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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
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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.

• MHRA , NPC , WHO
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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.

• MHRA
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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

• MHRA
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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

• MHRA
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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.

• MHRA
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admin February 24th, 2009

The FDA has issued a warning that zonisamide may be associated with metabolic acidosis in patients with with predisposing conditions or therapies. The young appear more at risk. Further info here.

The FDA recommends that healthcare professionals measure serum bicarbonate before starting treatment and periodically during treatment with zonisamide, even in the absence of symptoms. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing zonisamide (using dose tapering), and modifying the patient’s antiepileptic treatment as appropriate. If the decision is made to continue patients with metabolic acidosis on zonisamide, then alkali treatment should be considered.

• FDA
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admin February 19th, 2009

The MHRA reports on an EMEA decision on Efalizumab (Raptiva):

The European Medicines Agency has completed a review of efalizumab (Raptiva) after concerns about its safety. The Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of efalizumab do not outweigh its risks, and that the marketing authorisation should be suspended across the EU.

Efalizumab is used to treat adults with moderate to severe chronic plaque psoriasis (a disease that causes red, scaly patches on the skin) who have not responded to, or who are unable to take, other treatments for psoriasis (including ciclosporin, methotrexate, and PUVA).

This medicine was reviewed after reports of serious side effects, including three confirmed cases of progressive multifocal leukoencephalopathy (PML, a rare but serious disorder of the central nervous system) in patients who had received efalizumab for more than 3 years; two of these patients died.

Although psoriasis is a disabling condition that can cause social and psychological problems for patients, it is very rarely life-threatening. The Committee concluded that the risk of PML is unacceptable for patients taking efalizumab. They recommended that the marketing authorisation should be suspended until there is adequate new evidence to identify a group of patients in which the benefits of efalizumab outweigh its risks.

EMEA press release [PDF].

EMEA Q&A on efalizumab [PDF].

• EMEA , MHRA
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admin February 4th, 2009

Drug Safety Update by the MHRA includes this month:

• Tibolone (Livial): increased risk of breast cancer recurrence
• Non-steroidal anti-inflammatory drugs: cardiovascular risk
• Toremifene (Fareston): risk of QT prolongation
• Methylphenidate: new guidance for use in treatment of ADHD
• Correction: Temsirolimus—severe hypersensitivity reactions during infusion

• MHRA
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admin January 27th, 2009

Interesting news from the FDA:

The FDA is aware of published reports that clopidogrel (marketed as Plavix) is less effective in some patients than it is in others. Differences in effectiveness may be due to genetic differences in the way the body metabolizes clopidogrel, or that using certain other drugs with clopidogrel can interfere with how the body metabolizes clopidogrel.

Clopidogrel is an antiplatelet drug that is used to prevent blood clots that could lead to heart attacks or strokes in patients at risk for these problems. The drug clopidogrel is a “pro-drug” which means that it has to be metabolized by the body before it can be biologically active and have the effect of preventing blood clots. Understanding that there are differences in how the body metabolizes clopidogrel and there are effects that other drugs may have on its metabolism is important because decreases in the effectiveness of clopidogrel might be avoided, in part, by using other drugs with clopidogrel that do not interfere with its metabolism.

One class of drugs commonly used with clopidogrel is proton pump inhibitors (PPIs). Some reports suggest that use of certain PPIs may make clopidogrel less effective by inhibiting the enzyme that converts clopidogrel to the active form of the drug. Other reports do not suggest this effect. Proton pump inhibitors decrease stomach acid and are used to treat frequent heartburn and stomach ulcers. Clopidogrel can irritate the stomach so PPIs are commonly used with clopidogrel to help reduce this irritation.

PPIs include omeprazole, lansoprazole, pantoprazole, rabeprazole, and esomeprazole. The FDA note that they have no evidence that H2 blockers, such have ranitidine, or antacids have a similar effect, and are currently conducting a review with manufacturers. in the interim they have suggested the following:

• Healthcare providers should continue to prescribe and patients should continue to take clopidogrel as directed, because clopidogrel has demonstrated benefits in preventing blood clots that could lead to a heart attack or stroke.
• Healthcare providers should re-evaluate the need for starting or continuing treatment with a PPI, including Prilosec OTC, in patients taking clopidogrel.
• Patients taking clopidogrel should consult with their healthcare provider if they are currently taking or considering taking a PPI, including Prilosec OTC.

• FDA , Interactions
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