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.
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.
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].
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
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.
admin January 26th, 2009
The Yellow Card Centre West Midlands has published the 37th edition of their newsletter Reaction. PDF here. It includes:
Sex, drugs, & dental pain
Sexual dysfunction related to celecoxib.
Dropping into depression
Depression associated with topically applied beta-adrenergic receptor antagonists.
A prod about jabs
A discussion about the importance of reporting adverse reactions to vaccines.
admin January 19th, 2009
A member of our unit has written an article on patient reporting of adverse drug reactions at The Pharmaceutical Journal.
Evidence that patient reports complement professional reports of ADRs is growing. Differences in the types of report exist. In particular neuropsychiatric reactions appear to be a particular concern of patients, and it may be that healthcare professionals have been dismissive of this type of report in the past, or that patients may have been less comfortable in reporting such symptoms.
Regulators do value reports from patients, and there is evidence that such reports have contributed to drug safety signals and regulatory decisions, which is the primary purpose of spontaneous reporting schemes such as the yellow card scheme.
admin January 19th, 2009
The FDA Drug Safety Newsletter Volume 2, Number 1, 2009, has been published. It includes three postmarket reviews:
Varenicline and Bubropion: Reports of suicidality associated with use of varenicline (marketed as CHANTIX) and bupropion (marketed as ZYBAN and GENERICS)
Abacavir: Information for healthcare professionals on an abacavir (marketed as ZIAGEN, EPZICOM, and TRIZIVIR) hypersensitivity reaction, HLA-B*5701, and skin patch testing
Atomoxetine: Reports of serious liver injury associated with use of atomoxetine (marketed as STRATTERA)
admin January 16th, 2009
The FDA review of montelukast has not yet reached a definitive conclusion regarding the clinical trial data on mood and behavioral adverse events with montelukast. Although initial analysis of trial data supplied by companies has not shown a link, there is an ongoing analysis which may take months to report. The FDA are suggesting healthcare professionals should be aware of post-marketing case reports of neuropsychiatric events in the interim:
Post-marketing reports of neuropsychiatric events associated with montelukast, zafirlukast and zileuton have been reported to FDA’s Adverse Event Reporting System (AERS). Most of the reports of neuropsychiatric events are associated with montelukast, currently the most commonly prescribed drug that acts through the leukotriene pathway. The clinical details of some reports involving montelukast are consistent with a drug-induced effect. Because of the paucity of reports involving zafirlukast and zileuton, assessment of a drug–induced effect with these is limited. Accordingly, at this time, patients and prescribers should monitor for the possibility of neuropsychiatric events associated with these agents.
admin January 12th, 2009
The FDA have completed their review of the ENHANCE study, which compared ezetimibe plus simvastatin with simvastatin alone in patients with heterozygous familial hypercholesterolemia:
The FDA has completed its review of the final clinical study report of ENHANCE. Following two years of treatment, carotid artery thickness increased by 0.011 mm in the Vytorin group and by 0.006 mm in the simvastatin group. The difference in the changes in carotid artery thickness between the two groups was not statistically significant. However, the levels of LDL cholesterol decreased by 56% in the Vytorin group and decreased by 39% in the simvastatin group. The difference in the reductions in LDL cholesterol between the two groups was statistically significant.
The results from ENHANCE do not change FDA’s position that an elevated LDL cholesterol is a risk factor for cardiovascular disease and that lowering LDL cholesterol reduces the risk for cardiovascular disease. Based on current available data, patients should not stop taking Vytorin or other cholesterol lowering medications and should talk to their doctor if they have any questions about Vytorin, Zetia, or the ENHANCE trial.
