Back in October 2010 I made a request under the freedom of information to the European Medicines Agency [EMEA]. My request was partly met by the EMEA but, as ever with these regulatory bodies, lacked transparency.
Yesterday they came through with that request.
I basically wanted a breakdown of adverse reactions caused by each of the SSRi class of drugs.
Instead, the EMEA collated all the adverse reactions stating:
"According to 'Eudravigilance Access Policy for Medicines for Human Use', no medicinal product name can be disclosed can be disclosed upon request..."
A search, they told me, was conducted in Eudravigilance, based on the following criteria:
** Active substance - zimeldine 1; fluoxetine 2; citalopram 3; paroxetine 4; sertraline 5; alaproclate 6; fluvoxamine 7; etoperidone 8; escitalopram 9.
In other words:
1. Zimelidine [Brand names, Normud, Zelmid] has been banned worldwide due to serious, sometimes fatal, cases of central and/or peripheral neuropathy known as Guillain-Barré syndrome and due to a peculiar hypersensitivity reaction involving many organs including skin exanthema, flu-like symptoms, arthralgias, and sometimes eosinophilia. Additionally, zimelidine was charged to cause an increase in suicidal ideation and/or attempts among depressive patients.
2. Fluoxetine [Brand name Prozac, was introduced shortly after zimelidine was removed from the shelves]
3. Citalopram [Brand names Celexa, Cipramil] In the United States, citalopram, like other antidepressants, carries a black box warning stating that it may increase suicidal thinking and behavior in those under age 24. It is still prescribed to minors.
4. Paroxetine [Brand names Aropax, Paxil, Seroxat) - The most controversial of all SSRi's, classed as a teratogen in the United States but not in the UK
5. Sertraline [Brand names Zoloft, Lustral] In 1999, Zoloft came under great public scrutiny after it was discovered that Eric Harris, one of the two shooters involved in the Columbine High School massacre, had been taking the drug before taking Luvox. Many immediately pointed fingers at zoloft and fluvoxamine.
6. Alaproclate (GEA-654) is a psychoactive drug and research chemical derived from zimelidine (Normud, Zelmid) that was being developed as an antidepressant by the Swedish pharmaceutical company Astra AB (now AstraZeneca) in the 1970s. It acts as a selective serotonin reuptake inhibitor (SSRI), and along with zimelidine and indalpine, was one of the first of its kind. Development was discontinued due to the observation of liver complications in rodent studies.
7. Fluvoxamine [brand name Luvox] At the end of 1995, more than 10 million patients worldwide had been treated with fluvoxamine.
8. Etoperidone [Discontinued]
9. Escitalopram [Brand names Lexapro, Cipralex, Seroplex, Lexamil, Lexam] According to The New York Times, aggressive pharmaceutical marketing of escitalopram by Forest Laboratories has been controversial: the generic alternatives to the drug are cheaper, but a substantial number of doctors continue to prescribe the more expensive proprietary drug. The United States Senate Special Committee on Aging has released portions of the
"Lexapro Fiscal 2004 Marketing Plan" which gives some of the details of the plans to promote use of the drug by doctors.
The EMEA sent me a 57 page list of adverse reactions to the above drugs. Reactions which include; Blood and lymphatic system disorders, Cardiac disorders, Congenital, familial and genetic disorders, Ear and labyrinth disorders, Endocrine disorders, Eye disorders, Gastrointestinal disorders, General disorders and administration site conditions, Hepatobiliary disorders, Immune system disorders, Infections and infestations, Injury, poisoning and procedural complications, Metabolism and nutrition disorders, Musculoskeletal and connective tissue disorders, Neoplasms benign, malignant and unspecified (incl cysts and polyps), Nervous system disorders, Pregnancy, puerperium and perinatal conditions, Psychiatric disorders, Renal and urinary disorders, Reproductive system and breast disorders, Respiratory, thoracic and mediastinal disorders, Skin and subcutaneous tissue disorders, and Vascular disorders.
The 57 page list of adverse drug reactions can be passed on to those of you wishing to view it.
It's further evidence that the regulators are monitoring reactions...but doing very little about the drugs that cause them.
Fid
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'THE EVIDENCE, HOWEVER, IS CLEAR...THE SEROXAT SCANDAL' By Bob Fiddaman
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