cipramil (celexa) stories,, lundbeck, Newspaper and internet articles

Panorama Expose on Citalopram use in Pregnancy.

Unhappy pill

Next week BBC’s Panorama team are tackling the issue of antidepressant use in pregnancy. The programme will be broadcast on Mon 1st july, entitled ‘The Truth About Pills and Pregnancy‘.

According to the UK Independent “The programme will broadcast an interview with Anna Wilson, whose son David spent the first five weeks of his life in hospital. A 20-week scan had shown that David had a heart defect and would need surgery immediately after being born. Anna had been taking the prescription drug Citalopram to treat her anxiety four years before her pregnancy began, and was told that she was safe to continue whilst pregnant. The show will feature interviews with Prof Pilling, who will say that GP prescription guidelines are about to be updated to take into account evidence suggesting a link with SSRIs and heart defects.”

A manufacturer contacted by the BBC denies any link to major foetal malformations (no prizes for guessing Lundbeck here).

Panorama spoke to eight mothers who had babies born with serious heart defects after taking a commonly used SSRI (selective serotonin reuptake inhibitors) antidepressant while pregnant.

An article on BBC News stated “Lundbeck, the manufacturer of Citalopram, said a recent review of scientific literature concluded that the drug ‘does not appear to be associated with an increased risk of major foetal malformations’.”

It seems that Lundbeck are lying again or there is a serious lack of communication between the various medicines regulators and the pharmaceutical industry. Below is an adverse reaction report logged with the Irish Medicines Board involving a baby born with a Cleft Lip, associated with the mother’s use of Citalopram.

IMB 1

What about the following, also reported as Citalopram induced? This particular report concerns the intrauterine death of an unborn baby due to ‘Citalopram exposure during pregnancy’.

IMB 3

Then there was our meeting in Copenhagen with the two Lundbeck goons. We asked if Citalopram/Escitalopram was a teratogen. Their answers (or non-answers) may surprise you…

Leonie                       Right, will I go on because there’s no point, we’re stuck at that one?  Anyway.  Do you think that it’s advisable to virtually bathe foetuses in Serotonin given it is now accepted this family of drugs are firmly associated with birth defects?

Dr. Madsen               Virtually bathe?

Leonie                       Foetuses in Serotonin – pregnancy.

Tony                         Pregnant women.

Dr. Madsen               I don’t know what you mean by virtually bathe

Leonie                       I’m talking about anti-depressants are known to cause birth defects.  If you think so, would it not be better if women of child-bearing age were cautioned against, perhaps even contra-indicated from using this drug?  Citalopram or Escitalopram?

Dr. Madsen               Em, I think in…..

Leonie                       Your views?

Dr. Madsen               In pregnancy?

Leonie                       Yeah

Dr. Madsen               Em, I think em, physicians need to double their efforts to make sure that there is a correct risk versus eh, benefit eh, assessment of the em, of any action.

Leonie                       Is Citalopram and Escitalopram a teratogen?

Dr. Madsen               Em, meaning, what, what, what do you mean?

Leonie                       Can it cause harm to foetuses? Unborn babies.

Dr. Madsen               Em, obviously, in order to have our compounds approved we have done em, a large number of pre-clinical trials em, and we are constantly monitoring and the eh, while the recommendation I believe throughout, is to be, be extra cautious when administering any eh, medications to pregnant women…

Leonie                       Can it cause harm?….. to unborn babies?

Dr. Madsen               Anything can cause harm, can cause harm in any dose

Leonie                       So yes it can.

Dr. Madsen               depending on dose

Leonie                       Yep

Em, why if it can cause harm, is this not clearly, clearly stated on the packaging and information leaflet?

Mr. Schroll                Do you talk about the patient leaflet or do you talk about the SPC, the label that the Doctors use in order to prescribe the medication?

Leonie                       I’m talking about a pregnant woman that goes down and gets it in the chemist.  Is it on the patient information leaflet?

Mr. Schroll                In the patient leaflet it says you have to talk to your Doctor….

Leonie                       And what does it say in the Doctor’s leaflet?

Mr. Schroll                That he has to be extra cautious.  I think that if you go to the… to, to the Irish home page, I believe it is like that, it’s like that in Denmark and elsewhere.  If you go to the medicines agency authorities

Leonie                       So,

Mr. Schroll                the medicines agency authorities you can see what is in the checks that the Doctors and that is up to them to decide…..

Leonie                       So you are passing the buck back to the Doctor again.

Mr. Schroll                I think when it’s prescription medication, yes.  If it was eh, eh,

Leonie                       And will they be told that it can harm their unborn baby?

