<"https://www.yourlawyer.com/practice_areas/defective_drugs">Octagamâ€”Immune Globulin Intravenous (human) 5% Liquid Preparation is being withdrawn from the market due to risk of Thromboembolic eventsâ€”some seriousâ€”both the US Food and Drug Administration (FDA) and Octapharma USA just announced. Healthcare professionals have been advised that, effective immediately, Octapharma is initiating a voluntary market withdrawal of ALL lots of Octagam in the US market.
Octapharma determined, through consultation with the public health authorities at FDA, that until 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. Customers are asked to immediately quarantine the use of these lots and contact Octapharmaâ€™s Customer Service Department to arrange for product return.
Nine thromboembolic events were potentially associated with seven of the lots being withdrawn from the market.
Octagam is indicated for treatment of primary humoral immunodeficiency (PI), such as congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
Medscape noted that the withdrawal is being conducted while Octapharma investigates blood clots and embolisms linked to Octagam. On August 24, said Medscape, the agency announced that Octapharma was recalling 31 lots of the biologic. The company, at the FDAâ€™s request, has begun withdrawing all lots prepared in the United States.
“The FDA and Octapharma agree that until a root cause of the previously reported thromboembolic events can be determined, the most prudent course of action is to suspend further administration of Octagam,” the company stated in a press release, quoted Medscape.
Reuters just reported that in Europe, drug regulators are recommending that the Octogam license be suspended and all Octagam currently on the market there be recalled. The move could help Baxter, CSL, and Grifols, and other immunoglobulin product suppliers, noted Reuters. Spanish drug maker Grifols it would meet hospitals’ increased need for the drug, noted Reuters.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) took a look at the biologic after Germany and Sweden suspended Octagam marketing authorization following an increase in thromboembolic reaction reports such as stroke, heart attack, and pulmonary embolism in patients being treated with the biologic, said Reuters.
The increase in adverse reports could be connected with issues surrounding how the medication is processed during manufacture, said Reuters.
“As the medicine will no longer be made available, the agency recommends that doctors should stop using Octagam and should switch their patients to the most appropriate alternative treatment,” EMA said.