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FDA Warns Patients Over Teva's Reflux Drug

From Globes (Tel Aviv) (April 17, 2011)

April 17--The US Food and Drug Administration (FDA) has warned patients to stop using Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA; TASE:TEVA) Lanoprazole generic acid reflux drug administered by oral syringe or feeding tubes.

The FDA said it has received reports of clogging problems with the drug although no problems were reported with patients who took the product by mouth. Teva has voluntarily withdrawn its version of the drug from distribution but the FDA cautioned on its website that some stock may remain in pharmacies, other facilities or in patients' possession. The drug is a generic version of Takeda's Prevacid.

The orally disintegrating tablet version is designed to disintegrate when water is added to them. However, according to reports, the Teva tablets may not fully disintegrate, or may later form clumps that can stick to the inside walls of oral syringes and feeding tubes. In some cases, patients have had to seek emergency medical assistance and their feeding tubes had to be unclogged, or removed and replaced, the FDA said. The FDA said it will continue to review and monitor the issue and is seeking prompt correction of the problem by Teva.

Teva's share price was down 0.5 percent to NIS 169.50 on the TASE this morning. The share price rose 0.2 percent to $50.01 on Nasdaq on Friday, giving a market cap of $44.91 billion.

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Posted: April 2011