The Government Recognized The Flaws And Issued A FDA Recall
Fentanyl transdermal patches contain the powerful opioid fentanyl, which is stored in gel form in a reservoir. The painkiller, which is about 100 times stronger than morphine, is intended to be delivered over a period of several days.
Each consists of five basic layers:
(1) An impermeable backing that ensures that the medication 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 it to the patient’s skin
(5) A protective liner that protects the adhesive while inside the packaging
Under ideal circumstances, these products can provide relief for those with severe chronic pain, such as cancer patients. However, if a patch is defective or used incorrectly, there is a serious risk of adverse effects, including a potentially fatal overdose.
In the past two decades, there have been a number of recalls, 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 lots of the Duragesic brand that may have contained cuts along one side of the reservoirs. Not long after, a recall was issued for batches of the generic Actavis fentanyl patch due to a potential fold-over defect. Both of these kinds of imperfections can cause leaking that results in the patient or caregiver being directly exposed to the narcotic all at once rather than in the time-released system as designed.
Exposure to more than the recommended dose may very well lead to an overdose, which in turn can cause a fatal respiratory depression. The potential risk of overdose in using a fentanyl transdermal system is particularly high when:
• They are used by patients who do not have a tolerance for opioid medications
• There is off-label use
• The drug is combined with other narcotics
• The instructions are not followed exactly
• The product is leaky or defective
With respect to drug interactions, one potential cause of fentanyl toxicity is combining it with ritonavir (with the trade name Norvir), an antiretroviral used to treat HIV and AIDS. This combination may increase the effects of fentanyl in a patient’s system, leading to the same symptoms as an overdose and possible respiratory depression. Anyone who experiences the symptoms, including slowed heartbeat and breathing, clammy skin, pinpoint pupils, fainting, and seizures, should immediately seek medical treatment from a trained health care provider.
The FDA has issued public health advisories stressing that some uses, such as applying more than prescribed, could be dangerous. Any increase in the serum fentanyl concentration over the dosage prescribed by a doctor can be very dangerous. Patients should carefully read the full prescribing information, including all appropriate warnings.
Hundreds of deaths from fentanyl poisoning have occurred since the FDA began issuing warnings about the potential dangers. Though these deaths are sometimes related to inappropriate or recreational use, some have also been tied to defective products such as leaky Duragesic, to doctors prescribing for less than severe pain, or to confusion or misunderstanding of directions for use. Anyone who has suffered an injury or who has had a loved one suffer an injury related to fentanyl may want to consider consulting a personal injury lawyer to find out if they have a potential claim.
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Fentanyl Pain Patch Recall Lawsuits Attorneys
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