If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.
Mozyme Side Effects Reported to FDA
Mozyme Side Effect Report#6073378-3 No Therapeutic Response, Respiratory Failure, Sepsis
This is a report of a male patient (weight: NA) from United Kingdom, suffering from the following health symptoms/conditions: glycogen storage disease type ii, who was treated with Mozyme (alglucosidase Alfa) Powder For Solution For Infusion (dosage: 20 Mg/kg, Q2w, Intravenous, start time:
Sep 23, 2008), combined with: NA. and developed a serious reaction and side effect(s): No Therapeutic Response, Respiratory Failure, Sepsis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Mozyme (alglucosidase Alfa) Powder For Solution For Infusion treatment in male patients, resulting in No Therapeutic Response side effect.
The appearance of Mozyme on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.
Why Your Notes are Important
Your notes could be helpful in several ways:
You can use them to remind you of details that may alert your health care professional(s) to a problem
You will have a record to refer to in the future, in case you are ever prescribed the same medicine again
You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.
Medicine Name and Dosage:
Date & Time
Other Medicine(s) or Treatment(s)
Scale: 1 = very mild to 10 = very bad
Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Mozyme reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.
Genentech, Inc. is voluntarily recalling one lot of Pulmozyme because an unapproved re-filtration step was utilized to remove metal particulates that had been found in the concentrated bulk drum substance.