Know the real truth about Permax (pergolide)
Permax containing pergolide mesylate is used by patients suffering from Parkinson’s disease. When combined with carbidopa/levodopa, the effectiveness of this drug gets increased greatly. What actually brought this drug to the notice of all were the severe complications, many of which were life threatening, the same induced in patients taking this. Primarily pergolide is a dopamine agonist and the mode of action it follows is by stimulating the receptors responsible for dopamine production in brain. Constant warnings by FDA and many other researchers have lead to taking serious steps to avoid people from facing serious health issues. But, for those who have already become victims, there are various lawsuits filed to help such people get aptly compensated by the guilty. Here are some of such cases…
A news release:
Issued on March 29, 2007, this was by U.S. Food and Drug Administration (FDA), which announced a complete voluntary withdrawal of Permax from the U.S., drug industry. The announcement which focused on drugs containing pergolide also linked with Permax, which packed this in major percentage. The announcement was a result of the constant cases of patients who faced serious heart valve problems. The drug which is used to treat the symptoms of Parkinson’s disease was different from what it actually aimed at.
The post marketing evaluation and thorough research conducted by FDA helped in coming to the finding. The constant efforts finally lead to the removal of an unsafe drug from the shelves.
The study was further supported by two new publications in New England Journal of Medicine, which clearly stated that pergolide can induce increased chances of backflow of blood in the valves of the heart. This regurgitation condition is significantly dangerous and can cause severe complications like difficulty in breathing, palpitations and more.
Permax marketed by Valeant Pharmaceuticals was officially released after approval in 1988. The first case that let FDA issue warning was in 2002, when a patient suffering from Parkinson’s disease and administering Permax developed valvular heart disease. Since then there were many such cases noticed that lead to an issue of a black box warning in 2006 and complete withdrawal in 2007.
FDA also issued a PHA warning to help everyone get educated about the bad effects of Permax, which somehow remained hidden from the public before 2007. The withdrawals also lead the healthcare experts and researchers to find some safe alternative treatment options. These were treatments that could actually help patients suffering from Parkinson’s disease find relief, but without the risk of developing serious health complications.
A black box warning:
Permax, which was once the most popularly prescribed drug among patients suffering from Parkinson’s disease in 2006, had more than 12000 prescriptions, in U.S. in that year, But, a serious link of Permax with valvulopathy in the heart led to a great downfall in its popularity. The most serious of such warnings was issued in 2007 when more than 12 patients on Permax needed valve replacement to save their lives, which was moreover the result of Permax administration.
For the many people out there who became innocent victims of Permax, the few law articles mentioned above can help in motivating them to take action against the harm Permax has caused to their life or the life of their loved ones. Law can help such innocent victims by getting them rightly compensated for the loss they may have faced in the form of lost wages, medical bills and medicines that Permax consumption caused.