With recent FDA approval of Takeda Pharmaceutical’s drug, vedoluzimab, to treat Ulcerative Colitis and Crohn’s Disease, many doctors and patients are filled with hope. However, with a significant side effect profile, equal numbers are extremely cautious.
Less than two weeks ago, the FDA approved the newest drug to help those suffering from Ulcerative Colitis and Crohn’s Disease. Just days ago, the typically more conservative European Commission also approved the drug.
As one would expect, shares of Japan-based Takeda Pharmaceutical have risen sharply.
Amidst all of the hope and excitement, however, it is important to objectively assess this evolution.
Ulcerative Colitis and Crohn’s Disease are two extremely challenging medical conditions, as those with any inflammatory bowel disease can attest. From simple annoyance, to pain, to extreme discomfort, to acute attacks requiring hospitalization, to even an increased risk of cancer, these conditions demand serious attention.
Although more than 4 million people are affected worldwide, there still exists no definitive cure.
Medical doctors have few solutions to offer patients. Typically the treatment is to provide high dose potent medications to calm down acute flare-ups. For many patients, no maintenance medication is sufficient.
Certainly, dietary discretion can be quite powerful to help control the frequency and intensity of acute exacerbations. This requires extreme discipline, which many people realistically cannot do, often due to circumstances not fully within their control.
While some people with Ulcerative Colitis or Crohn’s Disease can receive benefit from careful dietary intake, others have a condition more severe that a form of additional assistance is necessary. As noted, the current medications on the market (prior to this recent release), have left many people disappointed.
Therefore, it is understandable that significant hope and excitement surrounds this new medication release to the public.
However, it is important to review the available information regarding the Clinical Trial Program that was conducted as part of the FDA approval process.
According to data, readily available on the Takeda Pharmaceutical website, 52% of the patients in the study using the drug reported adverse reactions. It was also noted that only 37% of the patients in the study who were given placebo reported any adverse reactions. This is rather remarkable, and worthy for one to explore further.
Just like many medications are mandated to report, the “adverse reactions” contain a laundry list of potential side effects (including nasopharyngitis, headache, arthralgia, nausea, pyrexia, upper respiratory tract infection, fatigue, cough, bronchitis, influenza, back pain, rash, pruritis, sinusitis, oropharyngeal pain, and pain in extremities).
This, by itself, is not something to necessarily make someone run. However, the fact that these symptoms occurred so frequently (more than in placebo) is what is quite concerning to many.
Many people prefer to avoid the pharmacologic treatment for their colitis, if at all possible.
Seeking a natural cure for Ulcerative Colitis or Crohn’s disease, or even helpful therapy rather than a cure, innovative scientists and doctors have aggressively studied the benefit of digestive enzymes and probiotics. While many clinical studies are already underway, there already exists significant evidence that medical-grade digestive enzymes, coupled with high quality probiotics, can help significantly.
One company dedicated to this pursuit, Purely Scientific, has had significant success with its signature product “3-in-1 Digestive Formula”. Formulated exclusively for doctors, patients across the country with Ulcerative Colitis and Crohn’s Disease have exhibited remarkable improvement.
Purely Scientific Spokesperson, Donald B. Opp, shares, “The demand of colitis on the body is extreme. That is why a potent, carefully-designed supplement is so critical. Our product provides three equally important components: 1) a comprehensive digestive enzyme component, 2) a patented enzyme complex which targets gluten and lactose (which are key offenders in colitis, often), and 3) high quality probiotics. We believe these three components, in just the right quantity, are responsible for the remarkable successes our doctors have been experiencing.”
Once available only to doctors, Purely Scientific’s “3-in-1 Digestive Formula” was recently released to the general public. It is currently available on Amazon.
As the medical landscape continues to evolve, more will become known about both the pharmaceutical and nutraceutical options to effectively treat Ulcerative Colitis and Crohn’s Disease.
Until then, each individual person and doctor needs to, ideally as a team, make the challenging decisions regarding which treatment options to utilize.