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Liraglutide Licensed for Diabetes
The Food and Drug Administration has approved liraglutide as a once-daily injection for the treatment of type 2 diabetes.
Liraglutide, a human glucagonlike peptide 1 (GLP-1) receptor agonist that promotes glucose-dependent insulin secretion, will be marketed by Novo Nordisk under the name Victoza. It was licensed for use in combination with diet, exercise, and certain other glucose-lowering medications, but not as initial therapy. The first drug in this class, exenatide (Byetta, Amylin/Eli Lilly), was approved in 2005.
It should be used with caution in people with a history of pancreatitis, the FDA said. The most common side effects observed with liraglutide were headache, nausea, and diarrhea.
Novo Nordisk is required to conduct postmarketing cardiovascular and cancer safety studies. Also included in the approval is a Risk Evaluation and Mitigation Strategy (REMS) consisting of a medication guide and a communication plan.
Oral Morphine Solution Approved
A concentrated oral solution of morphine sulfate has been approved, rescuing a formulation that had been slated to be taken off the market last year until physician groups spoke up about its clinical utility and lack of equivalent products.
The approval of Roxane Laboratories' product cements the FDA's decision in April 2009 to reinstate the high-concentration oral solutions of morphine sulfate to the market, but not other unapproved narcotic products for which the agency had deemed that acceptable alternatives were available.
The solution is indicated for the relief of moderate to severe, acute, and chronic pain in opioid-tolerant patients, defined as those who are taking the equivalent of 60 mg/day of morphine. It will be available in doses of 100 mg/5 mL and 20 mg/1 mL.
The FDA's decision is part of the ongoing Unapproved Drugs Initiative that the agency began in 2006. Numerous other previously unapproved drugs, including some opioid formulations, have been approved through the initiative.
Combo Approved for Breast Cancer
The FDA approved lapatinib in combination with letrozole for the treatment of postmenopausal women with advanced breast cancer that is hormone receptor and HER2 positive and for whom hormonal therapy is indicated.
A kinase inhibitor, lapatinib (Tykerb) targets the HER2 protein that is overexpressed in HER2-positive breast cancer. Letrozole (Femara), an aromatase inhibitor, is used in patients with hormone-dependent breast cancer.
In a study sponsored by lapatinib manufacturer GlaxoSmithKline, progression-free survival was more than twofold higher among the women who were treated with the all-oral combination of these two agents, compared with those who received letrozole (Femara) alone, according to the statement issued by the FDA.
“It is too early to determine whether an improvement in overall survival will be observed in the clinical trial,” the statement said.
In the trial, median progression-free survival was 35.4 weeks among the 111 women who received lapatinib (1,500 mg/day) plus letrozole (2.5 mg/day), compared with a median of 13 weeks among the 108 women who received letrozole alone, according to the revised label for lapatinib.
Drug to Aid Walking in MS Okayed
A sustained-release formulation of the potassium channel blocker dalfampridine has been approved as a treatment to improve walking in people with multiple sclerosis.
In a statement, the FDA announced that dalfampridine extended-release tablets had been approved for this indication, based on studies that found patients treated with the drug had faster walking speeds than did those treated with placebo. This is the first drug approved for this indication, according to the FDA.
Dalfampridine will be marketed as Ampyra by Acorda Therapeutics.
The recommended dose of dalfampridine is 10 mg twice a day. However, higher doses have been associated with seizures, and the drug should not be taken by patients with moderate to severe kidney disease, whose blood levels with dalfampridine approach the levels that have been associated with seizures, according to the FDA statement.
The drug has a long history of use in the United States despite never having been approved, according to background documents filed by the FDA. For more than 20 years, dalfampridine has been compounded in pharmacies and used off-label to improve walking in people with various neurologic conditions.
McNeil Recalls More OTC Drugs
McNeil Consumer Healthcare is expanding its recall of several over-the-counter medications following an investigation into complaints that some products had a moldy smell and caused temporary GI symptoms.
In a press briefing to announce the expanded recall, FDA officials called McNeil to task for acting too slowly.
The voluntary recall affects certain lots of Benadryl, Tylenol, Motrin IB, Rolaids, Simply Sleep, and St. Joseph Aspirin. A full list of the affected products and their lot numbers can be found at
The company is advising consumers who purchased products from among the recalled lots to stop using the product and contact McNeil for instructions on a refund or replacement.
This expanded recall comes after McNeil Consumer Healthcare recalled all lots of Tylenol Arthritis Pain 100 count in December 2009.
