PPTA Statements

PPTA Statement: Proven Safety of Human Albumin

Statements in the international media have described the events resulting from the retraction by several leading medical journals of a large number of articles describing scientific studies by a German physician, Joachim Boldt. Boldt was dismissed from his position as head of anesthesia in the Klinikum Ludwigshafen in the state of Rheinland-Pfalz in Germany in November 2010, following initial findings by a leading anesthesia journal that a paper describing a clinical study which Boldt published in the journal had been fabricated.

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Human Parvovirus PARV4 and plasma protein therapies

Parvoviruses are small, non-enveloped DNA viruses that infect both vertebrate and invertebrate hosts. The human Parvovirus PARV4 has first been described in 2005 by Jones et al. For PARV4 no associated disease or specific symptoms have been observed.

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Statement on the Safety of Plasma Protein Therapies and Swine Influenza Virus

PPTA member companies are committed to providing safe and effective therapies and PPTA understands that patients who rely on these often life-saving therapies may have concerns about the possible transmission of Swine Influenza Virus through them in view of the recent outbreak in humans. Therapies produced by PPTA members remain safe and available.

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PPTA Statement on Safety of Plasma Protein Therapies and the H5N1 Virus es

PPTA members are committed to providing safe and effective therapies and PPTA understands that patients who rely on plasma protein therapies may have concerns about the possible transmission of highly virulent strains of influenza H5N1 viruses through these therapies. Therefore, PPTA members continue to work to ensure that these viruses or any other emerging disease, do not compromise the safety of plasma protein therapies.

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Statement on Update on Safety of Albumin

[FDA Blood Products Advisory Committee: July 21, 2005]

The Plasma Protein Therapeutics Association (PPTA) appreciates actions taken by the FDA and the Blood Products Advisory Committee (BPAC) with respect to the safety of albumin.

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