Pancreatitis link to Gardasil to be investigated by the TGA

Aug 18 2008

Some Australian doctors are suggesting that a review of the cervical cancer vaccine Gardasil is called for after three patients contracted pancreatitis after having the vaccination.

Their concerns have prompted the Australian regulatory body, the Therapeutic Goods Administration (TGA) to investigate the claims made by Dr. Amitabha Das and several colleagues that three female patients injected with the quadrivalent medication were later diagnosed with pancreatitis.

Dr. Das and his colleagues say an extensive investigation could find no other cause for the pancreatitis and while a coincidental illness could not be ruled out, "neither can HPV vaccination be excluded as a potential cause".

Writing in the Medical Journal of Australia, the medics say in cases of abdominal pain following HPV vaccination that pancreatitis be considered.

The TGA will try to establish if the vaccine does pose a threat or whether the cases were mere coincidence.

According to the TGA, 3.7 million doses of the vaccine, Gardasil, have already been distributed in Australia and to date there have been about 1,013 reported adverse reactions, these have included soreness, swelling, redness or other reaction at the injection site, headaches, dizziness, nausea and vomiting.

The vaccine protects young women from the strains of the human papillomavirus (HPV) responsible for 70% of cervical cancers; three doses of the vaccine are required.

Acute pancreatitis is a sudden attack of severe upper abdominal pain where pancreatic enzymes irritate and burn the pancreas, and leak out into the abdominal cavity, which can result in serious complications including respiratory, kidney or heart failure, all potentially fatal.

The manufacturer of Gardasil CSL, says they are confident the drug is safe and effective, but they will also immediately investigate the reports of pancreatitis.

A two-year federal program to provide free Gardasil immunisation delivered by GPs for women aged 18-26 and girls 12-18 who missed out on the injections at school, finishes next June and thereafter Gardasil will cost $150 a dose.

The school-based program for girls aged 12-13 will continue but funding for older students will finish at the end of the year.