The recalls are based on consumer complaints going back to 2008 that some McNeil OTC products had an unusual moldy, musty, or mildewlike odor. The company also received complaints from consumers who temporarily became ill after taking the products. The most common symptoms reported were nausea, stomach pain, vomiting, and diarrhea.
After an investigation, the company concluded that the smell was caused by trace amounts of the chemical 2,4,6-tribromoanisole (TBA), which is used in treating the wood pallets used to transport and store product packaging materials. While the health effects of the chemical have not been well studied, officials at the FDA said no serious effects have been documented in the medical literature and so far all of the adverse events reported have been minor.
Fake Alli Has Dangerous Dose
An FDA analysis of counterfeit Alli, the OTC formulation of the lipase inhibitor orlistat, has found that the fake product also contains sibutramine and, when taken at the recommended daily dose, may deliver twice the recommended dose of that drug.
The agency reported that Alli manufacturer GlaxoSmithKline had determined there were counterfeit versions of Alli 60-mg capsules being sold over the Internet. The fake version contained sibutramine, a controlled substance marketed as Meridia by Abbott Laboratories.
Upon further analysis, the FDA determined that people taking the counterfeit pills may be getting up to three times the usual daily dose of sibutramine, or twice the recommended maximum dose. According to the agency, in healthy people, sibutramine can cause anxiety, nausea, heart palpitations, tachycardia, insomnia, and small increases in blood pressure. For those who have a history of cardiovascular disease, the excess dose can lead to elevated blood pressure, stroke, or MI.
CVD Contraindication for Sibutramine
The weight-loss drug sibutramine is now contraindicated in people with a history of cardiovascular disease, the FDA announced.
The recommendation was based on a review of data indicating an increased risk of MI and stroke is associated with use of the drug in this population.
The new contraindication states that sibutramine “is not to be used in patients with a history of cardiovascular disease,” including history of coronary artery disease, history of stroke or transient ischemic attack, history of heart arrhythmias, history of heart failure, history of peripheral artery disease, and uncontrolled hypertension.
The FDA announcement on the new contraindication came the day after the agency announced that counterfeit formulations of orlistat (Alli) were found to contain sibutramine.
COPD Inhaler Deemed Safe
Treatment with the Spiriva HandiHaler, which contains a dry powder formulation of the anticholinergic tiotropium, does not appear to be associated with an increased risk of stroke, MI, or cardiovascular death in patients with chronic obstructive pulmonary disease, the FDA announced.
The FDA has now completed its safety review of this product “and believes the available data do not support an association between the use of Spiriva HandiHaler and an increased risk for these serious adverse events,” according to a statement issued by the agency.
The Spiriva HandiHaler (Boehringer Ingelheim/Pfizer) was approved in 2004 for the long-term maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema. It is administered once daily.
In October 2008, the agency issued a statement about two published studies that suggested an increased risk of stroke, MI, and death in patients treated with tiotropium. But the latest FDA statement said that a 4-year study comparing treatment with the Spiriva Handi-Haler to placebo in almost 6,000 patients with COPD found no increase in the risk of these outcomes in the treatment arm.
Liraglutide Licensed for Diabetes
The Food and Drug Administration has approved liraglutide as a once-daily injection for the treatment of type 2 diabetes.
Liraglutide, a human glucagonlike peptide 1 (GLP-1) receptor agonist that promotes glucose-dependent insulin secretion, will be marketed by Novo Nordisk under the name Victoza. It was licensed for use in combination with diet, exercise, and certain other glucose-lowering medications, but not as initial therapy. The first drug in this class, exenatide (Byetta, Amylin/Eli Lilly), was approved in 2005.
It should be used with caution in people with a history of pancreatitis, the FDA said. The most common side effects observed with liraglutide were headache, nausea, and diarrhea.
Novo Nordisk is required to conduct postmarketing cardiovascular and cancer safety studies. Also included in the approval is a Risk Evaluation and Mitigation Strategy (REMS) consisting of a medication guide and a communication plan.
Oral Morphine Solution Approved
A concentrated oral solution of morphine sulfate has been approved, rescuing a formulation that had been slated to be taken off the market last year until physician groups spoke up about its clinical utility and lack of equivalent products.
The approval of Roxane Laboratories' product cements the FDA's decision in April 2009 to reinstate the high-concentration oral solutions of morphine sulfate to the market, but not other unapproved narcotic products for which the agency had deemed that acceptable alternatives were available.
The solution is indicated for the relief of moderate to severe, acute, and chronic pain in opioid-tolerant patients, defined as those who are taking the equivalent of 60 mg/day of morphine. It will be available in doses of 100 mg/5 mL and 20 mg/1 mL.
