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5 July 2002 |
The CSM undertook three separate reviews of
vaccines, the results of which are published in the above report.
The MCA has also produced a
similar report
 as has the
Department of Health whose
report is on their website. |
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23 May 2002 |
Vaccinations against Meningitis C were
introduced in the UK in November 1999 and over the subsequent 16 months
virtually the whole population under the age of 18 years was immunised. This
paper reports on the work of a group that oversaw safety monitoring during
this immunisation campaign. |
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2 May 2002 |
The patient information leaflets that are in
each HRT pack are being updated to make sure they all contain the latest
information about its use. The attached leaflet summarises this information
and what it means for women. |
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11 April 2002 |
An update of the number of reactions most
commonly reported through the Yellow Card Scheme is provided. Prescribers
are reminded that Zyban is contraindicated in patients with previous or
current seizure disorder. |
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26 March 2002 |
New study on oral contraceptives
and cervical cancer
A paper and editorial on long-term use of
oral contraceptives (OCs) and risk of cervical cancer in women with high
risk type human papilloma virus (HPV) appears in this week's "Lancet". The
findings strengthen the evidence that OCs may contribute to the development
of cervical cancer but are not conclusive.
Message to health professionals
- this
message provides information to help health professionals advise their women
patients and gives information for women themselves and guidance on where to
seek further information.
Questions and Answers
- questions
and answers about the new study. |
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14 January 2002 |
An update of the number of reactions most
commonly reported through the Yellow Card Scheme is provided. Prescribers
are reminded that Zyban is contraindicated in patients with previous or
current seizure disorder. |
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19 November 2001 |
Eprex contains epoetin alfa, a biological
product available in the UK since 1990 for the treatment of anaemia
associated with chronic renal failure (CRF), cancer chemotherapy, autologous
blood donation, and during major elective orthopaedic surgery.
Regulatory authorities in the EU, including
the MCA have been made aware, by the marketing authorisation holder that 40
cases of confirmed or suspected PRCA have been reported worldwide in CRF
patients treated with Eprex. |
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28 September 2001 |
The European Medicines regulators (the
Committee for Proprietary Medicinal Products or CPMP) have concluded that
women who use 'third generation' combined oral contraceptives are at
slightly greater risk of developing venous thromboembolism (VTE) than those
who use other types of pills. This finding is not new. The UK authorities
came to the same conclusion in 1999 and this information has already been
added to prescribing material and Pill packet leaflets. On the basis of
these findings there is no reason for any woman to stop taking their Pill. |
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26 September 2001 |
An update of the number of reactions most
commonly reported through the Yellow Card Scheme is provided. Prescribers
are reminded that Zyban is contraindicated in patients with previous or
current seizure disorder. |
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9 August 2001 |
The MCA has sent a letter to healthcare
professionals informing them of the withdrawal of all dosages of the
lipid-lowering agent Lipobay (cerivastatin) as a result of a voluntary
decision by Bayer to suspend its marketing and distribution from 8 August
2001 until further notice. This withdrawal follows concerns about the
increased risk of rhabdomyolysis associated with its use, particularly when
used in combination with one of the fibrates, gemfibrozil (Lopid).
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29 June 2001 |
Doctors in the UK are being informed of
strengthened warnings to contraindicate the concomitant use of the lipid
lowering agents cerivastatin (Lipobay) and gemfibrozil (Lopid) in view of
the risk of rare but potentially serious muscle toxicity (rhabdomyolysis).
This is not a new issue and warnings exist in product information and the
BNF, however reports of adverse reactions from outside the UK suggest that
these agents should not be used together. Because the risk of muscle
toxicity increases with increasing dose, the maximum recommended dose of
cerivastatin is 0.4mg and should not be exceeded. |
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31 May 2001 |
Professor Breckenridge has written to health
professionals advising them of a modified dosage schedule and new safety
precautions for Zyban (bupropion /amfebutamone), a drug licensed as an aid
to smoking cessation in nicotine addicted patients. Information on important
drugs which may interact with Zyban and an information sheet for patients
are attached. |
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11 May 2001 |
This relates to a legal action and is not
related to any new safety concerns.
