The Duragesic Pain Patch has been recalled by Johnson & Johnson because defects in the manufacture of the patch could lead to accidental overdoses. Johnson & Johnson is recalling about 32 million of the fentanyl-containing Duragesic Pain Patches, and the company estimates that about two out of every million patches could be defective.
The Duragesic and other similar pain patches are meant to treat persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age or older. Fentanyl is a highly addictive opiate that is 80 times more potent than morphine. Fentanyl is considered a Class II substance by the Drug Enforcement Administration, meaning it is associated with a high potential for abuse and a risk for fatal overdose.
Today’s Duragesic Patch recall includes all 25-microgram-per-hour patches that are sold in the U.S. by J&J’s PriCara unit and Sandoz; they are made by another J&J unit, Alza Corp. All of the recalled Duragesic patches have expiration dates on or before December 2009. The defective Duragesic patches have a sliced edge in the pouch that contains the fentanyl gel, which could result in the gel leaking. Exposure to fentanyl directly can cause serious harm, including breathing problems and overdose, which can be fatal. The 25-microgram-per-hour patches are prescribed mainly for lower-weight patients, children and patients just starting on the medicine.
The Duragesic Pain Patch has been a problematic device ever since it first came on the market. In 2004, 75 microgram-per-hour patches where recalled by Janssen Pharmaceutica Products for a similar leakage issue. In December, the Food & Drug Administration (FDA) issued an alert, warning patients and doctors that there was a high danger of accidental overdose associated with the use of the Duragesic Pain Patch. At the time, the FDA attributed the overdoses to patch “misuse” and ordered all fentanyl patch makers to create special “medication guides” for patients that spell out the dangers of overdoses and improper use in easy-to-understand language.
The December warning marked the second time the FDA had cautioned the public about overdose dangers associated with the Duragesic Pain Patch. In July 2005, the FDA issued a Public Health Advisory announcing its investigation of “death and other serious side effects involving overdoses” in patients using both the Duragesic painkilling patches and their generic competitors. At that time, the FDA said it had received 120 reports of deaths related to fentanyl pain patches. Between the 2005 and 2006 warnings, the FDA apparently received many more reports of accidental overdoses associated with the Duragesic Pain Patch, but declined to say how many.
Jerry Parker, Managing Partner at Parker Waichman Alonso, LLP, said today’s recall was not surprising considering Johnson & Johnson’s track record with medicated patches. “Both the Duragesic and the Ortho Evra Birth Control Patch have caused serious injuries to users because of defects that allow the patches to deliver far more medication than is safe,” Parker said. “This recall just points to the continuing problems Johnson & Johnson is having with its patch technology.” Parker’s law firm is currently representing plaintiffs who were injured by Johnson & Johnson’s Duragesic and Ortho Evra patches.
The Johnson & Johnson Ortho Evra Birth Control patch was the subject of an FDA warning only last month after a study linked Ortho Evra to the development of a potentially dangerous type of blood clot. That warning was the FDA’s second Ortho Evra blood clot warning issued since it was introduced to the market in 2002. In 2005, the FDA warned that women using Ortho Evra were exposed to approximately 60 percent more estrogen than those who use oral contraceptive pills. High levels of estrogen can greatly increase the risk of developing blood clots, heart attacks, strokes and other serious injuries. As of November 2005, the FDA had received twenty-one reports of life-threatening blood clots and other ailments associated with the use of Ortho Evra. Then in 2006, a study was published that showed women using Ortho Evra were twice as likely to suffer a type of blood clot called venous thromboembolisms (VTEs) — a clot that can travel to the lungs and cause a fatal pulmonary embolism – as those taking oral birth control pills. That study prompted the FDA to request a change on the Ortho Evra label to include a stronger safety warning.
