Page:PARAMOUNT Eli Lilly Informed Consent Document.djvu/5

 Studies in mice have shown that pemetrexed is harmful to the unborn fetuses of these mice. This means that pemetrexed may also be dangerous to the fetuses of mothers who are taking pemetrexed

Risks and Discomforts Associated with Other Drugs

Cisplatin

Like any other medication, cisplatin may cause side-effects. Nausea and vomiting, loss of appetite and a general feeling of sickness are the most common. Other reported adverse events are listed below:


 * Gastro-intestinal: Most patients have a loss of taste, stomach-aches and diarrhea. In rare cases inflammation of the mouth and a greyish discoloration of the gums have been reported.
 * Blood production: The number of blood cells (white blood cells, red blood cells and platelets) you have may decrease. As a consequence, this may increase your risk of infection, fatigue, abnormal bleeding and bruising.
 * Hearing: patients might experience tinnitus (ringing in the ears), vertigo (dizziness) or a loss of hearing.
 * Heart: Rarely, cisplatin affects the heart causing a change in heart rate. In very rare cases cardiac arrest has been reported when cisplatin was taken with other chemotherapy drugs.
 * Nervous system: In rare cases a numb feeling, tingling and a feeling of weakness in the limbs, tremor and partial loss of the sense of taste and sight, confusion, indistinct speech or amnesia may be experienced.
 * Urinary tract: Treatment with cisplatin may cause damage to the kidneys (decrease in normal function or kidney failure). In order to reduce the risk of serious kidney damage, plenty of intravenous fluids will be given before and after the administration of cisplatin.
 * Serious Allergic Reactions: including a rash, itching, redness and swelling of the face, trouble swallowing, wheezing, rapid heartbeat and a drop in blood pressure have been rarely reported. These effects may occur within a few minutes after infusion and are treated with appropriate medications.
 * Treatment with cisplatin may also cause symptoms of gout (sensitive, painful, swollen joints).
 * Laboratory Results: Treatment with cisplatin may influence the concentrations of the different substances found in your blood and/or urine.
 * Other: The area where cisplatin is injected may become temporarily swollen and sore. Other rare effects are a loss of hair, sensitive, swollen breasts, problems with fertility and problems with blood circulation.

Dexamethasone or other corticosteroids

The side effects reported by patients taking dexamethasone include edema (fluid retention), high blood pressure, sodium retention and/or potassium loss, increased appetite and weight gain, extreme mood swings, tiredness, depression, inability to sleep, nausea, vomiting. Patients may also experience increased sweating, increaseincreased [sic] blood sugar, irregularities in the menstrual cycle (periods), excess hair, thinning of bone, increased risk of picking up infections or mild infections get worse, hiccups, abdominal pain, stomach ulcers and skin disorders. Additionally some patients reported allergic reactions, blood clots, eye disorders including increased eye pressure. Patients with pre-existing schizophrenia, epilepsy may experience worsening of their disease; patients with heart disease may experience heart H3W-EW-S124 (b) Version: 26-October-2009