The first directive was issued to GlaxoSmithKline on March 26, 2013. They were told they had 30 days to change their package insert to add the following to the ‘Precautions’ section:
“Acute disseminated encephalomyelitis (ADEM): Acute disseminated encephalomyelitis (ADEM) may occur. In such cases, pyrexia, headache, convulsion, movement disorder, and disturbed consciousness, etc., generally occur within several days to 2 weeks after vaccination. If ADEM is suspected, diagnosis should be made by MRI etc., and appropriate measures should be taken.
Guillain-Barre syndrome: Guillain-Barre syndrome may occur. If any symptoms such as flaccid paralysis originating from the distal extremities, decreased or absent tendon reflexes, appropriate measures should be taken.”
NOTE: However, the directive was not addressed to Merck, because the package insert for Gardasil had already been ‘mysteriously’ altered to include a reference to the risks of ADEM and GBS at the time of the directive’s issuance.
The second directive, issued on June 14th, 2013 gave both Merck and GSK 30 days to add the following to the ‘Precautions’ section of the package inserts for Gardasil/Cervarix:
“Although the mechanisms of pathogenesis are unclear, severe pain which is not localized at the injection site (e.g. muscle pain, arthralgia and skin pain, etc.), numbness, weakness, etc., may occur after vaccination and these symptoms may persist for long time. Vaccine recipients and their guardians should be instructed to consult a healthcare provider who can provide appropriate medical care including making neurological and immunological differential diagnosis if any abnormalities are observed after vaccination.” READ MORE…