- According to the medication's prescribing information, 47.5 percent of patients receiving AmBisome during the largest clinical trial of the drug experienced chills, while 39.7 became nauseous, 31.8 percent vomited and 30.3 percent developed diarrhea. More than 10 percent of patients also experienced abdominal pain, anxiety, back pain, blood infections (i.e., sepsis), bloody urine, chest pain, confusion, decreased blood pressure, fluid buildup in the lungs, headache, increased blood pressure, increased cough, infections, insomnia, itching, lung disorders, nasal irritation, negative reactions to blood transfusions, nosebleeds (i.e., epistaxis), racing heartbeat (i.e., tachycardia), rash, upset stomach, weakness or whole-body pain.
- In addition to the physical effects, AmBisome produces adverse chemical changes in many patients. Clinically significant deficiencies in potassium---a condition known as hypokalemia---occurred in 42.9 percent of AmBisome-treated patients. Measurable drops in blood sugar, sodium, calcium and magnesium also occurred in between 4.1 percent and 23 percent of patients. Conversely, AmBisome injections significantly raised many patients' levels of freely circulating kidney and liver metabolism byproducts that should normally be excreted through urine and feces.
- Side effects that have been experienced by between 2 percent and 10 percent of patients receiving AmBisome include: abdominal swelling, facial swelling, neck pain, slowed or irregular heartbeat, flushing, new-onset heart disease, fecal incontinence, loss of appetite, liver damage, dry mouth, anemia, poor blood clotting, joint pain, muscle stiffness, dizziness, convulsions, somnolence, asthma, flu-like syndrome, respiratory failure, hair loss, injection-site reactions (such as redness and irritation), dry eyes, kidney failure and vaginal bleeding.
- A fact sheet prepared for MedlinePlus begins with the general warning that amphotericin B, the active ingredient in AmBisome, "can cause serious side effects. This medication should only be used for the treatment of potentially life-threatening ... infections and not to treat less serious ... infections of the mouth, throat, or vagina in patients with a normal immune system." AmBisome's prescribing information specifically warns that the administering of the drug should stop as soon as a patient shows symptoms of having a serious allergic reaction, such as suddenly breaking out in hives or losing consciousness.
- Care must be taken when AmBisome is administered to patients who are also receiving nitrogen mustard to treat cancer, or who are receiving certain antibiotics, other medications to treat fungal infections, or oral corticosteroids. Antibiotics of concern include gentamicin (e.g., Garamycin from Akorn) and neomycin (Neo-Fradin from X-Gen), while antifungals that can interact with AmBisome include fluconazole (e.g., Difulcan from Pfizer), itraconazole (e.g., Sporanox from Ortho-McNeil Janssen), and ketoconazole (e.g., Nizoral from Ortho-McNeil Janssen). The oral steroids of concern include dexamethasone (Decadron, Dexone) and prednisone.
previous post
next post