RAM Newsletter

Volume 30 No. 3 (October 2023) Download pdf (175KB)

1. New approach to RSV prophylaxis
2. Alcohol antiseptics and the prevention of fires in the operating room
3. Drug Safety News

Volume 30 nº 2 (June 2023) Download pdf (174KB)

1. Migraine prevention: New biologic drugs
2. Retroperitoneal fibrosis due to drugs. Underreporting in Spain?
3. Drug Safety News

Volume 30 #1 (April 2023) Download pdf (139KB)

1. Tubulointerstitial nephritis due to drugs
2. Unintentional weight loss such as RAM
3. Drug Safety News

Volume 29 No. 3 (October 2022) Download pdf (184KB)

1. Menstrual disorders and vaccines against COVID-19.
2. Drug-drug interactions.
3. Drug Safety News.

Volume 29 No. 2 (June 2022) Download pdf (170KB)

1. The Spanish pharmacovigilance database FEDRA: Big-data or Small-data.
2. Madrid's contribution to FEDRA: 1992-2022.
3. Drug Safety News.

Volume 29 #1 (April 2022) Download pdf (335KB)

1. 2021: The challenge of the Pharmacovigilance Center.
2. WOMAN: Adverse events reported with COVID-19 vaccines.
3. Drug Safety News.

Volume 28 No. 3 (October 2021) Download pdf (481KB)

1. Guillain-Barré and facial paralysis with COVID-19 vaccines.
2. Notifications received in the Community of Madrid with vaccines against COVID-19.
3. Drug Safety News.

Volume 28 No. 2 (June 2021) Download pdf (1400KB)

1. Update of information on vaccines against COVID-19.
2. The eclipse that killed the king. The expected and the observed.
3. Drug Safety News.

Volume 28 No. 1 (April 2021) Download pdf (515KB)

1. Who notifies with the vaccines against COVID-19 in Madrid?
2. Notifications with the vaccines against COVID-19.
3. Drug Safety News.

Volume 27 No. 3 (October 2020) Download pdf ( 383KB)

1. The quantity is not enough: Direct notifications to the centers vs. through the industry.
2. And in Madrid?
3. Drug Safety News.

Volume 27 No. 2 (June 2020) Download pdf (710KB)

1. THANK YOU!
2. Notifications of suspected ADR with treatments for COVID-19.
3. Drug Safety News.

Volume 27 No. 1 (April 2020) Download pdf (840KB)

1. Liquid presentations: Solution and problem?
2. Who reports alerting cases in Madrid?
3. Drug Safety News.

Volume 26 No. 3 (October 2019) Download pdf (650KB)

1. Signals identified from notifications made in Madrid.
2. Your notification can launch a CUE.
3. Drug Safety News.

Volume 26 No. 2 (June 2019) Download pdf (520KB)

1. Systemic adverse reactions with ophthalmic drugs.
2. Interpreting Public Information: Spontaneous notifications of ADR suspicions.
3. Drug Safety News.

Volume 26 No. 1 (April 2019) Download pdf (341KB)

1. Drug-induced pancreatitis.
2. …And now the forest doesn't let us see the trees.
3. Drug Safety News.

Volume 25 No. 3. Download pdf (432KB)

1. Notifications of Madrid citizens to the Spanish Pharmacovigilance System.
2. Ectopic pregnancies with progestin-containing plastic intrauterine devices.
3. Drug Safety News.

Volume 25 No. 2. Download pdf (432KB)

1. Safety profile of monoclonal antibodies in systemic inflammatory diseases associated with autoimmunity.
2. Three promising new FEDRA3 utilities.
3. Drug Safety News.

Volume 25 No. 1. Download pdf (356,82KB)

1. Drug-induced myasthenia.
2. Lisdexamfetamine (▼Elvanse®).
3. Drug Safety News.

Volume 24 No. 3 (October 2017) Download pdf (220,34KB)

1. Meningitis B vaccine: spontaneous notifications to SEFV-H.
2. Chronic drug-induced diarrhea: Non-infectious colitis and malabsorption syndromes.
3. Drug Safety News.

