U.S. Food and Drug Administration health news articles

Safety changes in labeling for cholesterol lowering drugs statins
Important safety changes to the labeling for some widely used cholesterol-lowering drugs known as statins are being announced by the U.S. Food and Drug Administration. These products, when used with diet and exercise, help to lower a person's "bad cholesterol (low-density lipoprotein cholesterol).

2 new pancreatic enzyme products Ultresa and Viokace to aid food digestion
Two new pancreatic enzyme products used to help aid food digestion, Ultresa (pancrelipase) and Viokace (pancrelipase), were approved today by the U.S. Food and Drug Administration.

Erivedge approved for skin cancer metastatic basal cell carcinoma
Erivedge or vismodegib was approved by the U.S. Food and Drug Administration to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The Erivedge drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients whose cancer has spread to other parts of the body (metastatic).

Prevnar 13 vaccine approved for people ages 50 and older
Prevnar 13, a pneumonia vaccine, is approved for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae.

Front Row Produce recalls contaminated grape tomatoes due to salmonella
Front Row Produce of St. Louis MO is recalling its 10oz pint and 10lb bulk grape tomatoes supplied by Rio Queen Citrus, Mission TX, because they have the potential to be contaminated with Salmonella.

Avastin bevacizumab approval revoked to treat breast cancer in US
US health agency FDA Commissioner Margaret A. Hamburg, M.D. has revoked the approval of the breast cancer indication for Avastin (bevacizumab) after concluding that the drug has not been shown to be safe and effective for that use.

35 new drugs approved in 2011 in US
Over the past 12 months, the U.S. Food and Drug Administration approved 35 new medicines for patients, like two new treatments for hepatitis C; a drug for late-stage prostate cancer; the first new drug for Hodgkin's lymphoma in 30 years; and the first new drug for lupus in 50 years.

Kraft Foods recalls 3 varieties of Velveeta Shells & Cheese, US
Kraft Foods Global, Inc. is voluntarily recalling three varieties of Velveeta Shells & Cheese Single Serve Microwaveable Cups with limited "best when used by" dates as a precaution due to the possible presence of small, thin wire bristle pieces.

Remicade infliximab approved to treat ulcerative colitis in children
The U.S. Food and Drug Administration approved Remicade (infliximab) to treat moderately to severely active ulcerative colitis (UC) in children older than 6 years who have had inadequate response to conventional therapy.

Chloroflouorocarbons OTC asthma inhalers will no longer be made or sold in US
The U.S. Food and Drug Administration says users of epinephrine inhalers containing chlorofluorocarbons (CFCs) should plan now to get a prescription for a replacement product because these inhalers will not be made or sold after Dec_31, 2011.

Listeria monocytogenes on Jensen Farms Rocky Ford brand cantaloupes confirmed
US Food and Drug Administration announced that it found Listeria monocytogenes in samples of Jensen Farms' Rocky Ford-brand cantaloupe taken from a Denver-area store and on samples taken from equipment and cantaloupe at the Jensen Farms' packing facility.

Do not eat Rocky Ford Cantaloupe shipped by Jensen Farms US
US FDA is warning consumers not to eat Rocky Ford Cantaloupe shipped by Jensen Farms of Granada, Colo. The majority of the patients reported eating cantaloupe marketed from the Rocky Ford growing region. FDA's traceback data from the State of Colorado about their confirmed cases of Listeria monocytogenes have identified a common producer of Rocky Ford cantaloupes. That producer is Jensen Farms. Although the investigation is ongoing, no other Rocky Ford cantaloupe producer has been found in common in the Colorado traceback.

Multistate outbreak of Listeria in US
The U.S. Food and Drug Administration is working closely with the Centers for Disease Control and Prevention and state health agencies to investigate a multi-state outbreak of listeriosis.

Label change expected for osteoporosis drugs Fosamax, Actonel and Boniva
A US FDA advisory committee wants the health agency FDA to limit the duration of bisphosphonate therapy for treatment of osteoporosis. The panel could not agree on what that time limit should be. The panel also endorsed a label change for osteoporosis drugs.

Adcetris approved to treat two types of lymphoma
The U.S. Food and Drug Administration recently approved Adcetris (brentuximab vedotin) to treat Hodgkin lymphoma (HL) and a rare lymphoma known as systemic anaplastic large cell lymphoma (ALCL).

