainland. Consumer advocates contend that that just shows how ineffective the FDA is, both on the island, and on the mainland. If those are the defects inspectors found, imagine which ones they didn’t, and are inside our bodies right now.
By 1.15.08
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The FDA’s announcement today that cloned beef and dairy is safe was met with criticism by several consumer groups, which isn’t surprising, and the US Department of Agriculture, which is—they say that food producers should continue to honor a “voluntary moratorium” for the indefinite future…
Make Money At Home Stuffing Supplement Capsules—No Anything Required
By 1.15.08
This personal testimony about health supplements from winstonthorne on today’s earlier post is too good—and disturbing—to leave buried in comments:One of my friends actually stuffs capsules for a living for a company making an herbal “sexual stimulant” – she literally sits there on her…
Eat Cloned Animals, FDA Says
By 1.15.08
According to a soon-to-be released FDA report on cloned animals, the government says it’s safe for you to eat Dolly, Dolly, Dolly and even Dolly. On every single measure of animal healthiness, the FDA analysis of cloned animals found virtually no difference between clones and animals reproduced by normal means.
Hormone-Filled Dietary Supplement Caused Cancer In Two Men, Say Doctors
By 1.15.08
A new article published today in Clinical Cancer Research says that two men “developed aggressive and incurable prostate cancer within months of taking the same supplement.” The doctors examined the supplement and discovered it contained testosterone and estradiol, and “when they tested it on tumor cells in the lab, they found it fueled the growth of prostate cancer cells more potently than testosterone alone.” Either don’t take herbal/hormonal dietary supplements, they urge, or make sure you fully disclose to your doctor what you’re taking.
By 1.10.08
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RECALLS: Kash N’ Gold Tinker Bell Novelty Lamps (lead), A.O. Smith Exhaust Fan Electric Motors (fire), Shims Bargain Pacifiers (choking), TJ Promotions Coin Banks (lead), Lowe’s Torchiere Lamps (fire), Honda ATVs (loss of speed control), Intermatic Digital Timers (shock), Pacific Cycle Children’s Trailer Bicycles (can detach from adult bicycle), Canondale Scalpel Mountain Bikes (crashing), Mark’s Quality Meats Beef (E.coli), New Era Mexican-Style Beans (botulism), Raw Oysters Harvested from the West Karako Bay Section of Growing Area 3 in Louisiana (norovirus), Shangai Chaojimengnan (actually Viagra).
FDA Warning: Chinese "Health Supplements" Contain Undeclared Sildenafil
By 12.29.07
Today the FDA announced that a group of Chinese “health supplements” from Puerto Rican-based Shangai Distributor, Inc., contain undeclared sildenafil, the active drug in Viagra, and are therefore illegal. The supplements are named Super Shangai, Shangai Ultra, Shangai Ultra X, Lady Shangai, and (perhaps the best name of the product line) Strong Testis. Shangai Regular, also known as Shangai Chaojimengnan, was found to have “an unapproved substance with a structure similar to sildenafil that may cause similar side effects and drug interactions,” and is therefore also included on the warning list.
New Era Green Beans Recalled For Botulism
By 12.28.07
Large institutional-sized cans of green beans have been recalled for botulism, says the FDA.
FDA Issues New Warnings Over Misuse Of Duragesic Patch
By 12.21.07
The FDA said today that a small number of preventable cases of accidental death have occurred since their first Duragesic warning in 2005, prompting them to ask Johnson & Johnson and the makers of a generic version to add new warnings. “Despite a July 2005 warning, the Food and Drug Administration ‘has continued to receive reports of deaths and life-threatening side effects after doctors have inappropriately prescribed the patch or patients have incorrectly used it,’ the agency said.”
By 12.21.07
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RECALLS: Man’s Trading Company Super Magnets (aspiration, intestinal hazards), Pre-Filled Heparin Lock Flush Solution (Serratia marcescens, life-threatening injuries, death), Empire Silver Teething Rings (choking), Manttra Pressure Cookers (burn), Liberty Apparel Girls’ Hooded Sweatshirts with Drawstrings (strangulation), Lenox Covered Warmer Dishes (fire, burn).
By 12.12.07
../../../..//2007/12/12/china-will-allow-us-food/
China will allow US food inspectors to be posted inside its factories. No doubt the factory owners will adapt by processing food outside the factory. [NYT]
By 12.11.07
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Recalls: Oceanic and AERIS SCUBA Regulators (drowning), Trader Joe’s Pinjur (small pieces of glass), Eclipse® 1175e Elliptical Trainers (falling), WEE CHI Ceramic Hairstyling Irons (fire, burn), Gamenamics Air-Powered Hockey Tables (burn), AtHome America Four-wick Decorative Candles (fire), QVC Cook’s Essential Electric Toasters (fire).
By 12.11.07
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Sales of bagged salads are up, even though the FDA food safety czar says they are not safe to eat because of e. coli contamination. The most recent bagged salad recall was September of this year. People love bagged salad![Bizjournal]
