gammagard การใช้

• The lack of a viral inactivation step at Baxter allowed some hepatitis C to contaminate Gammagard, Bresee said.
• Dozens of patients who were infected because of Gammagard have filed lawsuits against the Deerfield, Illinois-based company.
• Baxter pulled Gammagard off the market in February 1994 after it received reports of patients contracting hepatitis C from the drug.
• Baxter has since added a virus-killing method, and the new product, Gammagard S / D, is safe, the company said.
• So far, more than 130 cases of hepatitis C have been linked to taking Gammagard, according the Centers for Disease Control and Prevention in Atlanta.
• Eleven percent of those who received Gammagard contracted hepatitis C, compared with none of those who were given other immune globulin products, the researchers found.
• Patients who were given the Gammagard batches with the most hepatitis C virus particles, which were found later, had a 29 percent chance of contracting the disease, the researchers said.
• That means only people who received Gammagard between late 1993 and February 1994, when Baxter worked with the FDA to withdraw the product worldwide, might possibly be at risk, Carter said.
• Hundreds, if not thousands, of New Englanders who received an immune-boosting drug may have been exposed to hepatitis C before the drug, Gammagard, was taken off the market last year.
• The charges involve drugs such as Neupogen, which is often prescribed for cancer and HIV patients; Gammagard, for HIV patients; and Epogen, for patients with cancer, AIDS or kidney failure.
• And a review of court records Friday and interviews with plaintiffs'attorneys have turned up at least five lawsuits filed in Massachusetts against Baxter, alleging Gammagard led to the infection in two children and three adults.
• Researchers from CDC, the Food and Drug Administration and Harvard Medical School studied the case records of 341 people who were treated with Gammagard or other intravenous immune globulin products at Children's Hospital in Boston.
• Baxter International Inc .'s blood product Gammagard, used to boost the immune system, was the only product of its kind to infect patients with hepatitis C during an outbreak in 1993 and 1994, according to a study.
• Researchers said they were unable to determine the total number of Americans infected with the liver disease by Gammagard, although they said current estimates are too low, according to the study published in the Journal of the American Medical Association.
• The Massachusetts cases are part of a growing number of suits being filed nationally against Baxter, of Deerfield, Ill ., alleging hepatitis C infections as a result of Gammagard, before the firm took it off the market last year.
• The 15 who tested positive, participants in a Boston study of 300 children and adults receiving various versions of the drug, were all taking Baxter Healthcare Corp .'s Gammagard, according to documents relating to the US-funded research.
• The House Commerce Committee also is investigating, and sent letters last Friday to seven companies requesting detailed records on the pricing of certain drugs, including SmithKline's Kytril, Baxter International Inc .'s Gammagard, and Glaxo Wellcome's Zofran.
• In May, the House Commerce Committee questioned why Baxter International was charging Medicare $ 42.21 per dose for its Gammagard immune globulin, which is used to treat patients with immune deficiencies, when physicans and other providers were paying $ 16.12.
• The Wall Street Journal has reported that an estimated 10, 000 to 50, 000 patients worldwide may have been exposed to hepatitis C-contaminated Gammagard, and that the Food and Drug Administration and Baxter failed to take steps to keep the drug from spreading the bloodborne virus.
• Carter said that while Gammagard had been on the market since 1986, the first reports of hepatitis C infection did not appear until 1993, after the FDA ordered blood product manufacturers to use a more sophisticated test and exclude donated plasma with antibodies to hepatitis C . That order, ironically, may have allowed the virus to slip through, by screening out the antibodies that might have kept any live virus in check.