Duragesic Patch Alert: Fentanyl News: Lawyers, Pain Information, Injuries, Deaths, Lawsuit Attorneys

March 2008: Actavis Inc. Recalls Fentanyl Pain Patches Because Of Potential Leakage From Fold-Over Defect
Fentanyl Pain Patch News Alerts and Lawyer Updates

Actavis Inc. has announced its subsidiary is voluntarily recalling all lots of its Fentanyl transdermal system CII patches sold in the United States.

The latest action expands on the company’s Feb. 17, 2008 recall of 14 lots of Fentanyl transdermal patches because of a possible fold-over defect that could cause Fentanyl gel to leak, releasing a potentially fatal dose.

“The remaining lots of Fentanyl transdermal system patches are being recalled as a precautionary measure because Actavis lacks assurance that all patches are free from defects,” according to a press release from the Food and Drug Administration.

February 2008: Flawed Duragesic Pain Patches Recalled Because Of Potential For Lethal Overdose
Fentanyl Duragesic Patch News Alerts and Lawyer Updates

A unit of Johnson & Johnson has announced a voluntary recall of its Duragesic pain patch over fears that a leak could expose patients or caregivers to a lethal dose of a potent painkiller.

The recall, announced Feb. 12, is being conducted in cooperation with the U.S. Food and Drug Administration. News reports indicate that as many as 32 million of the Duragesic pain patches could be recalled. An estimated two patches out of every million may leak.

The recall is for the Duragesic 25 microgram-per-hour patches with expiration dates on or before December 2009. All are manufactured by ALZA Corporation. Also on the recall list is a generic Sandoz Inc. 25 microgram-per-hour pain patch.

The Duragesic and Sandoz patches contain the painkiller fentanyl. That Schedule II opioid medication was originally approved in 1990 to treat acute, postoperative and moderate-to-severe pain. Applied to the skin, the Duragesic adhesive patch delivers a powerful and constant dose of fentanyl in gel form, providing pain relief for up to 3 days.

The problem, according to a press release on Johnson & Johnson’s Web site: the recalled patches may have a cut along one side of the drug reservoir within the patch, allowing the gel to seep out. The cut edge in affected patches can be seen upon opening the sealed foil pouch that holds the patch. Six defective patches had turned up by the time the recall was announced.

The leak has the potential to deliver a deadly dose of the drug. Too much fentanyl gel can lead to “serious adverse events, including respiratory depression and possible overdose, which may be fatal,” the recall notice said.

The company warned anyone who comes in contact with fentanyl gel to “thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches with cut edges by flushing them down the toilet, using caution not to handle them directly.”

Patches with a cut edge that have leaked gel will not provide effective pain relief, the press release said.

Patients with the recalled 25 mcg/hr Duragesic patches were asked to call (800) 547-6446, while patients with the recalled 25 mcg/hr Sandoz Inc. patches were asked to call (800) 901-7236.

This is not the first time that pain patches have made headlines. Janssen Pharmaceutica Products, owned by Johnson & Johnson, issued a recall of all of their 75mcg/hr Duragesic patches in February 2004 due to a potential breach in the seal on one edge of the patch.

In July 2005, the FDA launched an investigation after 120 deaths were linked to patches which utilized fentanyl for pain control (see below). And last December, the U.S. Food and Drug Administration issued a safety warning about the patches, saying improper use could cause breathing difficulties and death.

FDA Investigating Deaths of 120 Patients Who Used Fentanyl Duragesic Patch
Fentanyl Duragesic Patch News Alerts and Lawyer Updates

On Friday, July 15, 2005, the U.S. Food and Drug Administration issued a Public Health Advisory regarding the safe use of transdermal fentanyl patches, which are used for pain control, and is conducting an investigation into 120 deaths associated with the patches.

The patches are marketed under the brand name Duragesic and contain fentanyl, a potent narcotic medication prescribed for pain. The FDA said the health advisory was primarily for health professionals because of concerns that the deaths were the result of abuse due to lack of proper patient education. In addition to the advisory, the FDA issued a patient information sheet identifying important safety precautions for the use of the patches, as well as signs of overdose, proper patch application, use of other medications while using the patch, safeguards for children and proper storage and disposal.

The FDA stated that directions for use of the patches must be followed exactly to prevent death or other serious side effects from overdosing. The agency believes at least some of the deaths resulted from accidental overdoses, and reports suggest that either the patients or their prescribers were unaware of the crucial safety information on the product’s label.

Duragesic was first approved in 1990, and a generic version of the fentanyl patches came onto the market in February 2005. Patient deaths were reported among users of both products.
Patients who use the patch should be aware of the following signs of fentanyl overdose: trouble breathing or shallow breathing; tiredness, extreme sleepiness, or sedation; inability to think, talk, or walk normally; and feeling faint, dizzy, or confused. If these signs occur, patients or their caregivers should get medical attention right away.

The FDA warns that fentanyl skin patches are very strong narcotic painkillers, and should only be prescribed at the lowest possible dose needed for pain relief, and only for pain that is constant. fentanyl skin patches should only be used by patients who are already taking other narcotic painkillers and who have chronic pain that is not well controlled with shorter-acting painkillers.

DURAGESIC PATCH FENTANYL LAWYERS / ATTORNEYS
If you or a loved one have suffered from the dangerous side effects of Duragesic or fentanyl skin patches, you should consider receiving a free legal evaluation from an experienced fentanyl lawyer. For a free evaluation of your situation please complete the following form and a fentanyl attorney will contact you promptly -- free of charge.

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DURAGESIC FENTANYL PATCH

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If yes, what was the lot/control number? Click here to find lot # on packaging

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FENTANYL DURAGESIC PAIN PATCH NEWS & LAWYER UPDATES

$772,500 Verdict Goes to Family of Duragesic Pain Patch Victim
Health Central - July 8, 2006
...The defeat came for Johnson & Johnson, when a Texas jury ruled July 7 that the company had to pay $772,500 in actual damages to the family of a woman who died because of leakage in a pain relief patch.

FDA Slow to Sound Alarm on Pain Drug
Los Angeles Times - November 25, 2005
... In the last six years, the Los Angeles County coroner's office has investigated more than 230 deaths involving fentanyl. Of the deaths, records show 127 were classified as "accidental"— suggesting that the victims inadvertently had taken too much. And evidence from other states and the Food and Drug Administration suggests there may be many more such cases nationwide.

Regulators Probe Pain Patches
The Street - July 17, 2005
... The Food and Drug Administration has issued a public health advisory on patches designed to relieve pain and is investigating about 120 deaths that may be related to their use.

Pain-Relief Patch Is Investigated in Patient Deaths
LA Times - July 16, 2005
... The FDA is looking into whether 120 cases could be the result of unintentional fentanyl overdoses.

Update 1-Johnson &Johnson adds warnings to Duragesic pain patch label
Reuters - July 8, 2005, Updated
... The Duragesic skin patch, used to manage persistent moderate to severe chronic pain, contains a high concentration of fentanyl, an opium-containing sedative.

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