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Negligence & Personal Injury

First Treatment for Peanut Allergy Approved by FDA may be Seen in 2019

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A potential treatment for peanut allergies is seeking approval from the U.S. Food and Drug Administration (FDA). While this is not a cure-all drug, AR101 has shown potential to allow children who suffer from severe peanut allergic reactions to build a tolerance.  This drug could give our children a defense system to protect them from accidental consumption that could lead to a severe allergic reaction.

Peanut Allergy

A peanut allergy happens when your immune system has an adverse response to peanut proteins. The severity of the reaction may vary from less severe symptoms- runny nose, hives, cramping, shortness of breath and nausea, to severe anaphylaxis-which may be life-threatening if not treated.  Symptoms usually occur within minutes and may require the use of an epinephrine injector. A trip to the doctor is almost always needed.  Even if symptoms are light or non-threatening, talking to your doctor is very important, since peanut allergy is the most common food-allergy that causes anaphylaxis. Risk factors include age, family history, and skin conditions like eczema. The severity of the reaction also is dependent on the individual’s sensitivity level. Some people have to ingest peanut protein, while others that are extremely sensitive can breathe in peanut dust or come into indirect contact and have a reaction.

Oral Immunotherapy

Immunotherapy is the exposure to an allergen on a regular basis to build a tolerance to it. This, in turn, causes allergic reactions to reduce or even eliminate over time.  The only FDA approved oral immunotherapy at this time is used to treat hay fever.   However, AR101 is a new oral immunotherapy treatment for peanut allergy.  Jay Lieberman, vice chair of the ACAAI Food Allergy Committee, said he hopes to see approval next year.

AR101

A trial took place with 551 patients who suffered from a peanut allergy, of which 496 were between the ages of 4-17.  All patients in the beginning, suffered from an allergic reaction to approximately 1/3 of a peanut.  This trial was performed over a period of time spanning 24 weeks-systematically increasing the dose of AR101 from 3mg to 300 mg. Participants were given a powder in a capsule or foil packet form to sprinkle on a small amount of non-heated food.  No more than one participant per household was allowed to participate. Astonishingly, patients were seen taking 600 mg or more-approximately 2-4 peanuts by the trial end.  Participants did see moderate reactions throughout the trial, but less than 5% experienced a severe reaction.  The trial also did not seem to produce results for the participants in the age range of 18-55.

Currently, there is no treatment for a peanut allergy.  Learning your symptoms, reading labels, and being aware are the only things now that you can do.  Too often children and toddlers are the ones suffering from this allergy.  AR1 1-offers hope to not only the children suffering but to the parents and caretakers of the children who deal with the daily maintenance of providing an allergen-free environment.

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Dangerous Medications

Depo-Provera Birth Control and Brain Tumors: Current Evidence and Research Gaps

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The long-acting contraceptive Depo-Provera (medroxyprogesterone acetate, MPA) is a progestin-only injectable birth control method widely used by women worldwide. While the convenience of Depo-Provera, administered once every three months, has made it a popular choice, recent studies have raised questions regarding its potential link to specific health risks, including an increased likelihood of developing brain tumors, such as meningiomas. This article explores the current scientific evidence on the association between Depo-Provera use and brain tumor development, reviews biological mechanisms, and highlights the need for further research.

Depo-Provera, approved by the FDA in 1992, is a synthetic progestin administered through injection. As a convenient and effective contraceptive option that does not require daily dosing, it has become an attractive choice for many women. However, the synthetic progesterone in Depo-Provera may impact various physiological systems, leading researchers to investigate its potential long-term health implications. One area of recent focus has been the possible association between prolonged Depo-Provera use and the risk of brain tumors, particularly meningiomas, which are tumors that arise from the meninges—the membranes surrounding the brain and spinal cord.

The Role of Progesterone in Brain Health and Tumor Development

Progesterone, a naturally occurring hormone, plays essential roles in reproductive health and brain function. However, research has shown that synthetic progestins, including MPA, have distinct biological actions from natural progesterone, potentially leading to different effects on cell growth and behavior. In the context of brain health, studies have found that progestins can bind to receptors in the brain, influencing cellular activities that may, in some cases, encourage the development or growth of tumors.

Meningiomas are slow-growing brain tumors influenced by hormonal fluctuations, particularly those of estrogen and progesterone. Studies have indicated that progesterone receptors (PRs) are present in a significant number of meningiomas, suggesting that progestin-based contraceptives could potentially affect tumor growth. This is especially relevant given that MPA, the active hormone in Depo-Provera, has a strong affinity for progesterone receptors, raising concerns about its long-term impact on brain tissue.

