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Mylotarg Recall: Cancer Drug Pulled Due to Health Risks, Low Benefits

  • Written by: Staff Writers
  • 5 Comments

The cancer drug Mylotarg is being pulled from the U.S. market after the FDA determined that it was ineffective and endangered patients’ health.

Pfizer issued a Mylotarg recall from the market at the behest of the FDA following clinical trials where the drug performed poorly. Not only did the drug not appear to work, but the subjects taking Mylotarg had a higher death rate than those treated with traditional chemotherapy.

Mylotarg (gemtuzumab ozogamicin) was originally created by Wyeth, which was bought by Pfizer. The drug was approved in 2000 by FDA for the treatment of patients ages 60 and older with recurrent acute myeloid leukemia (AML). The drug was designed to treat patients who did not respond to chemotherapy well.

AML is a form of bone cancer that affects about 13,000 new patients each year in the U.S. Pfizer estimates that less than 2,500 patients a year were using Mylotarg.

According to the FDA, regulators knew that the side effects of Mylotarg included a link to veno-occlusive disease, a life-threatening liver condition, when it was first approved. However, a post approval clinical trial started in 2004 has revealed that the rate of patients who develop Mylotarg liver problems is higher than they initially believed.

The study included a total of 627 patients. Those given Mylotarg as part of their treatment suffered a 5.7% death rate, as opposed to a death rate of 1.4% among those just given traditional chemotherapy. In addition, the study’s results did not show any indication of a clinical benefit for those taking Mylotarg.

The drug was approved under an accelerated process for drugs that fill a serious medical need for which there is no other drug. The accelerated approval process requires that the drug company do follow-up clinical trials after approval. If the drug does not perform, or has serious health risks, the FDA can have the drug pulled from the market more quickly than it could a drug approved through normal means.

Under the terms of the Mylotarg recall, patients currently taking the drug and those patients who have had it prescribed may continue to take it, if they decide to do so after consultation with their physicians. However, Pfizer and FDA recommend that no new patients be prescribed the drug, and its new drug application will be officially withdrawn on October 15, 2010, according to a Pfizer press release (pdf). It is unclear how long the drug will be available for those currently taking it.

It is also unclear whether Pfizer will withdraw the drug from foreign markets as well. Pfizer’s press release only said that the company was in consultation with foreign health agencies over the issue.

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5 comments

  1. Barbara Reply

    My mother was put on this medication after being diagnosed with AML. according to this news about Mylotarg this medication was used for patients that did not respond well to chemotherapy. My mother never had chemotherapy as this medication was given to her because it was THOUGHT that she would not do well on chemotherapy. Why would this medication be prescribed with hardly any benefit known for the patient? Why did my mother die? Was it because of AML or mylotarg? Was moma’s compromised state give someone a right to give this medication that has ” little to no effect?” I do not even think that a lever test was done for my mother…i am very upset with Pfizer for having this medication that causes harm to an already compromised state of health! To have had my mother longer would have been great, but now I fell she was never even given a chance to overcome this. How can companies be allowed to treat people like they are their research with out the permission of the sick and elderly population??

  2. Irma Reply

    Somebody is responsible for my Husband dead. I think the Dr.that treated him and the Drug Co. that Manufactured that Killer.

    companyCo

    .

  3. Aaron Reply

    Had this drug given to me twice in the span of 6 months.

  4. Ashley Reply

    My sister had Aml at 16 yrs old they gave her this drug which later killed her are lawsuits still being placed for this drug? Come on now 16 the limit was 60 and up this isn’t right

  5. Alisha Reply

    My son was 5 when he died from liver failure after taking this drug for YEARS He was painting and they came into his room and told me in a few hrs he would be gone! He fought cancer for 4 1/2 yrs to be taken out by a drug they knew was killing people! They recalled it 3 months after his death and I knew nothing about it till today! Smfh!

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