Zelboraf approved for late stage skin cancer
The U.S. Food and Drug Administration recently approved Zelboraf (vemurafenib), a drug to treat patients with late-stage (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.

Scorpion stings treatment Anascorp approved in US
The U.S. Food and Drug Administration approved Anascorp, the first specific treatment for a scorpion sting by Centruroides scorpions in the United States.

FDA panel votes to revoke approval for Avastin for advanced breast cancer
The Oncologic Drugs Advisory Committee, FDA, USA disapproved the Avastin which cited a lack of survival benefit. Now as two more trials have been analyzed -- neither showing a survival benefit -- the FDA stated that in the balance, the benefit did not outweigh the harm.

Inform Dual ISH to determine HER2 gene in breast cancer patients
Breast cancer is the second leading cause of cancer-related death among women. About 20 percent of women diagnosed with breast cancer are HER2-positive. The Inform Dual ISH test allows lab personnel to count the number of copies of HER2 genes on chromosome 17 in a small sample of the breast tumor. Copies of the HER2 gene appear black and copies of chromosome 17 appear red. Patients with more than the normal number of copies of the HER2 gene are considered candidates for Herceptin therapy.

Better inform consumers about sunscreen to help reduce skin cancer risk, early aging
Sunscreen products meeting modern standards for effectiveness may be labeled with new information to help consumers find products that, when used with other sun protection measures, reduce the risk of skin cancer and early skin aging, as well as help prevent sunburn. The final regulation allows sunscreen products that pass the FDA's test for protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays to be labeled as "Broad Spectrum."

New safety recommendations for high dose 80 mg simvastatin
Patients taking simvastatin 80 mg daily had an increased risk of muscle injury. The risk of muscle injury is highest during the first year of treatment with the 80 mg dose of simvastatin, and is frequently associated with a genetic predisposition for simvastatin-related muscle injury or myopathy.

Incivek for hepatitis C infection is approved in US
The U.S. Food and Drug Administration approved Incivek (telaprevir) to treat certain adults with chronic hepatitis C infection. Incivek is used for patients who have either not received interferon-based drug therapy for their infection or who have not responded adequately to prior therapies.

Zytiga approved for late stage prostate cancer
The U.S. Food and Drug Administration approved Zytiga (abiraterone acetate) in combination with prednisone (a steroid) to treat patients with late-stage (metastatic) castration-resistant prostate cancer who have received prior docetaxel (chemotherapy).

Vaccine to prevent meningococcal disease in infants and toddlers
The U.S. Food and Drug Administration today approved the use of Menactra in children as young as 9 months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Menactra already is approved for use in people ages 2 through 55 years.

US plans to reduce harm from opioid drugs
The White House on Tuesday unveiled a multi-agency plan aimed at reducing the "epidemic" of prescription drug abuse in the U.S.-including an FDA-backed education program that zeros-in on reducing the misuse and misprescribing of opioids.

Skippy Reduced Fat Peanut Butter Spread recalled
Unilever United States, Inc. announced a limited recall of Skippy Reduced Fat Creamy Peanut Butter Spread and Skippy Reduced Fat Super Chunk Peanut Butter Spread, because it may be contaminated with Salmonella, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Breast implants linked to ALCL a rare cancer
Saline and silicone gel-filled breast implants are linked to anaplastic large cell lymphoma (ALCL), a very rare type of cancer, announced by US Health Agency FDA.

Acetaminophen not more than 325 mg in each dose
The U.S. Food and Drug Administration is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 milligrams (mg) in each tablet or capsule.

Tiny Greens Brand Alfalfa Sprouts or Spicy Sprouts may contain Salmonella
US FDA is advising consumers not to eat Alfalfa Sprouts and Spicy Sprouts (which contain alfalfa sprouts mixed with radish and clover sprouts) from Tiny Greens Organic Farm of Urbana, Ill.

Gardasil approved to prevent anal cancer
The U.S. Food and Drug Administration today approved the vaccine Gardasil for the prevention of anal cancer and associated precancerous lesions due to human papillomavirus (HPV) types 6, 11, 16, and 18 in people ages 9 through 26 years.

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