May 2007 - FDA News

FDA: Don't Eat Monkfish (MedicineNet.com) Title: FDA: Don't Eat Monkfish

FDA: Don't Eat Monkfish (MedicineNet.com)
Title: FDA: Don't Eat Monkfish Category: Health News Created: 5/29/2007 Last Editorial Review: 5/29/2007

FDA Approvals - China ex-regulator gets death penalty (AP via Yahoo! News) China's

China ex-regulator gets death penalty (AP via Yahoo! News)
China's former top drug regulator was sentenced to death Tuesday for taking bribes to approve untested medicines, as the country's main quality control agency announced its first recall system for unsafe food products.

Mylan OK'D on Generic Prozac, 40 Mg (RedNova)
U.S generic firm Mylan said Wednesday it has been granted approval to sell a high-dose generic version of Eli Lilly's Prozac.

FDA To Inspect Wheat Gluten In Plants

Pet Food Recall Aggressive

FDA Approves Contraceptive for Continuous Use The Food and Drug

FDA Approves Contraceptive for Continuous Use
The Food and Drug Administration (FDA) today approved Lybrel, the first continuous use drug product for prevention of pregnancy.

FDA likely to OK pill to end period (Fort Worth

FDA likely to OK pill to end period (Fort Worth Star-Telegram)
Women looking for a simple way to avoid their menstrual period could soon have access to the first birth-control pill designed to let women suppress monthly bleeding indefinitely.

Gadolinium Causes Nephrogenic Systemic Fibrosis

A substance known as gadolinium is used as a contrast agent for certain MRIs appears to cause a rare condition known as nephrogenic systemic fibrosis. The disease is also referred to as nephrogenic fibrosing dermopathy. NSF (NFD) appears to affect people with kidney disease and impaired renal function. It causes hardening of the skin and joints, as well as damage to internal organs. NSF resists treatment and is often fatal.

More and more doctors request magnetic resonance imaging (MRI) - and magnetic resonance angiography (MRA) – as diagnostic tools for their patients. In some cases, in order to more clearly see the results of an MRI or MRA, a contrast agent – or dye - is injected into your body. For years, the contrast agents used were iodine-based dyes. Unfortunately, the iodine-based contrast agents have been known to cause kidney failure. New dyes that were considered to be safer were developed to avoid this problem. The new contrast agent dyes were made using a substance called gadolinium. Unfortunately, according to the FDA, a high number of people who have been injected with gadolinium-based dyes have been reported to have contracted nephrogenic systemic fibrosis and nephrogenic fibrosing dermopathy.

Attorneys specializing in product liability lawsuits including pharmaceutical injury litigation and defective medical device claims are representing victims of nephrogenic systemic fibrosis and nephrogenic fibrosing dermopathy. The law firm of Burg Simpson Eldredge Hersh & Jardine, P.C. represents victims of NSF and NFD nationwide. If you or a loved one has been diagnosed with NSF or NFD, we encourage you to contact Burg Simpson.

FDA/USDA Joint News Release: Scientists Conclude Very Low Risk to

FDA/USDA Joint News Release: Scientists Conclude Very Low Risk to Humans from Food Containing Melamine
There is very low risk to human health from consuming meat from hogs and chickens known to have been fed animal feed supplemented with pet food scraps that contained melamine and melamine-related compounds, according to an assessment conducted by scientists from five federal agencies.

EMS Swiss Dolorclast The EMS Swiss Dolorclast is a non-invasive

EMS Swiss Dolorclast
The EMS Swiss Dolorclast is a non-invasive device that generates therapeutic sound waves (extracorporeal shock wave therapy) used to treat heel pain associated with chronic proximal plantar faciitis. Chronic proximal plantar faciitis is recurring... (Approved: 5/8/2007)

R.A.B. Food Group, LLC Issues a Nationwide Recall of Sparkling

R.A.B. Food Group, LLC Issues a Nationwide Recall of Sparkling Grape Juices Product May Rupture (May 24)
Several bottles have been found to be fermenting which will cause additional pressure in the bottle. This may lead to the popping of the cap or rupturing of the bottle.

AMO Announces Voluntary Recall of Complete Moistureplus Multipurpose Solution (May 25)
In response to information received today from the U.S. Centers for Disease Control and Prevention (CDC) regarding eye infections from Acanthamoeba, a naturally occurring water-borne organism which can contribute to serious corneal infections, Advanced Medical Optics is immediately and voluntarily recalling its Complete MoisturePlus contact lens solutions.

Interstate Brands Corporation Issues Recall of Mispackaged Hostess Mini Pound Cake Bearing Code Date MAY 28 53 122; Product May Contain Walnuts (May 10)
Interstate Brands Corporation (IBC) is recalling the 3.25 oz. individual snack packages of Hostess Mini Pound Cake with the code date of May 28 53 122, UPC #4500041159 due to a packaging error.

FDA Approvals - Death Penalty for China Drug Official (Time Magazine) China's food

Death Penalty for China Drug Official (Time Magazine)

China's food and drug crackdown (Los Angeles Times)
A former official's death sentence in a bribery case is a reflection of increasing pressure to keep unsafe products off the market. BEIJING By the standards of Chinese corruption cases, the $832,000 that the former head of the State Food and Drug Administration was charged with skimming over a seven-year period was not huge. But the death sentence given in the bribery case Tuesday reflected ...

