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Acne Drugs Causing Birth Defects

The Dangers and Side Effects of Isotretinoin

A Closer Look at Accutane and Roaccutane

Isotretinoin, widely known by its brand names Accutane and Roaccutane, is a potent medication primarily used to treat severe acne. Despite its ‘apparent’ efficacy, isotretinoin has garnered significant attention due to its dangerous side effects and the legal battles surrounding its use.

A recent article in The Sydney Morning Herald highlights the dangers of taking drugs during pregnancy that carry an increased risk of genetic damage, birth defects and miscarriage.

Why This Is Important For Patients?

Isotretinoin, initially developed for chemotherapy, poses significant risks when used for acne. There is a strong argument for its removal from the market due to its dangerous side effects. According to the Academy of Dermatology, isotretinoin can cause severe birth defects, miscarriages, and stillbirths. This is crucial information for anyone with teenage children, grandchildren, or those considering isotretinoin for acne treatment.

This article explores the severe risks of isotretinoin, the history of Accutane and Roaccutane, their recalls, the associated deaths, and the numerous lawsuits. Understanding these dangers is vital for making informed healthcare decisions.

Background of Isotretinoin

Isotretinoin is a powerful retinoid derived from vitamin A, originally developed to treat severe, cystic acne that is unresponsive to other treatments. Introduced in the 1980s, Accutane quickly became a go-to solution for dermatologists. The drug works by reducing sebaceous gland activity and decreasing oil production, which in turn helps to clear severe acne.

Accutane and Roaccutane: Two Sides of the Same Coin

Accutane, marketed by Hoffmann-La Roche, and Roaccutane, its counterpart available in various international markets, are essentially the same medication. Both brands have been used extensively to treat severe acne, but their potent effects have not come without controversy.

Common Side Effects

While isotretinoin is effective in treating severe acne, it comes with a range of common side effects, including:

  • Dry Skin and Lips: The most frequently reported side effect, leading to cracked and bleeding lips and dry, flaky skin.
  • Nosebleeds: Recurrent bleeding due to the drying effect on nasal passages.
  • Muscle and Joint Pain: Many patients report discomfort and pain, especially after physical activities.
  • Sun Sensitivity: Increased risk of sunburn, necessitating strict sun protection measures.
  • Initial Acne Flare-Up: A temporary worsening of acne, known as an “initial breakout,” is common in the first few weeks of treatment.

Serious Side Effects

More concerning are the serious side effects associated with isotretinoin:

  • Birth Defects: Isotretinoin is highly teratogenic, meaning it can cause severe birth defects. Women who are pregnant or may become pregnant are strictly advised against using the drug. The risks include severe deformities of the face, heart, brain, and other vital organs. The dangerous drug can cause miscarriage – Spontaneous Abortion, or the death of the baby for delivery – known as Stillbirth.
  • Mental Health Issues: There have been reports linking isotretinoin to depression, anxiety, and even suicidal thoughts. While a direct causal relationship has not been definitively established, the potential for severe mental health side effects has raised alarm.
  • Gastrointestinal Disorders: Many patients have developed severe gastrointestinal conditions, including inflammatory bowel disease (IBD) and Crohn’s disease.
  • Liver Damage: Isotretinoin can affect liver function, necessitating regular blood tests to monitor liver enzymes.

Recalls and Legal Battles

Accutane was voluntarily recalled by Roche in 2009, not due to safety concerns directly, but rather because of declining sales and the availability of generic versions. However, the medication had already been the subject of numerous lawsuits. Patients who experienced severe side effects, particularly those who developed IBD or had children with birth defects, filed lawsuits against Roche. These legal battles often cited that the company failed to adequately warn users about the potential risks associated with the drug.

The recall of Accutane did not affect its availability under other names, including Roaccutane, which continues to be used worldwide. However, the legacy of these legal issues has led to stricter regulations and more comprehensive patient education regarding the risks of isotretinoin. They actually put health warnings on the box now.

