Mylotarg Withdrawn from the Market Over Safety Issues
Written By: Rheingold, Giuffra, Ruffo & Plotkin LLP
The FDA announced that Pfizer will withdraw Mylotarg from the market in
October after recent clinical studies have shown that the drug may not
be effective and poses greater risks than benefits to patients. The drug
was used in patients with acute myeloid leukemia. Read the FDA's notice
here.
The accelerated approval process employed by Pfizer was designed to bring drugs to patients with serious life threatening diseases, however clinical trials for this drug have shown that there is an increase rate of death in the first couple months of treatment. This is the first drug to be withdrawn from the market after using the abbreviated approval process.
Contact Rheingold, Giuffra, Ruffo & Plotkin LLP if you have been injured by a dangerous drug, for a free consultation.
Posted By
Rheingold, Giuffra, Ruffo & Plotkin LLP
Categories:
The accelerated approval process employed by Pfizer was designed to bring drugs to patients with serious life threatening diseases, however clinical trials for this drug have shown that there is an increase rate of death in the first couple months of treatment. This is the first drug to be withdrawn from the market after using the abbreviated approval process.
Contact Rheingold, Giuffra, Ruffo & Plotkin LLP if you have been injured by a dangerous drug, for a free consultation.