November 30, 2012
Ranbaxy Stops Production Of Generic Lipitor Due To Glass Particles
Connie K. Ho for redOrbit.com — Your Universe Online
New Delhi-based Ranbaxy Laboratories recently announced that they would stop production of Atorvastatin, a product similar to Pfizer Inc.´s Lipitor that focuses on fighting high cholesterol. The company´s decision was prompted by a recent recall by the U.S. Food and Drug Administration (FDA).The voluntary recall covers Atorvastatin tablets at 10mg, 20mg, and 40mg strengths. The tablets were recalled due to the possibility of contamination with minuscule glass particles. At this time, the FDA has not received any information regarding patients who have may have been harmed by the possible contamination. The FDA recommends that, for individuals who believe that they received a recalled product, they should discuss the medication with their pharmacists to receive confirmation on whether the product was recalled or not.
“Americans expect and deserve safe, effective, and high quality medications. The FDA continues to evaluate information associated with this recall and will notify the public as new information becomes available. The agency will continue to oversee the recall process, and work with the Ranbaxy to resolve these pharmaceutical quality issues,” wrote the authors of the FDA statement.
In a report by Bloomberg, the company stated that the recall and stop in production would not result in shortage of the pills.
As well, Reuters reported that Ranbaxy has had difficulties in the past. In 2008, the FDA banned the company from importing approximately 30 drugs. The FDA had discovered manufacture differences at two facilities in India, and the company agreed to have a third party complete a review of the various facilities as well as maintain “data integrity” and “good manufacturing practices.”
This incident has highlighted the difficulties of overseeing quality control in plants in other countries as compared to plants in the U.S.
“I have pretty good faith in companies and plants that make drugs in this country because I know from my own experience that they try to do a good job,” Prabir K. Basu, a past employee of pharmaceutical companies in manufacturing and global sourcing as well as executive director of the National Institute for Pharmaceutical Technology and Education, told The New York Times. “But my confidence is not that high when we are getting products from outside the country.”
Apart from the recall issue with Ranbaxy, high cholesterol has been a concern of medical professionals in the past. According to the Mayo Clinic, high cholesterol can result in fatty deposits in blood vessels. Cholesterol, a waxy substance found in fats, can help build healthy cells but can also elevate the risk of developing heart disease. Various factors that can increase the risk for heart disease include diabetes, high blood pressure, lack of exercise, obesity, a poor diet and smoking. With healthy life changes, individuals can reduce the level of cholesterol. Some tips in preventing high cholesterol include maintaining a healthy weight; eating plenty of fruits, vegetables, whole grains and a low-fat, low-salt diet; as well as exercising most days of the week with brisk activities like swimming and walking for a minimum of 30 minutes.