Pfizer To Withdraw Cancer Drug Mylotarg
Pfizer will withdraw cancer drug Mylotarg amidst concerns that the drug is ineffective and may actually decrease lifespan when compared to traditional chemotherapy, the Associated Press reports.
Although the study was intended to show that adding Mylotarg to chemotherapy increased lifespan, it indicated that Mylotarg failed to slow relapsed acute myeloid leukemia, the bone marrow cancer it was prescribed to treat. About 2,500 patients in the U.S. are treated with the product annually. Pfizer will withdraw the drug effective Oct. 15, 2010.
Mylotarg was granted an accelerated approval by the FDA in 2000 but it appears that the drug can’t live up to the early promise it had one shown. A follow-up study halted last August reported more deaths amongst patients taking Mylotarg plus chemotherapy than those undergoing chemotherapy alone.
Legal analysis by Shawn Cantley [profile], Shawn's Mail:
Drug manufacturers owe many duties to the users of their products. Specifically, they have a duty to not design or manufacture unreasonably dangerous drugs. Furthermore, they have a duty to warn users of the dangers of their medicines so individuals can make informed decisions. Although Mylotarg carries a warning label about a sometimes fatal liver condition called veno-occlusive disease, the FDA has stated that reports of the disease associated with the drug increased during its time on the market.
As more facts develop, Pfizer could face civil liability if they violated those duties by failing to accurately warn users of potential dangers their products posed. If you or someone you know has been injured by a dangerous drug you should consider speaking to an attorney with experience in these matters. They can provide valuable counsel as well as preserve evidence and protect your rights.
The drug will no longer be available to new patients.
For the AP story on the withdrawal click here.
For Wall-Street Journal subscribers an article on the withdrawal can be found by clicking here.
