6. Drugs Used in the Treatment of Disorders of the Endocrine System

Total Page:16

File Type:pdf, Size:1020Kb

6. Drugs Used in the Treatment of Disorders of the Endocrine System 6. Drugs used in the treatment of disorders of the Endocrine System 6.1 Drugs used in diabetes 6.1.1 Insulins 6.1.1.1 Short-acting insulins Soluble insulin - Human Actrapid® - Human Velosulin® - Humulin S® - Hypurin Neutral® - Insuman Rapid® - Pork Actrapid® Insulin aspart - NovoRapid® Insulin lispro - Humalog® 6.1.1.2 Intermediate- and long-acting insulins insulin detemir (initiated by Diabetologists only) insulin glargine (initiated by Diabetologists only ) insulin glulisine (initiated by Diabetologists only ) Isophane insulin - Human Insulatard® - Humulin I® - Hypurin Isophane® - Insuman Basal® - Pork Insulatard® Biphasic insulin aspart NovoMix 30® Biphasic insulin lispro Humalog® Mix25 Humalog® Mix50 Biphasic isophane insulin - Human Mixtard 10® - Human Mixtard 20® - Human Mixtard 30® - Human Mixtard 40® - Human Mixtard 50® - Humulin M3® - Insuman Comb® 6.1.2 Oral antidiabetic drugs - Pork Mixtard 30® Avandamet® (rosiglitazone/metformin) gliclazide glipizide metformin metformin MR (Diabetologists and Dr Staniland only) nateglinide pioglitazone 6.1.4 Treatment of hypoglycaemia rosiglitazone vildagliptin (only in line with NICE recommendations) glucagons 6.2 Thyroid and antithyroid drugs 6.2.1 Thyroid hormones liothyronine levothyroxine sodium/thyroxine sodium 6.2.2 carbimazole propylthiouracil 6.3 Corticosteroids 6.3.1 Replacement therapy fludrocortisone 6.3.2 Glucocorticoid therapy betametasone cortisone dexamethasone hydrocortisone methylprednisolone prednisolone 6.4 Sex Hormones 6.4.1 Female sex hormones 6.4.1.1 Estrogens and HRT - estradiol with progestogen Femoston Conti® tablets ( continuous ) Femoston® tablets - estradiol only estradiol implants estradiol transdermal patches ( FemSeven® ) estradiol vaginal ring ( Menoring® ) estradiol valerate (Elleste Solo® tablets) - ethinylestradiol ethinylestradiol raloxifene ( rheumatology and endocrinology only ) 6.4.1.2 Progestogens dydrogesterone hydroxyprogesterone caproate medroxyprogesterone acetate norethisterone progesterone 6.4.2 Male sex hormones and antagonists cyproterone acetate ( urology only ) testosterone & esters ( includes intramuscular injection, implants , Nebido ® - e ndocrinology only) Miscellaneous dehydroepiandrosterone ( endocrinology only - unlicenced) 6.5 Hypothalamic and pituitary hormones and anti-oestrogens 6.5.1 Hypothalamic and anterior pituitary chorionic gonadotrophin (hcg) hormones and anti-oestrogens clomiphene citrate gonadorelin (lhrh) menotrophin (lh & fsh) protirelin (trh) somatropin (in accordance with NICE guidance ) - Follow restricted high cost drug procedure when prescribing somatropin tetracosactide urofollitropin (fsh) 6.5.2 Posterior pituitary hormones and demeclocycline antagonists desmopressin terlipressin (Gastroenterology, A&E and EAU only ) vasopressin (Gastroenterology only ) 6.6 Drugs affecting bone metabolism 6.6.1 Calcitonin calcitonin salmon/salcatonin 6.6.2 Bisphosphonates alendronic acid (including once a week products ) disodium etidronate disodium pamidronate ibandronate IV ( Bonviva® ) (For use by consultant rheumatologists in the treatment of post-menopausal osteoporosis only) risedronate sodium (weekly risedronate is first line, except for male patients and patients with gastro-intestinal problems whereby alendronate should be considered first line) sodium clodronate strontium ranelate (Rheumatology and Elderly Care consultants only in accordance with Trust Guidelines for the Prevention and Management of Osteoporosis ) teriparatide (Dr T O'Neill only ) - Follow restricted high cost drug procedure when prescribing teriparatide tiludronic acid (Rheumatology only ) zoledronic acid (licensed indications only - for use by Urology and Haematology [Myeloma IX trial] directorates only) 6.7 Other endocrine drugs 6.7.1 Bromocriptine & other dopamine- bromocriptine receptor stimulants cabergoline ( obs & gynae only) 6.7.2 Drugs affecting gonadotrophins danazol Gonadorelin analogues buserelin goserelin (consultant only ) leuprorelin (Prostap® SR) (Obstetric and Gynaecology directorate only - a shared care protocol is required if care is to be continued in primary care ) 6.7.3 Metyrapone and trilostane metyrapone .
