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.
Thursday, January 28, 2010
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
Tuesday, January 12, 2010
CPSC Approves Final Rule on Guidelines for Mandatory Recall Notices
The U.S. Consumer Product Safety Commission (CPSC) unanimously approved a new rule setting guidelines and requirements for information in mandatory recall notices. A mandatory recall can be ordered by the Commission or a U.S. District Court.
Each section of the rule is either required by Section 214 of the Consumer Product Safety Improvement Act (CPSIA), or CPSC has determined it will likely increase recall effectiveness by helping consumers:
(a) Identify the product subject to a recall
(b) Understand the hazard identified with the product
(c) Understand what remedy is offered regarding the product.
Information required by the rule includes: product description, action being taken, number of units, identification of the substantial product hazard and reason for the action, identification of manufacturers and significant retailers, dates when product was manufactured and sold, number and description of any injuries or deaths, the ages of anyone injured or killed, remedy available to consumers and other information the Commission deems appropriate. The Commission could determine some of the information is unnecessary or inappropriate for a particular recall.
The rule does not contain requirements for voluntary recall notices but will serve as a guide for those notices. If CPSC decides to extend these requirements to voluntary recall notices, it would proceed with separate rulemaking.
In 2009, 100 percent of the recalls announced to consumers were done voluntarily and cooperatively with impacted firms. As more products get recalled each year, the high rate of cooperative recall announcements negotiated by CPSC staff is a benefit to the safety of consumers.
The requirement to create a mandatory recall rule was proposed as an amendment to the CPSIA by President Barack Obama when he was a member of the Senate.
The final rule goes into effect upon publication in the Federal Register.
Each section of the rule is either required by Section 214 of the Consumer Product Safety Improvement Act (CPSIA), or CPSC has determined it will likely increase recall effectiveness by helping consumers:
(a) Identify the product subject to a recall
(b) Understand the hazard identified with the product
(c) Understand what remedy is offered regarding the product.
Information required by the rule includes: product description, action being taken, number of units, identification of the substantial product hazard and reason for the action, identification of manufacturers and significant retailers, dates when product was manufactured and sold, number and description of any injuries or deaths, the ages of anyone injured or killed, remedy available to consumers and other information the Commission deems appropriate. The Commission could determine some of the information is unnecessary or inappropriate for a particular recall.
The rule does not contain requirements for voluntary recall notices but will serve as a guide for those notices. If CPSC decides to extend these requirements to voluntary recall notices, it would proceed with separate rulemaking.
In 2009, 100 percent of the recalls announced to consumers were done voluntarily and cooperatively with impacted firms. As more products get recalled each year, the high rate of cooperative recall announcements negotiated by CPSC staff is a benefit to the safety of consumers.
The requirement to create a mandatory recall rule was proposed as an amendment to the CPSIA by President Barack Obama when he was a member of the Senate.
The final rule goes into effect upon publication in the Federal Register.
Thursday, January 7, 2010
EPA Delays Report on Flea and Tick Products That May Harm Pets
EPA Delays Report on Flea and Tick Products That May Harm Pets
Pet owners continue to report adverse effects on animals
Pet owners worried about the adverse reactions thousands of animals nationwide have experienced to topical flea and tick products will have to wait a little longer for any action from the Environmental Protection Agency (EPA).
The agency previously told ConsumerAffairs.com that it planned to issue a report last fall about "spot-on" flea and tick products, which pet owners say have triggered "horrific" reactions in their dogs and cats. But according to the EPA, the agency is still reviewing reports and other "complex technical issues" regarding the problem, and will likely not take any action for weeks.
"[The] EPA has been evaluating the data submitted on adverse incidents associated with the spot-on flea and tick pet products and is nearing completion of its review," the agency's spokesman, Dale Kemery, said. "Due to the large amount of data and the complex technical
issues associated with the review of the data, our report is not ready for public release."
