Omontys recall has caused many serious health problems, including anaphylaxis, hypersensitivity reactions, and tumor progression. This article explores what you should know about this recall. You may be able to find answers to your questions through our lawsuit information. If you have any questions about the recall, feel free to contact us. Our attorneys work on contingency, which means that we won’t get paid until you win your case.
Omontys recall caused anaphylaxis
The company Affymax is a smaller manufacturer of late-stage drugs that hoped Omontys would be able to compete with the only other drug for kidney dialysis anemia, Epogen. Though Affymax hasn’t withdrawn the potentially defective drug, it has asked health care providers to stop using the product and quarantine their supply until further notice. The company will also hold a conference call with investors later this week.
Peginesatide, the active ingredient in Omontys, has been recalled by the manufacturers. The drug was linked to 3 deaths. The FDA approved peginesatide in March 2012, and it is sold in ten and twenty-mg multidose vials. Despite its safety, some patients have experienced severe hypersensitivity reactions and anaphylaxis.
The investigation into the causes of the Omontys recall will take time. Ideally, the investigation will start by looking at the raw materials used in production. Also, lab records of analytical work and deviations from standard operating procedures will be scrutinized. If it finds a common cause, it could lead to a lawsuit. Meanwhile, patients affected by the recall may be eligible for compensation. The investigation is ongoing and further information will be released in due course.
Omontys causes hypersensitivity reactions
The use of the anesthetic Omontys has caused several reports of severe allergic reactions. The drug, synthetic erythropoietin mimetic, was approved by the Food and Drug Administration (F.D.A.) in March 2012. It was intended to treat anemia in hemodialysis patients who suffer from chronic kidney disease. The drug comes in multidose vials of 10 or 20 mg.
The drug was approved by the FDA in March 2012, but it was recalled two months later due to serious adverse reactions, including fatalities. The drug is manufactured by the same company that developed Epogen. It is distributed Nationwide by specialty distributors. However, it is important to note that there is no clear link between Omontys and these allergic reactions. It is unknown if the drug is to blame or whether Omontys causes hypersensitivity reactions.
The FDA recalled the drug because of severe hypersensitivity reactions. The drug contains peginesatide, an erythropoiesis-stimulating agent, which helps to form red blood cells. The drug was approved by the FDA in March and was used in dialysis centers across the United States to treat anemia. However, the drug-seller Affymax notified the FDA of 19 reports of anaphylaxis from patients receiving the medication. Among those who experienced anaphylaxis, three of them died. Other patients required prompt medical attention and hospitalization.
Omontys causes tumor progression
Affymax filed a Form 10-Q in November 2012 stating that it would revise the label of Omontys to alert physicians about the possibility of serious allergic reactions. The revision reflected post-marketing reports of serious allergic reactions and tumor progression. During the time that Confidential Witness 2 was employed by Affymax, the company filed more than one thousand Adverse Event reports. But the FDA has yet to take action against the drug maker.
Affymax, based in Palo Alto, Calif., has partnered with Takeda, a big Japanese pharmaceutical company, to develop MONTHS. This collaboration will provide additional data on OMONTYS’s safety and potential attributes. The company has partnered with Takeda, a world-renowned biotech company, to commercialize the drug. But it will take time for the drug to reach the market.
The plaintiffs’ evidence is based on a 99-page Adverse Event Report, which lists adverse reactions associated with Omontys as reported to the FDA by the manufacturer. The study includes both patient and health care professional reports. The plaintiffs and defendants concede that the Adverse Event Report is accurate and relevant. The plaintiffs will likely seek a jury trial and will present all available evidence to prove their case.
