admin May 6th, 2008
The MHRA have issued May’s Drug Safety Update, including:
- Rimonabant (Acomplia): depression; psychiatric adverse reactions
- Exenatide (Byetta): risk of acute pancreatitis
- Has this reaction been reported before? Finding out about suspected adverse drug reactions reported to the MHRA
- Monitoring the safety of antiretroviral drugs
- Abacavir and didanosine: results of D:A:D study
- Enoxaparin (Clexane) contamination: advice for healthcare professionals
- Intrathecal drug pumps
- Patient Information Leaflet of the month: Vicks Sinex Soother Nasal Spray
- Pregnancy testing: top tips leaflet
admin May 2nd, 2008
The FDA note Amgen and Wyeth Pharmaceuticals’ revisions to prescribing information for etanercept:
The revisions include a BOXED WARNING about infections, including serious infections leading to hospitalization or death that have been observed in patients treated with Enbrel. Infections have included bacterial sepsis and tuberculosis. The ADVERSE REACTIONS section of the label was updated to include information regarding global clinical studies and the rate of occurrence of tuberculosis in patients treated with Enbrel. Healthcare professionals should screen patients for latent tuberculosis infection before beginning Enbrel. Patients should be educated about the symptoms of infection and closely monitored for signs and symptoms of infection during and after treatment with the drug. Patients who develop an infection should be evaluated for appropriate antimicrobial treatment and, in patients who develop a serious infection, Enbrel should be discontinued.
admin April 21st, 2008
Our unit has recently had a brief guide to the assessment, management and reporting of ADRs.
Cox AR. Assessing, managing and reporting adverse drug reactions may better equip us to minimise medicines-related harm. Pharmacy in Practice 2008;18(2):57-61
A PDF version is here, courtesy of Medicom. (Note this version contains a correction referred to in the following edition of Pharmacy in Practice.
admin April 9th, 2008
This month’s edition includes:
- Hormonal contraceptives: cervical cancer - latest evidence
- Combined hormonal contraceptives: venous thromboembolism - update
- Cyproterone acetate with ethinylestradiol (co-cyprindiol): recommended duration of use
- Carbamazepine: genetic testing in some Asian populations
- Yellow Card scheme update
- New addition to the Yellow Card scheme - the online reporting form
- Advising patients about safe use of herbal medicines - new help available
- Updated advice - Over-the-counter cough and cold medicines for children
- Combined oral contraceptives: prevention of ovarian cancer
- Antidepressants: suicidal thoughts and behaviour - summary report
- Clove oil: life-threatening reactions on overdose
admin March 28th, 2008
Our director has an editorial in the BMJ this week on the subject of over the counter medication.
Both overuse and underuse of effective medicines can cause serious harms. The benefits of self treatment probably apply to only a small subset of medicines. There is little evidence in the UK that the current policy governing the change from prescription-only to over the counter medicines has exacerbated the harm of overuse. Although we can take heart from the fact that major disasters such as thalidomide have been avoided by stringent licensing regulations, the global outlook is rather more sombre. Much of the world has little or no effective regulation of medicines once licensed, and the internet makes these medicines, or counterfeit versions of them, available worldwide. The Royal Pharmaceutical Society proposes a “seal of approval” for legitimate internet pharmacies, but many people seem prepared to risk fake drugs, often for erectile dysfunction or obesity, rather than confide in a prescriber and present the prescription at a recognised pharmacy. The society’s initiative is unlikely to plug the internet loophole, and we face the uninviting prospect that medicines regulation will become ineffective everywhere.
The safety of over the counter medicines has to be continually reviewed, even though this is difficult in practice. Since healthcare professionals may not be involved, we have to rely on patients to report adverse effects. The UK regulatory agency’s new simplified yellow card system inviting patients to report adverse drug reactions could therefore be helpful. When safety concerns are raised regulators should investigate. Since efficacy is also important, regulators should ask for clearer evidence of benefit at the over the counter dose if this is lower than the dose usually prescribed. Given the concerns, it would be wise to avoid any wholesale rush to reclassify medicines. Whole communities might lose out in the long run if indiscriminate overuse of widely available medicines were to lead to large numbers of avoidable but irreversible adverse effects.
