Dr. John Happel | Aug 28, 2018 | 0
FDA Approves a New Medicine for Varicose Vein Treatments
The newest and latest treatment for varicose veins has arrived.
Varithena is a new FDA approved drug for the treatment of varicose vein disease which will be introduced within the next month. Varithena’s main ingredient is a medication called polidocanol. Asclera (the trade name for polidocanol when manufactured by Merz Pharma) has been approved by the FDA in the past for the treatment of spider veins only. The most important difference between these two different types of polidocanol is that for varicose vein use the medicine needs to be made into a foam to be most effective. The consistency of this foam is similar to shaving cream. In this form, the Varithena or polidocanol foam can displace blood when it is injected into a vein making the medicine work more efficiently to get rid of the unwanted varicose veins. Varithena became FDA approved in November 2013 but will soon be available for doctors to use. It is directly injected into the varicose veins with a needle and syringe which is known as sclerotherapy. This medicine comes contained in a canister device and is mixed with low-nitrogen gas to make it safer. In controlled trials patients achieved significant clinical relief of their symptoms for the majority of the patients tested. Trials included treatment of both saphenous veins and varicose vein tributaries alleviating symptoms in a large number of patients. Only after using this drug for many more years will doctors know if it is equal or superior to present treatment methods which include laser, radiofrequency, and ambulatory phlebectomy.
At the present time, many vein specialists prefer not to use sclerotherapy for larger varicose veins because of the associated phlebitis and hyperpigmentation seen after injections. A canister of this injectable foam medicine will cost three thousand one hundred and ninety five dollars. According to BTG, the manufacturer of Varithena, insurance will cover the cost. The company recommends using a maximum of 15 ml of foam per patient. Approximately 45 ml of foam can be produced with each canister. That comes to $71.00 dollars per ml of foam. No more than 15 ml of foam should be given during one treatment and more than one treatment is usually necessary to close your varicose veins. The cost and effectiveness of this new medicine will be shown over the next few years by randomized controlled trials as compared to the present gold standards of treating varicose vein disease. For more information, call us at 724-969-0600.