ID Alert - June 2000
ID Alert - June 2000
The FDA has given full approval to Zyvox (linezolid). Produced by Pharmacia Corp, it is the first of the long-awaited new class of antimicrobials, the oxazolidinones. The oxazolidinones are specifically targeted to combat antibiotic-resistant organisms.
Linezolid reportedly has a mechanism of action different from that of Synercid (approved last fall for use against vancomycin-resistant organisms) and older drugs. It works to halt bacterial replication by inhibiting protein production early in the growth cycle.
The FDA says results of clinical trials show linezolid is effective in fighting both methicillin- and vancomycin-resistant infections. The drug is also approved for use against pneumonia and skin infections.
Pharmacia plans to make intravenous and oral forms of the drug and says both should be available within a few weeks.
The FDA recommends that administration of linezolid be initiated in a hospital or nursing home setting, although therapy may be concluded at home. The drug reportedly will be priced slightly lower than competitor Synercid.
The federal government's Advisory Committee on Immunization Practices has issued its recommendations regarding next season's flu vaccine, making substitutions for 2 of the 3 strains and lowering the recommended age for inoculation.
The committee is now advising people aged 50 to 65 to get the flu vaccine, citing statistics indicating that almost one third of adults in that age group have at least 1 medical condition that places them at high risk for flu-related hospitalization or death. Previously, the recommendation included only adults aged 65 or older.
The composition of the vaccine itself should also be changed, says the committee. Officials recommend that the vaccine include 2 new type A strains (A/Moscow and A/New Caledonia). These strains, which were first identified in 1999, will replace the A/Beijing and A/Sydney strains included in last year's vaccine. The CDC confirms that the B/Beijing strain will also constitute part of the vaccine.
The European Agency for the Evaluation of Medicinal Products (EMEA) has issued an urgent safety restriction on Viramune (nevirapine), Boehringer Ingelheim's AIDS drug, after receiving numerous reports of cutaneous and hepatic reactions.
The reactions, which have sometimes been fatal, have been associated with risk factors such as lack of adherence to dosing regimens and failure to promptly seek evaluation when adverse reactions first appear. Most cases of hepatitis occurred within the first 8 weeks of treatment, the agency says. The EMEA calls the first 8 weeks of therapy "critical," and recommends that during that time physicians closely monitor patients for signs of skin reactions, hepatitis, and hepatic failure. They also recommend that initial dosing regimens be closely adhered to. If a serious cutaneous reaction, a hypersensitivity reaction, or hepatic complications do develop in a patient who is taking nevirapine, treatment should immediately be terminated.
The United States military may be forced to suspend its anthrax inoculation program this summer because of a shortage of new supplies of the vaccine. The FDA has suspended production of the vaccine by Michigan-based Bioport Corp and has not yet approved existing supplies for distribution.
One official from the congressional General Accounting Office cites cash flow difficulties at Bioport as well as various problems with the way the company has conducted research on the vaccine as the reasons for production suspension.
A US House of Representatives subcommittee report, which was filed earlier this year, recommended that the Pentagon's mandatory vaccination program be changed to a voluntary system until a new vaccine is developed and perfected.
Red Book Available
The new edition of the Red Book, the authoritative reference source on control of infectious disease in children, has just been published by the American Academy of Pediatrics. Many of the changes in this latest edition -- the first in 3 years -- pertain to vaccine recommendations. Other revisions concern diagnosis and management of Lyme disease, rotavirus infection, varicella, polio, parasitic infections, fungal diseases, hepatitis A and C, and staphylococcal and streptococcal toxic shock syndrome. An updated list of related Web sites is also included. Copies may be obtained from the Academy at: http://www.aap.org/.
Contrary to promising earlier reports, the antiviral drug pleconaril does not appear to reduce the duration of the common cold any more than placebo, according to results of a preliminary study. In a separate study, the drug was ineffective in managing viral meningitis in children.
Even so, ViroPharma, the manufacturer, says it plans to begin 2 new trials of the drug within the next few months. The company notes that although some of the preliminary results with pleconaril were disappointing, it did produce some satisfactory results. For example, in patients who were not taking other cold medications at the time, pleconaril reduced the average duration of symptoms from 9 days to 6.75 days, according to the company.
ViroPharma also says it intends to confer with the FDA regarding the possibility of conducting another trial of pleconaril in the treatment of viral meningitis, this time in an adult population.
In an effort to combat the increasing problem of antibiotic resistance, the American College of Physicians-American Society of Internal Medicine (ACP-ASIM) is launching a significant new education program. The organization's efforts will include a series of educational messages in a variety of media and follow-up studies to assess the impact of the educational messages on physicians' prescribing behavior. Another aspect of the effort: antibiotic-use questions added to an existing system of surveys ("Q-Net").
At the government level, ACP-ASIM plans to lobby Congress for antibiotic-related initiatives, such as new labeling requirements for antibiotics, a national surveillance program, and a more efficient response system when disease outbreaks occur.
