Permax: FDA related information
The constant warnings of FDA have protected many from becoming victims of Permax (pergolide)
Permax, a drug used in treating Parkinson’s was a dopamine agonist that aimed at stimulating the level of this neurotransmitter/ receptor in the body. Considered effective in the first look, the real side of Permax came to light when many patients filed cases against the same for causing increased development of heart valve problems.
FDA initially approved the sale of Permax as a prescription drug for patients of Parkinson’s disease in 1988, when the same was released. The drug was also recommended for patients suffering from RLS or restless leg syndrome.
The initial popularity that the drug earned in the U.S. and the sudden downfall were all linked with the U.S. Food and Drug Administration/FDA’s involvement.
After its approval in 1988 and then reports of valve disorders in 2002, FDA announced a thorough research about the harmful effects of Permax. The drug was known to show interactions with many other drugs and patients were thus advised to discuss their complete medical history with the healthcare professionals before taking Permax. FDA announced that medications used for treating anxiety, psychosis or depression should in no condition be combined with pergolide that is the most established ingredient of Permax.
In March 2006, FDA announced a complete withdrawal of Permax from the market due to its increased risk of causing heart valve problems amongst patients. The decision got further support from many new studies that came to similar findings amongst patients administering Permax.
FDA finally pulled off Permax from the U.S. drug market in a warning that became effective from the 29th of March, 2007.
FDA did not add that black box warning to Permax till 2006, a precaution was announced but the lethal warning became effective only in December 2006.
The valve replacement procedure and also death in severe cases were some incidences that lead FDA to come to this finding. The role FDA plays in getting any drug approval in the industry and among patients and healthcare experts is significant. Its role in this scenario cannot be overshadowed. Thus, it appears imperative for FDA to keep a constant check on the report and overall effects of that particular drug amongst masses. Clinical findings may have proved positive, but actually doing the same among people can sometimes cause diversions and bring to notice many hidden realities. Permax, a very true example, of this category was responsible for causing severe irreversible damage to the health and wellbeing of patients taking this for Parkinson’s disease treatment.
FDA was made aware about the severe complications associated with Permax five years before its actual recall. This was through a report in 2002 by Mayo Clinic that showed a high risk associated with Permax intake among patients for developing heart valve disorders.
Heart valve damage is a serious health complication that can even turn fatal. The heart valve replacement surgery that involves open heart surgery appears as the only treatment alterative for all such patients. This surgery is a very costly procedure that is complicated and life threatening.
As per FDA till day there are 14 cases of patients who have undertaken the heart valve replacement surgery as an after effect of Permax.
Constant warnings by FDA have lead healthcare professionals to now stop prescribing the drug called Permax. This even lead to a complete ban on the sale and promotion of this drug in the U.S. FDA shares a significant association with drug approval in U.S., in fact, no drug is approved for sale before receiving a green signal from the agency.
In the case of Permax, particularly the drug recall followed a long path and time too. From approval in 1988 to ordering studies in 2002, the drug remained on sale till almost 2007, during which it significantly affected the lives of many taking this, and for no good.
It, thus, appears as the need of the hour to get educated about the good and the bad a drug can do to the life of one who has been advised. Researchers and healthcare professionals also need to get educated about all such possible effects, both good and bad, about any medication.