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	<title>Infants &#8211; LSD News</title>
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		<title>How the CDC&#8217;s decision on the Hepatitis B vaccine at birth could impact infants</title>
		<link>https://lsd.hu/how-the-cdcs-decision-on-the-hepatitis-b-vaccine-at-birth-could-impact-infants/</link>
		
		<dc:creator><![CDATA[LSD News Szerkesztőség]]></dc:creator>
		<pubDate>Tue, 09 Dec 2025 02:41:45 +0000</pubDate>
				<category><![CDATA[Health]]></category>
		<category><![CDATA[Birth]]></category>
		<category><![CDATA[CDCs]]></category>
		<category><![CDATA[Centers for Disease Control and Prevention]]></category>
		<category><![CDATA[decision]]></category>
		<category><![CDATA[hepatitis]]></category>
		<category><![CDATA[Impact]]></category>
		<category><![CDATA[Infants]]></category>
		<category><![CDATA[vaccine]]></category>
		<guid isPermaLink="false">https://lsd.hu/how-the-cdcs-decision-on-the-hepatitis-b-vaccine-at-birth-could-impact-infants/</guid>

					<description><![CDATA[The Centers for Disease Control and Prevention&#8217;s vaccine advisory panel on Friday voted to not recommend the Hepatitis B vaccine for everyone at birth, alarming many in the medical community. CBS News medical contributor Dr. Celine Gounder explains what to know about the decision and its potential impact.]]></description>
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<p>                <span class="now-playing__dek">The Centers for Disease Control and Prevention&#8217;s vaccine advisory panel on Friday voted to not recommend the Hepatitis B vaccine for everyone at birth, alarming many in the medical community. CBS News medical contributor Dr. Celine Gounder explains what to know about the decision and its potential impact.</span>
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		<title>Merck says experimental RSV treatment protected infants in trial, paving way for potential approval</title>
		<link>https://lsd.hu/merck-says-experimental-rsv-treatment-protected-infants-in-trial-paving-way-for-potential-approval/</link>
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		<dc:creator><![CDATA[LSD News Szerkesztőség]]></dc:creator>
		<pubDate>Fri, 18 Oct 2024 08:00:38 +0000</pubDate>
				<category><![CDATA[Business]]></category>
		<category><![CDATA[Approval]]></category>
		<category><![CDATA[AstraZeneca PLC]]></category>
		<category><![CDATA[Biotech and Pharmaceuticals]]></category>
		<category><![CDATA[Biotechnology]]></category>
		<category><![CDATA[Breaking news]]></category>
		<category><![CDATA[Breaking News: Business]]></category>
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		<category><![CDATA[experimental]]></category>
		<category><![CDATA[GSK plc]]></category>
		<category><![CDATA[Health care industry]]></category>
		<category><![CDATA[Infants]]></category>
		<category><![CDATA[Merck]]></category>
		<category><![CDATA[Merck & Co Inc]]></category>
		<category><![CDATA[paving]]></category>
		<category><![CDATA[Pfizer Inc]]></category>
		<category><![CDATA[Pharmaceuticals]]></category>
		<category><![CDATA[potential]]></category>
		<category><![CDATA[protected]]></category>
		<category><![CDATA[Respiratory Syncytial Virus]]></category>
		<category><![CDATA[RSV]]></category>
		<category><![CDATA[Sanofi SA]]></category>
		<category><![CDATA[treatment]]></category>
		<category><![CDATA[trial]]></category>
		<guid isPermaLink="false">https://www.lsd.hu/merck-says-experimental-rsv-treatment-protected-infants-in-trial-paving-way-for-potential-approval/</guid>

					<description><![CDATA[The logo for Merck is displayed on a screen at the New York Stock Exchange on Nov. 17, 2021. Andrew Kelly &#124; Reuters Merck on Thursday said its experimental treatment designed to protect infants from respiratory syncytial virus showed positive results in a mid- to late-stage trial, bringing the company one step closer to filing [&#8230;]]]></description>
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<p>The logo for Merck is displayed on a screen at the New York Stock Exchange on Nov. 17, 2021.</p>
<p>Andrew Kelly | Reuters</p>
