Safety Alerts & Recalls

What does this mean?

At this time, there have been no adverse event reports linked to particle contamination from Thyrogen. However, you should be aware that injecting solutions with particle contamination can cause adverse effects including pain, swelling, and inflammation at the injection site. It is also possible that the foreign particles could affect how well these products work.

If you are receiving Thyrogen injections, you may want to discuss these new risks with your health care provider and ask if there are other treatments that are appropriate for you.

After you receive an injection of Thyrogen, watch for redness, pain, discoloration, or hardness at the injection site and contact your doctor or other health care provider if these symptoms occur.

Possible Contamination of Thyrogen

The FDA has issued a warning about the potential for foreign particle contamination of several products made by Genzyme Corporation that are used to treat rare, serious, and life-threatening diseases. The contaminating particles include stainless steel fragments, non-latex rubber from the vial stopper, and fiber-like material from the manufacturing process. It is estimated that foreign particles have occurred in less than 1% of Genzyme's products. This problem affects all lots of Thyrogen (thyrotropin alfa) which have the prefix " A" (e.g. Lot A12345).

Thyrogen (thyrotropin alfa) is an intramuscular (IM) injection used as a diagnostic tool and treatment for thyroid cancer. Because other treatments may not be appropriate for some patients and there is a critical need for a continued access to Thyrogen, the FDA has decided to allow Thyrogen to continued to be marketed. However, the FDA has provided recommendations to health care providers for added steps to the preparation and administration of Thyrogen to reduce the risk of administration of a contaminated product.

The FDA is actively investigating the nature of the contamination and is working with Genzyme to identify corrective actions to manage the situation.

For more information, please visit: more information here

Source: FDA
Publication Date: 2009-11-14
Last Updated: 2009-12-18

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