Fentanyl Patch Defects May Cause Overdose

The Pain Patch Has A Delivery System That May Crack Allowing More Fentanyl Than Is Safe To The Patient

The fentanyl patch is prescribed for patients with severe chronic pain when lesser painkillers have proved ineffective. About 100 times stronger than morphine, fentanyl is an extremely powerful opioid and should only be used by victims of this kind of “breakthrough pain,” such as cancer patients and others conditioned to narcotic pain medication.

The narcotic is stored in gel form in a reservoir inside, intended for release over a period of about 72 hours. However, any imperfection carries the risk of serious adverse effects, including a potentially fatal overdose.

Each is constructed of five functional layers:

(1) An impermeable backing that ensures that the drug is delivered only on the adhesive side

(2) A reservoir where the drug is stored

(3) A rate-controlling membrane, which regulates the rate of delivery

(4) A skin adhesive, which attaches the product to the patient’s skin

(5) A protective liner that protects the adhesive while inside the packaging
There have been a number of recalls in the past two decades, the most recent being in 2008 when lots of two separate brands were recalled due to defects.

PriCara, a pharmaceutical company under the umbrella of Johnson & Johnson, first recalled a number of the Duragesic brand that may have contained cuts along one side of the drug reservoirs. A cut could cause the gel to leak out of the reservoir and into the packaging pouch, exposing patients or their caregivers to the narcotic directly as opposed to on a time-released system.

Not long after, a recall was issued for 14 lots of the generic Actavis transdermal patch due to a potential fold-over defect. This involves a seal breach that can allow the opioid to leak and also result in the patient or caregiver being exposed.

The FDA has gathered information suggesting that there are a number of different types of deficiencies possible, including malfunctions of the rate-controlling membrane and the “stringer leaker” weakness. The manufacturers have warned that direct exposure to the gel caused by leaking can lead to serious injury or even death.

Symptoms of an overdose include slowed heartbeat and breathing, pinpoint pupils, clammy skin, loss of consciousness, and seizures. In many cases, the victim will stop breathing completely.

The FDA has issued several public health advisories regarding this product. They have emphasized potential misuses, such as applying more than prescribed, that can result in dangerously high levels of the medication. They also stress that patients should carefully read the full prescribing information, including all appropriate warnings. These currently include many black box warnings, which indicate that the medication carries a significant risk of serious or even life-threatening adverse effects.

Patients using a fentanyl patch should carefully check for any imperfections, including tears, folds, or cuts, before using them. Any found to be defective should be flushed, and any exposed skin washed with water. Anyone who experiences any of the symptoms detailed above after using one should immediately contact their health care provider.