Clipping Board » Drug Poisoning ─ It is necessary to be aware of the toxic side effects before taking medication.
A special advisory committee of the U.S. Food and Drug Administration (FDA) on the 19th called for a ban on the use of cough and cold medicines for children under six years old, as there is no evidence that these medications alleviate symptoms in children, and there have been a few reports of serious harm caused by their use.
The committee passed the resolution with a vote of 13 to 9. The committee's recommendations are not binding on the FDA, but the agency usually accepts the committee's advice.
One of the committee members, epidemiologist Dr. Henning from the University of Pennsylvania, who is responsible for testing the efficacy of over-the-counter cold medicines, stated, "The data we currently have suggests that these drugs appear to be ineffective." Dr. Tinetti, the committee chair from Yale University School of Medicine, said, "The sentiment of the committee is that such drugs should be banned."
The advisory panel recommended banning drugs containing decongestants for nasal congestion, antihistamines for allergies, and antitussives for cough suppression, or any combination of these, for children under six. Expectorants for phlegm were not mentioned.
Dr. Jenkins, director of the FDA's new drug division, said, "If the agency decides to restrict the use of cold medicines for children under six, it may not necessarily lead to a ban on the drugs, but rather a warning label stating 'Do not use.' It could take anywhere from one to several years for a formal decision to ban to be made."
The advisory panel also stated that there is no evidence to support the effectiveness of over-the-counter cold medicines for children over six, but did not recommend extending the ban to this age group. Some parent representatives even expressed concern that parents might continue to use these medications despite a ban.
It is unclear how many children have experienced adverse reactions from taking such medications. The Centers for Disease Control and Prevention reported earlier this year that a survey found at least 1,500 children under two years old experienced complications from taking these medications between 2004 and 2005. An FDA review found dozens of cases of seizures, heart problems, breathing difficulties, neurological disorders, and other reactions, with at least 123 deaths.
In response to the U.S. expert committee's call for a ban on cough and cold medicines for children under six, Liao Jizhou, director of the Department of Pharmaceutical Affairs at Taiwan's Department of Health, stated that due to differences in drug regulation between Taiwan and the U.S., the department would carefully evaluate whether to change the way medications are administered to children under six.
Liao Jizhou mentioned that last week, three U.S. pharmaceutical companies announced the recall of 14 over-the-counter cold and cough medications specifically for infants under two years old. This time, the FDA's special advisory committee recommended that children under six should also not take these over-the-counter cold and cough medications, raising the age limit from two to six years old.The bureau will invite external experts to hold a meeting on October 18th and 19th to review the safety of children's cold medicines and provide recommendations.
Liu Liling, Deputy Director of the Pharmaceutical Affairs Department of the Department of Health, stated that it remains to be verified whether Taiwan has ever issued a license to import drugs containing hydrocodone. Tang Renbin, Director of the Children's Medical Department at Taipei Veterans General Hospital, mentioned that he is unfamiliar with the drug component hydrocodone and has never prescribed any medication containing this ingredient. He could only roughly identify from its English name that it is a type of codeine (codone) component.
According to the latest report from the U.S. Food and Drug Administration (FDA), from 1969 to 2006, at least 54 children died after taking over-the-counter medications to relieve nasal congestion, and 69 children died from taking medications containing antihistamine ingredients.
The report pointed out that cases of adverse reactions caused by children's cold medicines do not need to be mandatorily reported to the authorities, so the aforementioned death toll may be far lower than the actual situation. Additionally, a study by the U.S. Centers for Disease Control and Prevention stated that between 2004 and 2005, about 1,500 children under the age of two suffered serious health problems due to taking over-the-counter cold medicines.
Furthermore, among the approximately 800 types of children's cold medicines on the U.S. market, nearly 200 are unlicensed painkillers and cough medicines containing hydrocodone. The FDA issued an order on the 28th, stating that pharmaceutical companies must stop producing these drugs by October 31st at the latest.
The safety and effectiveness of hydrocodone for children have not been proven to date, and hydrocodone is classified as an "opioid-like substance," posing a risk of addiction.
