| Social Audit Ltd |
| P O Box 111 London NW1 8XG |
 Telephone/Fax 44 (0)171 586 7771 |
| Social Audit Ltd |
| P O Box 111 London NW1 8XG |
| Telephone/Fax 44 (0)171 586 7771 |
| Mr Roy Alder, Head of Executive Support | |
| Medicines Control Agency | |
| Market Towers, 1 Nine Elms Lane | |
| London SW8 5NQ | 21 January 2000 |
Dear Mr Alder,
By way of keeping the promise I made you yesterday, I am now writing to draw your attention to some of the claims made in the current Data Sheet/SPC for citalopram. Though approved by the MCA, several seem likely to mislead as to the quality of the drug and its uses and effects. Please would you let me know if the MCA considers each of the following data sheet entries to be satisfactory as it stands. If not, please let me know what action the MCA will take [a] to promote more accurate information about this drug; and [b] to ensure that standards as low as these would prove exceptions, not the rule.
Source: UK prescribing information provided by manufacturer (in line with MCA requirements) in Data Sheet/SPC, 1999/2000 |
Source: USA prescribing information provided by manufacturer (in line with FDA requirements) at http://www.celexa.com |
"Citalopram has no … carcinogenic potential" |
"There was an increased incidence of small intestine carcinoma in rats receiving …. approximately 1.3 and 4 times the maximum recommended human dose … " |
"Citalopram has no mutagenic … potential" |
"Citalopram was mutagenic in the … (Ames test) in 2 of 5 bacterial strains …" |
"Animal studies have not shown any evidence of teratogenic potential. and citalopram does not affect reproduction or perinatal conditions …" |
"In animal reproduction studies, citalopram has been shown to have adverse effects on embryo/fetal and postnatal development, including teratogenic effects" |
"Based on data from reproduction toxicity studies … there is no reason to have special concern for the use of citalopram in women of child-bearing potential." |
"When female rats were treated with citalopram … increased offspring mortality … and persistent offspring growth retardation were observed at … approximately 5 times the MRHD (maximum recommended human dose) … Similar effects on offspring mortality and growth were seen when dams were treated throughout gestation and early lactation at doses … approximately 4 times the MRHD on a mg/m2 basis. A no-effect dose was not determined in that study." |
"Citalopram appears in milk in very low concentrations … it is not known whether citalopram excreted in milk may affect the infant." |
" … citalopram is excreted in human breast milk. There have been two reports of infants experiencing excessive somnolence, decreased feeding, and weight loss in association with breast feeding …" |
| Overdose: In "8 cases considered due to citalopram alone … no case was fatal" | " … postmarketing reports of drug overdoses involving citalopram have included 12 fatalities … 2 with citalopram alone" |
| "Citalopram should be administered as a single oral dose of 20mg daily. Dependent on a individual patient response this may be increased to a maximum of 60mg daily…" | "Celexa should be administered at an initial dose of 20mg once daily, generally with an increase to a dose of 40mg/day … Although certain patients may require a dose of 60mg/day, the only study pertinent to dose response for effectiveness did not demonstrate an advantage for the 60mg/day dose over the 40mg/day dose; doses above 40mg are therefore not ordinarily recommended." |
| "Adverse effects observed with citalopram are in general mild and transient. They are most prominent during the first one or two weeks of treatment and usually attenuate as the depressive state improves … " | "Among 1063 patients who received Celexa in placebo-controlled trials of up to 6 weeks duration, 15% discontinued treatment due to an adverse effect …" |
| "In humans citalopram does not impair cognitive (intellectual function) and psychomotor performance and has no or minimal sedative properties …" | Percentage of patients on citalopram (n=1063) in placebo-controlled clinical trials reporting "Somnolence" - 18% |
| "This absence of effects on receptors could explain why citalopram produces fewer of the traditional effects such as dry mouth …" | Percentage of patients on citalopram (n=1063) in placebo-controlled clinical trials reporting "Dry mouth" - 20% |
You will appreciate that I could go on in the same vein at some length, and would need little prompting to do so. Any suggestion that such discrepancies were due to different dates of publication would, for example, be guaranteed to produce a galactic burst of new data.
You will understand that I am anxious also to make good use of the Code of Practice on Access to Government Information while I still can. Imperfect as the Code clearly is, it has to be preferable to the proposed "Freedom of Information" Act. I really do find the Bill sickening: it's not just the enormity of the betrayal; it's also the prospect of continuing regulatory inadequacy and lack of accountability, with all that implies for standards of treatment and public health.
Thank you for your attention. I look forward to hearing from you - failing which, you may look forward to hearing from me. Happy New Year too.
| Yours sincerely, | |
| Charles Medawar |
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