Recently, the Swiss pharmaceutical giant Roche to hide the report of the death or side effects by British regulators an urgent investigation. Roche responded that conceal the report “is not intentional.
According to British “Daily Mail” reported this morning, the death or adverse reaction reports is found in the earliest of these reports by the United Kingdom Medicines and Healthcare Products Regulatory Agency to carry out routine inspections to Roche headquarters traced back to 1997, are patients call “report” to the Roche U.S. companies.
reported that these phone records are documented, but they were “sealed” in the box. The staff did not pass these reports to the Roche drug safety staff. For the reason, the report said is unclear.
At present, the UK and EU regulatory authorities have ordered an investigation of Roche, and Roche to conceal actions have been taken.
British Drugs and Health Products Regulatory Agency said that the imperfect Roche’s problem reporting system, the agency is taking urgent action to ensure its immediate correction, but patients should continue taking the drug, the survey also found no patients with evidence of safety risk.
Europe and Drug Administration also said that issuing such a declaration in the Council does not happen often, because the issues involved in number of reports is too large, before taking any action. When asked Will Roche to take legal action, the agency said, “will consider all the options, the relevant departments may be fine.
involving at least eight drugs Roche began to self-examination
reported that the above-mentioned reports involving at least eight drugs, the main treatment for breast cancer, colorectal cancer, hepatitis B, the skin and eyes and other diseases (see table). But it has not confirmed these deaths or side effects and the Roche drug has a direct relationship.
British Drugs and Health Products Regulatory Agency pointed out that every year about 20 000 light in the UK every year there are 10 000 breast cancer patients need treatment, vision problems caused by an increase due to age.
reported that, if regulators found any safety problems, the data survey will determine the recall of these drugs or the doctor to change medication instructions.
In this regard, Roche released the statement in response, the company recognized that patients taking these drugs may have concerns. Did not disclose and deal with the problem report is not intentional, the company is currently take the necessary measures to address these issues.
Roche said it had preliminary assessment report of death, or cause side effects, and eventually involved the number to be determined. And it will handle all the problems with the fastest speed.
report covers eight drugs
breast cancer drug Avastin breast cancer drug Herceptin psoriasis drug Raptiva stroke drug A for the S & P enzyme hepatitis B drug Law School welcomes the rheumatic arthritis medicine care bead single Anti-SARS-Hodgkin’s lymphoma new drug rituximab colorectal cancer drug Tarceva
visits to China
three drugs for sale in China for at least 5 years/P>
reporter learned from the Roche official website this morning, Herceptin, Tarceva and the United rituximab three drugs are sold in China. As the world’s best-selling one of the anti-cancer drugs, Herceptin, listing up to 10 years in China; Tarceva to enter China has reached 5 years; rituximab to enter the Chinese market in 2000, long time to market in China 12 years.
this morning, the reporter called the Roche Media Ministry official told reporters, Roche is currently investigating the matter. As of press reporters, the company and give a formal response.
was established in 1896, Roche is the world’s top 500 enterprises, as early as the 1920s, Roche will be set up in Shanghai office. Roche in Shanghai in 1926 set up a subsidiary fully responsible for the Chinese market until 1950. In 1961, Roche’s return to China. Since then, Roche and exchanges in technology and business continue to increase.