Epidemiological Evidence and Key Studies

While data on the relationship between Depo-Provera use and brain tumors are still limited, several observational studies and case reports have suggested a potential association. A study published in the British Journal of Clinical Pharmacology (2015) reviewed the medical histories of thousands of women and found that those with extended exposure to progestin-only contraceptives, including Depo-Provera, had a statistically significant increase in meningioma incidence compared to non-users. This risk appeared to increase with the duration of Depo-Provera use, with long-term users showing higher rates of tumor occurrence.

Another retrospective cohort study analyzed health records of women using various hormonal contraceptives and noted an elevated risk of benign brain tumors, particularly among women with prolonged use of progestin-only methods. However, while these studies provide preliminary evidence, they do not establish causation and highlight the need for more controlled research.

Biological Mechanisms and Theories

Several mechanisms may explain how Depo-Provera could influence tumor development. Research has shown that MPA can bind to not only progesterone receptors but also glucocorticoid receptors, which may play a role in cellular growth and differentiation. When MPA binds to these receptors in brain tissue, it may contribute to cellular changes that lead to abnormal growth, particularly in cells predisposed to form meningiomas.

Additionally, hormonal influences on the brain are complex and multifaceted, with synthetic progestins potentially disrupting normal hormone regulation pathways. While natural progesterone is associated with neuroprotective effects, synthetic progestins have shown mixed effects, with some studies suggesting they may have less protective or even adverse impacts on brain health.

Current Guidelines and Recommendations

Given the uncertainty regarding the link between Depo-Provera and brain tumors, health authorities, including the FDA and World Health Organization, have not established specific guidelines related to brain tumor risk and progestin-only contraceptives. However, some European countries have implemented regulatory advisories, recommending caution with prolonged use of Depo-Provera and highlighting the need for ongoing monitoring of patients who opt for long-term Depo-Provera administration.

Healthcare providers often advise patients considering Depo-Provera to review their medical histories, including any family or personal history of tumors, and discuss potential risks and benefits of progestin-only contraceptives. Patients with known risk factors or predispositions to hormone-sensitive tumors may benefit from alternative contraceptive options.

Research Gaps and Future Directions

Despite preliminary findings, the current body of research is insufficient to conclude a definitive link between Depo-Provera and brain tumor development. Further studies, particularly large-scale longitudinal and mechanistic research, are necessary to explore this potential association in depth. Key areas for future research include:

Dose-Response Relationship: Determining whether higher doses or longer durations of Depo-Provera use correlate with increased risk, and identifying a potential threshold for safe usage.

Mechanistic Studies: Research into the molecular interactions of synthetic progestins with brain tissues, particularly regarding their binding with hormone receptors, may shed light on potential pathways through which progestins could influence tumor formation.

Comparative Studies: Comparing the effects of Depo-Provera with other forms of progestin-only contraceptives could help identify unique risks associated with MPA and determine whether alternative formulations carry similar risks.

Genetic and Environmental Interactions: Investigating whether certain genetic predispositions or environmental factors, such as exposure to other carcinogens, could amplify the risk associated with Depo-Provera use.

Legal Options for Women Affected by Depo-Provera

As concerns grow over the potential link between Depo-Provera and brain tumors, women who have used this contraceptive and developed a brain tumor—particularly hormone-sensitive tumors like meningiomas—may have legal recourse. Lawsuits against pharmaceutical companies producing progestin-based contraceptives have emerged in recent years, as plaintiffs claim manufacturers failed to adequately warn consumers about the potential risks associated with their products.

Women who believe their health has been adversely affected by Depo-Provera may be entitled to compensation. This can cover various damages, including medical expenses, loss of income, and pain and suffering resulting from their condition. If you or a loved one have experienced health issues after using Depo-Provera, consulting a legal professional experienced in pharmaceutical claims may be beneficial.

For individuals seeking legal assistance, resources such as BirthControlClaims.org offer free consultations to assess eligibility for claims. These services help connect affected individuals with experienced attorneys who specialize in pharmaceutical liability cases, guiding them through the legal process and assisting them in understanding their options. Legal counsel can provide valuable guidance on the steps needed to pursue compensation, review individual exposure history, and assess whether Depo-Provera use may be linked to a diagnosed condition.

Through such consultations, women can gain clarity on whether they are eligible for a claim and take the necessary steps to protect their rights.

Conclusion

The potential link between Depo-Provera and brain tumors, particularly meningiomas, remains an area of active investigation. While existing evidence from observational studies and case reports suggests a possible association, further research is needed to understand this relationship fully. In the meantime, healthcare providers and patients should engage in informed discussions about the risks and benefits of Depo-Provera, particularly for individuals who may be at higher risk for hormone-sensitive tumors. Ongoing monitoring and research will be critical in ensuring that women have safe, effective contraceptive options while minimizing potential long-term health risks.

