Knowing the FDA’s Black Box Warning and How Victoza Acquired the Label
Black box warning, the United States Food and Drug Administration’s strongest safety warning, is an indication that appears on a drug’s labeling information designed to call to attention major health risks linked to a certain medication, according to medical experts. Also called boxed warning, it shows a brief yet comprehensive summary of the possible undesirable side effects and health repercussions that may result from the use of a certain drug, designed to alert and help patients and doctors reach a well-informed choice before starting a treatment or prescribing a different medication. Some of the commonly used medications that obtained a black box warning, before and after they have been distributed into the market, include fluoroquinolone antibiotics such as Cipro and Levaquin, antidepressant medications Zoloft and Paxil, and diabetes medication Victoza.
Manufactured by Danish pharmaceutical company Novo Nordisk, Victoza, or liraglutide, is an injectable prescription medication usually prescribed to patients with type 2 diabetes. It primarily functions by promoting the production of insulin aiding in the regulation of blood sugar (glucose) levels in diabetic patients.
Victoza has also been reported as the fastest growing product of Novo Nordisk, bringing home $1.7 billion in sales for the company in 2012, according to online media reports. Moreover, findings from a Novo Nordisk study has also reportedly shown Victoza to be superior to another diabetes drug, known as Januvia, in helping patients reduce body weight and regulate blood sugar. On the other hand, apart from its benefits were potentially adverse effects and health risks that may have earned a black box warning from the United States Food and Drug Administration.
As the FDA announced in a press release declaring the approval of Victoza for use in relation to type 2 diabetes treatment, the agency also reported that the medication may also be linked to the development of thyroid gland tumors in laboratory rodents. The FDA further announced, as in its black box warning, that Victoza is contraindicated to patients at risk of developing medullary thyroid cancer (MTC), such as people with a family history of MTC and patients with multiple endocrine neoplasia syndrome type 2.
An emerging research also suggests that Victoza intake, and of other similar drugs, including Byetta and Januvia, may be associated with the development of pre-cancerous pancreatic cell growth in study cohorts. The FDA has reportedly started probing such emerging safety problem, and encourages patients to continue taking their medications as prescribed unless advised otherwise by their doctors. Meanwhile, a number of people who may have had a first-hand account of these purported adverse effects have reportedly brought a Victoza lawsuit against the drug manufacturer.
Sources:
drugs.about.com/od/medicationabcs/a/BlackBoxWarning.htmwebmd.com/a-to-z-guides/drug-side-effects-explainedaccessdata.fda.gov/drugsatfda_docs/label/2010/022341lbl.pdfmedicalnewstoday.com/articles/243855.phpfda.gov/downloads/ForConsumers/ConsumerUpdates/ucm107976.pdffda.gov/NewsEvents/Newsroom/PressAnnouncements/2010/ucm198638.htmbloomberg.com/news/2013-03-22/diabetes-drugs-may-cause-damage-to-pancreas-study-finds.html
Manufactured by Danish pharmaceutical company Novo Nordisk, Victoza, or liraglutide, is an injectable prescription medication usually prescribed to patients with type 2 diabetes. It primarily functions by promoting the production of insulin aiding in the regulation of blood sugar (glucose) levels in diabetic patients.
Victoza has also been reported as the fastest growing product of Novo Nordisk, bringing home $1.7 billion in sales for the company in 2012, according to online media reports. Moreover, findings from a Novo Nordisk study has also reportedly shown Victoza to be superior to another diabetes drug, known as Januvia, in helping patients reduce body weight and regulate blood sugar. On the other hand, apart from its benefits were potentially adverse effects and health risks that may have earned a black box warning from the United States Food and Drug Administration.
As the FDA announced in a press release declaring the approval of Victoza for use in relation to type 2 diabetes treatment, the agency also reported that the medication may also be linked to the development of thyroid gland tumors in laboratory rodents. The FDA further announced, as in its black box warning, that Victoza is contraindicated to patients at risk of developing medullary thyroid cancer (MTC), such as people with a family history of MTC and patients with multiple endocrine neoplasia syndrome type 2.
An emerging research also suggests that Victoza intake, and of other similar drugs, including Byetta and Januvia, may be associated with the development of pre-cancerous pancreatic cell growth in study cohorts. The FDA has reportedly started probing such emerging safety problem, and encourages patients to continue taking their medications as prescribed unless advised otherwise by their doctors. Meanwhile, a number of people who may have had a first-hand account of these purported adverse effects have reportedly brought a Victoza lawsuit against the drug manufacturer.
Sources:
drugs.about.com/od/medicationabcs/a/BlackBoxWarning.htmwebmd.com/a-to-z-guides/drug-side-effects-explainedaccessdata.fda.gov/drugsatfda_docs/label/2010/022341lbl.pdfmedicalnewstoday.com/articles/243855.phpfda.gov/downloads/ForConsumers/ConsumerUpdates/ucm107976.pdffda.gov/NewsEvents/Newsroom/PressAnnouncements/2010/ucm198638.htmbloomberg.com/news/2013-03-22/diabetes-drugs-may-cause-damage-to-pancreas-study-finds.html