Side effects (also called "adverse effects" or "adverse events") refer to the unintended or undesirable events subsequent to use of a medical treatment. They can sometimes be minor, but they can also involve serious health issues.
IMPORTANT: Talk to Your Doctor First!
If you believe you're experiencing side effects – or any other medical problems – the first thing you should do is contact your doctor or other health care providers so they can determine if any action needs to be taken.
All medications have risks as well as benefits. Before a medication is made widely available to patients, it undergoes rigorous clinical research to test its safety. Regulatory agencies such as the U.S. Food and Drug Administration (FDA) review this research thoroughly and grant approval to treatments whose benefits are determined to outweigh their risks. To ensure ongoing patient safety, these agencies also require companies like Sanofi Genzyme to continue studying the side effects of our products even after approval.
Sanofi Genzyme takes this responsibility very seriously. We conduct formalized post-approval studies, and we encourage all patients and their health care providers – even those not involved in studies – to communicate with us about any possible side effects. We in turn report this information to regulatory agencies and work with them and other medical experts to assess the information and determine any necessary course of action.
Reporting to the FDA
You are encouraged to report negative side effects of prescription drugs directly to the FDA via its MedWatch program:
If you are a patient in the United States taking a Sanofi Genzyme product and you are experiencing side effects, please inform us of your experience. (If you are outside the U.S., speak with your health care provider about local reporting requirements.)
To report side effects, call Sanofi Genzyme Medical Information at 800-745-4447, option 2. A Sanofi Genzyme representative will take your preliminary information; after reviewing it we may follow up with you or (with your permission) your physician for additional details.
Before you contact Sanofi Genzyme, please have the following information ready:
- Patient name, age, gender, and weight
- Patient phone number
- Physician name and phone number
- Sanofi Genzyme product taken and dosage
- Brief description of side effects