Fentanyl sublingual spray Subsys may put patients at risk of overdose

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by Heygood Orr and Pearson

Patients who are prescribed the new fentanyl sublingual spray Subsys may be at risk of an overdose unless the drug is properly administered by their physician. Subsys was approved by the Food and Drug Administration in January 2012 for the treatment of breakthrough cancer pain.

Because fentanyl is about 100 times more potent than morphine, doctors who prescribe Subsys or other fentanyl products must ensure that only eligible patients are prescribed these products and that their patients receive an appropriate dose. The FDA says that in order to reduce the risk of overdose only patients who have built up an opioid tolerance from other painkiller medications should be prescribed fentanyl products like Subsys.

Subsys is the first fentanyl sublingual spray (administered under the tongue) to be approved by the FDA. In addition to the fentanyl pain patch, other versions of this medication include a sublingual tablet called Abstral, a fentanyl lollipop known as Actiq, the Lazanda fentanyl nasal spray, and Onsolis, a fentanyl tablet that is placed in the cheek (buccal).

The families of hundreds of fentanyl users have filed lawsuits against physicians who improperly prescribed these potent medications, leading their patients to suffer an overdose or death. These fentanyl medical malpractice lawsuits have charged physicians with giving their patients too much fentanyl or with prescribing the drug to patients who were not eligible to use this potentially dangerous painkiller.