A popular pain killer marketed as the Duragesic Patch (fentanyl)by by PriCara and generically by Sandoz Inc., is now subject to a recall order by the FDA. The recall includes all 25-microgram-per-hour patches with expiration dates on or before December 2009. Acoording to sources the recall is due to a possible manufacturing defect involving the delivery of the prescription medication. The defect is described as a cut in the in the lining of the internal reservoir where the drug is stored in gel form. If the fentanyl gel leaks into the drug's packaging, it could cause a patient or caregiver to come into direct contact with this powerful "opioid" drug. This could result in difficulty breathing and a potentially fatal overdose.
This is the second warning in the last two years issued by the FDA regarding the safety of fentanyl patches.
The drug is intended for chronic pain in people used to narcotics, such as cancer patients, and can cause trouble breathing in people not used to this family of painkillers. Yet the FDA found cases where doctors prescribed it for headaches or post-surgical pain.
Acoording to the FDA "Despite issuing an advisory in July 2005 that emphasized the safe use of the fentanyl patch, FDA continues to receive reports of death and life-threatening side effects in patients who use the fentanyl patch. The reports indicate that doctors have inappropriately prescribed the fentanyl patch to patients for acute pain following surgery, for headaches, occasional or mild pain, and other indications for which a fentanyl patch should not be prescribed. In addition, the reports indicate that patients are continuing to incorrectly use the fentanyl patch by replacing the patch more frequently than directed in the fentanyl patch instructions, applying more patches than prescribed, or applying a heat source to the patch, all resulting in dangerously high fentanyl levels in the blood.
The fentanyl patch contains fentanyl, a very potent narcotic pain medicine. It is only intended for treating persistent, moderate to severe pain in patients who are opioid-tolerant, meaning those patients who take a regular, daily, around-the-clock narcotic pain medicine. This is extremely important because patients who are opioid-tolerant are more resistant to the dangerous side effects of narcotic pain medicines than patients who only occasionally take these medicines. For patients who are not opioid-tolerant, the amount of fentanyl in one fentanyl patch of the lowest strength is large enough to cause dangerous side effects, such as respiratory depression (severe trouble breathing or very slow or shallow breathing) and death. If you or a loved one have have experienced any medical complications while using the Duragesic Patch, please fill out the contact form to your right and a DrugSettlement.com attorney or representative experienced in drug litigation will help determine if further investigation or action is needed.