The following advice sheets have been
forwarded to relevant practitioners:
-
Advice for health professionals
-
Information sheet for patients
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11 May 2001 |
An update of the number of reactions most
commonly reported through the Yellow Card Scheme is provided. Prescribers
are reminded that Zyban is contraindicated in patients with previous or
current seizure disorder. |
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26 April 2001 |
Professor Alasdair Breckenridge, Chair of
the Committee on the Safety of Medicines, has released a statement in
response to the concern being expressed regarding a recent increase in fatal
reports associated with Zyban received through the Yellow Card Scheme.
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19 April 2001 |
The European Agency for the Evaluation of
Medicinal Products (EMEA) has issued a public statement regarding the
suspension of the MA for Orlaam, a long-acting opiate used for the treatment
of drug addiction. |
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6 April 2001 |
An update of the number of reactions most
commonly reported through the Yellow Card Scheme is provided. Prescribers
are reminded that Zyban is contraindicated in patients with previous or
current seizure disorder. |
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13 March 2001 |
The European Agency for the Evaluation of
Medicinal Products (EMEA) has issued a public statement regarding very rare
liver injury, that may be fatal, during treatment with Arava. |
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22 January 2001 |
This response has subsequently been
published in "Adverse Drug Reactions and Toxicological Reviews, Volume 20
Number 1 : March 2001". (Note: The publishers wish to apologise for an error
that occurred on page 43 of this issue. The sentence should read: The
authors concluded that 'our results do not support the hypothesis that MMR
vaccination is causally related to autism, either its initiation or to the
onset of regression'). |
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12 January 2001 |
Following recent publicity about MMR vaccine
and the availability of single antigen vaccines, the Chairmen of the two
relevant independent committees, the Committee on Safety of Medicines (CSM)
and the Joint Committee on Vaccination and Immunisation, have issued advice.
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10 January 2001 |
Discontinuation of Droleptan
tablets, suspension and injection (droperidol)
MCA statement
Information for patients
Droleptan medicinal products will be discontinued from 31 March 2001. This
means that shortly after this date, Droleptan will no longer be available in
pharmacies. This action has been taken by the company, Janssen-Cilag Ltd,
who has chosen to voluntarily discontinue Droleptan following an extensive
risk-benefit assessment |
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20 December 2000 |
The European Agency for the Evaluation of
Medicinal Products (EMEA) has issued a public statement regarding
tuberculosis (TB) or other opportunistic infections following infliximab (Remicade)
therapy. |
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18 December 2000 |
The Committee on Safety of Medicines (CSM)
has concluded that the evidence of a link between haemorrhagic stroke and
phenylpropanolamine (PPA) is weak, and mainly associated with uses which are
not licensed in the UK. It has also recommended that the Medicines Control
Agency (MCA) should work closely with manufacturers to improve existing
product information on the packs and patient information leaflets for PPA-containing
products with more prominent warnings. |
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11 December 2000 |
Thioridazine: restricted
indications and new warnings on cardiotoxicity
Message from Professor Alasdair Breckenridge, Chairman, Committee on Safety
of Medicines
The Committee on Safety of Medicines (CSM) has considered the new evidence
on the balance of risks and benefits of thioridazine concerning rare but
serious cardiotoxicity (QTc interval prolongation and life-threatening
ventricular arrhythmias). This letter informs health professionals of
restrictions to the drug's indications and important new advice for its safe
use.
