Generic Paxil Suicide Lawsuit

Citizens Commission on Human Rights Award Recipient (Twice)
Humanist, humorist

Sunday, June 29, 2014

Health Canada Secrets and Birth Defects

Canada's medicine watchdog, Health Canada, are in the news once again.

Last week it was reported that Health Canada were refusing to release its own internal report on the state of a GlaxoSmithKline plant in Quebec.

The American medicine regulator, the FDA, had previously found  bacterial contamination problems and had raised concerns about the purified water system at the plant. Health Canada carried out their own inspection but refused to release their findings [Health Canada Refusing to Release Glaxo's Dirty Secret]

Coming on the back of this is news is a report that Health Canada are also refusing to publish data on off-label drug side effects.

In a revealing editorial in The Star, David Bruser, Jesse McLean and data analyst Andrew Bailey report that Health Canada have been collecting the adverse reaction reports but refusing to publish them on the grounds that "It’s been collecting this information for six years but technical limitations with the database have prevented the public release."

"Indeed, the Star analyzed the information collected in the FDA database and found nearly 400 off-label cases from 2010 to 2013 that involve a range of side effects ranging from death to heart attacks, strokes, birth defects and organ failure.
"In Canada, the federal regulator collects the same information but removes the off-label details before publishing its side-effects database. Without this information, doctors and patients can’t ask the proper questions. It’s an offensive lack of transparency."

Dr. Joel Lexchin, one of Canada s leading authorities on drug safety, says, “There are significant public safety implications. This is a major problem for doctors and patients alike.”

Health Canada must publish this information and they must do it now. They have no right to keep this information from the public or health care professionals.

If evidence was needed as to why playing God has implications then one only has to read the latest news coming out of Canada regarding  a powerful anti-nausea drug being prescribed to women who are pregnant.

Zofran [ondansetron] has been approved by Health Canada to treat nausea and vomiting in chemotherapy and surgery patients but it has never been approved for use in pregnancy. However, like most drugs, Zofran is being prescribed in this population off-label.

The Star are reporting...

"At least 20 Canadian women treated with ondansetron for vomiting in pregnancy experienced serious suspected side-effects, including two infant deaths and multiple cases of newborns with heart defects and kidney malformations."

Back in 2013 I was contacted by Tomisha LeClair. She informed me that she fell pregnant in 1999 and like many women developed  nausea and vomiting and was prescribed Zofran.

At seven months gestation Tomisha was given an ultrasound and was told by doctors that her unborn daughter had a renal cyst; a fluid filled sac on one of her kidneys. The medical staff explained there are many children born with this complication and if necessary she could be treated with antibiotics upon birth.

She told me:

In the latter part of 2000 I wrote to the (FDA) the Food and Drug Administration to complete a Med-Watch form reporting my daughter’s “abnormalities”. I initiated a (FOIA) a Freedom of Information Act request to the Food and Drug Administration inquiring about the adverse reactions reported by other patients who had also been prescribed this drug, to compare them to Ahjanee’s abnormalities. My suspicions were that the “wonder drug” had caused Ahjanee’s abnormality’s. Several weeks later I received a 20 page alphabetical list of all the reported adverse reactions reported by other patients, compiled into percentiles.

She added...

The "adverse reaction" list from the FDA is 26 pages long and contains every "abnormality/anomaly" my daughter and many of the other children have.The Center for Drug Evaluation and Research (CDER) Report is alarming to say the least! If I had to be scientifically specific regarding what Zofran has caused within the children, I would say that Zofran prescription during pregnancy causes clusters of symptoms such as cranial abnormalities; my daughter has microcephaly  [Fig 1], and another child hascutis cutis aplasia (characterized by the absence of a portion of skin in a localized or widespread area at birth), and there is one more cranial/skull abnormality that I can't recall by name. One child has Ebstein anomaly (a congenital abnormality that is present from birth and affects flaps that make up the tricuspid heart valve) and another has Hirschsprung syndrome (missing nerve cells in the muscles of part or all of the baby's colon) and another has clubfoot.[Fig 2] - [See Are GSK Concerned About the Zofran Noise?]

Fig 1

Fig 2

Zofran is manufactured and marketed by GlaxoSmithKline.

Are we really surprised anymore?

In Canada the generic version of Zofran is sold by Mylan.

What exactly are Health Canada playing at here?

I thought you'd have to go a very long way to beat the ineptitude of the MHRA and FDA...Health Canada have beaten them in the Stupidity Stakes by a number of lengths!

For more information on Zofran birth defects visit MA'Z (Mother's Against Zofran Birth Defects), a Facebook community page created by Tomisha LeClair.

Bob Fiddaman

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