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.

Sibutramine withdrawn (Reductil)

admin January 22nd, 2010

Sibutramine has been withdrawn.

The European-wide review of the anti-obesity drug sibutramine (Reductil) has concluded and an opinion reached recommending the suspension of the licence for the medicine across Europe.

Evidence suggests that there is an increased risk of non-fatal heart attacks and strokes with this medicine that outweighs the benefits of weight loss, which is modest and may not be sustained in the long term after stopping treatment.

Prescribers are advised not to issue any new prescriptions for Reductil and to review the treatment of patients taking the drug.

Pharmacists are asked to cease dispensing the medicine. People who are currently taking Reductil are advised to make a routine appointment with their doctor to discuss alternative measures to lose weight. There are no health implications if people wish to stop treatment before seeing their doctor.

The EMEA document [PDF] and Questions and Answers [PDF]

Drug Safety Update January 2010

admin January 13th, 2010

The MHRA have published a new Drug Safety Update (January 2010 [PDF]), which includes information on phenytoin:

HLA-B*1502 may be associated with an increased risk of developing SJS in individuals of Thai or Han Chinese ethnic origin when treated with phenytoin. If these patients are known to be HLA-B*1502-positive, phenytoin should be avoided when alternative therapy can be given. Use of phenytoin should only be considered if the benefits are thought to outweigh the risks

• In the Caucasian and Japanese population, the frequency of HLA-B*1502 is extremely low, and thus it is not possible at present to conclude on risk association. Adequate information about risk association in other patients of other ethnic origin is currently not available

as well as, gadolinium-containing contrast agents, and methylphenidate in children.

re:Action 38

admin November 30th, 2009

The Yellow Card Centre West Midlands has issued re:Action number 38:

HPV vaccination
Varenicline and self-harm
Uncomfortable ulcers: Nicorandil-induced genital ulcers.

[PDF]

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.

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