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Independent Lab Raises Alarm on Benzene Levels in Acne Products

A recent report by Valisure, an independent

laboratory has shed light on concerning levels of benzene, a known carcinogen, found in certain acne treatment products containing benzoyl peroxide. The report indicates that benzene can form at levels deemed “unacceptably high,” surpassing regulatory limits set by the US Food and Drug Administration (FDA).

Tests conducted by Valisure revealed that when benzoyl peroxide acne treatments are exposed to high temperatures, such as those reached when left in a hot car, they can generate alarming levels of benzene. In one instance, a ProActiv acne product stored at 158 degrees Fahrenheit for nearly 17 hours yielded benzene levels exceeding safety thresholds.

While products containing other acne-fighting ingredients like salicylic acid or adapalene did not exhibit similar issues, benzoyl peroxide products seem to be particularly susceptible to benzene formation. Benzene exposure mainly occurs through inhalation, according to the American Cancer Society. Despite being a commonly used chemical in various industries, benzene poses significant health risks, including the development of leukemia and other blood disorders.

In response to Valisure’s findings, the FDA has received a citizen petition urging the recall and suspension of sales for products containing benzoyl peroxide. The agency has assured that it will review the petition and respond accordingly, emphasizing the importance of verifying data accuracy before regulatory decisions are made. Last year, the FDA had already alerted drug manufacturers about benzene contamination risks in certain products like hand sanitizers and aerosol drug products. However, this recent revelation regarding acne products underscores the need for continued vigilance in ensuring product safety.

While some brands, like Reckitt Benckiser’s Clearasil, assert the safety of their products when used and stored as directed, Valisure and other companies have been exploring formulations to mitigate benzene formation. Valisure’s co-founder and president, David Light, emphasized the urgency of addressing this issue, highlighting the fundamental instability of benzoyl peroxide products and the significant health implications associated with benzene exposure.

As this news unfolds, consumers are urged to stay informed and cautious when using acne treatment products, particularly those containing benzoyl peroxide.

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FDA Expands Warning on Lead Contamination in Cinnamon Products

In the wake of an alarming discovery regarding lead contamination, the US Food and Drug Administration (FDA) has issued an urgent warning to consumers regarding six brands of ground cinnamon. This comes after an investigation that initially focused on tainted cinnamon applesauce pouches in October.

The FDA’s investigation, now expanded, has revealed elevated levels of lead in various ground cinnamon products. These findings indicate a broader concern beyond the previously recalled cinnamon applesauce pouches, which were flavored with cinnamon imported from Ecuador. The agency disclosed on Wednesday that over 460 confirmed and suspected cases of lead poisoning have been linked to the consumption of applesauce pouches sold under certain brands like WanaBana, Schnucks, or Weis, flavored with tainted cinnamon. Most concerning is that many of these cases involve children and are still under investigation.

In response to these alarming findings, the FDA has taken swift action, issuing a letter to all US cinnamon manufacturers, processors, distributors, and facility operators to remind them of their responsibility in preventing contamination. Further testing has led the FDA to recommend recalls of ground cinnamon from six distributors. These brands include La Fiesta, Marcum, MTCI, Swad, Supreme Tradition, and El Chillar. The concentrations of lead found in these products, while lower than those in the cinnamon applesauce pouches, still pose significant health risks. The FDA urges consumers who possess these products to discontinue use immediately and dispose of them safely.

The concentrations of lead in the ground cinnamon products ranged from 2 to 3.4 parts per million, significantly lower than the levels found in the recalled cinnamon applesauce pouches, which ranged from about 2,300 to 5,100 parts per million. It is crucial to note that most individuals exposed to elevated lead levels may not exhibit immediate symptoms. However, the FDA advises anyone who suspects exposure to consult a healthcare provider promptly.

This latest development underscores the importance of rigorous oversight and consumer awareness in safeguarding public health. The FDA continues to monitor the situation closely and urges the public to remain vigilant in their consumption of cinnamon products.

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FDA Warns Against Using Smartwatches and Smart Rings for Blood Sugar Monitoring

In a recent announcement, the US Food and Drug Administration (FDA) has issued a cautionary alert regarding the use of smartwatches and smart rings for measuring blood glucose levels. The FDA highlighted significant risks associated with these devices, which claim to provide blood glucose readings without the need for skin piercing.