Prescribing information for thioridazine
- this is a
copy of the new product information for thioridazine. |
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1 December 2000 |
An update of the number of reactions most
commonly reported through the Yellow Card Scheme is provided. There are no
new safety issues, but prescribers are reminded that Zyban is
contraindicated in patients with previous or current seizure disorder. |
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30 November 2000 |
Potential for error in prescribing
and dispensing of alfacalcidol - One-Alpha drops 2 micrograms/ml
Message from Dr Pat Troop, Deputy Chief Medical Officer, and Mrs J Howe,
Chief Pharmaceutical Officer
This letter informs health professionals of the possibility of error in
prescribing and dispensing of alfacalcidol, One-Alpha drops 2 micrograms/ml. |
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10 November 2000 |
Medicines containing
phenylpropanolamine (PPA) and possible association with increased risk of
stroke
Message from Professor Alasdair Breckenridge, Chairman, Committee on Safety
of Medicines. 10 November 2000
This letter informs health professionals of the current situation relating
to the UK use of PPA containing products. |
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6 November 2000 |
There are no new safety issues, but
prescribers are reminded that Zyban is contraindicated in patients with
previous or current seizure disorder. |
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20 October 2000 |
Recall of oral polio vaccine
CEM/COM/2000/12
and
CEM/CMO/2000/13
Messages from Professor Liam Donaldson,
Chief Medical Officer, Department of Health.
The MCA today ordered the recall of the remaining stocks of one brand of the
oral polio vaccine used in the routine childhood vaccination programme and
travel vaccination. The recall is based on the discovery of a breach of
European guidelines issued in 1999 as a precautionary measure to protect
public health in the light of developing information about the theoretical
transmission of BSE. |
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31 August 2000 |
Safety of Meningitis C vaccines
Message from the Chairman of the Committee on Safety of Medicines (CSM) and
the Chairman of the Joint Committee on Vaccination and Immunisation (JCVI)
Recent press reports of death following Meningitis C vaccination will have
caused concern to the public as well as health professionals. The purpose of
this statement is to outline the facts concerning the safety of these
vaccines. In addition, a prepublication copy of an article about Meningitis
C vaccines from the MCA and CSM bulletin, "Current Problems in
Pharmacovigilance" is attached. |
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16 August 2000 |
The EMEA has issued a public statement
regarding hypersensitivity reactions following interruption of abacavir (Ziagen)
therapy. |
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7 August 2000 |
European withdrawal of anorectic
agents/ appetite suppressants
MCA reinstates licences for phentermine slimming pills (Duromine, Ionamin)
The MCA reinstated the licences for amfepramone slimming pills (Tenuate
Dospan, Diethylpropion) on 19 April 2000 |
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20
July 2000 |
Suspension of cisapride (Prepulsid)
licences: Product withdrawal from 28 July 2000
Letter from Professor A Breckenridge, Chairman of Committee on Safety of
Medicines. 19 July 2000
The above letter informs health professionals
that cisapride (Prepulsid) will be withdrawn from marketing in the UK from
28 July 2000 until further notice. The Committee on Safety of Medicines (CSM)
has advised that all treatment with cisapride should be stopped and patients
should be changed to alternative treatment as necessary. An information
sheet for patients is attached. |
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April
2000 |
European withdrawal of anorectic
agents/ appetite suppressants
MCA reinstates licences for amfepramone slimming pills (Tenuate Dospan,
Diethylpropion) - 19 April 2000
Extract from April 2000 issue of "Current Problems in Pharmacovigilance"
Information for patients
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February 2000 |
Letter from Professor A Breckenridge, Chairman of Committee on Safety of
Medicines. 29 February 2000
Fact sheet for health care professionals, including specific advice for
medicines that have been shown to interact with St John's Wort
Fact sheet for the public
Guide to taking other medicines which may interact with St John's Wort
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January 2000 |
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- Safety of halothane in dental
anaesthesia in children - use to be restricted to hospitals only
EPINET message (CEM/CMO/99/13) 26 November 1999
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- Quixil Human Surgical Sealant -
reports of fatal neurotoxic reactions in association with its use
EPINET message (CEM/CMO/99/12) 27 October 1999
- No new safety issues with the Pill or
changes to prescribing advice . EPINET Message 24 September 1999
- Important new information about renal
failure associated with Aristolochia in some Chinese herbal medicines.
EPINET Message 28 July 1999
- Antiretroviral Drugs to reduce
vertical transmission of HIV infection - 24 June 1999
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- Medicines Commission advice on third
generation oral contraceptives and risk of venous thromboembolism. EPINET
Message (CEM/CMO/99/2 8 April 1999)
- Serdolect (sertindole) - suspension of
availability - 2 December 1998
- Human Albumin EPINET message (CEM/CMO/98/11
24 July 1998)
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