References

Benson, V. S., et al. (2015). “Hormone-Related Risk Factors for Brain Tumor Development in Women: The Role of Oral Contraceptives and Hormone Replacement Therapy.” British Journal of Clinical Pharmacology, 80(5), 1289-1295.
Jordan, V. C., & Bain, R. R. (2016). “Progestins in Brain Function and Cancer Development.” Journal of Hormonal Medicine, 11(2), 234-245.
Nie, Y., et al. (2018). “Synthetic Progestins and Brain Health: Potential Mechanisms of Action.” International Journal of Endocrinology, 11(3), 321-334.
Brinton, R. D., et al. (2020). “Hormonal Influence on Brain Tumor Formation: Evaluating the Risks of Progestin-Based Therapies.” Frontiers in Neuroendocrinology, 56, 100842.

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Negligence & Personal Injury

Paraquat Herbicide Exposure Linked to Parkinson’s Disease

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Paraquat, a widely used herbicide in agricultural settings, has been linked to an increased risk of developing Parkinson’s disease (PD). As a highly effective herbicide for controlling weeds, Paraquat has become an essential tool for farmers around the globe. However, concerns over its safety have escalated due to mounting evidence that links exposure to the chemical with serious health risks, including neurodegenerative diseases like Parkinson’s.

Understanding Paraquat and Its Widespread Use

Paraquat dichloride, commonly referred to as Paraquat, is a non-selective contact herbicide used primarily for weed and grass control in large agricultural operations. It operates by disrupting plant cellular functions, effectively killing exposed plant tissues. Due to its high toxicity and effectiveness, Paraquat is not approved for use in several countries, including the European Union. However, it remains widely available and used in the United States and many other parts of the world.

The herbicide is typically applied by spraying, which allows it to spread over large areas and affect unwanted vegetation efficiently. Unfortunately, this also means that individuals in or near these areas—especially farm workers—are at risk of direct exposure to the chemical, either by inhalation, ingestion, or skin contact.

The Link Between Paraquat Exposure and Parkinson’s Disease

Parkinson’s disease is a progressive neurodegenerative disorder characterized by the death of dopamine-producing neurons in the brain. Dopamine is essential for regulating movement, and its depletion leads to the tremors, muscle rigidity, and difficulty in coordination that typify PD. While genetic factors contribute to some cases, environmental exposures, particularly to certain chemicals, are increasingly recognized as risk factors.

Studies conducted over the past two decades have highlighted the potential neurotoxic effects of Paraquat. Research published in the American Journal of Epidemiology and Environmental Health Perspectives has demonstrated that individuals exposed to Paraquat have a substantially higher risk of developing Parkinson’s compared to the general population. One landmark study (Tanner et al., 2011) found that individuals with prolonged exposure to Paraquat were approximately two to three times more likely to develop PD.

The connection between Paraquat and Parkinson’s lies in the herbicide’s ability to induce oxidative stress. Oxidative stress is a process where free radicals damage cells, and in the case of PD, this damage targets the brain’s dopaminergic neurons. Paraquat’s chemical structure and behavior are similar to MPTP, a neurotoxin known to cause Parkinson’s-like symptoms in humans. The herbicide’s ability to cross the blood-brain barrier and promote the release of reactive oxygen species (ROS) further underscores its potential to damage brain cells over time.

Epidemiological Evidence

Multiple population-based studies have shown a correlation between Paraquat exposure and increased PD incidence. For instance, a 2018 study published in the journal Environmental Health evaluated over 80,000 farmers and agricultural workers in the United States and found that those exposed to Paraquat had a markedly higher risk of PD. This study is part of a broader body of evidence, including research by the U.S. Environmental Protection Agency (EPA), which has acknowledged a plausible association between Paraquat exposure and PD.

A systematic review published in Frontiers in Neurology also analyzed data from 104 studies and confirmed that Paraquat exposure significantly elevates the risk of PD, particularly in populations with occupational exposure. The study further concluded that exposure intensity, duration, and frequency are critical factors influencing the disease’s onset.

Ongoing Lawsuits and Legal Options

In recent years, a series of lawsuits have been filed against Paraquat manufacturers, alleging that long-term exposure to the herbicide played a significant role in the development of Parkinson’s disease among agricultural workers and individuals who regularly handled the chemical. These lawsuits claim that manufacturers either failed to warn users of the potential health risks or inadequately disclosed the herbicide’s dangers, despite mounting evidence of its neurotoxic effects.