Moving Forward: Stricter Regulations and Patient Education

In response to the risks associated with isotretinoin, regulatory bodies have implemented stringent guidelines to ensure patient safety. For instance, the iPledge program in the United States mandates that women of childbearing age must use two forms of contraception and undergo regular pregnancy tests before, during, and after treatment.

Healthcare providers are now more vigilant in educating patients about the potential side effects and the importance of adhering to safety protocols. Dermatologists emphasize the need for regular follow-ups and monitoring to mitigate risks and manage any adverse effects promptly.

Conclusion

Isotretinoin, under the brand names Accutane and Roaccutane, remains a very commonly used tool in the treatment of severe acne. However, its use is not without significant risks. The history of recalls and lawsuits highlights the importance of stringent safety measures and thorough patient education. As awareness of its dangers grows, healthcare providers and patients must work together to ensure that the benefits of isotretinoin outweigh its risks, safeguarding the health and wellbeing of those who rely on this potent medication.

The Spinal Centre Comment

Isotretinoin, initially developed as a chemotherapy drug, has been repurposed for acne treatment, especially in young people. However, using a medication originally designed for cancer treatment comes with significant risks, making long-term use particularly dangerous.

Roaccutane is the brand name for isotretinoin in the UK, where it has been available since 1983. In the USA, it was branded as Accutane and approved in 1982. Despite the different names, both are the same drug, and this rebranding might be viewed as a strategy to downplay its potential dangers.

According to Miller and Zois, extensive medical studies have confirmed the severe side effects linked to Accutane. These findings led Roche Pharmaceuticals to withdraw and recall the drug. Thousands of lawsuits have been filed, highlighting how Accutane devastates lives. The conditions cited in these lawsuits include a high risk of suicide, seizures, bone degradation, heart attacks, and strokes. Additionally, many lawsuits focus on gastrointestinal issues like Crohn’s disease and Ulcerative Colitis, which can severely impact a person’s quality of life.

The report by the Sydney Morning Herald shares the tragic experiences of women who become pregnant while taking isotretinoin. Considering the peak age for acne is between 15 and 25 years, which coincides with peak fertility, unintended pregnancies are not uncommon. These young women, often influenced by societal and parental pressures, may be coerced into terminating their pregnancies to avoid severe birth defects caused by the drug.

Many young and impressionable patients are not fully informed about the severe risks of isotretinoin. Embarrassment and societal pressures can prevent open discussions about their sexual activities with healthcare providers, leading to uninformed decisions about their treatment.

If isotretinoin can cause severe birth defects, it raises the question of what other damage it might do to the body. For women, the drug could potentially harm their eggs, which are present from birth. Unlike men, who continuously produce sperm, women carry all their eggs throughout their lives, making the potential for lasting damage significant.

The expectation that isotretinoin will only target sebaceous glands while sparing other parts of the body is overly optimistic. The harsh reality includes increased risks of suicide, seizures, heart attacks, and strokes. Furthermore, the drug’s impact on the gastrointestinal tract can lead to chronic conditions like Crohn’s disease and Ulcerative Colitis, requiring lifelong medication and severely impacting one’s health.

Given these severe risks, it’s crucial to reconsider using isotretinoin for acne. While the promise of clear skin is tempting, the potential for severe, life-altering side effects is too significant to ignore.

There are safer, natural ways to manage acne that don’t involve the perilous consequences of isotretinoin. Patients and healthcare providers must prioritise holistic treatments to protect long-term health and wellbeing over the dangerous quick fix offered by Big Pharma.

We are here to tell you there is another way. A natural way. One that honours the body – and your digestive system. Without the side effects of dangerous drugs.

The Spinal Centre – Neuro-Musculoskeletal SolutionsThe Spinal Centre provides the Best Natural Medicines, Health Products and Nutritional Solutions to Free You of Pain and Improve Your Spinal Health.The Spinal Centre is a leader in the management and treatment of spinal pain and disability including:

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