According to the FDA, none of these smartwatches or smart rings have received authorization or approval for standalone blood glucose level measurement. The agency emphasized that relying on such unauthorized devices could result in inaccurate readings, posing serious threats to diabetes management and potentially endangering lives. The FDA clarified that while certain smartwatch apps may display data from FDA-approved continuous glucose monitoring devices that do pierce the skin, the unauthorized devices in question employ non-invasive techniques that have not been validated for accurate blood glucose measurement.

Although the FDA did not specify particular brands, it warned consumers to be wary of products claiming to measure blood glucose levels without skin penetration. These devices, despite their claims, do not provide direct blood glucose testing and should not be utilized for such purposes, the FDA stressed. Healthcare providers were also urged to engage in discussions with patients regarding the risks associated with unauthorized blood glucose measuring devices and to aid them in selecting appropriate FDA-authorized alternatives for their medical needs.

Furthermore, the FDA reiterated its commitment to preventing the illegal marketing of unauthorized smartwatches and smart rings for blood glucose monitoring. Consumers encountering adverse events or encountering inaccurate blood glucose measurements from using these unauthorized devices are encouraged to report such incidents through the FDA MedWatch Voluntary Reporting Form.

In light of these warnings, individuals dependent on accurate blood glucose measurements for medical management are advised to consult with their healthcare providers to ensure the use of FDA-approved devices for monitoring their condition effectively and safely.

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CDC Investigates E. coli Outbreak Linked to Raw Milk Cheese, Issues Consumer Advisory

The US Centers for Disease Control and Prevention (CDC) has issued a food safety alert following an outbreak of E. coli that has sickened ten people across multiple states. The outbreak has been linked to consumption of raw milk cheese, raising concerns about the safety of unpasteurized dairy products.

According to the CDC, four individuals have been hospitalized, with one person developing hemolytic uretic syndrome, a severe condition that can lead to kidney failure. While no deaths have been reported, the seriousness of the outbreak underscores the potential risks associated with contaminated food.

Six of the affected individuals reported consuming RAW FARM brand raw cheddar cheese, prompting the CDC to advise consumers against consuming this product, particularly in original and jalapeño flavors. RAW FARM is cooperating with the US Food and Drug Administration (FDA) and initiating a recall of its products as part of the ongoing investigation. RAW FARM raw cheddar cheese is made from whole raw milk, which has not undergone pasteurization. Pasteurization, a process of heating milk to kill harmful bacteria, is considered a crucial step in ensuring the safety of dairy products. Unpasteurized dairy can harbor dangerous bacteria such as listeria, salmonella, and E. coli, as highlighted by the CDC.

E. coli bacteria, particularly the strain known as Shiga toxin-producing E. coli, can cause symptoms including cramps, bloody diarrhea, and kidney failure in those exposed. Each year, approximately 265,000 infections of Shiga toxin-producing E. coli occur in the United States, posing a significant public health concern. The CDC’s investigation into the outbreak is ongoing, with efforts focused on identifying the source of contamination and preventing further cases. In the meantime, consumers are urged to avoid consuming RAW FARM raw cheddar cheese and to exercise caution when consuming unpasteurized dairy products.

This incident serves as a reminder of the importance of food safety practices and the potential risks associated with consuming raw or unpasteurized foods. Authorities continue to monitor the situation closely and provide updates as new information becomes available.

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FDA Approves Revolutionary Gene Therapies for Sickle Cell Disease, Offering Hope to Thousands

December 12, 2023

In a groundbreaking move, the U.S. Food and Drug Administration (FDA) has granted approval for two gene-based treatments for sickle cell disease, marking a pivotal moment in the field of genetic medicine. The newly approved therapies, Casgevy and Lyfgenia, signal the advent of a new era in treating genetic conditions and bring renewed hope to the estimated 100,000 people in the U.S. suffering from sickle cell disease, particularly affecting African Americans.

