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FDA 585 articles

FDA panel recommends severely limiting testosterone drug prescriptions

Low T

A U.S. Food and Drug Administration (FDA) advisory panel voted 20-1 Wednesday to impose strict new limitations on testosterone-replacement drugs, recommending changes to labeling that would limit FDA-approved prescription indications to men who have abnormally low testosterone levels due to injury or disease, but not aging. The changes, triggered by conflicting studies and a lack of evidence showing the efficacy of testosterone drugs for treating common age-related issues, would exclude millions of American men who currently use the drugs as antidotes for low libido, muscle loss, and lack of energy. The panel’s recommendations, which the FDA usually accepts, could also ... Read More

FDA to reassess appropriateness, usefulness of testosterone replacement drugs

Low T

The U.S. Food and Drug Administration (FDA) will hold an advisory panel meeting Sept. 17 on the safety and usefulness of testosterone replacement drugs, which a number of pharmaceutical manufacturers are promoting and selling aggressively to men who may be stricken with low testosterone levels, or “Low T.” FDA officials added briefing documents to the agency website earlier this month, acknowledging that while testosterone levels commonly drop in men as they age, studies indicate that lower levels of the hormone do not necessarily lead to serious health problems, such as testicular and pituitary disease. Still, as the agency notes, testosterone ... Read More

White & Blue Dragon recalls all lots of its tattoo ink, needles, etc. after discovery of unsafe bacteria

tattoo - image by WALB News Albany

According to the U.S. Food and Drug Administration (FDA), White & Blue Lion, Inc. has announced a voluntary recall of all its tattoo inks and needles after discovering a potential contamination of pathogenic bacteria. If the recalled products are used, it may lead to a bacterial infection in certain organs which can cause sepsis. In order to keep consumers safe, the company is recalling all of its tubes and ink cups as well. Although the company will be recalling all tattoo ink, needles, tubes, ink cups and kits distributed by White & Blue Lion for precaution, the ones specifically listed ... Read More

FDA and McCormick recall Ground Oregano, 0.75 oz. bottles due to risk of Salmonella

Recall - McCormick ground oregano

A voluntary recall has been issued by McCormick & Company after the possible Salmonella contamination of its McCormick® Ground Oregano, 0.75 oz. bottles. The UPC code on the recalled bottles is 0-523561-6 with code dates BEST BY AUG 21 16 H and AUG 22 16 H. All other McCormick Ground, Whole or Oregano Leaves products are not affected by this recall. The Salmonella that is believed that have contaminated the McCormick’s Ground Oregano products has the potential to cause serious, and sometimes fatal, health infections in those with weaker immune systems. Symptoms of Salmonella may include fever, nausea, diarrhea, vomiting ... Read More

Canadian regulators warn consumers about cardiovascular risks of testosterone drugs

Axiron

Canada’s national health regulators have issued a warning to consumers and health care providers about the serious risks associated with the use of testosterone-replacement drugs, which are being prescribed to increasing numbers of men as a treatment for low natural testosterone levels. Health Canada said its safety review of testosterone drugs involved evaluating the currently available studies and reports on the cardiovascular risks the drugs presented. In the course of its safety review, the agency found “a growing body of evidence suggesting a possible association between the use of testosterone replacement products and cardiovascular risk.” As in the U.S., men ... Read More

Nationwide fruit recall expanded over concerns of Listeria Monocytogenes contamination

Recall - peaches

A nationwide recall on nectarines, peaches, plums, and pluots potentially contaminated with the Listeria monocytogenes bacteria has been expanded to include additional retailers and store items made with the affected fruit. Cutler, Calif.-based Wawona Packing Co. voluntarily recalled the fruit on July 19 after an Australian importer’s test detected slight levels of the Listeria bacteria on three peaches. Wawona said in a statement that the Listeria it found fell “within tolerance levels” set by the Australian government. The U.S. Food and Drug Administration (FDA), however, has a zero-tolerance rule for listeria monocytogenes, prompting Wawona to retain a private laboratory to ... Read More

California fruit company issues nationwide recall after finding Listeria contamination

Recall - peaches

CUTLER, Calif. — A California fruit distributer has recalled several lots of nectarines, peaches, plums, and pluots sent out to retailers nationwide over fears that it could be contaminated with Listeria monocytogenes bacteria. Wawona Packing Co. President Brent Smittercamp said that the company was recalling the products after consultation with the U.S. Food and Drug Administration (FDA). Internal testing at Wawona’s Tulare County packing facility in central California found some of the fruit to be contaminated with Listeria, which can cause serious illness and may be fatal to young children the elderly, and people with weakened immune systems. Healthy individuals ... Read More

FDA revokes approval for seven painkillers containing acetaminophen

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The U.S. Food and Drug Administration (FDA) has revoked approval for seven narcotic painkillers containing acetaminophen, including versions of AbbVie Inc.’s Vicodin. The agency has done this in response to recent concerns about these drugs’ potential of causing liver damage. Just three years earlier, regulators announced a plan to cap the amount of acetaminophen allowed per dose to 325 milligrams. Three versions of Abbvie’s Vicodin that combine acetaminophen and hydrocodone were affected by this. Also, companies such as Actavis Inc., Nesher Pharmaceuticals USA LLC, West-Ward Pharmaceutical Corp, and Leitner Pharmaceuticals LLC, that all made products containing acetaminophen had those product ... Read More

FDA refuses Public Citizen’s request to ban transvaginal mesh from market

bladder sling

The U.S. Food and Drug Administration (FDA) has rejected the request made by Public Citizen in 2011 to recall existing surgical mesh products, specifically transvaginal mesh, and ban them from the market. The FDA says that a rigorous review is sufficient enough. The FDA said it “may consider future action against individual products or this product type as appropriate.” Transvaginal mesh is used to repair conditions such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The mesh is implanted through the vagina and is used to shore up pelvic organs that have become displaced due to age, childbirth, ... Read More

Corporate Action Network demands FDA remove transvaginal mesh from the marketplace

bladder sling

The Corporate Action Network has sent a letter to the U.S. Food and Drug Administration (FDA) demanding the immediate ban of the marketing of non-absorbable surgical mesh products specifically designed and labeled for transvaginal repair of pelvic organ prolapse (POP), otherwise known as Transvaginal Mesh (TVM), and asked the agency to order all manufacturers of these products to recall them immediately. Previously, on August 11, 2011, Public Citizen sent a letter to the FDA requesting that TVM be removed from the market. This letter detailed that there were high rates of complications associated with the product, some of which lead to ... Read More