Long-lasting lead damage
From the U.S. Department of Health and Human Services.
A study indicates people may never outgrow the damage that lead does to the brain. At Cincinnati Children’s Hospital Medical Center, Kim Cecil saw that in brain imaging of adults who were exposed to high levels of lead when they were children.
Cecil says adults who had higher lead exposure as children were more likely to have decreased activity in parts of the brain associated with attention and controlling impulses.
``What our study is showing is that, long after this exposure is over, the effects are irreversible.’’
Cecil says it’s another reason to keep kids free of things like lead-based paint.
The research, which was supported by the National Institutes of Health, was presented at a meeting of the Radiological Society of North America.
Wednesday, February 10, 2010
Tuesday, February 9, 2010
The science behind the SULPHITES story
The science behind the story
Sulphites are used as preservatives in a wide range of foods, in particular soft drinks, sausages, burgers, and dried fruit and vegetables. These additives maintain food colour and prolong shelf-life by preventing the growth of micro-organisms.
When the gas sulphur dioxide is dissolved in a liquid, such as wine, it is known as a sulphite.
Sulphur dioxide is produced naturally when wine and beer are made and it is often added to wine to stop it from continuing to ferment in the bottle. Usually, most of the ‘head space’ in a bottle of wine (the part of the bottle not filled with wine) is sulphur dioxide.
Some people who have asthma may react to inhaling sulphur dioxide. A very few people with asthma have had an attack after drinking acidic drinks (such as fruit-based drinks) containing sulphites, but this is not thought to be very common.
Read more about intolerance to sulphites and other additives at eatwell.gov.uk/healthissues/foodintolerance/foodintolerancetypes/foodadditiv/.
Sulphites are used as preservatives in a wide range of foods, in particular soft drinks, sausages, burgers, and dried fruit and vegetables. These additives maintain food colour and prolong shelf-life by preventing the growth of micro-organisms.
When the gas sulphur dioxide is dissolved in a liquid, such as wine, it is known as a sulphite.
Sulphur dioxide is produced naturally when wine and beer are made and it is often added to wine to stop it from continuing to ferment in the bottle. Usually, most of the ‘head space’ in a bottle of wine (the part of the bottle not filled with wine) is sulphur dioxide.
Some people who have asthma may react to inhaling sulphur dioxide. A very few people with asthma have had an attack after drinking acidic drinks (such as fruit-based drinks) containing sulphites, but this is not thought to be very common.
Read more about intolerance to sulphites and other additives at eatwell.gov.uk/healthissues/foodintolerance/foodintolerancetypes/foodadditiv/.
Thursday, February 4, 2010
United States Seizes more than 1,500 Cases of Food from Wisconsin Distribution Warehouse
Media Inquiries: Tom Gasparoli, 301-796-4737, thomas.gasparoli@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
United States Seizes more than 1,500 Cases of Food from Wisconsin Distribution Warehouse
FDA acts after inspections reveal filthy, rodent-infested facility
At the request of the U.S. Food and Drug Administration, U.S. Marshals on Tuesday seized a wide range of human and animal food products stored under insanitary conditions at Mid-States Closeouts, a distribution warehouse in Ellsworth, Wis. The products were seized under a warrant issued by the U.S. District Court for the Western District of Wisconsin.
U.S. Marshals seized all FDA-regulated human and animal food susceptible to rodent and pest contamination or other filth. The products are adulterated under the Federal Food, Drug, and Cosmetic Act (the Act) because they have been held under insanitary conditions whereby they may have become contaminated with filth.
During an FDA inspection of Mid-States Closeouts conducted in November and December 2009, the agency found widespread and active rodent infestation, numerous gnawed packages of human and animal food, rodent excreta pellets on, in, and around food packages and rodent nesting material. The facility also had structural defects permitting easy pest access to the entire facility, and rodent harborage areas near the warehouse.
"The violations at Mid-States Closeouts are widespread and significant,” said Michael Chappell, the FDA’s acting associate commissioner, Office of Regulatory Affairs. “The FDA took this action because the company failed to provide adequate safeguards to ensure that products they hold for sale remain free of contamination.”
The FDA has not received any reports of human or pet illness or death associated with consumption of food distributed by Mid-States Closeouts. However, the seized products were in permeable packages and held under conditions that could compromise the food’s quality.
Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator. Contact information for coordinators is located at http://www.fda.gov/Safety/ReportaProblem/ConsumerComplaintCoordinators.
Consumer Inquiries: 888-INFO-FDA
United States Seizes more than 1,500 Cases of Food from Wisconsin Distribution Warehouse
FDA acts after inspections reveal filthy, rodent-infested facility
At the request of the U.S. Food and Drug Administration, U.S. Marshals on Tuesday seized a wide range of human and animal food products stored under insanitary conditions at Mid-States Closeouts, a distribution warehouse in Ellsworth, Wis. The products were seized under a warrant issued by the U.S. District Court for the Western District of Wisconsin.
U.S. Marshals seized all FDA-regulated human and animal food susceptible to rodent and pest contamination or other filth. The products are adulterated under the Federal Food, Drug, and Cosmetic Act (the Act) because they have been held under insanitary conditions whereby they may have become contaminated with filth.
During an FDA inspection of Mid-States Closeouts conducted in November and December 2009, the agency found widespread and active rodent infestation, numerous gnawed packages of human and animal food, rodent excreta pellets on, in, and around food packages and rodent nesting material. The facility also had structural defects permitting easy pest access to the entire facility, and rodent harborage areas near the warehouse.
"The violations at Mid-States Closeouts are widespread and significant,” said Michael Chappell, the FDA’s acting associate commissioner, Office of Regulatory Affairs. “The FDA took this action because the company failed to provide adequate safeguards to ensure that products they hold for sale remain free of contamination.”
The FDA has not received any reports of human or pet illness or death associated with consumption of food distributed by Mid-States Closeouts. However, the seized products were in permeable packages and held under conditions that could compromise the food’s quality.
Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator. Contact information for coordinators is located at http://www.fda.gov/Safety/ReportaProblem/ConsumerComplaintCoordinators.
More tainted milk products found in China shops
Melamine-laced milk products have been found on sale in China, state media said on Monday, more than a year after the chemical was blamed for six deaths in a huge scandal over contaminated dairy goods.
Three Chinese companies have been found selling food products tainted with melamine, the chemical blamed for the deaths of six babies in a huge dairy scandal in 2008, state media said Monday.
Authorities in the southwestern province of Guizhou found that products made by three food companies contained illegally high levels of the toxic substance, the China Daily said.
It quoted a former dairy industry official as saying it was likely more tainted goods remained in supermarkets despite a major recall after the 2008 scandal, which highlighted China's persistent product safety problems.
The suspect products in Guizhou have been pulled from stores, the China Daily said, adding that the firms involved blamed milk powder bought from suppliers.
The report illustrated the apparent continued threat from tainted dairy goods long after the 2008 scandal when it was revealed that the industrial chemical -- which can, in large quantities, cause kidney failure and death -- was being abused by food producers.
At that time, melamine was found to have been added to milk to give the appearance of a higher protein content and was blamed for killing six infants and making nearly 300,000 others sick, according to official figures.
The scare led to foodstuffs containing dairy products being taken off shelves around the world. A total of 21 people were reportedly convicted of wrongdoing, with two executed and others sentenced to jail terms.
But other cases have since surfaced.
FULL STORY: http://www.bangkokpost.com/news/health/166430/more-tainted-milk-products-found-in-china-shops
Three Chinese companies have been found selling food products tainted with melamine, the chemical blamed for the deaths of six babies in a huge dairy scandal in 2008, state media said Monday.
Authorities in the southwestern province of Guizhou found that products made by three food companies contained illegally high levels of the toxic substance, the China Daily said.
It quoted a former dairy industry official as saying it was likely more tainted goods remained in supermarkets despite a major recall after the 2008 scandal, which highlighted China's persistent product safety problems.
The suspect products in Guizhou have been pulled from stores, the China Daily said, adding that the firms involved blamed milk powder bought from suppliers.
The report illustrated the apparent continued threat from tainted dairy goods long after the 2008 scandal when it was revealed that the industrial chemical -- which can, in large quantities, cause kidney failure and death -- was being abused by food producers.
At that time, melamine was found to have been added to milk to give the appearance of a higher protein content and was blamed for killing six infants and making nearly 300,000 others sick, according to official figures.
The scare led to foodstuffs containing dairy products being taken off shelves around the world. A total of 21 people were reportedly convicted of wrongdoing, with two executed and others sentenced to jail terms.
But other cases have since surfaced.
