FDA

New colorectal cancer drug shows promise in study

LOS ANGELES -- A medication for people with advanced colorectal cancer who have exhausted all other treatment options appears to slow tumor growth and extend life, according to new data.

Massage device causes strangulation death

After reports of a strangulation death associated with using the Shoulderflex massager, the federal Food and Drug Administration warned consumers Wednesday not to use the device.

Trace Minerals Research receives recertification

OGDEN — Trace Minerals Research has received Good Manufacturing Practices recertification with an “A” rating from the Natural Products Association.

Tainted wipes discovered three months ago just now recalled

MILWAUKEE — A potentially deadly bacterium was detected on alcohol prep pads produced by a New York medical manufacturer three months ago, but the product was not recalled until this week because federal regulators did not require it, the company said Wednesday.

Ogden dietary supplement company completes FDA inspection

OGDEN -- Mineral Resources International, Inc., a dietary supplement manufacturer of ionic minerals from Utah's Great Salt Lake, announced that it has completed its successful first cGMP (current Good Manufacturing Practices) inspection by the U.S. Food and Drug Administration. The FDA found no deficiencies or areas where corrective action notices.

MRI's manufacturing facility, based in Ogden, was the subject of a random, weeklong, on-site audit Aug. 31 to Sept. 8, to ensure the company's compliance with cGMPs.

(DAVE MARTIN/The Associated Press) Alivia Parker, 21 months, runs through circles of spraying water on a 100-degree day in Montgomery, Ala., Tuesday. Parker is wearing sunscreen with an SPF of 100. Federal regulators will require sunscreen manufacturers to test their products’ effectiveness against sun rays that pose the greatest risk of skin cancer. Under new rules, manufacturers also will have to follow stricter guidelines when describing how well their products block ultraviolet B rays — and the highest SPF value will be capped at 50, unless companies provide results of testing that support a higher number.

New rules to block sunscreen confusion

WASHINGTON -- Help is on the way if you're confused by sun protection numbers and other claims on sunscreens. Starting next summer, you can find SPF 15 bottles and tubes with the label "broad spectrum" and feel confident they're lowering your risk of skin cancer.

(JAMIE LAMPROS/Standard-Examiner correspondent)
Betty Patrick, 63, a South Weber resident who has diabetes, talks Wednesday about a new procedure she received on her ulcerated foot. Dermagraft is bioengineered human skin that is grafted onto the wound. Here, her husband, Charles, puts her shoe back on her foot.

South Weber woman: New procedure called Dermagraft saves 2 toes

OGDEN -- A new procedure that helps patients with nonhealing diabetic foot ulcers may have saved a South Weber woman from losing two of her toes to amputation.

FDA lowers 'Lap-Band' surgery's minimum weight limits

Millions of Americans may soon have another weapon in the battle of the bulge.

The Food and Drug Administration has approved use of the "Lap-Band" type of weight loss surgery at lower minimum weight limits, making an estimated 26 million Americans newly eligible for the procedure.

Previously, the surgery was restricted to people with a body mass index of 40, or 35 if they had an obesity-related health problem, such as diabetes, hypertension or joint pain.

Drugmakers blame FDA rules for drug shortages.

CHICAGO -- Hospitals across the country are running out of key drugs used in surgeries and to treat some diseases, including cancer, causing doctors to turn to older treatments.

In some cases, hospitals are paying higher prices to get their patients necessary care because wholesalers are hoarding needed medicines.

Part of the shortage is being caused by manufacturing issues and quality-control problems at a number of companies as they respond to the federal government's crackdown on drug safety. The quality issues can include toxins and "particulate matter" in medicines and workers inaccurately filling out the required paperwork to verify that the drugs, as well as the devices used to intravenously deliver the products to patients, are safe and effective.

FDA approves breast cancer drug

HACKENSACK, N.J. -- A new drug shown to prolong the lives of women who have metastatic breast cancer has been approved by the Food and Drug Administration.

Halaven, a new injection treatment synthetically created based on a sea sponge, was developed by Woodcliff Lake-N.J.-based Eisai Inc. 5/8In a multicenter study of 762 patients, those taking the drug lived a median of 2.5 months longer than those not given the medicine. Overall survival was slightly 5/8more than 13 months, compared with 10 1/2 months for those who did not receive it.

The FDA approved Halaven for patients with metastatic breast cancer who have previously undergone at least two chemotherapy treatments for early or advanced breast cancer. The drug binds to the proteins that help cells divide, slowing the progression of the disease.

Alcoholic energy drinks to be banned

WASHINGTON -- The Food and Drug Administration is expected to find that caffeine is an unsafe food additive to alcoholic drinks, essentially banning them, and manufacturers will then be warned that marketing caffeinated alcoholic beverages could be illegal.

(Evan Vucci/The Associated Press)
Three examples of proposed warning graphics that will appear on cigarette packaging as part of the government's new tobacco prevention efforts, seen in Washington on Wednesday.

Cigarette packages to have graphic warnings

LOS ANGELES -- In the first major change to cigarette packaging in a quarter-century, the Food and Drug Administration said Wednesday it will require graphic warning labels that cover half a package's front and rear and the top 20 percent of all cigarette ads.

FDA warns 8 companies marketing miracle cures

WASHINGTON — The Food and Drug Administration warned eight companies on Thursday to stop marketing miracle cures that claim to treat everything from autism to Parkinson’s disease by flushing toxic metals from the body.

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