Thyrogen Drug Used for Thyroid Cancer Treatment is Contaminated with Trash, Says FDA

[brat789]

I figured this was worth posting. Since we don't know where Morgellons originated this is food for thought. Contamination seems to be everywhere in our food and drugs. How many recalls in the last few years on beef, spinach, tomatoes...just to name a few. Now Thyroid cancer patients have been taking drugs contaminated with rubber, steel and fiber. Just what a cancer patient needs in their system. Makes you wonder how many other things are/were contaminated that they don't now about yet. It says this is the second time for this drug company, before it was viral contamination. Great...take medication to get sicker!


Thyrogen Drug Used for Thyroid Cancer Treatment is Contaminated with Trash, Says FDA
Thyrogen Drug Used for Thyroid Cancer Treatment is Contaminated with Trash, Says FDA
Friday November 13, 2009
This is not good news for thyroid cancer patients who rely on the drug Thyrogen (thyrotropin alfa). The Food and Drug Administration (FDA) has announced that they have found small particles of steel, rubber and fiber -- trash basically -- in vials of their drugs, including the thyroid drug Thyrogen. They also reported that this contamination could cause serious health effects for patients.
This is the second time just this year that Genzyme has been cited by the FDA for contamination of their products. In June of this year, Genzyme had to shut down a key production facility due to viral contamination. (Read FDA press release in PDF format, and Genzyme release.)

In addition to Thyrogen, other Genzyme drugs affected by the current contamination issue include Cerezyme, Fabrazyme, Myozyme, and Aldurazyme.

The FDA is not removing the products from the market, because they say that there are few alternatives to these drugs. The FDA is recommending, however, that practitioners take the following actions:

Discuss with patients and families the potential for foreign particle contamination and development of adverse events, taking into account the clinical necessity of these products, and the risks associated with untreated illness.
Visually inspect the powder in the vial for the presence of particles, before reconstitution.
Visually inspect the reconstituted powder (in solution) and the Aldurazyme solution for the presence of particles.
Do not use any product with visualized particles. Return contaminated products to Genzyme Corporation (1-800-745-4447, option 2).
Monitor for local or systemic allergic reactions after administration.
Consider the clinical utility of levothyroxine withdrawal, an effective and well-established alternative to Thyrogen, versus the potential safety risks from administration of Thyrogen that may contain foreign particles.

[brat789]

According to their site they also make these drugs...most for pretty serious life threatening illness. I wouldn't trust any of their medications.


Aldurazyme®
Aldurazyme (laronidase) is an enzyme replacement therapy for mucopolysaccharidosis I (MPS I).


Campath®
Campath (alemtuzumab for injection) is indicated for the treatment of B-cell chronic lymphocytic leukemia in patients who have been treated with alkylating agents and have failed fludarabine therapy.


Carticel®
Carticel (autologous cultured chondrocytes) employs a unique process to grow a patient’s own cartilage cells for implantation to correct certain types of knee cartilage damage.


Cerezyme®
Cerezyme (imiglucerase for injection) is an enzyme replacement therapy for Type 1 Gaucher disease.


Clolar®
Clolar (clofarabine) is indicated for the treatment of children with refractory or relapsed acute lymphoblastic leukemia (ALL).


Epicel®
Epicel (cultured epidermal autografts) is a permanent skin replacement product that is available for patients with life-threatening burns.


Fabrazyme®
Fabrazyme (agalsidase beta) is an enzyme replacement therapy for Fabry disease.


Hectorol®
Hectorol (doxercalciferol) is indicated for the treatment of secondary hyperparathyroidism in patients with stage 3 or stage 4 chronic kidney disease and patients with stage 5 chronic kidney disease on dialysis.


Mozobil®
Mozobil (plerixafor injection), is indicated for use in combination with granulocyte-colony stimulating factor (G-CSF) to mobilize hematopoietic stem cells to the bloodstream for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma.


Myozyme®
Myozyme (alglucosidase alfa) is an enzyme replacement therapy for Pompe disease.


Renagel®
Renagel (sevelamer hydrochloride) is a calcium-free, metal-free phosphate binder that controls serum phosphorus levels in patients with chronic kidney disease on hemodialysis.


Renvela®
Renvela (sevelamer carbonate)is a next-generation version of Renagel® (sevelamer hydrochloride), the most-prescribed phosphate binder in the United States.


Seprafilm®
Seprafilm is a temporary, physical adhesion barrier for abdominal and pelvic adhesion prevention.


SynviscOne™
Synvisc-One™ (hylan G-F 20) and SYNVISC® (hylan G-F 20) are used to relieve knee pain due to osteoarthritis (OA). They are for patients who do not get enough relief from simple painkillers such as acetaminophen, or from exercise and physical therapy.


Thymoglobulin®
Thymoglobulin [Anti-thymocyte Globulin (Rabbit)] is an immunosuppressive polyclonal antibody that is used in conjunction with concomitant immunosuppression to treat acute rejection in kidney transplant patients.


Thyrogen®
Thyrogen (thyrotropin alfa for injection) is an adjunctive diagnostic used in follow-up screenings of cancer patients with well-differentiated thyroid cancer who have had their thyroid glands removed.