Black box warning is the sternest safety warning found in the labeling information of a certain prescription medication which may have been tied to potentially adverse or fatal health concerns, health experts say. Also called boxed warning, it shows a brief yet comprehensive summary of the possible unanticipated side effects and health consequences 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.



 

Examples of medications that were required to yield a black box warning before and after gaining market clearance include antidepressant medications Paxil and Zoloft, fluoroquinolone antibiotics such as Levaquin and Cipro, and newer anti-diabetes medication Victoza.



Developed and sold by Danish drug maker Novo Nordisk, Victoza (liraglutide), is a prescription medication administered through injection, alongside other anti-diabetes drugs for the treatment of type 2 diabetes. It primarily helps in controlling blood sugar levels in diabetics by increasing the amount of insulin that the body produces.



 

Victoza has also been hailed as one of the top-selling diabetes medications, bringing home $1.7 billion in sales for its manufacturer in 2012, according to a Bloomberg report. It has also showed superiority over another similar medication, known as Januvia, in helping patients fight obesity and control blood sugar levels. However, alongside its benefits were serious adverse effects that may have warranted a black box warning from the United States Food and Drug Administration.



In an FDA news release announcing the approval of Victoza for use in relation to the treatment of type 2 diabetes, the federal agency reported that the medication caused rodents to develop thyroid gland tumors, although such adverse reaction has not been proven to occur to in humans. 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.



 

Findings from a recent study also links Victoza, and other anti-diabetes medications, including Byetta and Januvia, to pre-cancerous pancreatic cell growth and damage in some patients. 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.htm
• webmd.com/a-to-z-guides/drug-side-effects-explained
• accessdata.fda.gov/drugsatfda_docs/label/2010/022341lbl.pdf
• medicalnewstoday.com/articles/243855.php
• fda.gov/downloads/ForConsumers/ConsumerUpdates/ucm107976.pdf
• fda.gov/NewsEvents/Newsroom/PressAnnouncements/2010/ucm198638.htm
• bloomberg.com/news/2013-03-22/diabetes-drugs-may-cause-damage-to-pancreas-study-finds.html