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The Drug Safety Update is an NHS Evidence accredited provider
9th October 2008
The MHRA and CHM have published the October edition of Drug Safety Update. Included in this issue is drug safety advice on the risk of fibrotic reactions in chronic use of ergot-derived dopamine agonists and latest information on the use of antibiotics in premature labour. The hot topic is the risk of illicit use of pseudoephedrine and ephedrine nasal decongestants.
Action
Drug Safety Update is an essential read for everyone whose professional practice involves medicines. It is published every month in electronic format only.
Ergot-derived dopamine agonists: risk of fibrotic reactions in chronic endocrine uses
The European Medicines Agency has outlined that chronic use of ergot-derived dopamine agonists is associated with a risk of fibrosis, particularly cardiac fibrosis. For the use of these agents for the treatment of chronic endocrine disorders, such as hyperprolactinaemia and acromegaly, advice for healthcare professionals is as follows:
Cabergoline and bromocriptine
- Exclude cardiac valvulopathy as determined by echocardiography before treatment.
- Monitor patients for signs or symptoms of pleuropulmonary disease (eg dyspnoea, shortness of breath, persistent cough, or chest pain) and retroperitoneal disorders during treatment. Renal insufficiency or ureteral or abdominal vascular obstruction might occur, with pain in the loin or flank and leg oedema. Abdominal masses or tenderness could suggest retroperitoneal fibrosis.
Cabergoline
- Monitor patients for signs of cardiac fibrosis during treatment.
- Echocardiography should be done within 3–6 months of starting treatment and subsequently at 6–12-month intervals.
- Stop treatment if echocardiography shows new or worsened valvular regurgitation, valvular restriction, or valve leaflet thickening.
- Pregnancy should be excluded before administration of cabergoline.
- Women who are planning pregnancy should stop taking cabergoline 1 month before they try to conceive.
Key advice on the use of ergot-derived dopamine agonists for the treatment of Parkinson’s disease was given in the July 2008 issue of Drug Safety Update.
Use of antibiotics in premature labour: latest information
In the ORACLE Children Study — a 7-year follow-up (ORACLE I follow-up, ORACLE II follow-up) of a large randomised, placebo-controlled trial to investigate the effects of erythromycin and co-amoxiclav in premature labour — parents reported small increases in the number of children with mild functional impairment or cerebral palsy born to mothers whose membranes were intact and who had received antibiotics. This finding requires further study. Antibiotics save lives, and pregnant women with possible or obvious infections must be considered for treatment with antibiotics.
Advice for healthcare professionals is as follows:
- This research was conducted in a very specific group of women and so the results do not mean that antibiotics are generally unsafe for use in pregnancy. Untreated infections can be dangerous and potentially life-threatening for pregnant women and their unborn babies, and antibiotics should continue to be prescribed in line with current guidance and the product licence.
- The study confirms existing practice that antibiotics should not be given routinely to women who are in premature labour with intact membranes and who have no obvious infection.
- These results were unexpected and the mechanism by which this reported association occurred in women with intact membranes is unclear, particularly as no increase in functional impairment or cerebral palsy was reported in the children of mothers who received the same antibiotics but whose membranes had ruptured. Additional research is required to shed light on these findings.
Further information can be obtained from NHS Direct, the Oracle Children Study website, and a letter from the Chief Medical Officer. There is also a MeReC Stop Press blog on this subject.
Pseudoephedrine and ephedrine nasal decongestants: risk of illicit use
The MHRA has received further evidence of the illicit use of pseudoephedrine and ephedrine nasal decongestants in the manufacture of the Class A drug methylamphetamine.
The following legal restrictions were put in place from April 1, 2008 (see Drug Safety Update March 2008 for details):
- Small packs of products that contain no more than 720 mg pseudoephedrine (the equivalent of 12 tablets or capsules of 60 mg, or 24 tablets or capsules of 30 mg) may be purchased from retail pharmacies.
- Small packs that contain no more than 180 mg ephedrine may be purchased from retail pharmacies.
- A limit of one equivalent pack per customer per purchase.
Pseudoephedrine and ephedrine must be sold in line with the recent change in the law:
- It is illegal to sell or supply any product that contains more than 720 mg pseudoephedrine or 180 mg ephedrine without a prescription.
- It is illegal to sell or supply a combination of products that between them add up to more than 720 mg pseudoephedrine or 180 mg ephedrine without a prescription.
- It is illegal to sell or supply a product that contains pseudoephedrine and a product that contains ephedrine in one transaction.
Advice for pharmacists is as follows:
- Please brief your healthcare team on this recent incident of illicit use.
- Ensure all requests for more than one pack of a product that contains pseudoephedrine or ephedrine are referred to a pharmacist.
- Report any suspicious activity in line with guidance from the Royal Pharmaceutical Society of Great Britain – see the “Look, listen, report your suspicions” card.
Stop Press articles
- Theophylline: narrow therapeutic index and potential for misuse
Other information from the MHRA
- Central Alerting System: access to urgent safety guidance
- Patient Information Leaflet of the month: Livial (tibolone)
- Unlicensed medicines: latest imports
- Consultation: dispensing opticians and access to prescription medicines