Mylotarg Recall
From Pharmacy Drug Guide
On June 21, 2010, Pfizer, Inc. announced they would voluntarily withdraw the Mylotarg (gentuzumab ozogamicin) from the U.S. market. Mylotarg (gentuzumab ozogamicin) is used to treat patients with a certain bone marrow cancer called acute myeloid leukemia (AML). Mylotarg is a chemotherapy drug, and is administered as an injection. The medication is classified as an antineoplastic agent.
Although new patients will not be prescribed Mylotarg, the drug may continue to be used by those who have already begun treatment with it. However, Mylotarg was shown to have no proven benefit, despite 10 years on the market, and caused severe problems with the liver. Patients who received Mylotarg had higher rates of death than those who received other treatments.[1]
 Flickr: Anthony Mosely Photography | |
| Date of recall | Withdrawal announced on June 21, 2010[1] |
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| Originally approved | May of 2000[1] |
| Treats | Acute myeloid leukemia, AML, in patients aged 60 years and older.[1] |
| Reason for recall | Causes a serious and potentially fatal liver condition called veno-occlusive disease[2] |
| Manufacturer | Pfizer, Inc. |
| Disclaimer | The information provided by PharmacyDrugGuide.com is not a substitute for professional medical advice, diagnosis, or treatment. Do not take any action based on the information on this page without consulting a physician. |
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Mylotarg Recall Information
Pfizer, Inc. decided in June of 2010 to pull Mylotarg off the market because required post-marketing study did not confirm clinical benefit to patients who participated in the trials. AML, acute myeloid leukemia, is a serious disease with limited drug treatment options. After receiving the trial results, Pfizer has recommended that no new U.S. patients be prescribed Mylotarg. In some cases, treatment among those already receiving Mylotarg may be continued. Any health care providers administering Mylotarg have been advised to discuss the research results with their patients.[2]
Drug Side Effects
Mylotarg Recall Background
Mylotarg gained accelerated FDA approval in May 2000 for the treatment of acute myeloid leukemia patients over the age of 60 who were not candidates for other types of chemotherapy. Taking Mylotarg has been associated with a potentially fatal liver condition called veno-occlusive disease. Pfizer, Inc. is voluntarily withdrawing Mylotarg due to a request from the U.S. Food and Drug Administration. Concerns were raised after recent clinical trial results showed that product safety may be a concern, and that the cancer treatment drug did not provide a significant clinical benefit to participants in the trials.[2]
Mylotarg Side Effects
Some of the most common adverse reactions to Mylotarg include cold sores, upset stomach, reduced appetite, depression, weakness, bowel irregularity, insomnia, indigestion and diarrhea. Mylotarg users who experience the following adverse reactions are urged to contact a medical professional at once: cloudy urine, heartbeat irregularities, seizures, loss of control over movement, exhaustion, pale skin tone, blood in the urine or stool, breathing problems, dizziness, or upper respiratory infection.
Mylotarg is only to be administered by a qualified physician, and patients will be monitored for major side effects for a period of four hours after receiving a Mylotarg injection. Mylotarg can cause deadly liver illness, and is not used on patients with history of liver disease.[1]
Also see: Tylenol Recall, Miralax Recall, Lipitor Recall, Johnson and Johnson Recall, Benadryl Recall, Casodex Coupons, Arimidex Side Effects, Motrin Recall, Pfizer Patient Assistance Programs
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