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<p><span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-1">Merck<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><button class="AddToWatchlistButton-watchlistButton" aria-label="Add To Watchlist" data-testid="dropdown-btn"><span class="AddToWatchlistButton-addWatchListFromTag"/></button></span></span></span> on Thursday said its <a href="https://www.merck.com/news/merck-announces-topline-results-from-phase-2b-3-trial-of-clesrovimab-mk-1654-an-investigational-respiratory-syncytial-virus-preventative-monoclonal-antibody-for-infants/" target="_blank" rel="noopener">experimental treatment</a> designed to protect infants from respiratory syncytial virus showed positive results in a mid- to late-stage trial, bringing the company one step closer to filing for approval of the shot. </p>
<p>The pharmaceutical giant could emerge as a new competitor in the market for treatments against RSV, which causes <a href="https://www.cdc.gov/rsv/causes/index.html" target="_blank" rel="noopener">thousands</a> of deaths among older Americans and hundreds of deaths among infants each year. Complications from the virus are the leading cause of hospitalization among newborns, making Merck&#8217;s drug a valuable new treatment option if approved.</p>
<p>Merck plans to discuss the study data with regulators worldwide, with a goal of making the treatment available for infants as early as the 2025 to 2026 RSV season, according to a release. </p>
<p>The trial examined the safety and efficacy of a single dose of the treatment, clesrovimab, in healthy preterm and full-term infants entering their first RSV season. Merck presented the results at the medical conference IDWeek in Los Angeles.</p>
<p>The treatment reduced RSV-related hospitalizations by more than 84% and decreased hospitalizations due to lower respiratory infections by 90% compared with a placebo among infants through five months, according to Merck. Clesrovimab also reduced lower respiratory infections that required medical attention by more than 60% compared with a placebo through five months.</p>
<p>RSV is a common cause of <a href="https://www.mayoclinic.org/diseases-conditions/respiratory-syncytial-virus/symptoms-causes/syc-20353098" target="_blank" rel="noopener">lower respiratory tract infections</a> such as pneumonia. Results were consistent through both the five-month and six-month time points in the trial, Merck said.</p>
<p>The rates of adverse and serious side effects were comparable between patients who received Merck&#8217;s shot and those who took placebos in the trial. There were no treatment or RSV-related deaths in the study, the company added. </p>
<p>&#8220;These promising results demonstrating decreased incidence of RSV disease, including hospitalizations, highlight the potential for clesrovimab to play an important role in helping to alleviate the continued burden of RSV on infants and their families,&#8221; Dr. Octavio Ramilo, chair of the Department of Infectious Diseases at St. Jude&#8217;s Children&#8217;s Research Hospital, said in Merck&#8217;s release. Ramilo is also an investigator working on the trials. </p>
<p>Merck&#8217;s clesrovimab could potentially compete against a similar treatment from <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-6">Sanofi<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><button class="AddToWatchlistButton-watchlistButton" aria-label="Add To Watchlist" data-testid="dropdown-btn"><span class="AddToWatchlistButton-addWatchListFromTag"/></button></span></span></span> and <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-7">AstraZeneca<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><button class="AddToWatchlistButton-watchlistButton" aria-label="Add To Watchlist" data-testid="dropdown-btn"><span class="AddToWatchlistButton-addWatchListFromTag"/></button></span></span></span> called Beyfortus, which was in short supply nationwide last RSV season due to unprecedented demand. Both are monoclonal antibodies, which deliver antibodies directly into the bloodstream to provide immediate protection. </p>
<p>But Merck&#8217;s treatment can be administered to infants regardless of their weight, which the company said may offer convenience in terms of dosing. Meanwhile, the recommended dosage of Beyfortus is based on an infant&#8217;s body weight. </p>