Volume 24 nº 2 (June 2017) Download pdf (253,51KB)

1. Medication pemphigoid and pemphigus.
2. Hypocalcemia and denosumab.
3. Drug Safety News.

Volume 24 No. 1 (April 2017) Download pdf (498,16KB)

1. 25 years of pharmacovigilance in Madrid.
2. Cardiac disorders: Kounis, takotsubo and myocarditis.
3. News on drug safety.

Volume 23 No. 3. Download pdf (518,21KB)

1. EVITA Study: Survey on Pregnancies and Isotretinoin.
2. Could you be pregnant?
3. Drug Safety News.

Volume 23 No. 2. Download pdf (1091,78KB)

1. Serotonin syndrome: Linezolid, opioids, and trazodone.
2. Trazodone, a sedative antidepressant.
3. Security news.

Volume 23 No. 1. Download pdf (999,21KB)  

1. Mirabegron (▼Betmiga®).
2. Omalizumab (Xolair®).
3. Drug Safety News.

    

Volume 22 No. 3. Download pdf (395,02KB)

1. Allergy to food and medications.
2. Drug-induced breast cancer.
3. Drug Safety News.

Volume 22 No. 2. Download pdf (264,18KB)

1. Nursing and pharmacovigilance.
2. Two years of www.notificaRAM.es
3. Drug Safety News.

Volume 22 No. 1. Download pdf (340,66KB)

1. Hypothyroidism and medications.
2. Drug alopecia.
3. Drug Safety News.

Volume 21 No. 3. Download pdf (192,67KB)

1. Alterations of refraction and accommodation due to drugs. Notifications in children and adolescents.
2. Safe treatment of herpes zoster.
3. Drug Safety News.

Volume 21 No. 2. Download pdf (632,84KB)

1. PIELenRed: a platform for the investigation of severe skin reactions.
2. Copalchi: risk of hepatoxicity of a plant in diabetic patients.
3. Drug Safety News.

Volume 21 No. 1. Download pdf (499KB)

1. Severe skin drug reactions at FEDRA.
2. The first 1000 notifications in preFEDRAweb.
3. Drug Safety News.

Volume 20 No. 3. Download pdf (744KB)

1. Medication hiccups.
2. Acute liver disorders due to drugs: diagnosis and prognosis.
3. Drug Safety News.

Volume 20 No. 2. Download pdf (744KB)

1. Risks of intravenous immunoglobulins.
2. Peripheral neuropathy in Parkinson's, levodopa and B12.
3. //notifyRAM and the notification of citizens.
4. Drug Safety News.

Volume 20 No. 1.  Download pdf (490KB)

1. e-Notification against FEDRA.
2. Gynecomastia due to medications.
3. The RAM Bulletin, 20 years of edition.
4. Drug Safety News.

Volume 19 No. 3. Download pdf (365KB) 

1. New oral anticoagulants.
2. Hyperkalemia due to medications in Madrid.
3. Safety of oral colon cleansing preparations.
4. Drug Safety News.

Volume 19 No. 2.  Download pdf (392KB) 

1. Neuropsychiatric pictures with acyclovir and valacyclovir.
2. Acute noncardiogenic pulmonary edema in the postoperative period.
3. Medications containing ethanol and symptoms of alcohol poisoning.
4. Pharmacovigilance in social networks?
5. Drug Safety News.
    