Casgevy, developed by Vertex Pharmaceuticals and Crispr Therapeutics, is the first therapy utilizing the gene-editing technique CRISPR. Lyfgenia, created by bluebird bio, employs an older gene therapy approach. Both treatments have been cleared for individuals aged 12 and older with a history of vaso-occlusive crises, painful events associated with sickle cell disease.

The FDA’s approval has sparked optimism among the sickle cell community, addressing a condition long considered neglected by the pharmaceutical industry. Sickle cell disease, caused by a genetic mutation affecting red blood cells, results in misshapen cells that can cause organ damage and excruciating pain crises. Until now, the only potential cure involved a bone marrow or stem cell transplant, a solution often inaccessible due to the challenge of finding suitable donors.

Casgevy, priced at $2.2 million for a one-time treatment, and Lyfgenia, priced at $3.1 million, have raised concerns about affordability and access. The Institute for Clinical and Economic Review recommended a lower pricing range for cost-effectiveness. Discussions with insurance providers and Medicaid agencies are ongoing, but challenges related to treatment costs and the need for specialized medical infrastructure persist.

The groundbreaking CRISPR technology used in Casgevy enables precise gene editing to re-introduce fetal hemoglobin production, compensating for the defective hemoglobin causing sickle cell. Clinical trials, including that of 15-year-old Johnny Lubin, have shown promising results, with patients experiencing freedom from pain crises for extended periods.

While celebrating the transformative impact of these gene therapies, experts acknowledge the associated challenges, including the need for extensive medical care during treatment. The FDA has issued a black box warning for Lyfgenia, citing a potential risk of blood cancer, and ongoing research aims to improve the conditioning process to minimize side effects.

Despite these challenges, the approval of Casgevy and Lyfgenia represents a significant leap forward in treating sickle cell disease and offers hope for a future where cutting-edge therapies may become more accessible and sustainable for patients worldwide. The quest for continued advancements in gene therapy, including the exploration of pill-based alternatives, holds the potential to revolutionize treatment approaches for genetic disorders globally.

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The first postpartum depression pill has been approved by the FDA in the US.

The US Food and Drug Administration has granted approval for the medication zuranolone to treat postpartum depression, marking a significant milestone as it becomes the first FDA-approved oral pill specifically designed for postpartum depression in the United States. Postpartum depression, a serious mental illness affecting approximately 1 in 7 new mothers after childbirth, can lead to profound emotional distress, including feelings of sadness, guilt, and worthlessness, and in severe cases, even thoughts of self-harm or harm to the child.

The newly approved treatment, to be marketed under the brand name Zurzuvae, is administered as a once-daily pill to be taken over a 14-day period. The FDA’s announcement on Friday emphasized the importance of this medical advancement, given the potential life-threatening nature of postpartum depression and its potential impact on the maternal-infant bond, as well as the child’s overall physical and emotional development.

Dr. Tiffany R. Farchione, the director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, highlighted the significance of having an oral medication option for women facing extreme and potentially life-threatening emotions during this critical postpartum period. The approval of zuranolone offers a valuable and beneficial treatment option for those struggling with postpartum depression, providing hope for improved maternal mental health and well-being.

The FDA has added a boxed warning to the drug’s labeling, alerting users about its potential to impair driving and other hazardous activities. Patients may be unable to accurately assess their level of impairment, necessitating precautions to minimize harm. As a safety measure, the agency advises patients not to drive or operate heavy machinery for at least 12 hours after taking the drug.

The most common side effects cited by the FDA include drowsiness, dizziness, diarrhea, fatigue, nasopharyngitis (common cold), and urinary tract infection. Additionally, the drug’s use has been associated with an increased risk of suicidal thoughts and behavior, as well as potential harm to the fetus. To mitigate these risks, the agency recommends that women use effective contraception while taking the medication and for one week after its use.

Notably, severe postpartum depression may lead to suicidal ideation, with maternal suicides accounting for approximately 20% of all postpartum deaths. The FDA’s comprehensive warning aims to raise awareness of potential risks and promote safer medication practices for individuals experiencing postpartum depression.

Each year in the United States, it is estimated that over 400,000 babies are born to mothers experiencing depression. Without appropriate treatment, postpartum depression can persist for months or even years, as highlighted by the National Institute of Mental Health.