FULL STORY: http://www.bangkokpost.com/news/health/166430/more-tainted-milk-products-found-in-china-shops
Thursday, January 28, 2010
Important Information Concerning Medication for Parkinson's Disease Information Update
2010-14
OTTAWA - Health Canada is aware that two Canadian companies that manufacture and/or distribute medications for Parkinson's Disease have posted information on their websites concerning the availability of some of the drugs they manufacture and/or distribute.
Bristol Myers Squibb Canada, the Canadian distributor of Sinemet CR (200/50) has information on its website: www.bmscanada.ca or call the Bristol Myers Squibb Canada Information Line at 1-800-267-0005.
Apotex Inc. has information on its generic product, Apo-Levocarb CR (200/50) on its website or call 1-877-427-6839.
Patients who are currently using Apo-Levocarb CR (200/50) or Sinemet CR (200/50) and have concerns about the supply of their medication may want to check the information provided by these companies or call the companies. Patients may also consult their health care professional in order to explore alternative treatments if they are unable to maintain an uninterrupted supply of their medication.
OTTAWA - Health Canada is aware that two Canadian companies that manufacture and/or distribute medications for Parkinson's Disease have posted information on their websites concerning the availability of some of the drugs they manufacture and/or distribute.
Bristol Myers Squibb Canada, the Canadian distributor of Sinemet CR (200/50) has information on its website: www.bmscanada.ca or call the Bristol Myers Squibb Canada Information Line at 1-800-267-0005.
Apotex Inc. has information on its generic product, Apo-Levocarb CR (200/50) on its website or call 1-877-427-6839.
Patients who are currently using Apo-Levocarb CR (200/50) or Sinemet CR (200/50) and have concerns about the supply of their medication may want to check the information provided by these companies or call the companies. Patients may also consult their health care professional in order to explore alternative treatments if they are unable to maintain an uninterrupted supply of their medication.
Follow-Up to the November 2009 Early Communication about an Ongoing Safety Review of Sibutramine, Marketed as Meridia
The U.S. Food and Drug Administration (FDA) has reviewed additional data that indicate an increased risk of heart attack and stroke in patients with a history of cardiovascular disease using sibutramine, marketed as the weight loss medication Meridia. The sibutramine drug label already includes warnings against the use of sibutramine in patients with cardiovascular disease. However, based on the serious nature of the review findings, FDA requested and the manufacturer agreed to add a new contraindication to the sibutramine drug label.
The contraindication will state that sibutramine is not to be used in patients with a history of cardiovascular disease, including:
History of coronary artery disease (e.g., heart attack, angina)
History of stroke or transient ischemic attack (TIA)
History of heart arrhythmias
History of congestive heart failure
History of peripheral arterial disease
Uncontrolled hypertension (e.g., > 145/90 mmHg)
Patients currently using sibutramine should talk with their healthcare professional to determine if continued use of sibutramine is appropriate and discuss any questions they may have about their treatment.
Healthcare professionals should regularly monitor the blood pressure and heart rate of patients using sibutramine and if sustained increases in blood pressure and/or heart rate are observed, sibutramine should be discontinued. Additionally, sibutramine should be discontinued in patients who do not lose at least 5% of their baseline body weight within the first three to six months of treatment, as continued treatment is unlikely to be effective and exposes the patient to unnecessary risk.
The Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT) study was designed to show that weight loss with sibutramine and standard care was more effective in reducing the number of cardiovascular events compared to weight loss from a placebo and standard care. Patients included in the study were 55 years of age or older, overweight or obese, and had a history of cardiovascular disease or type 2 diabetes plus one additional cardiovascular risk factor. Patients who recently had a heart attack or stroke, or had poorly controlled congestive heart failure were not included in the study. Approximately 10,000 patients enrolled in the study.
The November 2009 Early Communication from FDA described preliminary results from the SCOUT study indicating cardiovascular events occurred in 11.4% of patients using sibutramine compared to 10% of patients using a placebo. This difference was higher than expected, suggesting that sibutramine was associated with an increased cardiovascular risk in the study population.
The additional data from the SCOUT study reviewed by FDA indicate that the increased risk for cardiovascular events with sibutramine occurred only in patients with a history of cardiovascular disease.
The results for cardiovascular events for each subgroup of the SCOUT study are found in the table below.