The FDA's decision is part of the ongoing Unapproved Drugs Initiative that the agency began in 2006. Numerous other previously unapproved drugs, including some opioid formulations, have been approved through the initiative.
Combo Approved for Breast Cancer
The FDA approved lapatinib in combination with letrozole for the treatment of postmenopausal women with advanced breast cancer that is hormone receptor and HER2 positive and for whom hormonal therapy is indicated.
A kinase inhibitor, lapatinib (Tykerb) targets the HER2 protein that is overexpressed in HER2-positive breast cancer. Letrozole (Femara), an aromatase inhibitor, is used in patients with hormone-dependent breast cancer.
In a study sponsored by lapatinib manufacturer GlaxoSmithKline, progression-free survival was more than twofold higher among the women who were treated with the all-oral combination of these two agents, compared with those who received letrozole (Femara) alone, according to the statement issued by the FDA.
“It is too early to determine whether an improvement in overall survival will be observed in the clinical trial,” the statement said.
In the trial, median progression-free survival was 35.4 weeks among the 111 women who received lapatinib (1,500 mg/day) plus letrozole (2.5 mg/day), compared with a median of 13 weeks among the 108 women who received letrozole alone, according to the revised label for lapatinib.
Drug to Aid Walking in MS Okayed
A sustained-release formulation of the potassium channel blocker dalfampridine has been approved as a treatment to improve walking in people with multiple sclerosis.
In a statement, the FDA announced that dalfampridine extended-release tablets had been approved for this indication, based on studies that found patients treated with the drug had faster walking speeds than did those treated with placebo. This is the first drug approved for this indication, according to the FDA.
Dalfampridine will be marketed as Ampyra by Acorda Therapeutics.
The recommended dose of dalfampridine is 10 mg twice a day. However, higher doses have been associated with seizures, and the drug should not be taken by patients with moderate to severe kidney disease, whose blood levels with dalfampridine approach the levels that have been associated with seizures, according to the FDA statement.
The drug has a long history of use in the United States despite never having been approved, according to background documents filed by the FDA. For more than 20 years, dalfampridine has been compounded in pharmacies and used off-label to improve walking in people with various neurologic conditions.
McNeil Recalls More OTC Drugs
McNeil Consumer Healthcare is expanding its recall of several over-the-counter medications following an investigation into complaints that some products had a moldy smell and caused temporary GI symptoms.
In a press briefing to announce the expanded recall, FDA officials called McNeil to task for acting too slowly.
The voluntary recall affects certain lots of Benadryl, Tylenol, Motrin IB, Rolaids, Simply Sleep, and St. Joseph Aspirin. A full list of the affected products and their lot numbers can be found at
The company is advising consumers who purchased products from among the recalled lots to stop using the product and contact McNeil for instructions on a refund or replacement.
This expanded recall comes after McNeil Consumer Healthcare recalled all lots of Tylenol Arthritis Pain 100 count in December 2009.
The recalls are based on consumer complaints going back to 2008 that some McNeil OTC products had an unusual moldy, musty, or mildewlike odor. The company also received complaints from consumers who temporarily became ill after taking the products. The most common symptoms reported were nausea, stomach pain, vomiting, and diarrhea.
After an investigation, the company concluded that the smell was caused by trace amounts of the chemical 2,4,6-tribromoanisole (TBA), which is used in treating the wood pallets used to transport and store product packaging materials. While the health effects of the chemical have not been well studied, officials at the FDA said no serious effects have been documented in the medical literature and so far all of the adverse events reported have been minor.
Fake Alli Has Dangerous Dose
An FDA analysis of counterfeit Alli, the OTC formulation of the lipase inhibitor orlistat, has found that the fake product also contains sibutramine and, when taken at the recommended daily dose, may deliver twice the recommended dose of that drug.
The agency reported that Alli manufacturer GlaxoSmithKline had determined there were counterfeit versions of Alli 60-mg capsules being sold over the Internet. The fake version contained sibutramine, a controlled substance marketed as Meridia by Abbott Laboratories.
Upon further analysis, the FDA determined that people taking the counterfeit pills may be getting up to three times the usual daily dose of sibutramine, or twice the recommended maximum dose. According to the agency, in healthy people, sibutramine can cause anxiety, nausea, heart palpitations, tachycardia, insomnia, and small increases in blood pressure. For those who have a history of cardiovascular disease, the excess dose can lead to elevated blood pressure, stroke, or MI.
CVD Contraindication for Sibutramine
The weight-loss drug sibutramine is now contraindicated in people with a history of cardiovascular disease, the FDA announced.