<p>Last year, <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-8">Pfizer<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><button class="AddToWatchlistButton-watchlistButton" aria-label="Add To Watchlist" data-testid="dropdown-btn"><span class="AddToWatchlistButton-addWatchListFromTag"/></button></span></span></span> and <span class="QuoteInBody-quoteNameContainer" data-test="QuoteInBody" id="RegularArticle-QuoteInBody-9">GSK<span class="QuoteInBody-inlineButton"><span class="AddToWatchlistButton-watchlistContainer" id="-WatchlistDropdown" data-analytics-id="-WatchlistDropdown"><button class="AddToWatchlistButton-watchlistButton" aria-label="Add To Watchlist" data-testid="dropdown-btn"><span class="AddToWatchlistButton-addWatchListFromTag"/></button></span></span></span> rolled out RSV vaccines that are administered to expectant mothers who can pass on protection to their fetuses. </p>
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		<title>Fisher-Price recalls baby swings that killed 5 infants</title>
		<link>https://lsd.hu/fisher-price-recalls-baby-swings-that-killed-5-infants/</link>
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		<dc:creator><![CDATA[LSD News Szerkesztőség]]></dc:creator>
		<pubDate>Fri, 11 Oct 2024 22:42:34 +0000</pubDate>
				<category><![CDATA[Business]]></category>
		<category><![CDATA[Baby]]></category>
		<category><![CDATA[FisherPrice]]></category>
		<category><![CDATA[Infants]]></category>
		<category><![CDATA[Killed]]></category>
		<category><![CDATA[Recalls]]></category>
		<category><![CDATA[swings]]></category>
		<guid isPermaLink="false">https://www.lsd.hu/fisher-price-recalls-baby-swings-that-killed-5-infants/</guid>

					<description><![CDATA[Fisher-Price is recalling parts of over 2 million infant swings across the U.S., Canada and Mexico due to a serious suffocation risk, following reports of five infant deaths. The U.S. Consumer Product Safety Commission warned that all models of Fisher-Price’s Snuga Swings should never be used for sleep or have bedding materials added. The products’ [&#8230;]]]></description>
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<br /><img decoding="async" src="https://fortune.com/img-assets/wp-content/uploads/2024/10/Screen-Shot-2024-10-11-at-2.52.26-PM-e1728684307165.png?w=2048" alt="Screen Shot 2024 10 11 at 2.52.26 PM e1728684307165" title="Fisher-Price recalls baby swings that killed 5 infants 2"></p>
<p>Fisher-Price is recalling parts of over 2 million infant swings across the U.S., Canada and Mexico due to a serious suffocation risk, following reports of five infant deaths.</p>
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<p>The U.S. Consumer Product Safety Commission warned that all models of Fisher-Price’s Snuga Swings should never be used for sleep or have bedding materials added. The products’ headrest and seat pad body support insert can increase risks of suffocation, the notice published Thursday said.</p>
<p>There have been five reports of deaths involving infants between 1 to 3 months old when the product was used for sleep, according to the commission. In most of those incidents, which took place from 2012 to 2022, bedding material was added to the product and the babies were unrestrained.</p>
<p>Consumers are urged to immediately cut off the headrest and remove the body-support insert before continuing to use the swing. New York-based Fisher-Price, a division of California toy giant Mattel, is providing a $25 refund to consumers who remove and destroy those parts of the product. Instructions can be <a href="https://newsroom.ap.org/a%20division%20of%20El%20Segundo,%20California-based" target="_blank" class="sc-93594058-0 fowfrQ  " aria-label="Go to https://newsroom.ap.org/a%20division%20of%20El%20Segundo,%20California-based" rel="noopener">found on Mattel’s recall website</a>.</p>
<p>In a statement, CPSC Commissioner Richard L. Trumka Jr. slammed Fisher-Price for what he called a “flawed” recall, saying the remedy provided by the company is not enough.</p>