FDA Approves Contraceptive for Continuous Use The Food and Drug

FDA Approves Contraceptive for Continuous Use
The Food and Drug Administration (FDA) today approved Lybrel, the first continuous use drug product for prevention of pregnancy.

FDA approves treatment for bacterial vaginosis (News-Medical-Net) Mission Pharmacal has

FDA approves treatment for bacterial vaginosis (News-Medical-Net)
Mission Pharmacal has announced that the U.S. Food and Drug Administration (FDA) approved Tindamax (tinidazole) for the treatment of bacterial vaginosis (BV), the most common vaginal infection among women of childbearing age in the United States.

FDA Says FluMist Vaccine Facility Still Not In Compliance (KOLR/KSFX Ozarks)
(Washington, DC) -- A flu vaccine manufactured in Britain by Maryland-based MedImmune remains intact despite FDA concerns over contamination at the plant.

FDA Approvals - Pharma majors shift production for overseas subsidiaries to India (rediff.com)

Pharma majors shift production for overseas subsidiaries to India (rediff.com)
After making big-ticket acquisitions abroad, leading Indian pharmaceutical companies like Dr Reddy's Laboratories, Ranbaxy Laboratories, and Aurobindo Pharma are rapidly shifting production to their Indian facilities.

Ex-China drug regulator to be executed (AP via Yahoo! News)
China's former top drug regulator was sentenced to death Tuesday for taking bribes to approve untested medicines, as the country's main quality control agency announced its first recall system for unsafe food products.

Congress Threatens To Subpoena FDA (KOLR/KSFX Ozarks)
(Washington, DC) -- Congress is threatening to get tough with the Food and Drug Administration. Lawmakers say they'll be forced to subpoena officials at the agency unless important documents about drug and food safety are turned over.

FDA Advises Manufacturers to Test Glycerin for Possible Contamination The

FDA Advises Manufacturers to Test Glycerin for Possible Contamination
The U.S. Food and Drug Administration (FDA) is warning pharmaceutical manufacturers, suppliers, drug repackers, and health professionals who compound medications to be especially vigilant in assuring that glycerin, a sweetener commonly used worldwide in liquid over-the-counter and prescription drug products, is not contaminated with diethylene glycol (DEG).

FDA Approvals - PuriCore Plc announces FDA Lists Sterilox Food Safety Solution for

PuriCore Plc announces FDA Lists Sterilox Food Safety Solution for Food Contact (SYS-CON Media)
MALVERN, PENNSYLVANIA, AND STAFFORD, UK, May 23, 2007-Sterilox Food Safety, a division of PuriCore (London Stock Exchange: PURI), today announced it received notification that the US Food and Drug Administration (FDA) formally listed its Sterilox Solution as an approved food contact substance.

Congress Threatens To Subpoena FDA (KOLR/KSFX Ozarks)
(Washington, DC) -- Congress is threatening to get tough with the Food and Drug Administration. Lawmakers say they'll be forced to subpoena officials at the agency unless important documents about drug and food safety are turned over.

Advanced Medical Optics Voluntarily Recalls Complete MoisturePlus Contact Lens Solution

Advanced Medical Optics Voluntarily Recalls Complete MoisturePlus Contact Lens Solution
Consumers who wear soft contact lenses should stop using the solution, discard all partially-used or unopened bottles and replace their lenses and storage container.

FDA Warning on Mislabeled Monkfish The Food and Drug Administration

FDA Warning on Mislabeled Monkfish
The Food and Drug Administration (FDA) is warning consumers not to buy or eat imported fish labeled as monkfish, which actually may be puffer fish, containing a potentially deadly toxin called tetrodotoxin. Eating puffer fish that contain this potent toxin can result in serious illness or death.

Some pills that limit or cut periods (Sharewatch) --Seasonique comes

Some pills that limit or cut periods (Sharewatch)
--Seasonique comes in packs with 84 active birth control pills and seven dummy pills, so it limits periods to every three months. Launched last August, it works the same as predecessor Seasonale, which got cheaper generic competition in September.

FDA approves contraceptive that stops periods (San Francisco Chronicle)
The Food and Drug Administration today approved the first birth-control pill that can stop a woman's period indefinitely. Lybrel, which is made by pharmaceutical giant Wyeth, contains hormone doses lower than oral contraceptives already available. It...

FDA likely to OK pill to end period (Fort Worth Star-Telegram)
Women looking for a simple way to avoid their menstrual period could soon have access to the first birth-control pill designed to let women suppress monthly bleeding indefinitely.

FDA Approves Tindamax(R) For Bacterial Vaginosis (Medical News Today) Mission

FDA Approves Tindamax(R) For Bacterial Vaginosis (Medical News Today)
Mission Pharmacal today announced that the U.S. Food and Drug Administration (FDA) approved Tindamax(R) (tinidazole) for the treatment of bacterial vaginosis (BV), the most common vaginal infection among women of childbearing age in the United States. [click link for full article]

FDA to Stop Sales of Unapproved Timed-Release Cold Medications (HealthDay via Yahoo! News)
FRIDAY, May 25 (HealthDay News) -- The U.S. Food and Drug Administration said Friday that it plans to stop companies from marketing unapproved products that contain the cold treatment guaifenesin in unapproved timed-release form.

A Costly Trade with China (The Epoch Times)
A May 24 U.S. Food and Drug Administration (FDA) press release warns of monkfish-also called puffer fish-laced with the deadly toxin Tetrodotoxin, which survives even cooking or freezing, imported ...