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Tag: food and drug administration

  • Fruit Sold at Costco and Trader Joe’s Recalled

    Wawona Packing Company, based in the Central Valley of California, has voluntarily recalled white and yellow peaches, white and yellow nectarines and various plum varieties.

    The whole fruits were packed between June 1 and July 12, and distributed to Trader Joe’s and Costco stores.

    The Food and Drug Administration issued a statement on the matter:

    “FOR IMMEDIATE RELEASE – July 19, 2014 – Wawona Packing Company of Cutler, Calif is voluntarily recalling certain lots of whole peaches (white and yellow), nectarines (white and yellow), plums and pluots packed between June 1, 2014 through July 12,2014 due to the potential of the products being contaminated with Listeria monocytogenes. Wawona Packing has notified retailers of the specific lots being recalled. No other products are impacted by this recall. No illnesses have been linked to this recall to date.”

    Listeria monocytogenes is the bacterium that causes the infection listeriosis, an illness which causes death in 20% to 30% of cases. Listeria is most dangerous to pregnant women, children and the elderly. If an infection progresses to listeric meningitis, mortality rate may reach 70%.

    Here is a small scientific piece on listeria:

    No listeriosis infections have been reported, and Brent Smittcamp, President of Wawona Packing Co., commented, “We are aware of no illnesses related to the consumption of these products. By taking the precautionary step of recalling product, we will minimize even the slightest risk to public health, and that is our priority.”

    Costco, the members-only warehouse club based in Issaquah, Washington, has been having some food issues, as of late. Back in March, the company dumped $2.8 million worth of perfectly good peanut butter into a New Mexico landfill due to a previous salmonella scare. The makers of the peanut butter, Sunland Inc., had asked Costco to at least donate the peanut butter to food banks, but the big box retailer declined.

    Image via Wikimedia Commons

  • New Grass Allergy Treatment Approved by the FDA

    The long, terrible winter that gripped the U.S. this year seems to finally be gone. With spring, however, comes a whole new set of challenges for those Americans who suffer from pollen and grass allergies. Luckily for them, the U.S. Food and Drug Administration (FDA) today approved a new treatment for those with grass allergies.

    The treatment, named Oralair, has been approved by the FDA for the treatment of allergic rhinitis, commonly known as hay fever and brought on through grass pollens. The drug is approved for use by patients aged 10 to 65.

    The FDA estimates that around 30 million Americans suffer from hay fever, a small subset of the more than 500 million people around the world that suffer from the allergy.

    The new drug is a once-daily tablet that dissolves under the tongue. It contains freeze-dried extracts from common grasses including Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal, and Timothy. It is manufactured by the European pharmaceutical company Stallergenes.

    “While there is no cure for grass pollen allergies, they can be managed through treatment and avoiding exposure to the pollen,” said Dr. Karen Midthun, director of the Center for Biologics Evaluation and Research at the FDA. “The approval of Oralair provides an alternative to allergy shots that must be given in a health care provider’s office. Oralair can be taken at home after the first administration.”

    Oralair was approved following a safety and effectiveness trial performed in the U.S. and Europe. The trial gave around 2,500 people either Oralair or a placebo. Those that received the real drug were found to have a 16% to 30% reduction in hay fever symptoms.

    As with all allergy medications, Oralair comes with a list of potential side effects. The most dangerous may be the risk the drug has of sparking severe allergic reactions itself. The most common side effect reported in the study, though, was itching of the mouth, ears, and tongue.

    Image via Thinkstock

  • Multiple Sclerosis Drug Delayed by FDA

    Multiple Sclerosis Drug Delayed by FDA

    Biogen Idec Inc. has stated that the U.S. Food and Drug Administration extended the review process its multiple sclerosis drug called Plegridy by three months to evaluate the application, though the FDA didn’t request any further studies. Biogen had planned to launch the new drug sometime in mid-2014, but is now delayed.

    Plegridy is an injectable medication designed to reduce the dosing schedule of standard interferon drugs like Biogen’s own Avonex, which are typically taken at least once a week. Interferon has intense side effects, leading to flu-like symptoms for a couple of days after each dose, causing some patients to be weary to continue treatment.

    According to Biogen, Plegrity (peginterferon beta-1a) is a pegylated compound derived from interferon beta-1a and is being investigated as a potential treatment dosed once every two weeks or every four weeks via subcutaneous injection for relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS).

    Multiple sclerosis (MS), also known as disseminated sclerosis or encephalomyelitis disseminata, is an inflammatory disorder in which the insulating covers of nerve cells in the brain and spinal cord become damaged. Communication between parts of the nervous system are affected, which leads to problems with motor skills and cognitive functions. MS can occur in acute attacks, or build up in a progressive form. Symptoms may completely disappear during acute episodes, though permanent neurological damage typically occurs as the disease progresses.

    MS was first described by Jean-Martin Charcot in 1868, and has no known cure. Existing drugs aren’t very effective, and the aforementioned side effects can be severe. While the cause is not completely clear, it has been theorized that a compromised immune system mistakenly begins to attack and destroy the protective sheath that envelopes nerve cells in the brain, optic nerve and spinal cord.

    It is thought that genetics and environmental factors that had lead to infections cause the onset of the disease.

    Image via Wikimedia Commons.