Recommended publications
  • Nitrate Prodrugs Able to Release Nitric Oxide in a Controlled and Selective
    Europäisches Patentamt *EP001336602A1* (19) European Patent Office Office européen des brevets (11) EP 1 336 602 A1 (12) EUROPEAN PATENT APPLICATION (43) Date of publication: (51) Int Cl.7: C07C 205/00, A61K 31/00 20.08.2003 Bulletin 2003/34 (21) Application number: 02425075.5 (22) Date of filing: 13.02.2002 (84) Designated Contracting States: (71) Applicant: Scaramuzzino, Giovanni AT BE CH CY DE DK ES FI FR GB GR IE IT LI LU 20052 Monza (Milano) (IT) MC NL PT SE TR Designated Extension States: (72) Inventor: Scaramuzzino, Giovanni AL LT LV MK RO SI 20052 Monza (Milano) (IT) (54) Nitrate prodrugs able to release nitric oxide in a controlled and selective way and their use for prevention and treatment of inflammatory, ischemic and proliferative diseases (57) New pharmaceutical compounds of general effects and for this reason they are useful for the prep- formula (I): F-(X)q where q is an integer from 1 to 5, pref- aration of medicines for prevention and treatment of in- erably 1; -F is chosen among drugs described in the text, flammatory, ischemic, degenerative and proliferative -X is chosen among 4 groups -M, -T, -V and -Y as de- diseases of musculoskeletal, tegumental, respiratory, scribed in the text. gastrointestinal, genito-urinary and central nervous sys- The compounds of general formula (I) are nitrate tems. prodrugs which can release nitric oxide in vivo in a con- trolled and selective way and without hypotensive side EP 1 336 602 A1 Printed by Jouve, 75001 PARIS (FR) EP 1 336 602 A1 Description [0001] The present invention relates to new nitrate prodrugs which can release nitric oxide in vivo in a controlled and selective way and without the side effects typical of nitrate vasodilators drugs.
    [Show full text]
  • Protocol Supplementary
    Optimal Pharmacological Management and Prevention of Glucocorticoid-Induced Osteoporosis (GIOP) Protocol for a Systematic Review and Network Meta-Analysis Supplementary Materials: Sample Search Strategy Supplementary 1: MEDLINE Search Strategy Database: OVID Medline Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily and Ovid MEDLINE(R) 1946 to Present Line 1 exp Osteoporosis/ 2 osteoporos?s.ti,ab,kf. 3 Bone Diseases, Metabolic/ 4 osteop?eni*.ti,ab,kf. 5 Bone Diseases/ 6 exp Bone Resorption/ 7 malabsorption.ti,ab,kf. 8 Bone Density/ 9 BMD.ti,ab,kf. 10 exp Fractures, Bone/ 11 fracture*.ti,ab,kf. 12 (bone* adj2 (loss* or disease* or resorption* or densit* or content* or fragil* or mass* or demineral* or decalcif* or calcif* or strength*)).ti,ab,kf. 13 osteomalacia.ti,ab,kf. 14 or/1-13 15 exp Glucocorticoids/ 16 exp Steroids/ 17 (glucocorticoid* or steroid* or prednisone or prednisolone or hydrocortisone or cortisone or triamcinolone or dexamethasone or betamethasone or methylprednisolone).ti,ab,kf. 18 or/15-17 19 14 and 18 20 ((glucocorticoid-induced or glucosteroid-induced or corticosteroid-induced or glucocorticosteroid-induced) adj1 osteoporos?s).ti,ab,kf. 21 19 or 20 22 exp Diphosphonates/ 23 (bisphosphon* or diphosphon*).ti,ab,kf. 24 exp organophosphates/ or organophosphonates/ 25 (organophosphate* or organophosphonate*).ti,ab,kf. 26 (alendronate or alendronic acid or Fosamax or Binosto or Denfos or Fosagen or Lendrate).ti,ab,kf. 27 (Densidron or Adrovance or Alenotop or Alned or Dronat or Durost or Fixopan or Forosa or Fosval or Huesobone or Ostemax or Oseolen or Arendal or Beenos or Berlex or Fosalen or Fosmin or Fostolin or Fosavance).ti,ab,kf.
