Navigation Links
FDA Announces Voluntary Withdrawal of Pergolide Products

The U.S. Food and Drug Administration (FDA) today announced that manufacturers of pergolide drug products, which are used to treat Parkinson’s disease, will voluntarily remove// these drugs from the market because of the risk of serious damage to patients’ heart valves.

The products being withdrawn are Permax, the trade name for pergolide marketed by Valeant Pharmaceuticals, and two generic versions of pergolide manufactured by Par and Teva. Pergolide is in a class of medications called dopamine agonists and is used with levodopa and carbidopa to manage the symptoms (tremors and slowness of movement) of Parkinson’s disease.

In 2006, an estimated 12,000 patients received prescriptions for pergolide from retail pharmacies in the United States. Patients taking pergolide should contact their doctors to discuss alternate treatments. Patients should not stop taking the medication, as stopping pergolide abruptly can be dangerous.

There are alternative therapies available for Parkinson’s disease, including three other dopamine agonists that have not been associated with valvular heart disease. The removal of pergolide products is not expected to adversely affect patient care because of the alternative therapies available.

“Based on important new drug safety information, FDA has been working with the manufacturers of pergolide products to voluntarily remove these drugs from the market,” said Douglas Throckmorton, M.D., deputy director of FDA’s Center for Drug Evaluation and Research. “The FDA’s increased evaluation of post-market safety is benefiting the public because, in this case, as new data about the product became available, we were able to remove a less safe drug from the market.”

Two recent New England Journal of Medicine studies confirm previous findings associating pergolide with increased chance of regurgitation (backflow of blood) of the mitral, tricuspid, and aortic valves of the heart. Valve regurgitat ion is a condition in which valves don’t close tightly, allowing blood to flow backward across the valve. Symptoms include shortness of breath, fatigue and heart palpitations.

In light of this additional post-market safety information, the companies that manufacture and sell pergolide will stop shipping pergolide for distribution and, in cooperation with FDA, will withdraw the products from the market.

Permax was approved in 1988 for Eli Lilly and Company as an adjunctive therapy with levodopa in Parkinson’s disease. Valvular heart disease was first described in association with pergolide in 2002. In 2003, FDA asked Lilly to add valvulopathy (abnormality of cardiac valves) to the warnings section of Permax labeling, at which time a Dear Healthcare Practitioner letter was sent by Lilly. In 2006, the warning was upgraded to a black box warning, the FDA’s strongest form of warning, because of new data concerning risks of heart valve damage.

FDA today is issuing a Public Health Advisory (PHA) detailing the removal of pergolide products from the market. The PHA, which is available at www.fda.gov/cder/drug/advisory/pergolide.htm includes information and recommended actions for physicians, pharmacists and patients.

The effect of the voluntary withdrawal on supplies of pergolide currently in pharmacies will not be immediate. This delay will allow time for health care providers and patients to discuss appropriate treatment options and time to change treatments.

FDA is working with the manufacturers of pergolide to determine if it might be possible, once the drug is withdrawn from the market, to make the drug available under an Investigational New Drug Application (IND) for those few patients who are currently receiving pergolide and who cannot be successfully converted to other available treatments.

Source-Bio-Bio Technlogy
SRM
'"/>




Related medicine news :

1. Ramdoss Announces Introduction of RCH-II
2. Britain Announces Third Transfusion Related Mad Cow Case
3. Tibet Announces the Dalai Lama’s Tour of South Americ
4. Indian PM Announces Of Setting Up India Study Center At Tashkent
5. PowderMed Announces Needle-Less Flu Vaccine
6. Malaysia Announces Prison term On People Donating HIV-Contaminated Blood
7. Gates Foundation Announces $287 Million In Grants Towards AIDS Vaccine
8. Australian Government Announces Survey To Tackle Childhood Obesity
9. New Zealand Announces 10-year Plan For Betterment Of Mental Health Care
10. Apollo Announces Research on Indian Cardiac Epidemic
11. Government Announces Steps To Promote Ayurvedic Medicine
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:10/13/2017)... , ... October 13, 2017 ... ... of Pharmacy (SOP) alumni Hannah Randall, PharmD ‘17, and Jennifer Huggins, PharmD ... on guideline updates for the primary prevention of cardiovascular diseases during the ...
(Date:10/13/2017)... ... 13, 2017 , ... Ellevate Network, the leading network for professional women, brought ... gender equality at their inaugural Summit in New York City in June. The event ... audience of over 3 million. To watch the Mobilize Women video, click here ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the Mountains to the ... save lost souls in the Philippines. “The Journey: From the Mountains to the Mission ... of the Bible. She has taught all ages and currently teaches a class of ...
(Date:10/12/2017)... WAUSAU, Wis. (PRWEB) , ... October 12, 2017 ... ... formulated standard products to meet the demand of today’s consumer and regulatory authorities ... team of probiotic experts and tested to meet the highest standard. , ...
(Date:10/12/2017)... ... 2017 , ... Dr. Parsa Mohebi, the Los Angeles based ... the newly revamped Cosmetic Town journal section, featuring articles written by ... as Follicular Unit Extraction (FUE). , Dr. Mohebi says “I enjoy ...
Breaking Medicine News(10 mins):
(Date:9/28/2017)... Cohen Veterans Bioscience and Early Signal Foundation announce a ... sensors for real-time monitoring of patients with trauma-related and ... focused on disruptive health solutions for rare disorders and ... record and integrate behavioral, cognitive, physiological and contextual data. ... ...
(Date:9/23/2017)... , Sept. 22, 2017 Janssen Biotech, ... complete response letter from the U.S. Food and Drug ... approval of sirukumab for the treatment of moderately to ... indicates additional clinical data are needed to further evaluate ... to severely active RA. ...
(Date:9/18/2017)... KALAMAZOO, Mich. , Sept. 18, 2017 /PRNewswire/ ... and OptiMed Specialty Pharmacy of Kalamazoo, Mich. ... a strategic hub service that expedites and streamlines patient ... spirometer, Spiro PD 2.0, and wellness management services.  ... a medical device used to measure lung function for ...
Breaking Medicine Technology: