Wednesday, December 16, 2009

New Vytorin® Warnings -- From FDA, Released Tonight


UPDATED: 12.17.09 @ 8:40 AM EST -- Per Salmon's keen eye:

EM has 10% mortality.

It's also considered a mild form of more serious skin toxicities including Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrosis (TENS).

In SJS, mucus membranes are involved so you have burning in the vagina, mouth, urethra, eyelids etc.. SJS also has 10% mortality. Survivors often have scarring.

In TENS, sheets of skin die and slough off the body. Mortality is 40%.

Salmon

December 17, 2009 8:05 AM

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Significantly less alarming than the Remicade/Simponi warnings (see below), yet these new FDA warnings are likely to continue to add to the looming government-reimbursement tangles, and more general Vytorin/Zetia sales erosion, in the United States:
. . . .Vytorin® (ezetimibe/simvastatin) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2009

ADVERSE REACTIONS
Post-Marketing Experience

erythema multiforme

PATIENT PACKAGE INSERT

What are the possible side effects of Vytorin?

Raised red rash, sometimes with target-shaped lesions. . . .

Ick.

3 comments:

Anonymous said...

Not just ick, lethal.

EM has 10% mortality.

It's also considered a mild form or more serious skin toxicities including Stevens Johnson Syndrome (SJS) and Toxic Epidermal Necrosis (TENS).

In SJS mucus membranes are involved so you have burning in the vagina, mouth, urethra, eyelids etc.. SJS also has 10% mortality. Survivors often have scarring.

In TENS sheets of skin die and slough off the body. Mortality is 40%.

Salmon

condor said...

Thanks!

Updated mine (see above), based on yours. I always welcome your insight!

Namaste

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