<p>The recall “is doomed to fail and will keep many babies in harm’s way,” Trumka <a href="https://www.cpsc.gov/About-CPSC/Commissioner/Richard-Trumka/Statement/Commissioner-Trumka-Warns-That-Fisher-Price%E2%80%99s-Snuga-Recall-Is-Not-Good-Enough-to-Keep-Babies-Safe-Multiple-Babies-Dead" target="_blank" class="sc-93594058-0 fowfrQ  " aria-label="Go to https://www.cpsc.gov/About-CPSC/Commissioner/Richard-Trumka/Statement/Commissioner-Trumka-Warns-That-Fisher-Price%E2%80%99s-Snuga-Recall-Is-Not-Good-Enough-to-Keep-Babies-Safe-Multiple-Babies-Dead" rel="noopener">stated</a>. He criticized Fisher-Price for only recalling a portion of the product and offering consumers a fraction of the $160 they originally spent.</p>
<p>“My advice: get your $25 refund and then throw this product away; do not keep it in your homes because even after the so-called ‘repair’ this product will still be unsafe for infant sleep,” Trumka added.</p>
<p>He also argued that Fisher-Price was repeating past failures — pointing to <a href="https://apnews.com/article/co-state-wire-lifestyle-business-7bcddf25d179fb9f106e89f9cef02d12" target="_blank" class="sc-93594058-0 fowfrQ  " aria-label="Go to https://apnews.com/article/co-state-wire-lifestyle-business-7bcddf25d179fb9f106e89f9cef02d12" rel="noopener">previous infant deaths</a> related to products like the brand’s “Rock ‘n Play” and <a href="https://apnews.com/article/politics-business-product-safety-us-consumer-commission-0d684c2b811890a03e8bc113bebb91d7" target="_blank" class="sc-93594058-0 fowfrQ  " aria-label="Go to https://apnews.com/article/politics-business-product-safety-us-consumer-commission-0d684c2b811890a03e8bc113bebb91d7" rel="noopener">“Newborn-to-Toddler Rockers”</a> devices.</p>
<p>“Fisher-Price should know better than to skimp on another recall,” Trumka stated. “Fisher-Price can do more to save babies lives — I think it needs to.”</p>
<p>A spokesperson for Mattel did not comment further about the recall when reached by The Associated Press Friday.</p>
<p>The Fisher-Price Snuga Swings now under recall were sold at major retailers — including Amazon, Walmart, Toys R Us and Target — across North America between October 2010 and January 2024, according to the CPSC. About 2.1 million swings were sold in the U.S., 99,000 in Canada and another 500 in Mexico.</p>
<p>There are more than 21 models of Snuga Swings, which were manufactured in China and Mexico, coming in a range of different colors and toy accessories. A list of impacted product numbers and descriptions can be found <a href="https://www.cpsc.gov/Recalls/2025/Fisher-Price-Recalls-More-than-2-Million-Snuga-Infant-Swings-Due-to-Suffocation-Hazard-After-5-Deaths-Reported" target="_blank" class="sc-93594058-0 fowfrQ  " aria-label="Go to https://www.cpsc.gov/Recalls/2025/Fisher-Price-Recalls-More-than-2-Million-Snuga-Infant-Swings-Due-to-Suffocation-Hazard-After-5-Deaths-Reported" rel="noopener">on Thursday’s recall notice</a>.</p>
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		<title>At least 6 infants stricken in salmonella outbreak linked to dog and cat food</title>
		<link>https://lsd.hu/at-least-6-infants-stricken-in-salmonella-outbreak-linked-to-dog-and-cat-food/</link>
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		<dc:creator><![CDATA[LSD News Szerkesztőség]]></dc:creator>
		<pubDate>Fri, 10 Nov 2023 03:43:37 +0000</pubDate>
				<category><![CDATA[Health]]></category>
		<category><![CDATA[Cat]]></category>
		<category><![CDATA[Dog]]></category>
		<category><![CDATA[Food]]></category>
		<category><![CDATA[Infants]]></category>
		<category><![CDATA[linked]]></category>
		<category><![CDATA[outbreak]]></category>
		<category><![CDATA[Product Recall]]></category>
		<category><![CDATA[Salmonella]]></category>
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					<description><![CDATA[A Texas pet food manufacturer is greatly expanding a recall to include dozens of different types of dry dog and cat food potentially contaminated with salmonella, with at least seven people — six of them infants — sickened. The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention are investigating the [&#8230;]]]></description>
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<p>A Texas pet food manufacturer is greatly expanding a recall to include dozens of <span class="link"><a href="https://www.cbsnews.com/news/product-recall-dog-food-salmonella/" target="_blank" data-invalid-url-rewritten-http="" rel="noopener">different types of dry dog</a></span> and cat food potentially contaminated with salmonella, with at least seven people — six of them infants — sickened.</p>
