Archive for the 'MHRA' Category

Drug Safety Update: Volume 3, Issue 8, March 2010

admin March 11th, 2010

The MHRA have published the March issue of Drug Safety Update, including:

  • Natalizumab (Tysabri): risk of progressive multifocal leukoencephalopathy increases after two years of therapy.
  • Fluoxetine: possible small risk of congenital cardiac defects, similar to that with paroxetine.
  • Sirolimus: different immunoassays for therapeutic drug monitoring—risk of incorrect dose adjustment.
  • Drug Safety Update gains NHS Evidence accreditation.
  • MHRA conference for doctors in training.
  • Patient Information Leaflet of the month: Human Varicella-Zoster Immunoglobulin vaccine.

Drug Safety Update Feb 2010

admin February 15th, 2010

Drug Safety Update has been issued, including the following safety advice

  • Tacrolimus: new oral liquid (Modigraf); formulations not interchangeable without careful therapeutic monitoring.
  • Yellow Card Scheme update
  • Problem with postal delivery of Yellow Cards.
  • Swine flu portal update
  • Suspected adverse reactions to flu antivirals and vaccines confirm recognised safety profile.
  • Orlistat safety update.
  • Nicotine replacement therapy and harm reduction.
  • Sibutramine: suspension of EU licenses recommended as evidence indicates risks outweigh benefits.
  • Off-label intraocular use of recombinant tissue plasminogen activator: risk of intraocular lens opacification.
  • Please report suspected adverse reactions associated with intra-articular use of local anaesthetics.

Sibutramine withdrawn (Reductil)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Sibutramine has been withdrawn.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.

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

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

Next »