Tag: FDA

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Political Showdown Over Tylenol: Why is the White House Warning Pregnant Women About Autism Risk?

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Trenton NJ, the debate over the safety of acetaminophen (commonly known as Tylenol) during pregnancy has exploded into a national political controversy. Following a push from the Trump administration, the FDA has initiated a process to change the labeling on Tylenol to suggest a possible link to autism and ADHD—a move that has drawn fierce backlash from leading medical groups and even led to a public break with federal guidance by the New Jersey Health Department.

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Urgent Update for Parents-to-Be: New Guidance Links Common Pain Reliever to Autism Risk

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the staff of the Ridgewood blog

Ridgewood NJ, new CDC guidelines suggest a possible link between a pregnant person’s use of acetaminophen and the development of autism. However, the FDA has not established a causal relationship. Leucovorin has also been approved as a possible treatment for autism symptoms.

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FDA Approves Updated COVID-19 Vaccines with New Restrictions: Only High-Risk Groups Recommended

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WASHINGTON, D.C. — The Food and Drug Administration (FDA) has approved updated COVID-19 vaccines for fall, but with the tightest restrictions yet on who should receive them.

Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced the approval on Aug. 27, stating that emergency-use authorizations have ended and that updated vaccines from Pfizer, Moderna, and Novavax are now approved for people considered at high risk of severe illness.

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FDA Warns on Contaminated Tattoo Ink

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Twp. of Washington NJ, the U.S. Food and Drug Administration is warning consumers, tattoo artists, and retailers about the risk of serious infections associated with tattoo inks contaminated by harmful bacteria, including Pseudomonas aeruginosa. Tattoo inks that are contaminated can cause infections and lead to severe health issues when injected into the skin during a tattooing procedure, as there is an increased risk of infection whenever the skin barrier is breached.

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FDA Panel Endorses Eli Lilly’s Experimental Alzheimer’s Drug Donanemab

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Ridgewood NJ, in a significant development, outside advisers to the U.S. Food and Drug Administration (FDA) unanimously endorsed the efficacy of Eli Lilly’s experimental Alzheimer’s drug, donanemab, for patients with early Alzheimer’s disease. This vote precedes the FDA’s impending decision on the drug’s approval. The panel’s discussion highlighted some unique aspects of Lilly’s trial, which differed notably from the trial design of Eisai and Biogen’s Leqembi, another Alzheimer’s drug that recently gained U.S. approval following a similar advisory committee review.

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How Do Federal Regulations Impact Cases Involving Defective Products?

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The landscape of product liability in the United States is complex and multifaceted, with federal regulations playing a critical role in shaping how cases involving defective products are handled. These regulations establish standards for product safety, outline the responsibilities of manufacturers and sellers, and influence the legal strategies employed in litigation. Understanding how federal regulations impact cases involving defective products is essential for consumers, manufacturers, legal professionals, and policymakers.

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Deadly Listeria Outbreak in New Jersey leads to Cheese Recall

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the staff of the Ridgewood blog

Ridgewood NJ, California-based Rizo-López Foods issued a comprehensive recall of all cheeses and dairy products manufactured in its facility on Tuesday. This precautionary measure follows an ongoing investigation into a listeria monocytogenes outbreak that has persisted for multiple years. Collaborative efforts between federal and local agencies, including the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), are underway to identify the source of the outbreak.

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FDA: ⁣Neptune’s Fix Products Contain the Dangerous and Addictive Ingredient Tianeptine

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Twp of Washington NJ, The FDA continues to receive severe adverse event reports after use of Neptune‘s Fix products, including seizures, loss of consciousness and death.⁣ Neptune’s Fix products are labeled to contain the dangerous and addictive ingredient tianeptine, which is not approved for any medical use in the United States.

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Science Fiction Become Reality as Musk Creates a Cyborg

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the staff of the Ridgewood blog

Ridgewood N J, Elon Musk has reported that the first human recipient of a Neuralink implant is recovering well, marking a significant milestone in the brain-computer interface industry. Neuralink’s implants, which use ultra-fine electrodes, aim to aid individuals with traumatic injuries, with future goals extending to addressing hearing and vision loss and even facilitating a merger between humans and artificial intelligence. Musk envisions the initial application, called Telepathy, allowing users to control devices through thought, benefiting those who have lost limb functionality.

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FDA Approves Florida’s Drug Importation Plan

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Jacksonville FL, the Food and Drug Administration granted approval on Friday to a two-year plan that permits Florida to import certain prescription drugs from Canada at a lower cost compared to the U.S. This landmark approval is viewed as a move towards reducing medication costs for American consumers and opens the door for other states to seek authorization for importing prescription drugs from Canada.

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Hackensack University Medical Center Using CRISPR Technology To Treat Patients With Sickle Cell Disease

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Hackensack NJ, the Food and Drug Administration (FDA) approved two gene editing therapies for the treatment of sickle cell disease. Experts hope it’s a cure, the first, for the inherited blood disorder that affects more than 100,000 Americans with extreme pain.

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FDA Approves Updated mRNA COVID-19 Vaccines for Currently Circulating Variants

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Ridgewood NJ, the U.S. Food and Drug Administration took action approving and authorizing for emergency use updated COVID-19 vaccines formulated to more closely target currently circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalization and death. Today’s actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc. Consistent with the totality of the evidence and input from the FDA’s expert advisors, these vaccines have been updated to include a monovalent (single) component that corresponds to the Omicron variant XBB.1.5.

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FDA Rules Popular Decongestant Does Not Actually Work

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Ridgewood NJ, an FDA advisory panel voted unanimously that nonprescription oral medications containing phenylephrine , a popular decongestant,  including Sudafed PE, Vicks Sinex and Benadryl Allergy Plus Congestion don’t do anything to ease congestion.

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CDC says Johnson & Johnson COVID-19 vaccine no longer available in U.S.

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Ridgewood NJ, more than 2 years after Johnson & Johnson’s vaccine was first approved by the FDA, it is now no longer available anywhere in the US, according to the CDC. Over 31.5 million doses of the J&J vaccine have been distributed across the country since March 2021 — 19 million of which made it into Americans’ arms, CNN reported.

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U.S. Is Offering A Second Round of Free At-Home Covid Tests

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Ridgewood NJ, free at-home COVID-19 tests are now available again for all Americans . Earlier this week, the Biden administration re-upped its free COVID-19 testing kit program. For the second year in a row, every household in America can now order a total of four free rapid tests via COVIDTests.gov. Note that the program stipulates four tests per household, not individual, so if you live with roommates, a partner, or children, you may want to procure extra testing kits to tide you through the winter.

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