<p>The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention are investigating the outbreak, the agencies <a href="https://www.fda.gov/animal-veterinary/outbreaks-and-advisories/fda-and-cdc-investigate-cases-salmonella-linked-pet-food-made-mid-america-pet-food-multiple-brands" target="_blank" rel="nofollow noopener">said</a> on Thursday.</p>
<p>Mid America Pet Food is now recalling all brands of the pet food the company makes, including 35 different products with best by dates before October 31, 2024, and produced at its plant in Mount Pleasant, Texas, the company said in a news <a href="https://mapf.com/news/mid-america-pet-food-expands-voluntary-recall-to-include-additional-dog-and-cat-food-products-due-to-possible-salmonella-health-risk" target="_blank" rel="nofollow noopener">release</a>.</p>
<aside class="newsletter_signup ">
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<p>The recalled brands include Victor super Premium Dog Foods, Wayne Feeds Dog Food, Eagle Mountain Pet Food and some Member&#8217;s Mark varieties distributed to retailers nationwide.</p>
<figure class="embed embed--type-image is-image embed--float-none embed--size-medium"><span class="img embed__content"><img fetchpriority="high" decoding="async" src="https://assets2.cbsnewsstatic.com/hub/i/r/2023/11/09/9e42655a-66ce-4123-82ec-838a490f3da0/thumbnail/620x671/0b566c96cb20d4637d7db9e9f65ddb84/image-1-100.png?v=8afad5e29ac9a704fff9d98ba34d3649#" alt="image-1-100.png " height="671" width="620" srcset="https://assets2.cbsnewsstatic.com/hub/i/r/2023/11/09/9e42655a-66ce-4123-82ec-838a490f3da0/thumbnail/620x671/0b566c96cb20d4637d7db9e9f65ddb84/image-1-100.png?v=8afad5e29ac9a704fff9d98ba34d3649 1x" title="At least 6 infants stricken in salmonella outbreak linked to dog and cat food 5"></span><figcaption class="embed__caption-container"><span class="embed__caption">Recalled pet food produced by Mid America Pet Food, Mount Pleasant, Texas.</span></p>
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<p>                Food and Drug Administration</p>
<p>                          </span><br />
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<p>The move furthers two prior recalls, the first coming in early September and involving one lot of Victor brand Hi-Pro Plus dog food and the second 10 days ago and involving three lots of Victor super Premium Dog Food, Select Beef Meal &amp; Brown Rice Formula. </p>
<p>The <span class="link"><a href="https://www.cbsnews.com/news/product-recall-dog-food-salmonella/" target="_blank" data-invalid-url-rewritten-http="" rel="noopener">initial recalls </a></span>came after random sampling found salmonella, which can sicken pets as well as people who come in contact with it. </p>
<p>The latest recall noted that seven people had reported salmonella infections as of November 1, 2023, Mid America Pet Food said in a <a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mid-america-pet-food-expands-voluntary-recall-include-additional-dog-and-cat-food-products-due" target="_blank" rel="nofollow noopener">notice</a> posted by the FDA. (See a list of the recalled products <a href="https://www.fda.gov/media/173750/download?attachment" target="_blank" rel="nofollow noopener">here</a>.)</p>
<figure class="embed embed--type-image is-image embed--float-none embed--size-medium"><span class="img embed__content"><img alt="image-5-12.png " height="631" width="620" class=" lazyload" srcset="https://assets3.cbsnewsstatic.com/hub/i/r/2023/11/10/41a7f144-4e52-46a0-b834-fe658bd17ccc/thumbnail/620x631/440e6b37fe788a6d8f452fc2aa951afd/image-5-12.png?v=8afad5e29ac9a704fff9d98ba34d3649 1x"/></span><figcaption class="embed__caption-container"><span class="embed__caption">Recalled pet food.</span></p>
<p>                  <span class="embed__credit"></p>
<p>                U.S. Food and Drug Administration</p>
<p>                          </span><br />
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<p>When two or more people get the same illness from the same contaminated food or drink, it is viewed as an outbreak, according <a href="https://www.cdc.gov/salmonella/outbreaks.html" target="_blank" rel="nofollow noopener">to</a> the CDC.</p>
