Monitoring the safety of a drug during clinical trials AND after is called pharmacovigilance. “Pharma” comes from the Greek word “pharmakeia”—for drugs, medicines, or remedies. “Vigilance” is from the Latin “vigilantia,” meaning wakefulness, watchfulness, or attention.
At Genentech, over 2000 employees monitor and analyze reports of adverse events from healthcare providers and people like you.
An adverse event is any concerning issue that arises when someone is taking a medication, even if the connection between the event and the medication is not obvious.
We partner with the community to collect global data that are studied in aggregate to look for patterns. This gives us the clearest, most robust, and constantly evolving picture of how a drug is working in a real-world setting.
Every adverse event report is thoroughly reviewed, and follow-up is performed if more information is needed to fully analyze it.
If we identify that the balance of beneﬁt to risk of a medicine has changed, we proactively notify the FDA and determine if the medication's package insert or label should be updated. These updates are then shared with healthcare professionals and the community.
Help us stay vigilant. If you or someone you know experiences an adverse event while taking a Genentech medication, inform your healthcare professional and contact Genentech right away.
Adverse events may be reported to Genentech at (888) 835-2555. You may also report adverse events to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
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