Also reported at the BBC.
admin March 19th, 2008
The FDA’s Winter 2008 Drug Safety Newsletter has been published. Contents include:
Exenatide (marketed as BYETTA): Acute Pancreatitis
PHOSPHODIESTERASE TYPE 5 (PDE5) INHIBITORS: Sildenafil citrate (marketed as VIAGRA and REVATIO), vardenafil hydrochloride (marketed as LEVITRA), and tadalafil (marketed as CIALIS): Sudden Hearing Loss
TUMOR NECROSIS FACTOR ALPHA (TNF-α) ANTAGONISTS: Infliximab (marketed as REMICADE), etanercept (marketed as ENBREL), and adalimumab (marketed as HUMIRA): Serious Skin Reactions
New Molecular Entity (NME) - 3 Years Later: Duloxetine (marketed as CYMBALTA)
Feature Article: Pharmacogenomics and Its Role In Drug Safety
admin March 19th, 2008
The FDA have announced in an early communication that ongoing safety monitoring has identified a possible increased risk of stroke in patients who take tiotropium.
Boehringer Ingelheim reported to the FDA that it has conducted an analysis of the safety data from 29 placebo controlled clinical studies (“pooled analysis”). In 25 of the clinical studies, patients were treated with Spiriva HandiHaler. In the other 4 clinical studies patients were treated with another formulation of tiotropium approved in Europe, Spiriva Respimat. The 29 clinical studies included approximately 13,500 patients with COPD. Based on data from these studies, the preliminary estimates of the risk of stroke are 8 patients per 1000 patients treated for one year with Spiriva, and 6 patients per 1000 patients treated for one year with placebo. This means that the estimated excess risk of any type of stroke due to Spiriva is 2 patients for each 1000 patients using Spiriva over a one year period.
It is important to interpret these preliminary results with caution. FDA has not confirmed these analyses. Pooled analyses can provide early information about potential safety issues. However, these analyses have inherent limitations and uncertainty that require further investigation using other data sources. This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.
No causal relationship is as yet proven. The FDA are currently reviewing post-marketing data and further data from the UPLIFT study will be available in June of this year.
Bottom line: There is no proven link between stroke and tiotropium at present. However, healthcare professionals should be aware that any suspected adverse effects to tiotropium can be reported via the Yellow Card scheme.
admin March 14th, 2008
Prezista (darunavir) has had warnings added in relation to hepatotoxicity by the FDA:
FDA and Tibotec Therapeutics notified healthcare professionals of changes to the WARNINGS section of the prescribing information for Prezista (darunavir) tablets regarding the risk of hepatotoxicity. In clinical trials and postmarketing experience, drug induced hepatitis has been reported in patients receiving combination therapy with Prezista/ritonavir. Appropriate laboratory testing should be conducted prior to initiating therapy with Prezista/ritonavir and patients should be monitored during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases, especially during the first several months of Prezista/ritonavir treatment.
Darunavir is currently a black triangle drug in the United Kingdom, meaning that any adverse effects, no matter how trivial, should be reported to the Yellow Card scheme.
admin March 14th, 2008
The FDA have issued warnings related to Erythropoiesis Stimulating Agents (ESAs):
Increased Mortality and/or Tumor Progression section of the Aranesp and EPOGEN/PROCRIT labeling to update information describing the results of two additional studies showing increased mortality and more rapid tumor progression in patients with cancer receiving ESAs. Based on the results of these studies, the prescribing information has been revised as follows: ESAs shortened overall survival and/or time to tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of ≥ 12 g/dL.
admin February 28th, 2008
FDA news:
Biogen Idec, Elan and FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose of Tysabri. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients. Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury. Physicians should inform patients that Tysabri may cause liver injury.
