FDA Warns Leukemia Patients that Blood Disorder Could Result from Taking Idhifa (Enasidenib)
The U.S. Food and Drug Administration (FDA) issued an urgent warning to Leukemia patients prescribed Idhifa. The FDA communication released on November 29, 2018, indicates that Idhifa patients are at a higher risk of suffering from a blood disorder that could go undiagnosed by doctors. The FDA warns that differentiation syndrome, or retinoic acid syndrome, can be fatal and symptoms must be treated immediately in cancer patients suffering from acute myeloid leukemia. The FDA suggests that early detection of the signs and symptoms of differentiation syndrome can save a patient’s life.
Parker Waichman LLP, a national plaintiff’s law firm, is currently accepting clients who personally or a member of their family suffered from differentiation syndrome while taking Idhifa for acute myeloid leukemia and there was a misdiagnosis, failure of diagnosis, or slow diagnosis that lead to increased health complications or death. Parker Waichman LLP’s Idhifa side effect attorneys have extensive experience bringing claims on behalf of clients against major drug manufacturers for failing to warn about the potential side effects caused by a drug or for having a defect in its manufacturing process that led to severe injury, illness, or death.
Failing to Diagnose Differentiation Syndrome Could Be Fatal
The FDA requires enasienib manufacturers to include in their literature a warning that differentiation syndrome is a possible side effect. In fact, information concerning differentiation syndrome must be included within the “boxed warning” on Idhifa’s label. The FDA clarified, however, that doctors were failing to diagnose differentiation syndrome in patients despite knowledge of Idhifa’s potential side effects. The failure to diagnose this medical condition can result in the patient becoming extremely ill and possibly dying. Accordingly, the FDA recommends that patients report symptoms of differentiation syndrome as soon as possible and physicians treat the illness aggressively.
Symptoms of Differentiation Syndrome
The symptoms of Differentiation syndrome vary and may present as an ordinary respiratory infection and are therefore easily confused with or concealed by another illness or infection. However, the FDA lists the most common symptoms of Differentiation Syndrome as:
- A fever,
- Severe shortness of breath accompanied by a cough. The patient’s shortness of breath could require the use of supplemental oxygen,
- Swelling of the arms and legs, as well as around the groin, neck, and underarm areas,
- Rapid and substantial weight gain of ten pounds or more in one week,
- Pain that feels deep in the bones, and
- Dizziness or loss of balance.
A person suffering from any one or a combination of these symptoms and who is taking Idhifa must see a doctor or go to an emergency room as soon as possible. The FDA notes that symptoms can occur as recent as ten days after the first infusion of Idhifa up to five months after. Although the symptoms of differentiation syndrome appear to be primarily respiratory in nature, the cause of the syndrome may be found in myeloid cells in the patient’s blood that proliferate and then differentiate.
The FDA suggests that the proper way to treat differentiation syndrome is with a heavy dose of corticosteroid medication. According to the FDA, doctors should prescribe 10 mg every 12 hours while continuing with Idhifa unless the patient has been intubated for 48 hours.
The FDA is Well Aware of the Potential Problems with Idhifa
The FDA approved Idhifa for use in mid-2017 even though the agency continues to measure the efficacy and danger of the drug. The FDA indicated that five people died from differentiation syndrome between May 1, 2018, and July 31, 2018, while taking Idhifa from differentiation syndrome either on its own or as a complication associated with other medical conditions.
Justice is a Phone Call Away
Someone suffering from acute myeloid leukemia already has a difficult fight, and it should not be compounded by reckless drug makers who race drugs to market with the rubber stamp approval of the FDA. That is why Idhifa injury attorneys from Parker Waichman LLP are ready to fight for justice for you and your family. Call 1800-YOURLAWYER today to find out more.
Sources:
FDA Safety Announcement
UpToDate: Differentiation syndrome associated with the treatment of acute leukemia
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