adr.org.uk West Midlands Centre for Adverse Drug Reactions

West Midlands Centre for Adverse Drug Reactions

The West Midlands Centre for Adverse Drug Reactions (CADRE) is an educational and academic unit concerned with the study of adverse drug reactions and other issues related to the adverse effect of medicines. It has been based at City Hospital in Birmingham since 1993, and has strong links to the Department of Clinical Pharmacology at Birmingham Unversity. The centre's staff undertake research and education within the region, and present research both regionally, nationally, and internationally - as well as publishing in the scientific press. The centre's staff also edit the Adverse Drug Reaction Bulletin, which has been published since 1966.

The centre maintains a rolling news service related to drug safety on this page.

Yellow Card Scheme

admin November 7th, 2009

Report here: http://www.yellowcard.gov.uk

Drug Safety Update: Volume 3 Issue 3, October 2009

admin October 12th, 2009

The MHRA have issued the October 2009 Drug Safety Update.

  • Ceftriaxone: incompatibility with calcium-containing solutions—updated advice
  • High-dose cyproterone acetate: potential risk of (multiple) meningiomas
  • Yellow Card Scheme update
  • Human papillomavirus (HPV) immunisation programme—first year safety review
  • Smoking and smoking cessation: clinically significant interactions with commonly used medicines
  • Aspirin: not licensed for primary prevention of thrombotic vascular disease
  • Varenicline and suicidal behaviour: cohort study provides some reassurance

Varenicline and neuropsychiatric reactions

admin October 6th, 2009

In recent years concerns about neuropsychiatric adverse drug reactions associated with varenicline have been raised both in the UK and the US. In Europe warnings were issued by EMEA. A recent BMJ study using the GPRD database has cast some doubt on the strength of such an association. We recently performed an analysis of the utility of using spontaneous patient reports of suspected adverse reactions to varenicline left on a number of blogs. Here is a poster we are presenting at the International Society of Pharmacovigilance conference this week.

Varenicline: evaluation of the utility of spontaneous consumer reports of suspected adverse effects filed on internet sites [PDF]

Angioedema and angiotensin-II receptor blockers

admin October 6th, 2009

Angioedema is a rare serious adverse drug reaction (ADR) to angiotensin-converting enzyme inhibitors (ACE-I), with an incidence of 0.1% to 1.0%. If untreated it can be life-threatening. Debate exists over the safety of switching to an angiotensin-II receptor blocker (ARB), due to case reports of angioedema, and the mechanism of ARB-associated angioedema. The DoTS system of ADR classification provides a structured template for examining the Dose and Time relationship, and potential Susceptabilities to an ADR.

Here is a poster we are presenting at the International Society of Pharmacovigilance conference this week.

Angioedema associated with angiotensin-II receptor blockers: a DoTS classification
and analysis [PDF].

Natalizumab (Tysabri) and progressive multifocal leukoencephalopathy (PML)

admin September 22nd, 2009

The FDA have reported on a continuing number of reports of progressive multifocal leukoencephalopathy associated with natalizumab:

From July 2006, (when Tysabri marketing resumed) to September 8, 2009, 13 reported cases of Tysabri-related PML were confirmed worldwide in patients being treated for MS with Tysabri monotherapy. There have been no postmarketing reports of PML in patients treated with Tysabri for Crohn’s disease. Less than 2% of Tysabri use in the U.S. has been in patients with Crohn’s disease. Based on available data from the U.S. and outside of the U.S., the current rate of PML in patients who have received at least 24 infusions ranges from 0.4 to 1.3 per 1,000 patients.

The risk appears to increased with the number of infusions administered.

  • FDA
  • Comments Off

Oseltamivir (Tamiflu) update

admin September 14th, 2009

Just a short post to draw attention to the National Prescribing Centre’s Evidence Summary blogs on the use of oseltamivir (Tamiflu) in both children and adults.

Readers may also be interested in the World Health Organisation briefing note on the use of anti-virals during the current pandemic, which do not support the routine use of anti-virals in either children or adults experiencing mild symptoms of H1N1 infection.

Adults:

For patients who initially present with severe illness or whose condition begins to deteriorate, WHO recommends treatment with oseltamivir as soon as possible. Studies show that early treatment, preferably within 48 hours after symptom onset, is strongly associated with better clinical outcome. For patients with severe or deteriorating illness, treatment should be provided even if started later. Where oseltamivir is unavailable or cannot be used for any reason, zanamivir may be given.

