Roszdravnadzor has withdrawn from trafficking the drug “Avastin”, introduced blinded to the patients in the research Institute. Helmholtz
Federal service on surveillance in healthcare (Roszdravnadzor) has suspended the implementation of the drug “Avastin”, after which apply some patients of the Moscow research Institute of eye diseases named after Helmholtz, according to media reports, lost vision. The corresponding message was published on the official website of the Department.
We are talking about the withdrawal from circulation of the drug “Avastin concentrate for solution for infusion 100mg/4ml, vials(1), pallets cardboard (1), packs cardboard” series В7035 production “F. Hoffmann-Laroche Ltd., Switzerland/Packed CJSC “ORTAT” Russia”.
“The Ministry offers the subjects of circulation of medicines, medical institutions to carry out checks for the specified series of the medicinal product, the results of which inform the territorial body Roszdravnadzora”, – added in Department.
The territorial bodies of the Federal service has also been instructed to ensure control over the detection and withdrawal from circulation of the specified series of the medicinal product and inform Roszdravnadzor about the work done.
October 4 in Moscow research Institute of eye diseases named after Helmholtz reported improvement in the patients, which, according to the previously leaked information in the media, lost his sight after the injection of the drug “Avastin”. The Institute leadership has questioned the quality of the entered drugs, not the clinic.
On the stabilization of patients ‘ condition reported the chief doctor of the Institute. Helmholtz Marina Kharlampidi. “All patients who got complications after the introduction of the drug “Avastin” September 26, is out of surgery and feel well”, she explained.
Kharlampidi, said that all the victims were shot “Avastin” patients “with severe progressive diseases of the eye, was at the dispensary, and some of them had different groups of disability.” “The appropriate treatment they were shown, as this is the only way to stop the progression of the disease,” – said the chief doctor.
At the same time, Kharlampidi gave to understand that the clinic staff had every reason to apply the “Avastin” for the treatment of their patients. “I would also like to note that this drug recommended by the world health organization for the treatment of these diseases, the who experts acknowledged that use of the drug greater than the risk of side effects with the drug inside the eye,” concluded the doctor.
The day before the Investigative Committee informed on excitation of criminal case in connection with the received information in the media about the loss of vision in several patients of the Moscow research Institute of eye diseases. Helmholtz. The case was brought on signs of the crime under part 1 of article 238 of the criminal code of Russian Federation (“Rendering services not meeting safety requirements”).
According to investigators, in September in the small operating room of the clinic of eye diseases, located on the street Suvorov in Moscow, 11 patients were rendered medical service that does not meet the security requirements of the health consumer. It is established that the victim held unregistered in accordance with the instructions on the application of intravitreal (eye) injection of the drug “Avastin”, which came partial loss of vision, have explained in SK.
In the company “Roche” producing “Avastin”, the version of the investigators actually confirmed. The firm reported that the drug is not registered for use in ophthalmology. The assurance of the representative of “Rosh” in the instructions for use there is a warning that the drug is not intended for intravitreal injection (method of administering drugs by injection directly into the vitreous body of the eye. – Approx. NEWSru.com). In addition, the company had previously informed the health Ministry about the cases of patients with heavy defeats of organs of vision in the application of “Avastin” for unregistered indications in ophthalmology. The company promised to contribute to the investigation of the situation with the loss of vision in treated in the clinic of eye diseases named after Helmholtz.
The investigative Committee drew attention to the situation in the clinic on September 30, when the resonant story of lost sight patients hit the media. The head of the Ministry of health Veronika Skvortsova gave Roszdrava order to carry out an inspection on this fact.