| TYSABRI | | Health Canada | 17-May-10 | The Health Products and Food Branch (HPFB) posts on the Health Canada Web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties.
TYSABRI is authorized for the treatment of patients with a form of multiple sclerosis (MS) called relapsing-remitting (periods of symptoms alternating with periods without symptoms).
The risk of PML increases the longer you are receiving treatment, especially if you have been on treatment for over 24 months.
|
| TYSABRI | | MHRA | 09-Mar-10 | MHRA Drug Updates:
Natalizumab (Tysabri): risk of progressive multifocal leukoencephalopathy increases after two years of therapy.
Fluoxetine: possible small risk of congenital cardiac defects, similar to that with paroxetine.
Sirolimus: different immunoassays for therapeutic drug monitoring—risk of incorrect dose adjustment. |
| TYSABRI | | FDA | 05-Feb-10 | FDA notified healthcare professionals and patients that the risk of developing progressive multifocal leukoencephalopathy (PML) increases with the number of Tysabri infusions received.
This new safety information, based on reports of 31 confirmed cases of PML received by the FDA as of January 21, 2010, will now be included in the Tysabri drug label and patient Medication Guide.
Information about the occurrence of Immune Reconstitution Inflammatory Syndrome (IRIS) in patients who have developed PML and subsequently discontinued Tysabri has also been added to the drug label.
IRIS is a rare condition characterized by a severe inflammatory response that can occur during or following immune system recovery, causing an unexpected decline in a patientâ¬(TM)s condition after return of immune function.
Based on the available information, FDA believes that the clinical benefits of Tysabri continue to outweigh the potential risks.
Revisions to the drug label and patient Medication Guide, with the continued use of the TOUCH Prescribing Program, are intended to maximize the safe use of Tysabri and the identification of new PML cases.
|
| TYSABRI | | FDA | 17-Sep-09 | 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 Crohnâ¬(TM)s disease in January 2008.
From July 2006, (when Tysabri marketing resumed) to September 8, 2009, 13 reported cases of Tysabri-related PML were confirmed worldwide in patients being treated for MS with Tysabri monotherapy.
There have been no postmarketing reports of PML in patients treated with Tysabri for Crohnâ¬(TM)s disease.
Less than 2% of Tysabri use in the U.S. has been in patients with Crohns disease.
Based on available data from the U.S. and outside of the U.S., the current rate of PML in patients who have received at least 24 infusions ranges from 0.4 to 1.3 per 1,000 patients.
The risk for developing PML appears to increase with the number of Tysabri infusions received.
At this time, the FDA is not requiring changes regarding PML to the Tysabri prescribing information or to the Tysabri risk management plan, called the TOUCH Prescribing Program.
|
| TYSABRI | | MHRA | 04-Mar-09 | MHRA has issued drug updates:
Methylphenidate: updated guidance on safe and effective use in ADHD
Atomoxetine: risk of psychotic or manic symptoms
Antipsychotics: use in elderly patients with dementia
Exenatide (Byetta): risk of severe pancreatitis and renal failure
Bisphosphonates: atypical stress fractures
Efalizumab (Raptiva): recommendation to suspend marketing authorisation
Patient-controlled analgesia extension sets: risk of inadequate pain relief
Effects of MRI on implantable drug pumps
Oral bowel cleansing solutions: risk of harm |
| TYSABRI | | Health Canada | 18-Feb-09 | Biogen Idec Canada Inc, in consultation with Health Canada, has informed Canadian healthcare professionals of an important update to safety information concerning TYSABRI (natalizumab).
TYSABRI is authorized for the treatment of patients with a form of multiple sclerosis (MS) called relapsing-remitting (periods of symptoms alternating with periods without symptoms).
There have been reports of a rare brain infection called progressive multifocal leukoencephalopathy (PML) in patients who have been given TYSABRI.
The prescribing information is available by contacting the Tysabri Care ProgramTM at 1-888-827-2827.
|
| TYSABRI | | MHRA | 01-Sep-08 | MHRA has issued drug updates:
Fentanyl patches: serious and fatal overdose from dosing errors, accidental exposure, and inappropriate use
Viracept: update on carcinogen contamination (ethyl mesylate)
Natalizumab (Tysabri): progressive multifocal leukoencephalopathy
Intrathecal drug pumps: missing propellant
Caffeine for apnoea of prematurity: correction
Recall of reagent for paracetamol levels |
| TYSABRI | | FDA | 25-Aug-08 | FDA informed healthcare professionals of two new cases of progressive multifocal leukoencephalopathy (PML) in European patients receiving Tysabri monotherapy for multiple sclerosis for more than one year.
PML, which is usually fatal, is a known risk of Tysabri treatment, but previous cases in patients with multiple sclerosis were seen in combination with other immunomodulatory therapies.
Approximately 39,000 patients have received treatment with Tysabri worldwide, with approximately 12,000 patients receiving treatment for a least one year.
No new cases have been seen in the US, where about 7,500 patients have received the drug for greater than one year and approximately 3,300 patients have received the drug for at least one and one-half years.
In the U.S., Tysabri is available only to patients with relapsing multiple sclerosis or Crohns disease who are enrolled in the risk minimization plan called the TOUCH Prescribing Program.
Under this program, every Tysabri-treated patient is closely monitored and followed for the occurrence of PML and other serious opportunistic infections.
While the two patients who developed PML were on monotherapy, the FDA still believes that Tysabri monotherapy may confer a lower risk of PML than when Tysabri is used together with other immunomodulatory medications.
Prescribing information for Tysabri will be revised to include information informing prescribers and patients that cases of PML have occurred in patients taking Tysabri as monotherapy.
Healthcare professionals should continue to monitor patients for sign and symptoms of PML.
Additionally, Tysabri should not be infused if PML is suspected.
|
| TYSABRI | | Health Canada | 06-Jun-08 | Biogen Idec Canada Inc., in consultation with Health Canada, would like to inform you about new safety information regarding the risk of liver injury and hypersensitivity in patients receiving TYSABRITM (natalizumab).
In post-marketing experience, there have been rare reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurring as early as 6 days after the first dose.
The Canadian prescribing information for TYSABRI has been updated to include new information about liver injury and hypersensitivity in the Warnings and Precautions and about herpes infections in the Adverse Reactions section.
|
| TYSABRI | | MHRA | 04-Jun-08 | MHRA has issued drug updates:
Natalizumab (Tysabri): safety overview—progressive multifocal leukoencephalopathy, hypersensitivity, and hepatotoxicity
Nicorandil: gastrointestinal ulceration
Ezetimibe: new data from the ENHANCE trial
Herbal products marketed for erectile dysfunction |
|