Children under six should not take over-the-counter cold medicines. Parents spend 500 million annually on purchases. FDA advisory panel deems them ineffective and potentially causing complications. Source: http://www. worldjournal. com/ wj- us- news. php? nt_seq_id=1611030 [Comprehensive Washington, 19th Telegraph Report]
The special advisory panel of the U.S. Food and Drug Administration (FDA) unanimously agreed on the 19th that the FDA should not allow children under six to take over-the-counter cough and cold medicines because they are ineffective. However, no similar recommendation was made for children aged six to eleven.
After a two-day hearing, the 22-member advisory panel concluded that there is insufficient evidence to prove the effectiveness of these drugs for children. The panel is debating whether to recommend that the FDA take action, including banning the sale of certain drugs, issuing stronger warnings about these drugs, or providing more specific instructions on how to safely take these drugs. The panel's recommendations are not binding on the FDA, but the FDA usually follows them.
This recommendation applies to over-the-counter drugs containing decongestants, expectorants, antihistamines, and antitussives. There are about 800 types of children's cold and cough medicines sold in the U.S., with parents spending 500 million annually on purchases. The FDA questioned the effectiveness of these drugs, and with increasing evidence showing that these drugs cause serious complications such as severe hallucinations, irritability, seizures, high blood pressure, and potentially life-threatening heart and respiratory diseases, the hearing was held. Health and consumer groups called on the FDA to ban the use of these drugs during the hearing.
Dr. Blomberg of the American Academy of Pediatrics said, "In the absence of evidence showing the effectiveness of these drugs, any risks associated with the treatment of these drugs are unacceptable."He called for stronger warnings on these medications, stating that there is no evidence showing their effectiveness for children under six years old and highlighting potential serious risks. Winnie Landis from the American Pharmacists Association proposed several recommendations, including eliminating confusing droppers, spoons, and other dosing methods to prevent overdosing.
A week ago, major pharmaceutical companies voluntarily stopped selling 14 types of cough and cold medications targeted at children under two years old, including well-known brands such as Dimetapp Decongestant Plus Infant Drops, Tylenol Concentrated Infants' Drops Plus Cold, and Robitussin Infant Cough DM Drops. Additionally, after the deaths of four children in Baltimore due to these medications, the city's health commissioner, Sharfstein, initiated a petition urging the FDA to ban the sale of these drugs to children under two, add warnings against use for children under six on dozens of still-available medications, and prohibit the labeling of "for infants" on packaging.
The exact number of children who have experienced adverse reactions from these medications is unclear, but the CDC reported this year that a survey found at least 1,500 children under two suffered complications from these drugs in 2004 and 2005. The FDA's review identified dozens of cases of seizures, heart issues, breathing difficulties, neurological complications, and other reactions, with at least 123 deaths.
China Times, September 30, 2007
US Calls for Ban on Cold Medications for Children Under Six
Source: http:/ / news. chinatimes. com/ 2……0503+112007093000231,00. html
By Yin Dehan and Huang Tianru
Health experts from the US FDA published a report on the 28th, recommending a ban on over-the-counter cold and cough medications for children under six. The FDA will convene external experts on October 18 and 19 to review the safety of children's cold medications and make recommendations.
Liu Liling, Deputy Director of the Health Department's Pharmaceutical Affairs Division, stated that it remains to be confirmed whether Taiwan has ever issued permits for the import of medications containing hydrocodone. Tang Renbin, Director of Pediatric Medicine at Taipei Veterans General Hospital, expressed unfamiliarity with hydrocodone and has never prescribed any medication containing this ingredient, noting that it appears to be a codeine-like substance based on its English name.
According to the latest FDA report, from 1969 to 2006, at least 54 children died after taking over-the-counter nasal decongestants, and 69 children died from antihistamine-containing medications.
The report noted that adverse reactions from children's cold medications do not require mandatory reporting to authorities, suggesting that the actual number of deaths may be much higher. Additionally, a CDC study found that between 2004 and 2005, about 1,500 children under two experienced severe health issues from taking over-the-counter cold medications.
Furthermore, among the approximately 800 types of children's cold medications on the US market, nearly 200 contain hydrocodone, an unapproved pain reliever and cough suppressant.The Food and Drug Administration issued a directive on the 28th, stating that pharmaceutical companies must cease production of these drugs by October 31st at the latest.
