Reporting Arava Side Effects to the FDA

MedWatch is the FDA's program that allows consumer to report serious reactions and problems with medical products. So far, there have been at least 130 cases of severe liver problems (hepatoxicity) and 22 deaths since Arava's arrival to the market in 1998. It is estimated that there is a 10-100 fold of underreporting that occurs with a drug's adverse effects. Not reporting serious adverse Arava side effects can result in continued instances of death and serious health conditions that may have been prevented. If you, or a family member, have suffered the serious and potentially deadly Arava side effects, it is encouraged for you to report it, and there are several different reporting options available.

Your health care provider or the FDA online reporting form allows consumers to notify the FDA of important and useful information regarding patient safety. The FDA's MedWatch has outlined the injuries that constitute a serious adverse event. If you, or a family member, have experienced any of these adverse Arava side effects you are encouraged to report it to the FDA. To learn your legal rights regarding Arava, contact us to receive your free consultation with an expert Arava attorney.

Death
Report if the patient's death is suspected as being a direct outcome of the adverse Arava event.
Life-Threatening
Report if the patient was at substantial risk of dying at the time of the adverse Arava event or it is suspected that the use or continued use of the product would result in the patient's death.
Hospitalization (initial or prolonged)
Report if admission to the hospital or prolongation of a hospital stay results because of the adverse Arava event.
Disability
Report if the adverse Arava event resulted in a significant, persistent, or permanent change, impairment, damage or disruption in the patient's body function/structure, physical activities or quality of life.
Congenital Anomaly
Report if there are suspicions that exposure to a medical product prior to conception or during pregnancy resulted in an adverse outcome in the child.
Requires Intervention to Prevent Permanent Impairment or Damage
Report if you suspect that the use of Arava may result in a condition, which requires medical or surgical intervention to preclude permanent impairment or damage to a patient.

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