Monday, 15 June 2015

Asthma and the drug Prednisolone (Prednisone)

Earlier today (15th June 2015) I received an email advertising the drug, Prednisolone, which was directed at GP's. Drug companies cannot advertise prescription drugs to the general public in Britain, but they can advertise their wares to doctors, and they certainly do this.

The advert, quite unremarkably, began with outlining the reasons for prescribing this asthma drug.

"Despite a plateau in the prevalence of asthma since the late 1990s, the UK still has some of the highest rates in Europe; Asthma UK reports that there are around 5.4 million people in the UK presently receiving treatment for asthma. Out-of-hours services and walk-in centres are increasingly the first port of call for people experiencing an exacerbation.

"Even though it has been estimated that around 90% of deaths from asthma in the UK are preventable, asthma still kills. Over the last decade, the number of deaths from asthma in the UK has not significantly reduced from year to year, remaining at around 1000 deaths per year.

"A confidential report published in 2014, reviewing the circumstances surrounding nearly 200 deaths from asthma for a 12-month period between 2012 and 2013, found that almost half of the deaths occurred before admission to hospital. 

"Many of these deaths occur in patients who have received inadequate steroid treatment.

"Given these facts, national guidelines recommend that all patients over the age of five years who present to healthcare professionals with severe or life-threatening exacerbations of asthma should be treated with oral or intravenous steroids within one hour of the presentation of symptoms.

"Recommended treatments include a dose of 20mg prednisolone...." and continues to inform doctors what they should be prescribing.

"The early use of steroids in asthma emergencies, whether presenting in primary care, out of hours or the hospital emergency department, may reduce the need for hospital admission, prevent relapse in symptoms, lessen the need for β2 agonist therapy, and more importantly reduce the mortality caused by severe asthma exacerbations.

All this is quite unremarkable, really. So what is the problem with this information. 

Well, it sounds like we have a drug that can cope with the problems of asthma, as outlined in the advert. Yet Prednisolone (Prednisone) has been around since the 1950's, around 60 years! So it is hardly new, and if it was going to tackle the serious epidemic levels of asthma we face today, it would surely have done so by now.

But then, of course, there are the serious dangers involved in taking this awful drug! I was going to look them up for the purpose of this blog, but then discovered they were listed at the bottom of the advert. I suppose drug companies have to do this by law. I also suppose that doctors should tell their patients about the dangerous side effects of this drug, but they usually don't do the full enormity of the harm they can cause justice!

GP's would barely have the time to read them all.

I reproduce them all here, just as they appear on the advert. Please don't read them all, unless you need to do so, if you are taking the drug, or someone close to you is taking it! It is a veritable horror story. The point of reproducing it is to ask two simple questions.
  1. Have drug companies really got nothing better to offer us? Is there nothing safer? Is there nothing more effective, after 60 years?
  2. Do doctors know about the serious side effects, and yet still prescribe such a drug to us? Are they prepared to harm us in this way?

Contraindications:
Hypersensitivity to the active substance or any excipient. System infections. Live virus immunization. Tuberculosis, peptic ulcer, psychosis, ocular herpes simplex.

Special warnings and precautions for use: 
Suppression of the inflammatory response and immune function increases susceptibility to infections and their severity. Masking of serious infections (septicaemia and tuberculosis) and minor illnesses (chicken pox or herpes zoster) which can become fatal in immunocompromised patients. Avoid exposure to measles and live vaccines, due to diminished antibody response. Caution is advised with renal insufficiency, hypertension or congestive heart failure due to possible fluid retention. Worsening of diabetes mellitus, osteoporosis, hypertension, glaucoma and epilepsy may occur. Severe psychiatric adverse reactions can occur within days or weeks of starting treatment. Caution is advised in individuals with history of severe affective disorders. Closely monitor patients with steroid myopathy, peptic ulceration, hypothyroidism, recent myocardial infarction, liver failure or tuberculosis. Irreversible, dose related growth retardation may occur in children. Prolonged therapy can result in adrenal cortical atrophy and suppression of the HPA axis. Withdrawal following prolonged treatment should occur gradually and doses should be tapered over days or weeks.

Drug Interactions: 
Rifampicin, rifabutin, carbamazepine, phenobarbitone, phenytoin, primidone, ephedrine, aminoglutethimide, mifeprostone, erythromycin and ketoconazole inhibit the metabolism and reduce the therapeutic effects of corticosteroids. Ciclosporin, oestrogens and oral contraceptives potentiate the effects of glucocorticoids. Corticosteroids inhibits the effects of hypoglycaemic agents, anti-hypertensives, diuretics, anticholinesterases, cholecystographic x-ray media and growth homone somatotropin. Corticosteroids enhance the efffects of coumarin anticoagulants, warfarin, acetazolamide, loop diuretics, thiazide diuretics, carbenoxolone and cardiac glycosides. Increased risk of GI bleeding and ulceration occur with aspirin and NSAIDs. Risk of hypokalaemia increased with theophylline, amphotericin, bamuterol, fenoterol, formoterol, ritodrine, salbutamol, salmeterol and terbutaline. Increased risk of haematological toxicity with methotrexate.

Fertility, pregnancy and lactation: 
Only prescribe if benefits outweigh the risks. Animal studies and prolonged use have shown increased risk of foetal abnormalities. Corticosteroids are excreted in small amounts in breast milk.

Undesirable effects: 
Dizziness, headache, vertigo, malaise, dyspepsia, nausea, vomiting, abdominal distension, abdominal pain, diarrhoea, oesophageal ulcer, peptic ulcer haemorrhage, peptic ulcer perforation and acute pancreatitis. Glaucoma, cataracts, papiloedema, chorioretinopathy, corneal thinning. Skin atrophy, acne, skin striae, urticaria, hyperhidrosis and hirsutism. Fluid retention, hypokalaemia, electrolyte imbalance, hypertension, congestive heart failure, myocardial rupture, weight gain Impaired healing and increased susceptibility to opportunistic and latent infections. Leucocytosis, hypersensitivity reactions, hypothalamic-pituitary adrenal suppression, cushingoid, carbohydrate intolerance, exacerbation of diabetes, increased appetite, weight gain and total protein abnormal. A wide range of psychiatric disorders, affective disorder, abnormal behaviour, anxiety, sleep disorder, confusion, amnesia. Irregular menstruation and amenorrhoea. Myopathy, myalgia, tendon rupture, osteoporosis, spinal fractures and osteonecrosis. 

Paediatric Population: 
Psychiatric reactions, increased intracranial pressure with papiloedema and growth retardation. 

Withdrawal: 
Rapid reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotenstion and death. Effects may resemble relapse of the disease being treated. Other effects include benign intracranial hypertension with headache and vomiting and papilloema due to cerebral oedema.