JEDDAH, 6 July 2006 — The manufacturers of an ophthalmic solution suspected of causing eye infections is actively pulling out the product from the Saudi market, according to a statement issued yesterday by the Saudi Ophthalmology Society.
On June 26, Arab News reported on the selling of ReNu with MoistureLoc in pharmacies here despite announcements over a month ago by Bausch & Lomb that it was recalling the product from markets worldwide. The manufacturers announced their decision in May after an outbreak of a fungal eye infection in the US was linked to the use of the products.
The Saudi Ministry of Health also issued a precautionary note and later sent circulars to pharmacies to remove all ReNu products from their shelves, but even after removing them ReNu with MoistureLoc was still available for sale.
Pharmacies visited by Arab News last week said they were not aware of the circular or of the harm the product might cause to the eye.
The Saudi Ophthalmology Society issued a statement that its chairman, Prince Abdul Aziz ibn Ahmed, had directed the society to follow up on the international developments.
The society’s board member and joint president of the International Association for Combating Blindness in the Middle East, Dr. Abdul Aziz Al-Rajhi, said that the society sent an official letter to the company inquiring on the reports and local sales representative’s actions in the Kingdom in response to the recall.
Al-Rajhi said that the company’s initial response was that the product being sold in the Kingdom came from a European plant, and not the US plant that was linked to the outbreak of the infection. Later, the company decided to recall the entire line, regardless of where the product was manufactured.
Al-Rajhi said that the company assured the society that it is currently pulling out voluntarily ReNu with MoistureLoc from the Saudi market and sent letters and press releases to ophthalmologists not to use the product, and supplying them with ReNu Multiplus instead.
In a statement issued by the US Food and Drug Administration (FDA) on May 15, scientific and epidemiological data suggested that ReNu with MoistureLoc may increase susceptibility to Fusarium and that Bausch & Lomb has decided to permanently remove the product worldwide.
Other ReNu brand products were not found to have any problems at that time, although there have been some allegations that ReNu MultiPlus users have contracted the fungal eye infection.
Meanwhile, the FDA and the Centers for Disease Control and Prevention are investigating the multistate outbreak and have sent field officers to inspect the Bausch & Lomb plant and facilities in Greenville, South Carolina, one of the plants where the product is manufactured.
“ReNu with MoistureLoc contact lens solution, manufactured in the Greenville, SC plant, was voluntarily withdrawn from the market in the United States on April 13, 2006. To date, a majority of the confirmed Fusarium cases have been associated with the ReNu with MoistureLoc,” said the FDA statement.
