Author Topic: Gilenya label to include PML warning according to FDA  (Read 151 times)

0 Members and 0 Guests are viewing this topic.

Offline agate

  • Administrator
  • *****
  • Posts: 8244
  • MS diagnosed 1980
  • Location: Pacific Northwest
Gilenya label to include PML warning according to FDA
« on: August 04, 2015, 02:29:30 pm »
From MedPage Today, August 4, 2015:

Quote
FDA Warns of Fingolimod PML Cases

Neither patient had been on a previous immunosuppressive agent

by Kristina Fiore
Staff Writer, MedPage Today

The FDA has warned about two cases of progressive multifocal leukoencephalopathy (PML) -- one definitive, one probable -- in patients taking fingolimod (Gilenya) for multiple sclerosis (MS).

The agency said these are the first cases to be tied to the drug in patients who haven't been on other immunotherapies. A previous case of PML, reported in 2013, couldn't be definitively tied to fingolimod because the patient had been on other immunosuppressant drugs, including interferon-beta and azathioprine.


That patient had also been taking intravenous corticosteroids while on fingolimod.

At that time, fingolimod drugmaker Novartis said in a statement that "several features of this case of PML make it unlikely to be attributable to Gilenya."

For the two new cases FDA is reporting, neither patient had been previously treated with an immunosuppressant drug for MS or any other medical condition.

FDA recommended that patients taking fingolimod should contact their physicians immediately if they experience symptoms such as new or worsening weakness, increased trouble using their arms or legs, or changes in thinking, eyesight, strength, or balance.

Fingolimod joins other MS treatments that have also been associated with PML, including natalizumab (Tysabri) and extended-release dimethyl fumarate (Tecfidera).

The article can be seen here.

MS Speaks--online for 13 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.

Offline agate

  • Administrator
  • *****
  • Posts: 8244
  • MS diagnosed 1980
  • Location: Pacific Northwest
The actual alert as it appears on Drugs.com can be seen here.
MS Speaks--online for 13 years

SPMS, diagnosed 1980. Avonex 2001-2004. Copaxone 2007-2010.