    [Show full text]
  • Vasopressin in Pediatric Critical Care
    182 Review Article Vasopressin in Pediatric Critical Care Karen Choong1 1 Department of Pediatrics, Critical Care, Epidemiology and Address for correspondence Karen Choong, MB, BCh, MSc, Biostatistics, McMaster University, Hamilton, Ontario, Canada Department of Pediatrics, Critical Care, Epidemiology and Biostatistics, McMaster University, 1280 Main Street West, Room 3E20, J Pediatr Intensive Care 2016;5:182–188. Hamilton, Ontario, Canada L8S4K1 (e-mail: [email protected]). Abstract Vasopressin is a unique hormone with complex receptor physiology and numerous physiologic functions beyond its well-known vascular actions and osmoregulation. While vasopressin has in the past been primarily used in the management of diabetes insipidus and acute gastrointestinal bleeding, an increased understanding of the physiology of refractory shock, and the role of vasopressin in maintaining cardiovascular homeostasis prompted a renewed interest in the therapeutic roles for this hormone in the critical care setting. Identifying vasopressin-deficient individuals for the purposes of assessing responsiveness to exogenous hormone and prognosticating outcome has expanded research into the evaluation of vasopressin and its precursor, copeptin as Keywords useful biomarkers. This review summarizes the current evidence for vasopressin in ► vasopressin critically ill children, with a specific focus on its use in the management of shock. We ► pediatrics outline important considerations and current guidelines, when considering the use of ► shock vasopressin or its
    [Show full text]
  • Attachment: Extract from Clinical Evaluation Bosentan
    AusPAR Attachment 1 Extract from the Clinical Evaluation Report for Bosentan Proprietary Product Name: Tracleer Sponsor: Actelion Pharmaceuticals Australia Pty Ltd First round report: 25 October 2016 Second round report: 3 February 2017 Therapeutic Goods Administration About the Therapeutic Goods Administration (TGA) · The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and is responsible for regulating medicines and medical devices. · The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary. · The work of the TGA is based on applying scientific and clinical expertise to decision- making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices. · The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action. · To report a problem with a medicine or medical device, please see the information on the TGA website <https://www.tga.gov.au>. About the Extract from the Clinical Evaluation Report · This document provides a more detailed evaluation of the clinical findings, extracted from the Clinical Evaluation Report (CER) prepared by the TGA. This extract does not include sections from the CER regarding product documentation or post market activities. · The words [Information redacted], where they appear in this document, indicate that confidential information has been deleted. · For the most recent Product Information (PI), please refer to the TGA website <https://www.tga.gov.au/product-information-pi>.
