North Myrtle Beach, SCGail's mother has been in chronic pain for eight years. She relied on the duragesic pain patch to help her cope —but this winter it nearly killed her.
"My mother suffered a work-related injury about eight years ago - she broke her back. She subsequently had spinal fusion and has been dealing with chronic pain ever since. One of the best treatments for her pain is the duragesic patch, and she's been taking it without incident for about three and a half years," Gail told Lawyers and Settlements in an interview.
"One morning this winter she put on her patch, which she replaces about every three days. Very shortly afterward she started having difficulty breathing," Gail said.
"My mother is not the type of person to go the hospital at all. So, when I found out later that day that she had spent most of the afternoon in the emergency department of the local hospital I knew something was seriously wrong," she said.
Gail's mother told her that she was having such difficulty breathing she thought she was going to die. "She lives way out in the country and was afraid to call an ambulance in case it arrived too late, so she drove herself to the hospital. They treated her in ER as if she were an asthmatic- they gave her an inhaler treatment and sent her home with inhalers and prednisone. They didn't give her any information on what had happened at all. But she did feel better," Gail said.
No one realized that the medication was the problem. "My mother has no history of respiratory problems. But she had a bad cough and was recovering from a cold, so I thought her breathing difficulties may have been related to that," Gail said.
Very recently, Gail's mother noticed that the manufacturer of the duragesic patch, Johnson and Johnson, had in fact recalled some of the patches. "She asked me to look into that for her. When I did, I discovered that certain lots of the duragesic patch had been recalled due to the likelihood of them tearing and resulting in an overdose. So I got the information from my mother about her patches, such as the lot number, the name of the prescribing physician, the expiration date--and found out that her medication was part of the lot that had been recalled," Gail said.
"I then found out that the difficulty in breathing my mother experienced is a serious side effect listed with these patches. This just happened to come up through my research, but I had no idea that the difficulty in breathing and the duragesic patches were related until then."
But there is a long history of potentially lethal side effects associated with the duragesic patch. As background, on April 6, 2004, Johnson and Johnson recalled several lots of their 75 mcg/hour patch due to reports of faulty patches which were leaking. In July 2005, the Federal Food and Drug Administration (FDA) launched an investigation into 120 deaths among people using the duragesic patch, as it appeared that some of the deaths could have been 'accidental overdoses'. And in July 2006, a jury in Texas awarded $772,500 in damages to the family of a woman who died as a result of a leaking duragesic patch.
This year, in February, Johnson and Johnson recalled approximately 32 million duragesic pain patches. The recall includes all 25-microgram-per-hour patches that are sold in the U.S. by J&J's PriCara unit and Sandoz, with expiration on or before December 2009.
And, most recently, this March, the following recall was issued: "...all lots of 25 microgram/hour (mcg/hr) DURAGESIC® (fentanyl transdermal system) CII patches sold by PriCara in the United States and all 25 mcg/hr fentanyl patches sold by Sandoz Inc. in the United States are being voluntarily recalled as a precaution from wholesalers and pharmacies. The recalled patches all have expiration dates on or before December 2009...All 25 mcg/hr fentanyl patches manufactured by ALZA and sold in Canada also are being recalled. DURAGESIC 25 mcg/hr (fentanyl transdermal system) and Sandoz Inc. 25 mcg/hr fentanyl transdermal system patches being recalled may have a cut along one side of the drug reservoir within the patch."
As it turns out, Gail's mother likely saved her own life, because she had heard about the breathing problems associated with the duragesic patch. "She had remembered reading somewhere that this is a potential problem. "As soon as she started having major difficulty breathing, she removed the patch," Gail said. "By the time she was done with the ER she was feeling better - not great - but better."
"My mother said it was the first time in her life she thought she could possibly be dying. When I read how severe the side effects could be and that people were suffering lethal overdoses, I thought My God, maybe I'm about to lose my mother, and I wouldn't even be aware of it," Gail said.