The recommendation was based on a review of data indicating an increased risk of MI and stroke is associated with use of the drug in this population.
The new contraindication states that sibutramine “is not to be used in patients with a history of cardiovascular disease,” including history of coronary artery disease, history of stroke or transient ischemic attack, history of heart arrhythmias, history of heart failure, history of peripheral artery disease, and uncontrolled hypertension.
The FDA announcement on the new contraindication came the day after the agency announced that counterfeit formulations of orlistat (Alli) were found to contain sibutramine.
COPD Inhaler Deemed Safe
Treatment with the Spiriva HandiHaler, which contains a dry powder formulation of the anticholinergic tiotropium, does not appear to be associated with an increased risk of stroke, MI, or cardiovascular death in patients with chronic obstructive pulmonary disease, the FDA announced.
The FDA has now completed its safety review of this product “and believes the available data do not support an association between the use of Spiriva HandiHaler and an increased risk for these serious adverse events,” according to a statement issued by the agency.
The Spiriva HandiHaler (Boehringer Ingelheim/Pfizer) was approved in 2004 for the long-term maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema. It is administered once daily.
In October 2008, the agency issued a statement about two published studies that suggested an increased risk of stroke, MI, and death in patients treated with tiotropium. But the latest FDA statement said that a 4-year study comparing treatment with the Spiriva Handi-Haler to placebo in almost 6,000 patients with COPD found no increase in the risk of these outcomes in the treatment arm.
Liraglutide Licensed for Diabetes
The Food and Drug Administration has approved liraglutide as a once-daily injection for the treatment of type 2 diabetes.
Liraglutide, a human glucagonlike peptide 1 (GLP-1) receptor agonist that promotes glucose-dependent insulin secretion, will be marketed by Novo Nordisk under the name Victoza. It was licensed for use in combination with diet, exercise, and certain other glucose-lowering medications, but not as initial therapy. The first drug in this class, exenatide (Byetta, Amylin/Eli Lilly), was approved in 2005.
It should be used with caution in people with a history of pancreatitis, the FDA said. The most common side effects observed with liraglutide were headache, nausea, and diarrhea.
Novo Nordisk is required to conduct postmarketing cardiovascular and cancer safety studies. Also included in the approval is a Risk Evaluation and Mitigation Strategy (REMS) consisting of a medication guide and a communication plan.
Oral Morphine Solution Approved
A concentrated oral solution of morphine sulfate has been approved, rescuing a formulation that had been slated to be taken off the market last year until physician groups spoke up about its clinical utility and lack of equivalent products.
The approval of Roxane Laboratories' product cements the FDA's decision in April 2009 to reinstate the high-concentration oral solutions of morphine sulfate to the market, but not other unapproved narcotic products for which the agency had deemed that acceptable alternatives were available.
The solution is indicated for the relief of moderate to severe, acute, and chronic pain in opioid-tolerant patients, defined as those who are taking the equivalent of 60 mg/day of morphine. It will be available in doses of 100 mg/5 mL and 20 mg/1 mL.
The FDA's decision is part of the ongoing Unapproved Drugs Initiative that the agency began in 2006. Numerous other previously unapproved drugs, including some opioid formulations, have been approved through the initiative.
Combo Approved for Breast Cancer
The FDA approved lapatinib in combination with letrozole for the treatment of postmenopausal women with advanced breast cancer that is hormone receptor and HER2 positive and for whom hormonal therapy is indicated.
A kinase inhibitor, lapatinib (Tykerb) targets the HER2 protein that is overexpressed in HER2-positive breast cancer. Letrozole (Femara), an aromatase inhibitor, is used in patients with hormone-dependent breast cancer.
In a study sponsored by lapatinib manufacturer GlaxoSmithKline, progression-free survival was more than twofold higher among the women who were treated with the all-oral combination of these two agents, compared with those who received letrozole (Femara) alone, according to the statement issued by the FDA.
“It is too early to determine whether an improvement in overall survival will be observed in the clinical trial,” the statement said.
In the trial, median progression-free survival was 35.4 weeks among the 111 women who received lapatinib (1,500 mg/day) plus letrozole (2.5 mg/day), compared with a median of 13 weeks among the 108 women who received letrozole alone, according to the revised label for lapatinib.
Drug to Aid Walking in MS Okayed
A sustained-release formulation of the potassium channel blocker dalfampridine has been approved as a treatment to improve walking in people with multiple sclerosis.
In a statement, the FDA announced that dalfampridine extended-release tablets had been approved for this indication, based on studies that found patients treated with the drug had faster walking speeds than did those treated with placebo. This is the first drug approved for this indication, according to the FDA.