The FDA has given full approval to Zyvox (linezolid). Produced by Pharmacia Corp, it is the first of the long-awaited new class of antimicrobials, the oxazolidinones. The oxazolidinones are specifically targeted to combat antibiotic-resistant organisms.
Linezolid reportedly has a mechanism of action different from that of Synercid (approved last fall for use against vancomycin-resistant organisms) and older drugs. It works to halt bacterial replication by inhibiting protein production early in the growth cycle.
The FDA says results of clinical trials show linezolid is effective in fighting both methicillin- and vancomycin-resistant infections. The drug is also approved for use against pneumonia and skin infections.
Pharmacia plans to make intravenous and oral forms of the drug and says both should be available within a few weeks.
The FDA recommends that administration of linezolid be initiated in a hospital or nursing home setting, although therapy may be concluded at home. The drug reportedly will be priced slightly lower than competitor Synercid.
The federal government's Advisory Committee on Immunization Practices has issued its recommendations regarding next season's flu vaccine, making substitutions for 2 of the 3 strains and lowering the recommended age for inoculation.
The committee is now advising people aged 50 to 65 to get the flu vaccine, citing statistics indicating that almost one third of adults in that age group have at least 1 medical condition that places them at high risk for flu-related hospitalization or death. Previously, the recommendation included only adults aged 65 or older.
The composition of the vaccine itself should also be changed, says the committee. Officials recommend that the vaccine include 2 new type A strains (A/Moscow and A/New Caledonia). These strains, which were first identified in 1999, will replace the A/Beijing and A/Sydney strains included in last year's vaccine. The CDC confirms that the B/Beijing strain will also constitute part of the vaccine.
The European Agency for the Evaluation of Medicinal Products (EMEA) has issued an urgent safety restriction on Viramune (nevirapine), Boehringer Ingelheim's AIDS drug, after receiving numerous reports of cutaneous and hepatic reactions.
The reactions, which have sometimes been fatal, have been associated with risk factors such as lack of adherence to dosing regimens and failure to promptly seek evaluation when adverse reactions first appear. Most cases of hepatitis occurred within the first 8 weeks of treatment, the agency says. The EMEA calls the first 8 weeks of therapy "critical," and recommends that during that time physicians closely monitor patients for signs of skin reactions, hepatitis, and hepatic failure. They also recommend that initial dosing regimens be closely adhered to. If a serious cutaneous reaction, a hypersensitivity reaction, or hepatic complications do develop in a patient who is taking nevirapine, treatment should immediately be terminated.
The United States military may be forced to suspend its anthrax inoculation program this summer because of a shortage of new supplies of the vaccine. The FDA has suspended production of the vaccine by Michigan-based Bioport Corp and has not yet approved existing supplies for distribution.
One official from the congressional General Accounting Office cites cash flow difficulties at Bioport as well as various problems with the way the company has conducted research on the vaccine as the reasons for production suspension.
A US House of Representatives subcommittee report, which was filed earlier this year, recommended that the Pentagon's mandatory vaccination program be changed to a voluntary system until a new vaccine is developed and perfected.
Red Book Available
The new edition of the Red Book, the authoritative reference source on control of infectious disease in children, has just been published by the American Academy of Pediatrics. Many of the changes in this latest edition -- the first in 3 years -- pertain to vaccine recommendations. Other revisions concern diagnosis and management of Lyme disease, rotavirus infection, varicella, polio, parasitic infections, fungal diseases, hepatitis A and C, and staphylococcal and streptococcal toxic shock syndrome. An updated list of related Web sites is also included. Copies may be obtained from the Academy at: http://www.aap.org/.
Contrary to promising earlier reports, the antiviral drug pleconaril does not appear to reduce the duration of the common cold any more than placebo, according to results of a preliminary study. In a separate study, the drug was ineffective in managing viral meningitis in children.
Even so, ViroPharma, the manufacturer, says it plans to begin 2 new trials of the drug within the next few months. The company notes that although some of the preliminary results with pleconaril were disappointing, it did produce some satisfactory results. For example, in patients who were not taking other cold medications at the time, pleconaril reduced the average duration of symptoms from 9 days to 6.75 days, according to the company.
ViroPharma also says it intends to confer with the FDA regarding the possibility of conducting another trial of pleconaril in the treatment of viral meningitis, this time in an adult population.
In an effort to combat the increasing problem of antibiotic resistance, the American College of Physicians-American Society of Internal Medicine (ACP-ASIM) is launching a significant new education program. The organization's efforts will include a series of educational messages in a variety of media and follow-up studies to assess the impact of the educational messages on physicians' prescribing behavior. Another aspect of the effort: antibiotic-use questions added to an existing system of surveys ("Q-Net").
At the government level, ACP-ASIM plans to lobby Congress for antibiotic-related initiatives, such as new labeling requirements for antibiotics, a national surveillance program, and a more efficient response system when disease outbreaks occur.
Source...