thromboembolic events, recalls and Noncompliance - oh my

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Re Octapharma is going down!

Octapharma is truly having a lot of problems. You really wonder who is driving this ship because of the way that US Operations is being handled. Octagam may not be out for a while (3rd Quarter) and even if they do get it back not too may people will want to buy it because of the issues that just hit the company in August/September 2010. This may be a slow death for Octapharma! CSL is taking it to all of the IVIG companies!

4 reps were just fired and it is rumored another one just quit! I am sure that more will follow!

Sad situation getting worse by the day.
 






You are right. They're done. No one wants product that they think will kill them. No doctor wants to prescribe an inferior product that may kill their patient. I Wish it was a publicly traded company. I would short the shit out out of it. Octapharma - I fart eight times in your general direction.
 




































What's interesting here is that the fall of Octapharma may hinder the ability of Grifols to merge with Talecris. It may be the thing that the FTC looks to when they try to break the deal up based on concerns over pricing and supply.
 






Regardless of what happens with the Grifols/Talecris merger - at least the plasma supply will be cleaner without Octapharma. Bad OPI plasma and drug could bring the whole industry down a notch. Is anyone really looking at how long that stuff is out of the freezer during morning packing??
 






Re: - oh my!

Octapharma never bought into the PPTA's voluntary QSEAL program that introduced manufacturing voluntary standards higher than the FDA standards. All of the other major manufacturers were on board with these tough standards but Octapharma, regrettably chose not to. However they still remain the largest financial supporter of the Alliance for Plasma Therapies. Why one must ask ? And one must ask how they got into this awful mess.
 






Anonymous said:
Regardless of what happens with the Grifols/Talecris merger - at least the plasma supply will be cleaner without Octapharma. Bad OPI plasma and drug could bring the whole industry down a notch. Is anyone really looking at how long that stuff is out of the freezer during morning packing??
Click to expand...

Nope no time record. The FDA will see that. It could be out for more than an hour and no one would notice. For that matter, no one really keeps track of how long it is sedentary after it's collected. Some of the centers don't use timers so who knows how long before it's frozen. It gets shiped hemolyzed, icteric, and lipemic just the same.
 






The reality is not reality at all. It is comic relief def jam style. The gradient folds have remained unfolded while the production flags fly at half staff. The winds of misfortune are blowing briskly as the white caps erode the shoreline, for sure. Octapharma has been built on quick sand and the regulatory tides are washing it slowly out to sea. Shipwrecked is a possible fate but only King Neptune can be sure. As far as I know he has never been formerly introduced to Mr. Magoo. That may be for the better! Finding Nemo may be the easier of hunts. Finding OctaPharma salvation and redemption may be lost in translation.
 






























CBER had concerns over Octagam from the start:
(Like my colleague says: Last one out, turn off the lights.)

CBER's Office of Compliance and Biologics Quality reviewed a card file and dosage guide for Octagam 5% [Immune Globulin Intravenous (Human)], which were disseminated at the Octapharma booth at the American Academy of Allergy, Asthma and Immunology meeting in San Antonio March 18-22.

The agency also reviewed the company's website and determined the file card, dosage guide and website were misleading because they failed to reveal the risks and contained unsubstantiated safety, effectiveness and/or superiority claims.

According to the FDA-approved PI, Octagam is a solvent/detergent treated, sterile, 5% liquid preparation of highly purified, immunoglobulin G (1gG) de rived from large pools of human plasma. Octagam is indicated for treatment of primary immune deficient disease, such as congenial agammaglobulinemia agammaglobulinemia /agam·ma·glob·u·lin·emia/ (a-gam?ah-glob?u-li-ne´me-ah) absence of all classes of immunoglobulins in the blood. See also hypogammaglobulinemia. and hypogamma globulin globulin, any of a large family of proteins of a spherical or globular shape that are widely distributed throughout the plant and animal kingdoms. Many of them have been prepared in pure crystalline form. common variable immunodeficiency Common Variable Immunodeficiency Definition

Common variable immunodeficiency is an immunodeficiency disorder characterized by a low level of antibodies. Patients with this disease are subject to recurring infections. .


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The PI included a black box warning regarding reports of renal dysfunction, acute renal failure acute renal failure Acute kidney failure Nephrology An abrupt decline in renal function, triggered by various processes–eg, sepsis, shock, trauma, kidney stones, drug toxicity-aspirin, lithium, substances of abuse, toxins, iodinated radiocontrast. , osmotic nephrosis nephrosis (nəfrō`səs), kidney disease characterized by lesions of the epithelial lining of the renal tubules, resulting in marked disturbance in the filtration function and the consequent appearance of large amounts of protein (albumin) and death associated with the use of this product. But, although the website mentioned adverse drug reactions, there was no additional information on contraindications, black box warnings or other warnings.

Moreover, the file card contained text stating, "Unsurpassed viral safety." FDA FDA
abbr.
Food and Drug Administration

FDA,
n.pr the abbreviation for the Food and Drug Administration. said it was unaware of data consisting of substantial evidence or clinical experience supporting this claim.

Finally, Octapharma USA failed to submit its promotional material to FDA at the time of initial dissemination. AE, F-B, PMA; Doc. 13579W
 






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