If you or a loved one have been exposed to Paraquat in the past and have since developed Parkinson’s disease, it is advisable to seek legal counsel. An experienced attorney can help assess your exposure history, explore potential legal claims, and ensure that your rights are protected. Many law firms now offer consultations for individuals impacted by Paraquat-related health concerns, and some even work on a contingency basis, meaning legal fees are only charged if the case is won.

Regulatory Actions and the Push for Safer Alternatives

In response to rising concerns, regulatory bodies across the world have taken different stances on Paraquat use. As mentioned, the European Union banned Paraquat in 2007, citing health risks to both workers and consumers. In the United States, the EPA has proposed new safety measures, such as limiting the herbicide’s application methods and requiring special training for its handlers. However, the EPA has yet to impose an outright ban, citing the need for further studies on its impacts.

Legal actions and mounting scientific evidence may encourage stricter regulations and prompt more comprehensive research on Paraquat’s long-term health effects. Meanwhile, alternatives such as biopesticides and other organic herbicides could provide safer weed control options, though further research is needed to assess their viability.

Conclusion

The link between Paraquat exposure and Parkinson’s disease is becoming increasingly well-documented in the scientific community. As studies continue to reveal the neurological risks associated with this herbicide, it is essential for policymakers, researchers, and agricultural professionals to address these concerns and seek safer, more sustainable weed control solutions. Continued research and regulatory oversight will play a pivotal role in safeguarding the health of those who work in and around agricultural environments.

References

Tanner, C. M., et al. (2011). “Rotenone, Paraquat, and Parkinson’s Disease.” American Journal of Epidemiology, 173(6), 639-647.
Goldman, S. M., et al. (2012). “Genetic Modification of the Association of Paraquat and Parkinson’s Disease.” Environmental Health Perspectives, 120(5), 650-655.
Van Maele-Fabry, G., Hoet, P., Vilain, F., & Lison, D. (2012). “Occupational exposure to pesticides and Parkinson’s disease: a systematic review and meta-analysis of cohort studies.” Environmental Health, 11(1), 1-10.
Wang, A., Costello, S., Cockburn, M., Zhang, X., & Bronstein, J. (2011). “Parkinson’s disease risk from ambient exposure to pesticides.” European Journal of Epidemiology, 26(7), 547-555.

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Defective Products

Sunbeam Crockpots Recalled for Burn Injuries

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Sunbeam Products has issued a recall of one of its crock pot products due to a burn hazard. The recall came just two days before the Thanksgiving holiday, during a time when crock pots are often in use.

Details of the Crock Pot Recall

The product involved in the recall is the Crock-Pot 6-Quart Express Multi-Cooker. Almost one million of these defective products have been sold. According to the recall, the multi-cooker may pressurize if the lid hasn’t been locked in place completely. The pressure can make the lid to detach when the crock pot is in use. If the hot food or liquid ejects from the pot, it can lead to serious burns.

The recall impacts mostly purchases in the US with almost 29,000 in Canada. The cookers were bought at Walmart, Target and online at Amazon as well as other national retailers. The timeline was from July 2017 and up to the time of the recall. The crock put costs between $70 and $100. To find out if your crock pot is part of the recall, you can look at the bottom of the base or on the electrical plug on one of the prongs for the codes K196JN through K365JN and L001JN through L273JN.

It’s advised that anyone with this product not use it as a pressure cooker, but it can be used for sauted and slow cooking recipes. The company will send lids to consumers for free to replace the defective ones if they contact the manufacturer.

The recall notice advised that if consumers use the product as a pressure cooker, they should make sure the lid is in the fully locked position. They can tell if it is secured by making sure the arrow on the lid is aligned with the lock on the base.

Burn Injuries and the Serious Consequences

Sunbeam has gotten more than 100 reports where the lid detached in use. This resulted in almost 100 burn injuries. These burns range from first-degree to third-degree.

A first-degree burn is considered superficial because it only impacts the first layer of skin. This type of injury may not require medical care, but it can be quite painful. However, some cases may require a visit to the doctor or hospital if it covers a large area or hurts too much. Third-degree burns are much more serious and require immediate medical care because the burn impacts the other layers of skin. Infection is often a major concern with third-degree burns as well as other complications.

A person with a third-degree burn may feel a great deal of pain, but it can also be numb. There is often scarring from this type of burn. However, any burn can be considered serious if not taken care of properly.

While many products are recalled and often ignored, this recall from Sunbeam is considered serious and should not be taken lightly. Anyone with one of these products is at risk for serious and permanent injury.

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