<p>Seven illnesses, including one hospitalization, tied to a specific lot of Victor brand Hi-Pro Plus dry dog have been reported in seven states: Alabama, California, Florida, Hawaii, Kentucky, Minnesota and Oklahoma, the CDC <a href="https://www.cdc.gov/salmonella/kiambu-11-23/details.html" target="_blank" rel="nofollow noopener">said</a>. People began getting sick in mid-January and illnesses continued into August, according to the agency, which said the actual number of individuals sickened in the outbreak is likely much higher than reported. </p>
<p>&#8220;People likely got sick by touching this dog food, touching things like dog bowls that contained this dog food, or touching the poop or saliva of dogs that were fed this dog food,&#8221; the CDC stated, noting that most of those who fell ill were infants.</p>
<figure class="embed embed--type-image is-image embed--float-none embed--size-medium"><span class="img embed__content"><img decoding="async" src="https://assets1.cbsnewsstatic.com/hub/i/r/2023/11/09/41f5526f-2494-4043-8fed-42647b04be2d/thumbnail/620x691/cb358280d0a25211cbe1410791422076/image-6-11.png?v=8afad5e29ac9a704fff9d98ba34d3649#" alt="image-6-11.png " height="691" width="620" srcset="https://assets1.cbsnewsstatic.com/hub/i/r/2023/11/09/41f5526f-2494-4043-8fed-42647b04be2d/thumbnail/620x691/cb358280d0a25211cbe1410791422076/image-6-11.png?v=8afad5e29ac9a704fff9d98ba34d3649 1x" title="At least 6 infants stricken in salmonella outbreak linked to dog and cat food 6"></span><figcaption class="embed__caption-container"><span class="embed__caption">Recalled pet food.</span></p>
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<p>                Food and Drug Administration</p>
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<p>Salmonella bacteria causes an estimated 1.3 million infections in Americans every year, resulting in an average of more than 26,000 hospitalizations and 420 deaths, CDC data shows.</p>
<p>Pets infected with salmonella may be lethargic and have diarrhea or bloody diarrhea, fever and vomiting. Some may lose their appetite and have abdominal pain. Humans can suffer from similar symptoms and in some cases experience more serious symptoms, according to the FDA.</p>
<p>People should destroy the recalled pet food in a way that children, pets and wildlife can&#8217;t reach it, as well as wash pet bowls and storage containers, the agency advised.</p>
<figure class="embed embed--type-image is-image embed--float-none embed--size-medium"><span class="img embed__content"><img alt="image-4-20.png " height="623" width="620" class=" lazyload" srcset="https://assets1.cbsnewsstatic.com/hub/i/r/2023/11/09/448af550-3646-4da9-8852-0ab0f1632ee9/thumbnail/620x623/a7e581aadb20f8884ff9b67a6f3ad8f2/image-4-20.png?v=8afad5e29ac9a704fff9d98ba34d3649 1x"/></span><figcaption class="embed__caption-container"><span class="embed__caption">Pet food recalled due to potential salmonella contamination.</span></p>
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<p>                Food and Drug Administration</p>
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<p>Customers can contact Mid America Pet Food for additional information at <a href="https://www.cbsnews.com/news/product-recall-salmonella-dog-cat-food-mid-america-pet-food/mailto:info@mapf.com" target="_blank" rel="nofollow noopener">info@mapf.com</a> or at (888) 428-7544 Monday through Friday from 8 a.m. to 5 p.m. Central time.</p>
<p>The recall is among more than half a dozen this year of pet food found to contain salmonella or potentially harmful elevated levels of vitamins.</p>
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		<title>FDA warns about giving probiotics to preterm babies after infant&#8217;s death</title>
		<link>https://lsd.hu/fda-warns-about-giving-probiotics-to-preterm-babies-after-infants-death/</link>
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		<dc:creator><![CDATA[LSD News Szerkesztőség]]></dc:creator>
		<pubDate>Thu, 26 Oct 2023 18:42:39 +0000</pubDate>
				<category><![CDATA[Health]]></category>
		<category><![CDATA[Babies]]></category>
		<category><![CDATA[children]]></category>
		<category><![CDATA[Death]]></category>
		<category><![CDATA[FDA]]></category>
		<category><![CDATA[giving]]></category>
		<category><![CDATA[Infants]]></category>
		<category><![CDATA[preterm]]></category>
