Recently, the State Food and Drug Administration (SFDA) of China issued a notice stating that in view of the risk of increased heart valve damage from the preparation of Pergolide mesylate, it was decided that from January 1, 2008, the production, sale, and use of the drug should be stopped by the drug manufacturing, operating and using units, and the approval certificate of the drug will also be withdrawn at the same time.
Pergolide mesylate tablets, the indications are that this product is a dopamine receptor agonist and a synergistic drug for the compound levodopa preparation.
Pergolide is a drug used to treat Parkinson’s disease. The safety issues of adverse reactions to severe damage to heart valves are well established. Together with its use as second-line adjuvant therapy in the later stages of Parkinson’s disease treatment. Its therapeutic status can be replaced.
On March 29, the FDA declared that the drug manufacturer has voluntarily withdrawn the drug from the U.S. market. The products withdrawn from the market include the products of the original issuer Eli Lilly and Company and two generic products.
There are currently two companies in China that hold the approval number for the product. Pergolide mesylate tablets were manufactured by Tianjin Central Pharmaceutical Co. and approved for marketing in 1996. Lilly and Company’s Pergolide Mesylate Tablets (trade name Xie Liang Xing), were approved for marketing in 1994.
On December 1, 2005, Eli Lilly and Famalink transferred the marketing rights of pergolide mesylate tablets in China to Famalink by signing an agreement for the transfer of the trademark rights, manufacturing technology, and drug registration information. The latter is fully responsible for the sales and marketing of Pergolide Mesylate in China.
According to Cao Xin, the manager of the drug registration department of Famalink (Shanghai) Pharmaceutical Consulting Services, “The delisting does not have much impact on the company. According to SFDA’s requirements, in order to ensure the supply, the sales of such products in the market will not stop until 2008, and the loss will be minimized.”
According to Cao Xin, China is currently using this type of product for about 1,000 Parkinson’s disease patients, coupled with the factors of the Chinese physique, the use of the product is only one-sixth of the European and American races can be effective. Therefore the use of the amount is not very large. Annual sales are about 3 million yuan. This type of product has also been monitored for the manifestation of adverse reactions, but it is not the effect on the cardiac system.
A person from Tianjin Central Pharmaceuticals said in an interview, “has not received a formal notice of discontinuation from the SFDA, it is inconvenient to comment.”
Industry sources analyzed that the statistics of the sales of this type of product in 2004 showed that it had a market size of about 20 million yuan in China. In addition to the products of British Eli Lilly, Tianjin Central Pharmaceutical developed APIs and tablets of such products in 1999. And obtained the production approval of this type of product.
The SFDA department said that the notice has just been issued and no feedback has been received from the companies. At the same time, SFDA reminded patients that due to the sudden discontinuation of Pergolide can cause nerve blocker malignant syndrome. Patients who are ready to discontinue pergolide are advised to gradually reduce the dosage and stop the drug. And take appropriate alternative treatment measures.