Dalfampridine will be marketed as Ampyra by Acorda Therapeutics.
The recommended dose of dalfampridine is 10 mg twice a day. However, higher doses have been associated with seizures, and the drug should not be taken by patients with moderate to severe kidney disease, whose blood levels with dalfampridine approach the levels that have been associated with seizures, according to the FDA statement.
The drug has a long history of use in the United States despite never having been approved, according to background documents filed by the FDA. For more than 20 years, dalfampridine has been compounded in pharmacies and used off-label to improve walking in people with various neurologic conditions.
McNeil Recalls More OTC Drugs
McNeil Consumer Healthcare is expanding its recall of several over-the-counter medications following an investigation into complaints that some products had a moldy smell and caused temporary GI symptoms.
In a press briefing to announce the expanded recall, FDA officials called McNeil to task for acting too slowly.
The voluntary recall affects certain lots of Benadryl, Tylenol, Motrin IB, Rolaids, Simply Sleep, and St. Joseph Aspirin. A full list of the affected products and their lot numbers can be found at
The company is advising consumers who purchased products from among the recalled lots to stop using the product and contact McNeil for instructions on a refund or replacement.
This expanded recall comes after McNeil Consumer Healthcare recalled all lots of Tylenol Arthritis Pain 100 count in December 2009.
The recalls are based on consumer complaints going back to 2008 that some McNeil OTC products had an unusual moldy, musty, or mildewlike odor. The company also received complaints from consumers who temporarily became ill after taking the products. The most common symptoms reported were nausea, stomach pain, vomiting, and diarrhea.
After an investigation, the company concluded that the smell was caused by trace amounts of the chemical 2,4,6-tribromoanisole (TBA), which is used in treating the wood pallets used to transport and store product packaging materials. While the health effects of the chemical have not been well studied, officials at the FDA said no serious effects have been documented in the medical literature and so far all of the adverse events reported have been minor.
Fake Alli Has Dangerous Dose
An FDA analysis of counterfeit Alli, the OTC formulation of the lipase inhibitor orlistat, has found that the fake product also contains sibutramine and, when taken at the recommended daily dose, may deliver twice the recommended dose of that drug.
The agency reported that Alli manufacturer GlaxoSmithKline had determined there were counterfeit versions of Alli 60-mg capsules being sold over the Internet. The fake version contained sibutramine, a controlled substance marketed as Meridia by Abbott Laboratories.
Upon further analysis, the FDA determined that people taking the counterfeit pills may be getting up to three times the usual daily dose of sibutramine, or twice the recommended maximum dose. According to the agency, in healthy people, sibutramine can cause anxiety, nausea, heart palpitations, tachycardia, insomnia, and small increases in blood pressure. For those who have a history of cardiovascular disease, the excess dose can lead to elevated blood pressure, stroke, or MI.
CVD Contraindication for Sibutramine
The weight-loss drug sibutramine is now contraindicated in people with a history of cardiovascular disease, the FDA announced.
The recommendation was based on a review of data indicating an increased risk of MI and stroke is associated with use of the drug in this population.
The new contraindication states that sibutramine “is not to be used in patients with a history of cardiovascular disease,” including history of coronary artery disease, history of stroke or transient ischemic attack, history of heart arrhythmias, history of heart failure, history of peripheral artery disease, and uncontrolled hypertension.
The FDA announcement on the new contraindication came the day after the agency announced that counterfeit formulations of orlistat (Alli) were found to contain sibutramine.
COPD Inhaler Deemed Safe
Treatment with the Spiriva HandiHaler, which contains a dry powder formulation of the anticholinergic tiotropium, does not appear to be associated with an increased risk of stroke, MI, or cardiovascular death in patients with chronic obstructive pulmonary disease, the FDA announced.
The FDA has now completed its safety review of this product “and believes the available data do not support an association between the use of Spiriva HandiHaler and an increased risk for these serious adverse events,” according to a statement issued by the agency.
The Spiriva HandiHaler (Boehringer Ingelheim/Pfizer) was approved in 2004 for the long-term maintenance treatment of bronchospasm associated with COPD, including chronic bronchitis and emphysema. It is administered once daily.
In October 2008, the agency issued a statement about two published studies that suggested an increased risk of stroke, MI, and death in patients treated with tiotropium. But the latest FDA statement said that a 4-year study comparing treatment with the Spiriva Handi-Haler to placebo in almost 6,000 patients with COPD found no increase in the risk of these outcomes in the treatment arm.