The safety and efficacy of the ingredient hydrocodone for children have not been confirmed to date. Hydrocodone is classified as an "opioid substance," which carries the risk of addiction.
US Recommends Ban on Cold Medicine for Children under 6
The committee passed the resolution with a vote of 13 to 9. The committee's recommendations are not binding on the FDA, but the agency usually accepts the committee's advice.
One of the committee members, epidemiologist Dr. Henning from the University of Pennsylvania, who is responsible for testing the efficacy of over-the-counter cold medicines, stated, "The data we currently have suggests that these drugs appear to be ineffective." Dr. Tinetti, the committee chair from Yale University School of Medicine, said, "The sentiment of the committee is that such drugs should be banned."
The advisory panel recommended banning drugs containing decongestants for nasal congestion, antihistamines for allergies, and antitussives for cough suppression, or any combination of these, for children under six. Expectorants for phlegm were not mentioned.
Dr. Jenkins, director of the FDA's new drug division, said, "If the agency decides to restrict the use of cold medicines for children under six, it may not necessarily lead to a ban on the drugs, but rather a warning label stating 'Do not use.' It could take anywhere from one to several years for a formal decision to ban to be made."
The advisory panel also stated that there is no evidence to support the effectiveness of over-the-counter cold medicines for children over six, but did not recommend extending the ban to this age group. Some parent representatives even expressed concern that parents might continue to use these medications despite a ban.
It is unclear how many children have experienced adverse reactions from taking such medications. The Centers for Disease Control and Prevention reported earlier this year that a survey found at least 1,500 children under two years old experienced complications from taking these medications between 2004 and 2005. An FDA review found dozens of cases of seizures, heart problems, breathing difficulties, neurological disorders, and other reactions, with at least 123 deaths.
In response to the U.S. expert committee's call for a ban on cough and cold medicines for children under six, Liao Jizhou, director of the Department of Pharmaceutical Affairs at Taiwan's Department of Health, stated that due to differences in drug regulation between Taiwan and the U.S., the department would carefully evaluate whether to change the way medications are administered to children under six.
Liao Jizhou mentioned that last week, three U.S. pharmaceutical companies announced the recall of 14 over-the-counter cold and cough medications specifically for infants under two years old. This time, the FDA's special advisory committee recommended that children under six should also not take these over-the-counter cold and cough medications, raising the age limit from two to six years old.The bureau will invite external experts to hold a meeting on October 18th and 19th to review the safety of children's cold medicines and provide recommendations.
Liu Liling, Deputy Director of the Pharmaceutical Affairs Department of the Department of Health, stated that it remains to be verified whether Taiwan has ever issued a license to import drugs containing hydrocodone. Tang Renbin, Director of the Children's Medical Department at Taipei Veterans General Hospital, mentioned that he is unfamiliar with the drug component hydrocodone and has never prescribed any medication containing this ingredient. He could only roughly identify from its English name that it is a type of codeine (codone) component.
According to the latest report from the U.S. Food and Drug Administration (FDA), from 1969 to 2006, at least 54 children died after taking over-the-counter medications to relieve nasal congestion, and 69 children died from taking medications containing antihistamine ingredients.
The report pointed out that cases of adverse reactions caused by children's cold medicines do not need to be mandatorily reported to the authorities, so the aforementioned death toll may be far lower than the actual situation. Additionally, a study by the U.S. Centers for Disease Control and Prevention stated that between 2004 and 2005, about 1,500 children under the age of two suffered serious health problems due to taking over-the-counter cold medicines.
Furthermore, among the approximately 800 types of children's cold medicines on the U.S. market, nearly 200 are unlicensed painkillers and cough medicines containing hydrocodone. The FDA issued an order on the 28th, stating that pharmaceutical companies must stop producing these drugs by October 31st at the latest.
The safety and effectiveness of hydrocodone for children have not been proven to date, and hydrocodone is classified as an "opioid-like substance," posing a risk of addiction.
Children under six should not take over-the-counter cold medicines. Parents spend 500 million annually on purchases. FDA advisory panel deems them ineffective and potentially causing complications. Source: http://www. worldjournal. com/ wj- us- news. php? nt_seq_id=1611030 [Comprehensive Washington, 19th Telegraph Report]
The special advisory panel of the U.S. Food and Drug Administration (FDA) unanimously agreed on the 19th that the FDA should not allow children under six to take over-the-counter cough and cold medicines because they are ineffective. However, no similar recommendation was made for children aged six to eleven.