Mr. Schroll                Sorry?

Leonie                       Will the pregnant woman be told that the drug can, can harm her unborn baby?

Mr. Schroll                It would be part of the discussion to talk about the risks and the benefits and that would be up to the Doctor.

Leonie                       It would be up to the Doctor to tell them that the drug can harm their unborn baby?

Mr. Schroll                Eh, now, you’re talking…..

Leonie                       It’s not up to Lundbeck, no?  It’s up to the Doctor to tell the woman that the drug can harm their unborn baby?

Mr. Schroll                To be cautious, yes, yes.

The Irish word ‘amadáin’ springs to mind. I could think of a few English ones too but think I’d better refrain. The Panorama programme should be excellent viewing as usual, particularly with Shelley Jofre as reporter. She did the previous expose concerning GSK and Seroxat suicides. I can see her putting Lundbeck in their place.

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Lundbeck Meeting here.

IMB adverse reaction reports.

MHRA (UK) adverse reaction reports.

Newspaper and internet articles

Moms-To-Be–Are You Taking This Dangerous Drug?

opednews.com

By Martha Rosenberg 

March 11, 2011

Moms-To-Be–Are You Taking This Dangerous Drug?

Americans are getting used to the withdrawal or severe restriction of drugs “previously thought safe.” From last year’s Avandia warnings to the withdrawal of Vioxx, Bextra, Baycol, Meridia, Trovan and Fen Phen, “Pill Buyer Beware” seems to be a shrewd stance, especially when a drug is new.

Still, the parade of heart, liver and muscle complications seen with withdrawn drugs has lacked the side effect that sends shivers down the spines of consumers, regulators and drug-makers: birth defects.

But this month FDA issued a warning that pregnant women who take the antiepileptic drug Topamax are twenty times as likely to have their babies develop cleft lip and cleft palate as they would otherwise be, says Reuters. Children are three times as likely to develop the facial anomalies as infants exposed to other seizure drugs, adds the Associated Press.

Johnson & Johnson’s Topamax is FDA-approved to treat seizures and migraine headache. But like the off-label marketed seizure drugs Neurontin and Lyrica (for which Pfizer paid massive fines), J & J agreed to a $6.1 million fine for illegally marketing Topamax for psychiatric conditions, less than a year ago.

Another Wonder Drug by Martha Rosenberg

And the marketing worked. Thanks to J & J’s subsidiary Ortho-McNeil’s “Doctor-for-a-Day” scheme in which it paid outside physicians to call on health care providers along with sales reps and speak at meetings and dinners, according to the AP, Topamax made J & J a cool $2 billion a year by 2006. (A lot less than the $6.1 million it paid in criminal fines for the marketing that made the $2 billion.)

Thanks to wide marketing, Topamax has become such a catch-all drug in the military for general pain conditions and other unapproved uses (often in untested   psychoactive drug “cocktails” which are now under investigation) it’s called “Stupamax” because of its brain-fogging properties says Army Times.

Nor is this month’s alert the first safety warning for Topamax.

As early as 2004, FDA warned J & J its sales pieces downplayed the “serious side effects associated with Topamax, including oligohidrosis (decreased sweating), hyperthermia, and metabolic acidosis,” a violation of the Federal Food, Drug and Cosmetic Act. “These materials raise serious public health concerns because they encourage the unsafe use of Topamax, including, particularly, in pediatric patients,” said FDA.

In 2006, FDA warned that Topamax can cause a serious eye condition “characterized by acute myopia and secondary angle closure glaucoma.” The eye side effects can lead to “permanent loss of vision,” if medical care is not sought, says the prescribing information.

In 2008, FDA warned that patients on all antiepileptic drugs should be “monitored for the emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in mood or behavior,” and warnings on drug labels were soon required.

And last year FDA refused to approved a diet drug candidate, Qnexa, which includes Topamax along with phentermine, the “good” drug in the Fen Phen combo, because of   surfacing Topamax doubts.

Qnexa probably would have worked as a diet drug. People who have used Topamax on the drug rating site askapatient say it does decrease appetite. But the action stems from Topamax making food and drinks taste terrible write more than 33 people. Others say in addition to making you lose weight, Topamax makes you lose your memory, word recall and even hair. Line forms to the left.

Of course widely promoted drugs which turn out to be dangerous after millions use them is nothing new. Many are calling for an end to the pharma Wild West in which even after fines for illegal drug marketing and personal injury settlements, pharma still profits and no principals go to jail.

 Especially after Topamax’s new side effects.