AstraZeneca is committed to protecting the
Safety of patients exposed to our drugs.
All pharmacologically effective drugs have benefits and risks. The risk may be insignificant or may be acceptable in relation to the drug's therapeutic action. The continued monitoring of the safety of a product throughout the duration of its use, helps to ensure that its risk and benefits remains acceptable
- To identify rare and very rare side effects
- Regular review of safety database for new risks or signals
- To provide current and accurate updates on safety profiles of the drugs
- Identification of different profiles of known adverse reactions with regards to severity, nature or outcome
In lay terms an adverse event may also be known as a side effect. In simple terms, an adverse event is any unwanted response to a medication.
An adverse event can be a symptom (feeling) that you have such as nausea or chest pain.
It may also be something that can be observed such as rash, fever, or a rapid heart rate.
An abnormal test result would also be an adverse event – e.g. raised blood sugar level.
An adverse event is also the worsening of a medical condition that you had prior to taking the medication – i.e. if you had a history of headaches, and the headaches increased or became more frequent after taking the medication, then this would also be considered an adverse event.
Adverse events are not necessarily caused by the medication – they are just associated with its use – i.e. the adverse event just needs to have occurred after you or the patient took the medication.
The minimum details needed to make a valid case are:
Patient- Identifying details Eg. Age, sex and Initial
Event- The adverse, side effect details
Reporter- Physician’s name, phone number
Drug- Medicine(s) taken by the patient
Contact Us at:
Email:
med.info3@astrazeneca.com
Tel No: 1 800 4252031
Click here to Download The Adverse Event Reporting Form
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