After a two-day hearing, the 22-member advisory panel concluded that there is insufficient evidence to prove the effectiveness of these drugs for children. The panel is debating whether to recommend that the FDA take action, including banning the sale of certain drugs, issuing stronger warnings about these drugs, or providing more specific instructions on how to safely take these drugs. The panel's recommendations are not binding on the FDA, but the FDA usually follows them.
This recommendation applies to over-the-counter drugs containing decongestants, expectorants, antihistamines, and antitussives. There are about 800 types of children's cold and cough medicines sold in the U.S., with parents spending 500 million annually on purchases. The FDA questioned the effectiveness of these drugs, and with increasing evidence showing that these drugs cause serious complications such as severe hallucinations, irritability, seizures, high blood pressure, and potentially life-threatening heart and respiratory diseases, the hearing was held. Health and consumer groups called on the FDA to ban the use of these drugs during the hearing.
Dr. Blomberg of the American Academy of Pediatrics said, "In the absence of evidence showing the effectiveness of these drugs, any risks associated with the treatment of these drugs are unacceptable."He called for stronger warnings on these medications, stating that there is no evidence showing their effectiveness for children under six years old and highlighting potential serious risks. Winnie Landis from the American Pharmacists Association proposed several recommendations, including eliminating confusing droppers, spoons, and other dosing methods to prevent overdosing.
A week ago, major pharmaceutical companies voluntarily stopped selling 14 types of cough and cold medications targeted at children under two years old, including well-known brands such as Dimetapp Decongestant Plus Infant Drops, Tylenol Concentrated Infants' Drops Plus Cold, and Robitussin Infant Cough DM Drops. Additionally, after the deaths of four children in Baltimore due to these medications, the city's health commissioner, Sharfstein, initiated a petition urging the FDA to ban the sale of these drugs to children under two, add warnings against use for children under six on dozens of still-available medications, and prohibit the labeling of "for infants" on packaging.
The exact number of children who have experienced adverse reactions from these medications is unclear, but the CDC reported this year that a survey found at least 1,500 children under two suffered complications from these drugs in 2004 and 2005. The FDA's review identified dozens of cases of seizures, heart issues, breathing difficulties, neurological complications, and other reactions, with at least 123 deaths.
China Times, September 30, 2007
US Calls for Ban on Cold Medications for Children Under Six
Source: http:/ / news. chinatimes. com/ 2……0503+112007093000231,00. html
By Yin Dehan and Huang Tianru
Health experts from the US FDA published a report on the 28th, recommending a ban on over-the-counter cold and cough medications for children under six. The FDA will convene external experts on October 18 and 19 to review the safety of children's cold medications and make recommendations.
Liu Liling, Deputy Director of the Health Department's Pharmaceutical Affairs Division, stated that it remains to be confirmed whether Taiwan has ever issued permits for the import of medications containing hydrocodone. Tang Renbin, Director of Pediatric Medicine at Taipei Veterans General Hospital, expressed unfamiliarity with hydrocodone and has never prescribed any medication containing this ingredient, noting that it appears to be a codeine-like substance based on its English name.
According to the latest FDA report, from 1969 to 2006, at least 54 children died after taking over-the-counter nasal decongestants, and 69 children died from antihistamine-containing medications.
The report noted that adverse reactions from children's cold medications do not require mandatory reporting to authorities, suggesting that the actual number of deaths may be much higher. Additionally, a CDC study found that between 2004 and 2005, about 1,500 children under two experienced severe health issues from taking over-the-counter cold medications.
Furthermore, among the approximately 800 types of children's cold medications on the US market, nearly 200 contain hydrocodone, an unapproved pain reliever and cough suppressant.The Food and Drug Administration issued a directive on the 28th, stating that pharmaceutical companies must cease production of these drugs by October 31st at the latest.
The safety and efficacy of the ingredient hydrocodone for children have not been confirmed to date. Hydrocodone is classified as an "opioid substance," which carries the risk of addiction.