FDA approves needle-less transdermal fentanyl pump IONSYS for sale in U.S.

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by Jim Orr

The Food and Drug Administration has granted approval for the first transdermal fentanyl pump device to go on sale in the U.S. Marketed as IONSYS and sold by The Medicines Co., the pain pump allows patients to control the release of fentanyl on an as-needed basis through the use of electrical currents, rather than needles, to deliver the medication to their body.

IONSYS (fentanyl iontophoretic transdermal system) was originally developed by Johnson & Johnson and was approved by health regulators in the U.S. and Europe in 2006. However, the pain pump was recalled in 2008 after its release in Europe because of problems with the device, and was never placed on sale in the U.S. According to The Medicines Co., IONSYS will go on sale and be available for patients by the second half of 2015.

IONSYS is a small pre-programmed electronic device about the size of a credit that allows patients to control the amount of fentanyl they need to deal with pain following surgery. The device will only be issued to patients who are enrolled in at IONSYS Risk Evaluation and Mitigation Strategies program in order to reduce their risk of potentially fatal respiratory depression from a fentanyl overdose. Health care providers will be advised to discontinue treatment with IONSYS when patients are discharged from the hospital.

Overdose Risks Persist Despite New Fentanyl Technologies

Despite efforts to limit the number of fentanyl overdoses through new products such as IONSYS, thousands of patients have died because of an overdose caused by this dangerous drug. Many of these deadly fentanyl overdoses occurred because patients were given too much fentanyl by their doctors or because they were given the drug despite the fact that they were not eligible to use fentanyl under FDA guidelines.

Fentanyl products can also be deadly when they are prescribed in combination with other drugs that suppress the central nervous system. The interaction between fentanyl and other CNS depressant medications can lead to a combined drug overdose, which can cause respiratory depression and death.

Doctors have to be extremely careful, and follow established protocols, when prescribing multiple central nervous system depressants (sometimes abbreviated as “CNS depressants”) to the same patient. Sometimes doctors prescribe too many of these powerful painkillers, in dosages that are too high, or with other drugs that can cause dangerous and even fatal drug interactions. When doctors fail to follow established protocols for prescribing these drugs, drug abuse, addiction, tolerance or overdose may be the result.

Heygood, Orr & Pearson and Fentanyl Overdose Lawsuits

The lawyers at Heygood, Orr & Pearson are committed to helping patients and their families who have been affected by doctors who irresponsibly prescribe opioid painkillers and other potentially deadly drugs to their patients.

Heygood, Orr & Pearson has represented numerous patients who have suffered complications from excessive painkiller prescriptions by a doctor or hospital. In fact, our firm has successfully resolved hundreds of fentanyl lawsuits, more than all other law firms in the United States—combined. These cases have included a verdict of $5.5 million in a Florida case involving the death of a man who died while wearing a fentanyl patch, and a verdict resulting in payment of more than $21 million for the death of another fentanyl patient in Illinois.

The lawyers at Heygood, Orr & Pearson have examined hundreds of drug company executives, scientists, engineers, physicians, and manufacturing workers under oath and retained expert witnesses in the areas of toxicology, pathology, pharmaceutical manufacturing, and patch technology as part of our efforts on behalf of our clients. Our firm has obtained millions of pages of documents from the drug companies during our research for lawsuits regarding fentanyl patches, enabling our attorneys to amass the most extensive library and collection of documents and depositions related to fentanyl patches.

If you or a loved one have suffered a fentanyl overdose due to opioid overprescription or a combined drug overdose, contact the lawyers at Heygood, Orr & Pearson to learn more about whether you may qualify to file a lawsuit. For more information and a free consultation about your case, call toll-free at 1-877-446-9001, or follow the link to our free case evaluation form and answer a few simple questions to get started with your consultation.