TABLE 1. Cardiovascular Events in the SCOUT Study by Predefined Subgroups
Study Group † Placebo
(% of patients) Sibutramine
(% of patients) Hazard Ratio
(95% Confidence Interval) p-value
DM Only Group
Total patients (n) Cardiovascular Events*
1,178 77
(6.5%)
1,207 79
(6.5%)
1.010 (0.737, 1.383) 0.951
CV Only Group
Total patients (n) Cardiovascular Events*
793 66
(8.3%)
759 77
(10.1%)
1.274 (0.915, 1.774) 0.151
CV + DM Group
Total patients (n) Cardiovascular Events*
2,901 346
(11.9%)
2,906 403
(13.9%)
1.182 (1.024, 1.354) 0.023††
† Patients in the SCOUT study comprised 3 subgroups: 1) History of type 2 diabetes but no cardiovascular disease (DM only subgroup); 2) History of cardiovascular disease (CV only subgroup); 3) History of cardiovascular disease and type 2 diabetes (CV + DM subgroup).
* Defined as heart attack, stroke, resuscitated cardiac arrest, or cardiovascular death.
†† Statistically significant result.
Once FDA completes its review of the full study report for SCOUT, which is expected to be submitted to the FDA by the sponsor in March 2010, and other relevant information related to sibutramine’s potential benefits and risks, an open public advisory committee meeting will be convened to discuss sibutramine’s benefit/risk profile and to determine if additional regulatory actions should be taken to ensure safe use of the medication.
-Related Information
Information for Meridia (sibutramine hydrochloride)
Early Communication about an Ongoing Safety Review of Meridia (sibutramine hydrochloride)
11/20/2009
Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review
1/21/2010
- Contact UsReport a Serious Problem
1-800-332-1088
1-800-FDA-0178 Fax
MedWatch Online
Regular Mail: Use postage-paid FDA Form 3500
Mail to: MedWatch 5600 Fishers Lane
Rockville, MD 20852-9787
The contraindication will state that sibutramine is not to be used in patients with a history of cardiovascular disease, including:
History of coronary artery disease (e.g., heart attack, angina)
History of stroke or transient ischemic attack (TIA)
History of heart arrhythmias
History of congestive heart failure
History of peripheral arterial disease
Uncontrolled hypertension (e.g., > 145/90 mmHg)
Patients currently using sibutramine should talk with their healthcare professional to determine if continued use of sibutramine is appropriate and discuss any questions they may have about their treatment.
Healthcare professionals should regularly monitor the blood pressure and heart rate of patients using sibutramine and if sustained increases in blood pressure and/or heart rate are observed, sibutramine should be discontinued. Additionally, sibutramine should be discontinued in patients who do not lose at least 5% of their baseline body weight within the first three to six months of treatment, as continued treatment is unlikely to be effective and exposes the patient to unnecessary risk.
The Sibutramine Cardiovascular Morbidity/Mortality Outcomes in Overweight or Obese Subjects at Risk of a Cardiovascular Event (SCOUT) study was designed to show that weight loss with sibutramine and standard care was more effective in reducing the number of cardiovascular events compared to weight loss from a placebo and standard care. Patients included in the study were 55 years of age or older, overweight or obese, and had a history of cardiovascular disease or type 2 diabetes plus one additional cardiovascular risk factor. Patients who recently had a heart attack or stroke, or had poorly controlled congestive heart failure were not included in the study. Approximately 10,000 patients enrolled in the study.
The November 2009 Early Communication from FDA described preliminary results from the SCOUT study indicating cardiovascular events occurred in 11.4% of patients using sibutramine compared to 10% of patients using a placebo. This difference was higher than expected, suggesting that sibutramine was associated with an increased cardiovascular risk in the study population.
The additional data from the SCOUT study reviewed by FDA indicate that the increased risk for cardiovascular events with sibutramine occurred only in patients with a history of cardiovascular disease.
The results for cardiovascular events for each subgroup of the SCOUT study are found in the table below.
