Tysabri is a drug prescribed to help patients with multiple sclerosis or Crohn’s disease. Recent reports to the FDA has shown that Tysabri infusions increase the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Cases of PML have been reported to the FDA in patients taking Tysabri who were recently or concomitantly treated with immunomodulators or immunosuppressants, as well as in patients receiving Tysabri as monotherapy.

Tysabri Side Effects

Tysabri PML is a rare and often fatal infection of the brain. The risk of developing PML increases with the number of Tysabri infusions a patient has received. There is no known cure for progressive multifocal leukoencephalopathy (PML).

Tysabri FDA Warning

The FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri. Tysabri was approved by the FDA for the treatment of relapsing forms of multiple sclerosis (MS) in November 2004 and for moderately to severely active Crohn’s disease in January 2008.

Tysabri and PML Information

• Progressive Multifocal Leukoencephalopathy (PML)
• Tysabri Label Update
• Tysabri PML Count Climbs, Reflections From Biogen CEO
• Tysabri Patient with PML – Last to be Reported on Biogen Site
• FDA Statement On Tysabri Review Time
• Tysabri Q&A Regarding Lifting of the Clinical Hold
• Tysabri (natalizumab) Questions and Answers
• FDA Issues Warning on Tysabri, a New Drug for MS
• Suspended Marketing of Tysabri (natalizumab)
• Tysabri Approved by the FDA for Multiple Sclerosis
• Questions and Answers on Tysabri

Tysabri PML Lawyer

If you or a family member has been diagnosed with PML, or been treated with Tysabri infusions, contact our law firm to speak to a PML lawyer about your legal options. Every attorney at our law firm is dedicated to fighting for the rights of those that have been harmed by dangerous and recalled drugs and medical devices. For over 25 years, Attorney David Willis has been a trial lawyer representing seriously injured clients in product liability and personal injury lawsuits such as defective drug litigation, class action drug lawsuits and medical device recall lawsuits. If Tysabri has harmed you, or a loved one, contact us right now to discuss your potential case in filing a Tysabri PML Lawsuit with an Attorney.

Morristown, NJ – Further to its previously announced voluntary recall of 18 lots of Fentanyl Transdermal System 25 mcg/hour C-II patches, Actavis is encouraging consumers to return any product in their possession from the October 21, 2010 recall.

Consumers with Actavis 25 mcg/h Fentanyl patches may call 1-877-422-7452 (24 hours/day, 7 days/week) for return instructions and information.

Actavis identified one lot of 25 mcg/hour Fentanyl patches (Control/Lot # 30349) shipped to market that contained one patch that released its active ingredient in laboratory testing faster than the approved specification. An accelerated release of Fentanyl from a 25 mcg/hour patch could lead to adverse events for at-risk patients such as children and the elderly, including excessive sedation, respiratory depression, hypoventilation (slow breathing), and apnea (temporary suspension of breathing).

The Control/Lot number appears on the bottom of the product box and on the black and white side of each individual patch packaging, in the lower left corner.

Recalled Control/Lot #s

30041, Exp 12/2011
30049, Exp 12/2011
30066, Exp 12/2011
30096, Exp 01/2012
30097, Exp 02/2012
30123, Exp 01/2012
30241, Exp 02/2012
30256, Exp 02/2012
30257, Exp 03/2012
30258, Exp 03/2012
30349, Exp 03/2012
30350, Exp 03/2012
30391, Exp 03/2012
30392, Exp 04/2012
30429, Exp 04/2012
30430, Exp 04/2012
30431, Exp 04/2012
30517, Exp 04/2012

Corium International Inc., a third-party supplier for Actavis, manufactured the recalled patches at its Grand Rapids, Michigan facility. The patches are packaged individually and boxed in quantities of five patches per box.

Fentanyl Transdermal System is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around-the-clock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate release opioids.

As part of the voluntary recall, all wholesalers and retailers were asked to return the product from the listed lots that they may still have on hand or in stock. Actavis also is encouraging consumers to return product in their possession. Fentanyl patches sold by Actavis in Europe are not impacted by the recall.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Information also is available through the Actavis U.S. website at www.actavis.us by going to the “Fentanyl Recall Information” link on the front page.

Press Release – 03 NOV 2010 / Product

Actavis Encourages Consumers to Return Fentanyl Transdermal System 25 mcg/h

Morristown, NJ – (November 3, 2010) – Further to its previously announced voluntary recall of 18 lots of Fentanyl Transdermal System 25 mcg/hour C-II patches, Actavis is encouraging consumers to return any product in their possession from the October 21, 2010 recall.

Consumers with Actavis 25 mcg/h Fentanyl patches may call 1-877-422-7452 (24 hours/day, 7 days/week) for return instructions and information.

Actavis identified one lot of 25 mcg/hour Fentanyl patches (Control/Lot # 30349) shipped to market that contained one patch that released its active ingredient in laboratory testing faster than the approved specification. An accelerated release of Fentanyl from a 25 mcg/hour patch could lead to adverse events for at-risk patients such as children and the elderly, including excessive sedation, respiratory depression, hypoventilation (slow breathing), and apnea (temporary suspension of breathing).

The Control/Lot number appears on the bottom of the product box and on the black and white side of each individual patch packaging, in the lower left corner.

Recalled Control/Lot #s

30041, Exp 12/2011
30049, Exp 12/2011
30066, Exp 12/2011
30096, Exp 01/2012
30097, Exp 02/2012
30123, Exp 01/2012
30241, Exp 02/2012
30256, Exp 02/2012
30257, Exp 03/2012
30258, Exp 03/2012
30349, Exp 03/2012
30350, Exp 03/2012
30391, Exp 03/2012
30392, Exp 04/2012
30429, Exp 04/2012
30430, Exp 04/2012
30431, Exp 04/2012
30517, Exp 04/2012　

Corium International Inc., a third-party supplier for Actavis, manufactured the recalled patches at its Grand Rapids, Michigan facility. The patches are packaged individually and boxed in quantities of five patches per box.

Fentanyl Transdermal System is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around-the-clock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate release opioids.

As part of the voluntary recall, all wholesalers and retailers were asked to return the product from the listed lots that they may still have on hand or in stock. Actavis also is encouraging consumers to return product in their possession. Fentanyl patches sold by Actavis in Europe are not impacted by the recall.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Actavis Fentanyl Pain Patch Overdose Lawsuit Attorney

Poorly designed and dangerous devices and medications such as the Actavis fentanyl pain patch, or any other defective fentanyl pain patch, may cause accidental overdose or other severe and devastating injuries or death.

If you or a loved one has been severely injured as a result of an Actavis fentanyl pain patch or other fentanyl pain patch, talk to an Actavis Fentanyl Pain Patch Lawsuit Attorney at the Willis Law Firm for legal advice about a potential Fentanyl Pain Patch lawsuit.  You are not alone.  Join other Actavis fentanyl pain patch victims and their families in fighting for their legal rights. It may be too late to recover from some of the devastating effects of the Actavis Fentanyl Pain Patch, but an experienced pharmaceutical products liability attorney at the Willis Law Firm can assist you in a legal action against the makers of the Actavis Fentanyl Pain Patch and in filing a Fentanyl Pain Patch Lawsuit.

Please fill out the Free Case Evaluation to the right or call us toll-free at 1-800-883-9858 for immediate help. Please keep in mind that certain states have a statute of limitations that limits the amount of time you have to file an Actavis Fentanyl Pain Patch lawsuit or to seek legal action. Contact our law firm immediately so we may explain the rights and options available to you and your family.