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Urgent Warning Issued Over Infliximab Shortage for IBD Patients

Urgent Warning Issued Over Infliximab Shortage for IBD Patients

A gastroenterology super-specialist issued a stark warning regarding the severe consequences of discontinuing treatment for patients with inflammatory bowel diseases (IBD) due to a critical Infliximab shortage.

According to Jadeh Makhsoos Information Base, Dr. Alireza Sima, speaking to Mehr reporter, highlighted the critical condition of IBD patients. He explained that individuals with ulcerative colitis and Crohn’s disease require regular Infliximab injections to manage their illness. The country has imported this vital medication for years, and patients follow a scientific protocol, receiving injections every four or eight weeks.

Sima explicitly criticized the Food and Drug Organization’s performance in managing the drug supply chain. He noted that despite ongoing drug imports, various reasons cause distribution delays. This disruption has left patients searching pharmacies for the past six months, effectively halting their treatment.

The gastroenterology super-specialist emphasized that discontinuing or delaying this drug has irreversible consequences. He stated that if patients miss their scheduled injection, their body produces antibodies against the drug, reducing its serum level. Often, antibody formation causes the drug to permanently lose its effectiveness. This deprives patients of a highly effective treatment option.

Jadeh Makhsoos reports, Sima continued, stating that stopping treatment leads to severe disease relapse. This can cause severe gastrointestinal bleeding, unbearable abdominal pain, intestinal obstruction, and even fistula or abscess formation. This situation drastically reduces patients’ quality of life and pushes them towards serious disability and expensive surgeries.

Sima stressed that this crisis extends beyond patients. He noted that controlling the disease with the primary drug significantly reduces treatment costs for the health system. However, when patients relapse severely due to drug discontinuation, hospitalization, surgery, intensive care, and alternative treatment costs multiply for the health system. Untimely drug supply, he concluded, threatens patient lives and wastes the country’s limited health resources.

Sima discussed alternative drugs available in the market. He mentioned that an Indian version of this drug currently exists, but this brand lacks valid and reliable clinical studies. Without clear information on the Indian brand’s safety and efficacy, replacing the original drug is impossible. He warned that changing a biologic drug without scientific evidence of its safety and efficacy can pose serious patient risks.

He added that this trend could lead to a silent crisis in inflammatory bowel diseases. This crisis, he warned, carries human, therapeutic, and economic consequences far heavier than the cost of timely foreign currency provision for importing and distributing the main drug.

Meanwhile, the Food and Drug Organization’s public relations department responded to the Infliximab shortage, offering explanations.

The Food and Drug Organization’s public relations announced that domestic production now supplies injectable Infliximab (Remicade). This drug treats inflammatory diseases and some gastrointestinal disorders. This move facilitates patient access and reduces import dependency.

The Food and Drug Organization stated that the domestic product complies with international standards and meets patient needs. They emphasized that domestic production directly results in stable drug supply and improved access.

Physicians have noted the domestic sample, and a significant portion of prescriptions now specify domestic production.

The Food and Drug Organization assures patients they can confidently receive this drug, trusting its quality. They state that the treatment process can continue without disruption, aiming to resolve the Infliximab shortage.