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July 3rd, 2009 at 4:57 am
I Have used fentanyl patches ever since a little while after I was diagnosed with MS. I have used both the Name brand Duragesic and the Generic Sandos. They both use the same method of delivery. The patch contains a gel which is able to pass though the semi permeable layer which sticks to the skin. I have known since I started using them that if they are damaged or even sometimes moved they can rip and leak. I have removed them and moved them before and they did not rip. Maybe if it got stuck to itself during improper placement. Since then a generic brand called Mylan is making a patch with a different technology. It has no gel I believe the medication is impregnated into the glue on the patch. They are smaller too. I prefer the original design as the newer patches are less water resistant and I have lost a couple in a warm shower.
My main reason for this post is to tell people that this is not a very large problem as all I could attribute this to is like above the patches are not made correctly (in which any pharmacy would take back as long as they are sure there is not funny business I.E. trying to return a patch with no gel inside) or Misuse i.e., deliberately opening the patch to get to the gel or by wearing more than one patch at a time or by wearing them on the palm of your hands (the one place on your body it is not meant to be worn on)
To me these patches are wonderful I used to have to take a pill every four hours so I would have to wake up two times a night to take a pill. The patch is wonderful all i have to do is change it every three days.
All I have to say is I believe MOST of the Overdoses were due to uneducated users (which could be their fault for not making sure they are using them correctly, or the pharmacists for not telling them how to use it.) or misuse as from the start I was warned how to correctly use them and this was years before the recalls.
So in all this is my opinion that this is needed information but it has been overblown but this is common with prescription drugs as people expect them to be infallible due to regulations but they don’t stop to think about human error. There has been overdoses and deaths caused by not dosing by people who simply forget. So Prescriptions can never be infallible unless the human element is removed which is currently impossible. Maybe in the future we will have drugs that can be administered by a professional that lasts a month. Until then human error will always be an issue.
Thank You
July 20th, 2009 at 2:46 pm
Had a person in my area that od’d from this patch. Rumor says the medication was removed and taken intravenously by the deceased. Is it possible to do this? Everything I’ve read says it’s a jel form.
August 21st, 2009 at 2:21 am
Hi bc, I recently was put on the fentanyl patch, except mine don’t have the gel in them. They sound like what the poster named “anonincali” described.
But as for the gel ones, I have a close friend in nursing who told me people would do routinely wear the old one for the three days the new one was on, to get all the drug out, so they always had an old and a new one on. Then they’d wonder why they were getting burning and itching!
Some would heat up the area where they wore it, with a hairdryer, to get more drug out. Again, burns. And apparently it was popular to just cut them open and suck on them. So if one can suck the stuff out, I guess they can draw it out with a syringe.
I’m glad mine aren’t made that way. I just want to feel better, I don’t want something like all that!
September 18th, 2009 at 1:08 pm
The Real Deal.
I have been on the patch since before there was a generic. I am the reason for many of the patch changes, designed to deter pharmaceutical drug abusers from abusing the drug in an unintended way. When I first started using the patch it was pure Fentanyl. Unfortunately, drug abusers were able to freeze the drug and suck on it like a lollipop. So L & L then added a chemical to keep the Fentanyl from freezing. They were also able to stick needles into the patch, withdraw the Fentanyl and shoot it into their arms. So L & L added yet another chemical to make it too thick to shoot in the arm. Now I have to worry about all the extra chemicals added to a drug that I take for pain because assholes want to use it for the high. I say take it back to its original form and screw the addicted. Why do we need to compromise our needs for those who cannot control theirs?
October 26th, 2009 at 4:46 am
I was a victim of these patches. Please don’t tell me there haven’t been problems with the patch. I have multiple crushed vertebrae and herniated disks. I used one of the patches one night. When I awoke in the morning I was in respiratory distress and could not walk straight. If it were not for the fact that I was trained as a bio-chemist and EMT I would not have know to remove the patch immediately and probably would have died. The exact same thing happened to my nephew three months later, after using the patch once. Both of us were told by our doctors that it could not possible be the patch. Wonder what stock they own?
January 30th, 2010 at 12:17 am
I am prescribed the non-gel version, 100mcg every 48 hours. Have any of the non-gel patches been recalled? Is there any risk associated with using the non-gel version of the patch? For example, they are kind of tricky to put on and often “bend” slightly. I don’t think I’ve ever ripped one. Would a slight bend during normal application be okay?