TABLE 1. Cardiovascular Events in the SCOUT Study by Predefined Subgroups
Study Group † Placebo
(% of patients) Sibutramine
(% of patients) Hazard Ratio
(95% Confidence Interval) p-value
DM Only Group
Total patients (n) Cardiovascular Events*
1,178 77
(6.5%)
1,207 79
(6.5%)
1.010 (0.737, 1.383) 0.951
CV Only Group
Total patients (n) Cardiovascular Events*
793 66
(8.3%)
759 77
(10.1%)
1.274 (0.915, 1.774) 0.151
CV + DM Group
Total patients (n) Cardiovascular Events*
2,901 346
(11.9%)
2,906 403
(13.9%)
1.182 (1.024, 1.354) 0.023††
† Patients in the SCOUT study comprised 3 subgroups: 1) History of type 2 diabetes but no cardiovascular disease (DM only subgroup); 2) History of cardiovascular disease (CV only subgroup); 3) History of cardiovascular disease and type 2 diabetes (CV + DM subgroup).
* Defined as heart attack, stroke, resuscitated cardiac arrest, or cardiovascular death.
†† Statistically significant result.
Once FDA completes its review of the full study report for SCOUT, which is expected to be submitted to the FDA by the sponsor in March 2010, and other relevant information related to sibutramine’s potential benefits and risks, an open public advisory committee meeting will be convened to discuss sibutramine’s benefit/risk profile and to determine if additional regulatory actions should be taken to ensure safe use of the medication.
-Related Information
Information for Meridia (sibutramine hydrochloride)
Early Communication about an Ongoing Safety Review of Meridia (sibutramine hydrochloride)
11/20/2009
Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review
1/21/2010
- Contact UsReport a Serious Problem
1-800-332-1088
1-800-FDA-0178 Fax
MedWatch Online
Regular Mail: Use postage-paid FDA Form 3500
Mail to: MedWatch 5600 Fishers Lane
Rockville, MD 20852-9787
Public Citizen to FDA: Pull Fibromyalgia Drug from the Market
Medication has limited efficacy, risky effects, group says
Public Citizen is calling on the Food and Drug Administration (FDA) to pull the fibromyalgia drug Savella from the market immediately.
In its petition to the FDA, Public Citizen notes that the European Medicines Agency (EMEA), which regulates drugs on the Continent, rejected Savella's approval for fibromyalgia in July 2009, stating that its benefits were "marginal" and "did not outweigh its risks." This was shortly after the FDA approved the drug in January 2009.
Since the drug went on the market in the U.S., approximately 250,000 prescriptions have been filled, with doctors writing more prescriptions every month.
In two randomized clinical trials, Savella, also known by its generic name milnacipran, was found to increase blood pressure, heart rate and suicidal thoughts, Public Citizen's petition said. Among patients who had normal blood pressure at the beginning of the study, 19.5 percent of those who took Savella developed hypertension, compared with 7.2 percent of those on a placebo.
"Because Savella is a drug that produces only a marginal effect on pain, the main problem for which patients seek treatment, and has the potential to be quite dangerous, it is clear that it should not be sold," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. "The FDA never should have approved Savella for fibromyalgia and should now immediately order the drug company to remove it from the market before large numbers of people suffer serious harm," Wolfe said.
Read more: http://www.consumeraffairs.com/news04/2010/01/pubcit_fda_fibromyalgia.html#ixzz0dIrfRCay
Public Citizen is calling on the Food and Drug Administration (FDA) to pull the fibromyalgia drug Savella from the market immediately.
In its petition to the FDA, Public Citizen notes that the European Medicines Agency (EMEA), which regulates drugs on the Continent, rejected Savella's approval for fibromyalgia in July 2009, stating that its benefits were "marginal" and "did not outweigh its risks." This was shortly after the FDA approved the drug in January 2009.
Since the drug went on the market in the U.S., approximately 250,000 prescriptions have been filled, with doctors writing more prescriptions every month.
In two randomized clinical trials, Savella, also known by its generic name milnacipran, was found to increase blood pressure, heart rate and suicidal thoughts, Public Citizen's petition said. Among patients who had normal blood pressure at the beginning of the study, 19.5 percent of those who took Savella developed hypertension, compared with 7.2 percent of those on a placebo.
"Because Savella is a drug that produces only a marginal effect on pain, the main problem for which patients seek treatment, and has the potential to be quite dangerous, it is clear that it should not be sold," said Dr. Sidney Wolfe, director of Public Citizen's Health Research Group. "The FDA never should have approved Savella for fibromyalgia and should now immediately order the drug company to remove it from the market before large numbers of people suffer serious harm," Wolfe said.
Read more: http://www.consumeraffairs.com/news04/2010/01/pubcit_fda_fibromyalgia.html#ixzz0dIrfRCay
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