What Is Octagam?
Octagam is a sterilized solution, derived from human plasma, which contains antibodies that aid the immune system in fighting infections and diseases. The product, marketed by Octapharma, is used to treat those who suffer from primary immune deficiency conditions.
The conditions include: congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiencies.
Octagam is actually made from human plasma that has been donated; and, as such can contain virus transmitted through the donor. Moreover, Octagam is known to cause renal (kidney) damage, and it is to be administered with caution for those who suffer from diabetes. All those initial side-effects aside, as recently as September 25, 2010, Octapharma, at the urging of the Food and Drug Administration ("F.D.A."), initiated a market withdrawal of all lots of the product.
The reason Octapharma recalled Octagam is that, as the FDA determined, there have been increased reports of thromboembolic events (blood clots), which have been associated with at least seven (7) of the lots that Octapharma is recalling. Moreover, the recall notice, which can be viewed here, directs all healthcare providers who currently have the product, to quarantine it from their general population of similar products, and contact Octapharma to arrange for return of the product.
The Food and Drug Administration Warnings Against Octagam
As of September 25, 2010 , the F.D.A. released the following warning statement regarding Octagam:
The F.D.A. has warned that although "a root cause of the previously reported thromboembolic events can be determined and the problem corrected, the most prudent course of action is to suspend further administration of octagam."
Thankfully, Octapharma is working with the F.D.A. in the recall; however, the recall, in-and-of-itself, does not remedy those who have been injured by use of Octagam, which is specifically identified as it appears below:
Octagam (Immune Globulin Intravenous (human)) 5% Liquid Preparation
What Are The Side Effects Of Octagam?
The symptoms of Octagam side effects caused by thromboembolic events (which occur when a blood clot, or thrombosis, detaches from where it is affixed, passed through the blood-stream, and clogs a blood vessel) include:
Symptoms of peripheral embolism:
- Paresthesias;
- Tingling;
- Numbness;
- Pain;
- Weakness; and,
- Weak pulse.
Symptoms of brain embolism:
- Suddenly numb or weak in the face, or extremities, on one side of the body;
- Suddenly confused, difficulty with speech or comprehension;
- Suddenly difficult to see with at least one, or even two eyes;
- Suddenly difficult to walk, dizzy; and,
- Suddenly having a headache without observable reason.
Symptoms of kidney embolism:
- Kidney failure; and,
- High blood pressure.
Symptoms of gastrointestinal embolism:
- Severe abdominal pain;
- Nausea;
- Vomiting; and,
- Shock.
These symptoms are, in some patients permanent, thereby robbing them of their quality of lief in some instances, and even potentially causing death in others.
What Is The Mechanism For Injury; and, Which Lots Are Effected?
Octagam has been causally linked to thromboembolic events, and the results of those thromboembolic events can cause significant damage to those who have been administered Octagam.
The lots effected can be seen below:
Legal Help for Octagam Injury Victims
To further understand your rights, consult with an attorney who is knowledgeable regarding the dangerous side effects of Octagam.
If you, a family member, or friend have suffered due to the use of Octagam, please contact a Octagam Injury Attorney at the Finz firm today at (855) TOP-FIRM to speak with an experienced attorney now or fill out the Free Octagam Injury Case Evaluation form.
