The Medicines and Healthcare products Regulatory Agency has issued updated advice regarding the safety and prescribing of atomoxetine (Strattera)®.
Prescribers have previously been warned about rare but severe hepatic disorders and concerns over suicidal thoughts and behaviour.
This update raises awareness of the risk of seizures and prolongation of QT interval. These new warnings are the result of a European review of the risks and benefits of atomoxetine.
Atomoxetine should be started with caution in patients with a history of seizures. Discontinuation should be considered if a patient develops seizures or if seizure frequency increases.
Prolonged QT interval has been associated with atomoxetine. It should be used in caution in patients with prolonged QT interval of any cause (congenital, acquired or drug induced).
Action: The review concluded that overall the benefits outweigh the risks of treatment, however prescribers should remain mindful of the above issues.
A paper1 published in the New England Journal of Medicine (NEJM) has concluded that Calcium and Vitamin D supplementation has limited effect in preventing hip fractures.
36,282 women aged 50 to 79 years old were recruited to this study from the Women's Health Initiative (WHI). They were randomised to Calcium and Vitamin D or placebo and followed up for 7 years. Data were collected on fracture events. A sub-group of 2,431 had bone mineral density (BMD) assessments periodically.
Despite a statistically significant rise in BMD in the group receiving Calcium and Vitamin D there was no difference in the rate of hip fractures or all fractures. A benefit was apparent in those patients who continued to take the medication and in 'higher risk' patients although women in the active arm of the study also had a greater risk of kidney stones.
There were confounders in this study; the fracture rate in the placebo arm was half the expected number, 24% stopped the study medication, only 59% were taking more than 4 in 5 doses and the dose of Vitamin D was inadequate by current standards (400IU per day rather than 800IU per day).
Action: Calcium and Vitamin D supplementation may be unsuitable for otherwise healthy postmenopausal women if fracture prevention is the aim of treatment. In women at higher risk of fractures supplementation has a positive effect and should be offered as part of a comprehensive treatment plan.
- Women's Health Initiative Investigators. Calcium plus Vitamin D Supplementation and the Risk of Fractures. NEJM 2006;354:669-83
Ximelagatran (Exanta)® has been withdrawn globally following reports of serious liver injury in the EXTEND clinical trial. A press release from the manufacturers gives further detail.
Ximelagatran has not been made available in the UK although it is available in the United States and several other European countries. There has been a lot of interest in this drug as it was seen as a replacement to warfarin. However, several studies have indicated that chronic use of this drug can lead to liver damage and the EXTEND study has added to these concerns.
Action: The withdrawal of ximelagatran will not affect any patients in the United Kingdom but clinicians may wish to be aware of this development.
The first court case to examine the availability of Trastuzumab (Herceptin)® on the NHS for early stage breast cancer has returned its decision.
The woman who brought a court case against Swindon PCT after she was originally denied the drug has lost her legal challenge. The judge, while sympathetic to the situation, stated he must base his decision on whether Swindon PCT had acted unlawfully.
Herceptin is not licensed in early stage breast cancer yet and NICE guidance is expected in August 2006.
Action: Clinicians may need to be aware of the courts decision in this case to enable them to respond to patients' questions.
The Scottish Medicines Consortium has rejected tramadol 37.5mg/ paracetamol 325mg (Tramacet)® and nicotinic acid modified release (Niaspan)® for use on the NHS in Scotland.
Tramacet is a compound analgesic containing both paracetamol and tramadol. The review concluded that tramacet has similar efficacy to other compound analgesics but the individual components are available separately at significantly lower cost.
Suitable alternatives include different analgesics or, if necessary, paracetamol and tramadol separately.
Niaspan is a high dose preparation of a vitamin for dyslipidaemia that increases HDL and reduces triglyderides and to some extent LDL. The review found no evidence of benefit in terms of patient outcomes such as reductions in cardiovascular events.
Suitable alternatives include statins, such as simvastatin and other lipid lowering drugs.
Action: Clinicians should avoid using either of these drugs. Alternatives are suggested above.