    [Show full text]
  • LOKELMA Is Sodium Zirconium Cyclosilicate, a Potassium Binder
    HIGHLIGHTS OF PRESCRIBING INFORMATION • For oral suspension: 10 g per packet (3) These highlights do not include all the information needed to use LOKELMA™ safely and effectively. See full prescribing information for ------------------------------ CONTRAINDICATIONS ----------------------------­ LOKELMA™. None. (4) ----------------------- WARNINGS AND PRECAUTIONS ---------------------­ LOKELMA™ (sodium zirconium cyclosilicate) for oral suspension • Gastrointestinal Adverse Events in Patients with Motility Disorders. Initial U.S. Approval: [2018] (5.1) --------------------------- INDICATIONS AND USAGE -------------------------­ • Edema. (5.2) LOKELMA is a potassium binder indicated for the treatment of hyperkalemia in adults. (1) ------------------------------ ADVERSE REACTIONS ----------------------------­ Most common adverse reactions with LOKELMA: mild to moderate edema. Limitation of Use (6.1) LOKELMA should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action. (1) To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ---------------------- DOSAGE AND ADMINISTRATION ---------------------­ • Recommended starting dose is 10 g administered three times a day for ------------------------------ DRUG INTERACTIONS ----------------------------­ up to 48 hours. (2.1) In general, other oral medications should be administered at least 2 hours • For maintenance treatment, recommended dose is 10 g once daily. (2.1) before
    [Show full text]
  • Tiludronate 1105 Osteoporosis
    Strontium Ranelate/Tiludronate 1105 Osteoporosis. Strontium ranelate, given orally with calcium temic hypersensitivity reactions should be borne in mind. Hyper- Data on combination therapy are limited, but some studies sug- and vitamin D supplements, has been found to reduce the risk of calcaemia may develop with teriparatide or the acetate and it is gest that teriparatide with HRT is more effective than HRT vertebral1 and non-vertebral2 fractures in postmenopausal wom- therefore contra-indicated in patients with pre-existing hypercal- alone.9 The effect of teriparatide with the antiresorptive bisphos- en with osteoporosis. A pooled analysis of data from these 2 caemia. phonates has yet to be determined.2,6,9,10 Although there is some studies concluded that strontium ranelate reduced both vertebral suggestion that teriparatide still increases bone formation after 3 Teriparatide is contra-indicated in patients with severe renal im- 9 and non-vertebral fractures in patients aged 80 years or older. pairment and should be used with caution with those with mod- treatment with alendronate, a study in men found that, when Protection against fractures was detected within 12 months, and erate impairment. given together, alendronate impaired the anabolic effects of teri- sustained throughout 3 years of treatment. Hip fractures were paratide.11 For this reason, some consider that teriparatide be also reduced over 3 years, but this did not reach statistical signif- There have been reports of osteosarcoma in rats given teripara- started immediately after stopping bisphosphonates.10 It has been icance; the authors concluded that the analysis may not have tide and patients who may be at increased risk, including those suggested that the degree of suppression of bone turnover before been sufficiently powered in this respect.
    [Show full text]
  • Glypressin Ferring Pharmaceuticals Pty Ltd PM-2010-03182-3-3 Final 26 November 2012
    Attachment 1: Product information for AusPAR Glypressin Ferring Pharmaceuticals Pty Ltd PM-2010-03182-3-3 Final 26 November 2012. This Product Information was approved at the time this AusPAR was published. Product Information ® GLYPRESSIN Solution for Injection NAME OF THE MEDICINE Terlipressin (as terlipressin acetate). The chemical name is N-[N-(N-Glycylglycyl)glycyl]-8-L- lysinevasopressin. Terlipressin has an empirical formula of C52H74N16O15S2 and a molecular weight of 1227.4. CAS No: 14636-12-5. The pKa is approximately 10. Terlipressin is freely soluble in water. Although the active ingredient is terlipressin, the drug substance included in this product contains non-stoichiometric amounts of acetic acid and water, and this material is freely soluble in water. The structural formula of terlipressin is DESCRIPTION GLYPRESSIN is for intravenous injection. It consists of a clear, colourless liquid containing 0.85 mg terlipressin (equivalent to 1 mg terlipressin acetate) in 8.5 mL solution in an ampoule. The concentration of terlipressin is 0.1 mg/mL (equivalent to terlipressin acetate 0.12 mg/mL). List of excipients GLYPRESSIN contains the following excipients: Sodium chloride, acetic acid, sodium acetate trihydrate, Water for Injections PHARMACOLOGY Pharmacodynamics Terlipressin belongs to the pharmacotherapeutic group: Posterior pituitary lobe hormones (vasopressin and analogues), ATC code: H 01 BA 04. Terlipressin is a dodecapeptide that has three glycyl residues attached to the N-terminal of lysine vasopressin (LVP). Terlipressin acts as a pro-drug and is converted via enzymatic cleavage of its three glycyl residues to the biologically active lysine vasopressin. A large body of evidence has consistently shown that terlipressin given at doses of 0.85 mg and 1.7 mg respectively (equivalent to terlipressin acetate 1 mg and 2 mg respectively) can effectively reduce the portal venous pressure and produces marked vasoconstriction.