		<category><![CDATA[Probiotics]]></category>
		<category><![CDATA[Warns]]></category>
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					<description><![CDATA[U.S. Food and Drug Administration is warning about using probiotic products for preterm infants due to potentially fatal health risks. The news comes weeks after the agency announced it was investigating the death of a preterm baby that was given a probiotic in the hospital, which ultimately caused the child&#8217;s death. &#8220;Probiotic products contain live organisms such [&#8230;]]]></description>
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<p>U.S. Food and Drug Administration is warning about using probiotic products for preterm infants due to potentially fatal health risks. The news comes weeks after the agency announced it was <span class="link"><a href="https://www.cbsnews.com/news/fda-warning-probiotics-preterm-infant-death-linked-evivo/" target="_blank" data-invalid-url-rewritten-http="" rel="noopener">investigating the death of a preterm baby</a></span> that was given a probiotic in the hospital, which ultimately caused the child&#8217;s death.</p>
<p>&#8220;Probiotic products contain live organisms such as bacteria or yeast and are commonly marketed as foods, including as dietary supplements,&#8221; the agency said in a <a href="https://www.fda.gov/news-events/press-announcements/fda-raises-concerns-about-probiotic-products-sold-use-hospitalized-preterm-infants" target="_blank" rel="nofollow noopener">news release</a> Thursday.</p>
<p>The FDA said preterm infants who are given probiotics are at risk of &#8220;invasive, potentially fatal disease, or infection, caused by the bacteria or yeast&#8221; contained in the products.</p>
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<p>In addition to recently sending a letter to health care providers about these risks, the agency has also issued two <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/abbott-laboratories-669353-10242023" target="_blank" rel="nofollow noopener">warning letters to companies</a> for illegally selling these types of products.</p>
<p>&#8220;Adverse events in any infant following the use of a probiotic are a concern to the FDA. We especially want to make clear that products containing live microorganisms may present serious risks to preterm infants in hospital settings,&#8221; Dr. Peter Marks, director of the FDA&#8217;s Center for Biologics Evaluation and Research, said in the news release. </p>
<p>&#8220;With today&#8217;s message, we want to warn parents, caregivers and healthcare providers that if these products are used for the prevention or treatment of disease, they have not undergone the agency&#8217;s rigorous premarket process to evaluate their safety, effectiveness and quality for these medical uses,&#8221; Marks said.</p>
<p>The FDA says these products have been associated with &#8220;more than two dozen other reported adverse events in the United States since 2018.&#8221;</p>
<p>The most recent death followed use of Evivo with MCT Oil, a probiotic manufactured by California-based Infinant Health (formerly Evolve BioSystems Inc.). The product is now recalled.</p>
<p>Infinant Health, Inc received one of the FDA&#8217;s warning letters; the other was sent to Abbott Laboratories on Tuesday for its product, Similac Probiotic Tri-Blend. </p>
<p>&#8220;Abbott has agreed to discontinue sales of its Similac Probiotic Tri-Blend product and is working with the FDA to take additional corrective actions,&#8221; the FDA&#8217;s release says. </p>
<p>The <span class="link"><a href="https://www.cbsnews.com/news/fda-warning-probiotics-preterm-infant-death-linked-evivo/" target="_blank" data-invalid-url-rewritten-http="" rel="noopener">FDA previously noted</a></span> that no probiotics have been approved for use as a drug or biological product in babies, meaning probiotics are not subject to the &#8220;agency&#8217;s rigorous manufacturing and testing standards&#8221; for other medications regulated by the FDA.</p>
<p>Probiotics are allowed to be sold in the U.S. as dietary supplements, bypassing the FDA&#8217;s higher bar for drug and biologics approvals.</p>
<p><em>-Alexander Tin contributed to this report.</em></p>
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