New limit on drug causing cancer side effects may be in place

Three days after the Food and Drug Administration warned Pfizer to develop a four-week supply of a medicine that could help combat the side effects of a cancer drug, the agency told the company…

New limit on drug causing cancer side effects may be in place

Three days after the Food and Drug Administration warned Pfizer to develop a four-week supply of a medicine that could help combat the side effects of a cancer drug, the agency told the company in a letter on Monday that the drug could be made available to adults as soon as Friday, reports Reuters.

The FDA said it has expressed its concerns about the antifungal drug, called ocrelizumab, which could give patients a more convenient option to stop taking the potentially dangerous medicine oxaliplatin, a chemotherapy drug for about 3,500 people with colorectal cancer, reports Reuters.

The FDA has placed a restriction on the drug, which is prescribed in the U.S. to reduce infecsions and gastrointestinal symptoms, by ordering that people only obtain the drug through a prescription until a two-week supply can be obtained by filling a prescription.

In a statement sent to CNN, Pfizer said, “Pfizer continues to work with the FDA on a safe and effective formulation that provides for long-term use. We look forward to working with the FDA toward that goal and to providing the therapy to patients who need it.”

The FDA has repeatedly requested that Pfizer submit new data before this Friday.

“These patients may use higher doses of ocrelizumab over the two-week ‘supply’ duration to mitigate the risks of ocrelizumab,” the FDA wrote in its May 17 letter to Pfizer.

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