    [Show full text]
  • Date Database Search Strategy Filters Results Results After Duplicates
    Date Database Search Strategy Filters Results Results after Duplicates Removed 12/12/2018 PubMed (("Patient Participation"[Mesh] OR "Patient Participation" OR “Patient Filters: 120 108 Involvement” OR “Patient Empowerment” OR “Patient Participation Rates” English OR “Patient Participation Rate” OR “Patient Activation” OR “Patient Engagement” OR "Refusal to Participate"[Mesh] OR "Refusal to Participate" OR "Self Care"[Mesh] OR "Self Care" OR "Self-Care" OR “Well-being” OR Wellbeing OR “well being” OR "Walking"[Mesh] OR Walking OR Walk OR Walked OR Ambulation OR "Gait"[Mesh] OR Gait OR Gaits OR "Mobility Limitation"[Mesh] OR "Mobility Limitation" OR Mobility OR “Mobility Limitations” OR “Ambulation Difficulty” OR “Ambulation Difficulties” OR “Difficulty Ambulation” OR “Ambulatory Difficulty” OR “Ambulatory Difficulties” OR “Difficulty Walking” OR "Dependent Ambulation"[Mesh] OR "Dependent Ambulation" OR “functional status” OR “functional state” OR "Community Participation"[Mesh] OR "Community Participation" OR “Community Involvement” OR “Community Involvements” OR “Consumer Participation” OR “Consumer Involvement” OR “Public Participation” OR “Community Action” OR “Community Actions” OR "Social Participation"[Mesh] OR "Social Participation" OR "Activities of Daily Living"[Mesh] OR "Activities of Daily Living" OR ADL OR “Daily Living Activities” OR “Daily Living Activity” OR “Chronic Limitation of Activity” OR "Quality of Life"[Mesh] OR "Quality of Life" OR “Life Quality” OR “Health- Related Quality Of Life” OR “Health Related Quality Of
    [Show full text]
  • Hormones in Pregnancy
    SYMPOSIUM Hormones in pregnancy Pratap Kumar, Navneet Magon1 Department of Obstetrics and Gynecology, Kasturba Medical College, Manipal University, Manipal, Karnataka, 1Air Force Hospital, Nathu Singh Road, Kanpur Cantt, Uttar Pradesh, India ABSTRACT The endocrinology of human pregnancy involves endocrine and metabolic changes that result from physiological alterations at the boundary between mother and fetus. Progesterone and oestrogen have a great role along with other hormones. The controversies of use of progestogen and others are discussed in this chapter. Progesterone has been shown to stimulate the secretion of Th2 and reduces the secretion of Th1 cytokines which maintains pregnancy. Supportive care in early pregnancy is associated with a significant beneficial effect on pregnancy outcome. Address for correspondence: Prophylactic hormonal supplementation can be recommended for all assisted reproduction Dr. Navneet Magon, techniques cycles. Preterm labor can be prevented by the use of progestogen. The route of Head, Department of Obstetrics administration plays an important role in the drug’s safety and efficacy profile in different and Gynecology, Air Force trimesters of pregnancy. Thyroid disorders have a great impact on pregnancy outcome and Hospital, Nathu Singh Road, needs to be monitored and treated accordingly. Method of locating review: Pubmed, scopus Kanpur Cantt, U.P. India. E‑ mail: [email protected] Key words: Oestrogen, hormones, progesterone, thyroid INTRODUCTION about 250 mg/day. Almost all of the progesterone produced by the placenta enters the placenta, contrast to oestrogen. Steroid hormones like progesterone have been extensively Progesterone production is independent of he precursor studied in the literature with controversies in early available, fetal status including the wellbeing.
