FENTORA RISKS AND SIDE EFFECTS

September 26, 2007: The FDA issues a public health notice warning patients about the possible serious risks, including death, in patients using Fentora.

Background:

In 2006, the FDA approved Fentora for patients with breakthrough pain from cancer who had already become tolerant to opioid treatment. Breakthrough pain is intense increases in pain that occur with rapid onset, even when opioid pain-control medication is being used.

On September 10, 2007, Fentora manufacturer Cephalon sent a letter to healthcare professionals to provide information about recent reports of serious adverse events including death. This letter discussed ways to reduce the risk of respiratory depression in patients using Fentora. Respiratory depression is a potentially life-threatening condition.

On September 26, 2007, the FDA issued a public health advisory to warn health care professionals and patients about the use of Fentora after recent reports of deaths and adverse events. The FDA has asked the company to strengthen its warnings and improve the dosage instructions in the labeling. The FDA also requested that the company improve their education plan for physicians and pharmacists on how to safely use the medication.

What you can do:

If you have experienced serious side effects associated with use of Fentora, you are urged to see your doctor. It may also be important to contact an attorney who can help you protect your potential legal claim. If you would like more information, or would just like to talk with a lawyer experienced with this issue, please call attorney Stacy Hauer at 1.800.755.0098 for a free confidential consultation or click here to fill out a confidential, free online case review. We welcome any questions you may have.