Read more: http://www.consumeraffairs.com/news04/2010/01/fleatick02.html#ixzz0bzey59NW
Pet owners continue to report adverse effects on animals
Pet owners worried about the adverse reactions thousands of animals nationwide have experienced to topical flea and tick products will have to wait a little longer for any action from the Environmental Protection Agency (EPA).
The agency previously told ConsumerAffairs.com that it planned to issue a report last fall about "spot-on" flea and tick products, which pet owners say have triggered "horrific" reactions in their dogs and cats. But according to the EPA, the agency is still reviewing reports and other "complex technical issues" regarding the problem, and will likely not take any action for weeks.
"[The] EPA has been evaluating the data submitted on adverse incidents associated with the spot-on flea and tick pet products and is nearing completion of its review," the agency's spokesman, Dale Kemery, said. "Due to the large amount of data and the complex technical
issues associated with the review of the data, our report is not ready for public release."
Read more: http://www.consumeraffairs.com/news04/2010/01/fleatick02.html#ixzz0bzey59NW
Monday, January 4, 2010
FDA Takes Action Against New Jersey Cheese Manufacturer Quesos Mi Pueblito
FDA Takes Action Against New Jersey Cheese Manufacturer
Company failed to correct violations despite federal, state warnings
The U.S. Food and Drug Administration today announced intentions to ask a federal court to shut down a New Jersey cheese manufacturer with an alleged history of operating under insanitary conditions and producing cheese contaminated with Listeria monocytogenes.
The U.S. Department of Justice filed a complaint for permanent injunction against Quesos Mi Pueblito and two of its officers, Felix Sanchez and Jesus Galvez. The complaint alleges that recent inspections by the FDA and the New Jersey Department of Health and Senior Services found Listeria-contaminated cheese and insanitary conditions at the Passaic company.
If entered by the court, the injunction would stop the company and its officers from manufacturing and distributing food until they can bring their operations into full compliance with FDA food safety regulations and produce cheese that does not test positive for the presence of Listeria.
The complaint for permanent injunction was filed in the U.S. District Court - District of New Jersey."FDA’s work with federal and state partners to root out or remedy food manufacturers not compliant with food safety laws ensures safer foods get to our dinner tables," said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs.
Quesos Mi Pueblito currently manufactures and distributes a variety of soft, semi-soft, and hard Mexican cheeses in grocery stores and supermarkets in Connecticut, Massachusetts, New York, North Carolina, Florida, Virginia and the District of Columbia. Among Quesos Mi Pueblito’s products are queso oaxaca, queso fresco, queso requeson and queso cotija molido.
Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator.
Company failed to correct violations despite federal, state warnings
The U.S. Food and Drug Administration today announced intentions to ask a federal court to shut down a New Jersey cheese manufacturer with an alleged history of operating under insanitary conditions and producing cheese contaminated with Listeria monocytogenes.
The U.S. Department of Justice filed a complaint for permanent injunction against Quesos Mi Pueblito and two of its officers, Felix Sanchez and Jesus Galvez. The complaint alleges that recent inspections by the FDA and the New Jersey Department of Health and Senior Services found Listeria-contaminated cheese and insanitary conditions at the Passaic company.
If entered by the court, the injunction would stop the company and its officers from manufacturing and distributing food until they can bring their operations into full compliance with FDA food safety regulations and produce cheese that does not test positive for the presence of Listeria.
The complaint for permanent injunction was filed in the U.S. District Court - District of New Jersey."FDA’s work with federal and state partners to root out or remedy food manufacturers not compliant with food safety laws ensures safer foods get to our dinner tables," said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs.
Quesos Mi Pueblito currently manufactures and distributes a variety of soft, semi-soft, and hard Mexican cheeses in grocery stores and supermarkets in Connecticut, Massachusetts, New York, North Carolina, Florida, Virginia and the District of Columbia. Among Quesos Mi Pueblito’s products are queso oaxaca, queso fresco, queso requeson and queso cotija molido.
Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator.
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