    [Show full text]
  • Phvwp Class Review Bisphosphonates and Osteonecrosis of the Jaw (Alendronic Acid, Clodronic Acid, Etidronic Acid, Ibandronic
    PhVWP Class Review Bisphosphonates and osteonecrosis of the jaw (alendronic acid, clodronic acid, etidronic acid, ibandronic acid, neridronic acid, pamidronic acid, risedronic acid, tiludronic acid, zoledronic acid), SPC wording agreed by the PhVWP in February 2006 Section 4.4 Pamidronic acid and zoledronic acid: “Osteonecrosis of the jaw has been reported in patients with cancer receiving treatment regimens including bisphosphonates. Many of these patients were also receiving chemotherapy and corticosteroids. The majority of reported cases have been associated with dental procedures such as tooth extraction. Many had signs of local infection including osteomyelitis. A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, radiotherapy, corticosteroids, poor oral hygiene). While on treatment, these patients should avoid invasive dental procedures if possible. For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw. Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.” Remaining bisphosphonates: “Osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection (including osteomyelits) has been reported in patients with cancer receiving treatment regimens including primarily intravenously administered bisphophonates. Many of these patients were also receiving chemotherapy and corticosteroids. Osteonecrosis of the jaw has also been reported in patients with osteoporosis receiving oral bisphophonates. A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g.
    [Show full text]
  • Guideline for Preoperative Medication Management
    Guideline: Preoperative Medication Management Guideline for Preoperative Medication Management Purpose of Guideline: To provide guidance to physicians, advanced practice providers (APPs), pharmacists, and nurses regarding medication management in the preoperative setting. Background: Appropriate perioperative medication management is essential to ensure positive surgical outcomes and prevent medication misadventures.1 Results from a prospective analysis of 1,025 patients admitted to a general surgical unit concluded that patients on at least one medication for a chronic disease are 2.7 times more likely to experience surgical complications compared with those not taking any medications. As the aging population requires more medication use and the availability of various nonprescription medications continues to increase, so does the risk of polypharmacy and the need for perioperative medication guidance.2 There are no well-designed trials to support evidence-based recommendations for perioperative medication management; however, general principles and best practice approaches are available. General considerations for perioperative medication management include a thorough medication history, understanding of the medication pharmacokinetics and potential for withdrawal symptoms, understanding the risks associated with the surgical procedure and the risks of medication discontinuation based on the intended indication. Clinical judgement must be exercised, especially if medication pharmacokinetics are not predictable or there are significant risks associated with inappropriate medication withdrawal (eg, tolerance) or continuation (eg, postsurgical infection).2 Clinical Assessment: Prior to instructing the patient on preoperative medication management, completion of a thorough medication history is recommended – including all information on prescription medications, over-the-counter medications, “as needed” medications, vitamins, supplements, and herbal medications. Allergies should also be verified and documented.
    [Show full text]
  • June 2011 Circular No
    7 th June 2011 Circular No. P06/2011 Dear Healthcare Professional, Re: European Medicines Agency finalises review of bisphosphonates and atypical stress fractures Bisphosphonates have been authorised in the EU for hypercalcaemia and the prevention of bone problems in patients with cancer since the early 1990s. They have also been available since the mid 1990s for the treatment of osteoporosis and Paget’s disease of the bone. Bisphosphonates include alendronic acid, clodronic acid, etidronic acid, ibandronic acid, neridronic acid, pamidronic acid, risedronic acid, tiludronic acid and zoledronic acid. They are available in the EU as tablets and as solutions for infusion under various trade names and as generic medicines2. In 2008, the CHMP’s Pharmacovigilance Working Party (PhVWP) noted that alendronic acid was associated with an increased risk of atypical fracture of the femur (thigh bone) that developed with low or no trauma. As a result, a warning was added to the product information of alendronic acid-containing medicines across Europe. The PhVWP also concluded at the time that it was not possible to rule out the possibility that the effect could be a class effect (an effect common to all bisphosphonates), and decided to keep the issue under close review. In April 2010, the PhVWP noted that further data from both the published literature and post- marketing reports were now available that suggested that atypical stress fractures of the femur may be a class effect. The working party concluded that there was a need to conduct a further review to determine if any regulatory action was necessary. Page 1 of 3 Medicines Authority 203 Level 3, Rue D'Argens, Gzira, GZR 1368 – Malta.
    [Show full text]