Tag: FDA

FDA issues warning over possible radioactive shrimp | Live Science

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Frozen shrimp imported to the U.S. from an Indonesian-based company may have been exposed to a radioactive substance, the U.S. Food and Drug Administration (FDA) warned Tuesday (Aug. 19).

The products were processed by PT. Bahari Makmur Sejati, also referred to as BMS Foods. The FDA launched an investigation after U.S. Customs officials detected cesium-137 (Cs-137) — a radioactive form of cesium — in shipping containers carrying the shrimp that were delivered to Los Angeles, Houston, Savannah, Georgia, and Miami.

Analyses of the containers’ contents confirmed the presence of Cs-137 in one sample of breaded shrimp. The containers that tested positive were not allowed to enter the U.S., and no products that tested positive have entered the food supply.

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CRISPR used to ‘reprogram’ cancer cells into healthy muscle in the lab | Live Science

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Scientists have transformed cancer cells into healthy muscle tissue in the lab using CRISPR gene-editing technology — and they hope new cancer treatments can be built on the back of this experiment.

In a study published Aug. 28 in the journal PNAS, researchers found that disabling a particular protein complex in cells of rhabdomyosarcoma (RMS) — a rare cancer in skeletal muscle tissue that mainly affects children under age 10 — in the laboratory causes the tumor cells to turn into healthy muscle cells.

Although the research is still in its early days, this process of “resetting” cancer cells into healthy cells, broadly known as differentiation therapy, has already been tested in other types of cancer, such as bone and blood cancer. Four drugs have been approved by the U.S. Food and Drug Administration (FDA) to treat the latter disease and generally work by inhibiting a specific protein in the cancer cells.

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Why are food brands adding sesame? To skirt the FDA’s new allergy law | Fast Company

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On January 1, the U.S. government began recognizing sesame as a major food allergen, making it the ninth such ingredient subject to specific labeling and manufacturing regulatory requirements. It’s a long-awaited update, coming as a result of the Food Allergy Safety, Treatment, Education, and Research Act (FASTER Act). The rollout means food and restaurant brands must now disclose if products contain or even potentially could have come into contact with sesame seeds. Data shows that as many as 1.6 million Americans have an allergy to sesame, roughly the same number as those allergic to soy.

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FDA approved a 1st-of-its-kind treatment made from human poop. What does it do? | Live Science

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For the first time, the Food and Drug Administration (FDA) has approved a treatment that’s made using donated human poop, the agency announced(opens in new tab) Wednesday (Nov. 30). The treatment, called Rebyota, contains gut bacteria collected from the stool of healthy human donors and is approved for the prevention of a potentially life-threatening bacterial infection.

By administering the liquid treatment into a patient’s rectum through a tube, doctors can help restore balance to the patient’s gut microbiome, the community of microbes living in the lower digestive tract.

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Fitbit’s AFib detection is live and it could save yours | Digital Trends

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Fitbit’s atrial fibrillation (AFib) detection feature is finally live following its FDA approval and is poised to do a lot of good for its users. AFib is a heart condition where a person’s heartbeat rhythm is irregular making them much more susceptible to things like strokes, heart attacks, and other critical heart conditions. Now that your Fitbit is able to detect AFib, the wearable tech might just save your life.

AFib affects millions of people globally, but it’s difficult to detect in its early stages due to a general lack of noticeable symptoms before severe ones take over and threaten the lives of those affected. Luckily, Fitbit’s AFib detection feature can notice irregular heartbeats and alert the wearer if they’re displaying symptoms of AFib.

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FDA clears Johnson and Johnson COVID-19 vaccine for emergency use | Live Science

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The U.S. Food and Drug Administration (FDA) authorized Johnson & Johnson’s COVID-19 vaccine for emergency use on Saturday (Feb. 27), making it the third shot cleared for use in the country.

“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement.

An FDA analysis showed that the single-shot vaccine had a 72% overall efficacy rate in the U.S. and 64% in South Africa, where a highly-transmissible coronavirus variant is causing most new cases, The New York Times reported. The efficacy rate in South Africa is slightly higher than the company had estimated in a recent report, up by seven percentage points.

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The FDA Asks Companies to Stop Selling Ranitidine | WIRED

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With its promise of taming the ravages of stomach acid, ranitidine—best known under the brand name Zantac—was counted among the agents of pharmaceutical salvation, the enduring and reliable drugs that treat intractable diseases and make daily life more tolerable. In 1987, Zantac became the most-prescribed drug in the world.

But last week ranitidine was essentially erased from the US market. The US Food and Drug Administration asked manufacturers to withdraw ranitidine products, both in prescription and over-the-counter forms, because of an “impurity” in the pharmaceutical compound. Overtime or in the presence of heat, ranitidine can form unacceptable levels of a probable carcinogen known as N-nitrosodimethylamine, or NDMA, the agency determined.

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Former FDA adviser wants LASIK eye surgery banned | BGR

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LASIK is one of the most popular kinds of eye procedures around. Once prohibitively expensive, laser eye surgery is now cheaper than ever, and patients often experience very little downtime afterward. Lots and lots of people love their results, but that doesn’t mean there aren’t complications, sometimes severe complications, in certain cases.

Now, a former adviser who worked with the Food and Drug Administration and voted to approve LASIK as a medical procedure, says that the FDA is ignoring data that suggests LASIK should be banned. As CBS News reports, Morris Waxler has regrets about his prior approval of LASIK, and wants the medical community to reevaluate the risks.

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The FDA Is Investigating a Possible Link Between E-cigarettes and Seizures | Live Science

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The U.S. Food and Drug Administration (FDA) is investigating a possible link between e-cigarette use and seizures, the agency announced today (April 3).

The FDA said that, between 2010 and 2019, there were 35 reported cases of people who had seizures shortly after they used e-cigarettes. Most of these reports involved teenagers or young adults.

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What Makes the Newly Approved Drug for Depression So Different? | Live Science

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On Tuesday (March 5), the U.S. Food and Drug Administration (FDA) approved a ketamine-like nasal spray for patients with depression who haven’t responded to other treatments.

But what makes this newly approved treatment so different?

The drug, called Spravato and made by Janssen Pharmaceuticals, contains the active ingredient esketamine. This substance has the same molecular formula as ketamine but a different chemical structure. (In other words, it contains the same type and number of elements but in a different configuration.) Ketamine is typically used as an anesthetic, but it’s also been used as an illicit party drug.

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