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Pharmacies Ignore Pullout Order, Sell Harmful Ophthalmic Solution

Jun 26, 2006 | Despite the announcement a month ago by the manufacturers of a highly harmful ophthalmic solution that they were recalling the product, the item is still available in pharmacies across Jeddah.

Bausch & Lomb, the manufacturers of the contact lens clearing solution ReNu with MoistureLoc, announced their decision to call back the product from markets worldwide due to a high rate of eye infection associated with it. The Saudi Ministry of Health also issued a precautionary note around the same time.

Pharmacies visited by Arab News said they were not aware of the circular or of the harm the product might cause to the eye until last week. Although many pharmacies have removed the product from their shelves, some continue to sell it.

According to a statement issued by the US Food and Drug Administration (FDA) on May 15, the multinational eye care company Bausch & Lomb, which has its headquarters in Rochester, New York, decided to permanently withdraw ReNu with MoistureLoc due to data suggesting that the liquid may increase susceptibility to Fusarium Keratitis, a fungus that causes an eye infection affecting the cornea and which can lead to total blindness.

The Centers for Disease Control and Prevention (CDCP) is investigating the multi-state outbreak of Fusarium Keratitis that may be associated with contact lens use.

However, the risk of getting the fungus from contact lenses remains extremely low. Contact lens wearers who experience unusual redness, pain, tearing, light sensitivity, blurry vision, discharge or swelling should consult their doctor immediately. The CDCP is continuing its investigation to identify specific factors that may have placed people at risk for developing the infection, including hygiene practices, overnight usage and specific solutions used.

The Saudi Ministry of Health issued warnings in the local papers a month ago about possible infections associated with the use of ReNu with MositureLoc. Last week pharmacies began receiving a circular from the ministry ordering them to remove all ReNu brand products. They were also informed of the pullout by the distribution agent.

“I only found out about the circular a few days ago from my neighbor who is an optician,” said pharmacist Mohammed Fathi.

The optician, Osama Hussein, said many pharmacists he encountered have not read the reports in the papers nor have they received the circular. “There hasn’t been any follow-up from the ministry to check on whether the product has been removed from the shelves or whether it is still being sold,” he said.

ReNu products, especially ReNu Multiplus, are the most common brands bought by contact lens users, according to pharmacists.

Manal Ahmed, 36, has been using ReNu for the past seven years. She bought ReNu with MoistureLoc last week from a local supermarket and did not know that it was harmful and was supposed to be pulled out.

“This (Fusarium Keratitis) is a very rare type of fungus and we have not received any cases here until now,” said Dr. Ihab El-Hawary, ophthalmology consultant at El-Maghrabi Eye Center on Madinah Road. “Although it might affect contact lens wearers, especially those who use distilled water to clean their lens, it mainly affects people who work in agriculture or have low immunity due to diseases such as cancer, uncontrolled diabetes or have some kind of organ transplant,” he explained.

Even if there were some cases in the Kingdom, they might not have been reported or diagnosed correctly, said Dr. El-Hawary.

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