This recommendation applies to all patient groups, including pregnant women, and all age groups, including young children and infants.

For patients with underlying medical conditions that increase the risk of more severe disease, WHO recommends treatment with either oseltamivir or zanamivir. These patients should also receive treatment as soon as possible after symptom onset, without waiting for the results of laboratory tests.

As pregnant women are included among groups at increased risk, WHO recommends that pregnant women receive antiviral treatment as soon as possible after symptom onset.

Children:

WHO recommends prompt antiviral treatment for children with severe or deteriorating illness, and those at risk of more severe or complicated illness. This recommendation includes all children under the age of five years, as this age group is at increased risk of more severe illness.

Otherwise healthy children, older than 5 years, need not be given antiviral treatment unless their illness persists or worsens.

Remember, adverse effects suspected to be related to anti-virals (oseltamivir or zanamivir) used to treat H1N1 influenza should be reported at the MHRA’s Swine Flu portal: http://swineflu.mhra.gov.uk.

Drug Safety Update: August and September

admin September 14th, 2009

Apologies for the lack of postings.

There have been two Drug Safety Updates published since July:

August:

  • Safety information on oseltamivir (Tamiflu) and zanamivir (Relenza) for pandemic swine influenza A/H1N1
  • Herbal products: safety update
  • Monitoring the impact of regulatory action taken by the MHRA
  • Rotigotine patches: lifting of prescribing restrictions
  • Infant medicine feeder: recall due to overdose risk

September:

  • Insulin glargine (Lantus): studies of possible cancer link
  • Pseudoephedrine and ephedrine: update on measures to reduce risk of illicit use
  • Over-the-counter painkillers containing codeine or dihydrocodeine
  • Clopidogrel and proton pump inhibitors: interaction—clarification

Further information about the restrictions on codeine are available at the MHRA website.

Drug Safety Update July 2009: Vol 2 (12)

admin July 7th, 2009

The MHRA have published Drug Safety Update July 2009: Vol 2 (12):

  • Clopidogrel and proton pump inhibitors: interaction
  • Abacavir: risk of myocardial infarction – update from epidemiological studies
  • Use of long-acting ?-agonists in chronic obstructive pulmonary disease
  • Mycophenolate mofetil: pure red cell aplasia
  • Hydroxycut range of food supplements: risk of liver damage
  • Priadel Liquid: potential for dosing errors
  • Clarification: ACE inhibitors and angiotensin II receptor antagonists – use during breastfeeding
  • Patient Information Leaflet of the month: sulfasalazine
  • Consultation: proposals to strengthen and rationalise EU pharmacovigilance

Swine Flu ADR Portal

admin July 6th, 2009

The MHRA have launched a dedicated adverse drug reaction reporting site for antiviral medication:

With the increased usage of antiviral medicines (tamiflu and relenza) for the treatment of swine flu the MHRA has put place measures to monitor the safety of these important medicines. Suspected side effects to antivirals, and when available H1N1 swine flu vaccines, should be reported via a dedicated internet-based reporting system, the ‘Swine Flu ADR Portal’. The MHRA has developed this Portal to sit alongside the Yellow Card Scheme and act as the main channel through which healthcare professionals and patients/carers can report suspected side effects.

http://swineflu.mhra.gov.uk

Drug Safety Update June 2009 and NPC podcast

admin June 19th, 2009

Drug Safety Update June 2009 has been published including:

Antipsychotics: risk of venous thromboembolic events
Chloral hydrate (Welldorm) and Triclofos: not first-line options for insomnia
Oral salicylate gels: not for use in those younger than age 16 years
Topical ketoprofen: reminder on risk of photosensitivity reactions
Yellow Card scheme update
The Black Triangle Scheme
Counterfeit medicines: patient guidance for distribution via pharmacies
Clopidogrel and proton pump inhibitors: possible interaction
Erlotinib: new safety information
Counterfeit insulin pen Novofine needles: vigilance needed for lot number 08J02S
Prescription of blood lancet devices: hepatitis risk from incorrect use

The May issue of Drug Safety Update was recently discussed in the NPC podcast, which can be downloaded here, or subscribed to via itunes.

« Prev - Next »