Clinical Trial Death Linked To Pfizer Drug

The European Medicines Agency (EMA) and the FDS each issued updates of reviews of drugs that have been the subject of recent controversies, according to Forbes.

A clinical trial may be linked to the death of one patient who was taking the drug tofacitinib, a pill designed to treat rheumatoid arthritis, Pfizer reports.

The patient died of respiratory failure. Three other patients taking the same drug also died during the study, but their deaths were determined to be unrelated to the drug.

According to Pfizer, over 1,000 patients have taken tofacitinib during clinical trials, and the overall death rate for these study patients is similar to other biologic treatments for rheumatoid arthritis.

The reasons for the other deaths included a patient who died of acute heart failure, one death caused by brain injury following trauma, and one case of worsening rheumatoid arthritis. The brain injury death happened 22 days after the patient stopped taking tofacitinib, and the patient who died of worsening rheumatoid arthritis had stopped taking tofacitinib six weeks beforehand.

In the past, certain rheumatoid arthritis drugs have worsened congestive heart failure, and it’s possible that tofacitinib could have a similar effect, according to Citi Investment Research analyst John Boris.

Common side effects of tofacitinib include infections, headache, bronchitis, nausea and vomiting. More serious side effects are increased cholesterol levels and increased creatinine levels. 

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