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Tuesday, January 19, 2016

Is Contraceptive Pill, Rigevidon, Safe?





Is the contraceptive pill, Rigevidon, safe? Well, the MHRA seem to think so, unless, of course, they have been misquoted by the press.

I don't normally write about drugs outside of the psychiatric medication circle but this one grabbed my attention as it's from Birmingham and we can see clearly how the MHRA operate. To be honest, I'm flabbergasted at their shrug of the shoulders. I'll explain why later. First, here's the story...

Teaching assistant Fallan Kurek, 21, Tamworth, died after taking the contraceptive pill, Rigevidon and an inquest into her death has opened this morning.

According to the Birmingham Mail, "A scan revealed that Fallan had a large clot on her lung, causing the right side of her heart to become inflamed." Furthermore, her parents claim that doctors told them that she may have died as a result of taking the contraceptive pill, Rigevidon.

The shoulder shruggers, the Medicines and Healthcare products Regulatory Agency (MHRA), were contacted by the Birmingham Mail and  "insists the pill is safe and that women should continue to take it."

Wait a minute here...

Here we have parents of a dead girl who claim that doctors told them that their daughter may have died as a result of taking a drug - and the MHRA are disputing this because they claim the pill is safe?

So, let's just get this straight.

If a doctor, or doctors, file an adverse reaction report to the MHRA implicating a drug in the death of someone then the MHRA (because they are already convinced of a drug's safety) dismiss the adverse reaction? Furthermore, they go public with their opinion?

I'm somewhat baffled. Isn't the premise of the regulator to investigate adverse reaction reports impartially?

How are they being impartial in this instance with such a broad statement?

Let's take a look at the patient information leaflet (PIL) for Rigevidon, ironically hosted on the MHRA website.


The pill and thrombosis

Your chances of having a blood clot are only increased slightly by taking the Pill.

• Of 100,000 women who are not on the Pill and not pregnant, about 5 will have a blood clot in a year.
• Of 100,000 women taking a Pill such as Rigevidon, about 15 will have a blood clot in a year

So, 10 more women are more likely to develop a blood clot when taking Rigevidon, yet the MHRA claim it's "safe and that women should continue to take it."

The leaflet goes on to tell us...

Venous thrombosis

The use of any combined pill, including Rigevidon, increases a woman’s risk of developing a venous thrombosis (formation of a blood clot in vessels) compared with a woman who does not take any contraceptive pill.

Yet the MHRA claim it's "safe and that women should continue to take it."

The leaflet goes on to tell us possible side effects...

Like all medicines, Rigevidon can cause side effects, although not everybody gets them.

These side effects have been reported in women using the pill, which can occur in the first few months after starting Rigevidon, but they usually stop once your body has adjusted to the pill.

The following serious adverse events have been reported in women using combined oral contraceptives...


  • Venous thromboembolism (a blood clot in vessels)
  • Arterial thromboembolic disorders (the blocking of an artery)


Yet the MHRA claim it's "safe and that women should continue to take it."

Maybe the Birmingham Mail misquoted the MHRA or maybe the MHRA have now decided to ignore warnings on patient information leaflets?

I'm perplexed as to why the MHRA can claim a drug is safe and that women should continue taking it when the patient information leaflet suggests otherwise.

Rigevidon is marketed and manufactured by Hungarian pharmaceutical company, Gedeon Richter.


Bob Fiddaman.


**UPDATE**

Coroner returns narrative verdict.

http://www.birminghammail.co.uk/news/midlands-news/fallan-kurek-inquest-contraceptive-pill-10755513



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