Volume 19 No. 1. Download pdf (390KB) 

1. Signals in the Community of Madrid 1992-2011.
2. Risk management of new drugs.
3. Drug Safety News:
   1. Gonadotropin-releasing hormone (GnRH) analogues and risk of depression.
   2. HMG-CoA reductase inhibitors (statins) and risk of diabetes.
   3. Aliskiren (Rasilez®, Riprazo®, Rasilez Htc®): Reassessment of the benefit-risk balance.
   4. Risk of hypomagnesaemia associated with proton pump inhibitor (PPI) drugs.
   5. The European evaluation of somatropin confirms the favorable benefit-risk ratio under the authorized conditions of use.
   6. Atomoxetine (Strattera®) and increased blood pressure and heart rate: new recommendations.
   7. Domperidone and cardiac risk.
   8. Rosuvastatin: risk of gynecomastia.
   9. Tibolone: ​​risk of venous thromboembolism, myocardial infarction, breast cancer and ovarian cancer.
   10. Topiramate and risk of congenital malformations.
   11. Escitalopram: prolongation of the QT interval of the electrocardiogram.
   12. Spironolactone and risk of hyperkalaemia.
   13. Antiepileptics and risk of bone alterations.
   14. Dabigatran (Pradaxa®) and risk of bleeding: new recommendations for monitoring renal function.
   15. Metoclopramide: Restrictions of use in children and adolescents.
   16. Citalopram and prolongation of the QT interval of the electrocardiogram.
   17. Angiotensin II Receptor Antagonists (ARBs): Available data do not support their association with cancer risk.
   18. Terpene derivatives in suppositories: restrictions of use in children.
   19. Dronedarone: conclusions from the reassessment of its benefit-risk ratio.
   20. Lenalidomide (Revlimid®) and risk of second neoplasms.
   21. Medications with known risk of Stevens-Johnson Syndrome and toxic epidermal necrolysis.
   22. Revatio® (sildenafil for the treatment of pulmonary arterial hypertension): increased risk of mortality in pediatric patients at doses higher than those recommended.

Volume 18 No. 3. Download pdf (415KB)

1. Roflumilast safety.
2. Ejaculation disorders with silodosin.
3. Drug Safety News:

1. Fusidic acid-statin interaction: rhabdomyolysis.
2. Antipsychotics: extrapyramidal effects and withdrawal symptoms in newborns after exposure during pregnancy.
3. Dronedarone (MULTAQ®): reassessment of its benefit-risk ratio.
4. Pioglitazone: European evaluation of its possible association with bladder cancer.
5. Varenicline: evaluation of a new analysis on cardiovascular reactions.
6. Oral contraceptives containing drospirenone as a progestin: risk of venous thromboembolism.
7. Buflomedil (Lofton®): marketing suspension.
8. Cilostazol (Ekistol®, Pletal®): cardiovascular adverse reactions.
9. Plantago ovata: inhalation hypersensitivity reactions.
10. Temsirolimus (Torisel®): Adverse events with fatal outcome in patients with hepatic impairment.
11. Bortezomib (Velcade®): the contraindication for use in patients with severe hepatic insufficiency is eliminated.

Volume 18 No. 2. Download pdf (415KB)

1. dronedarone safety
2. Safety of agomelatine.
3. 20 years of Pharmacovigilance in the Community of Madrid.
4. Drug Safety News:

1. Pandemrix® and narcolepsy.
2. Bisphosphonates and atypical fractures of the femur.
3. Fosamprenavir (Telzir®): contraindication for administration with alfuzosin and sildenafil (pulmonary arterial hypertension).
4. Furosemide and bumetanide: the risk of basal cell carcinoma is not confirmed.
5. Lenalidomide (Revlimid®): second primary neoplasms.
6. Prasugrel (Efient®): hypersensitivity reactions.
7. Thromboembolic events with Vivaglobin® (human immunoglobulin).
8. New contraindication for Vernakalant (Brinavess®).
9. Restrictions on the use of Tigecycline (Tygacil®).
10. Restrictions on the use of Zerit® (stavudine).
11. Montelukast: psychiatric reactions.
12. Paracetamol and risk of asthma in children after exposure during pregnancy and childhood: the available evidence does not support a causal relationship.

Volume 18 No. 1. Download pdf (415KB)

1. Gliptin safety.
2. Drug Safety News:

1. Concomitant use of insulin and pioglitazone-heart failure.
2. Dronedarone (Multaq®): liver disorders.
3. Sitaxentan (Thelin®): marketing suspension.
4. Fluoroquinolones: prolongation of the QT interval.
5. Rosiglitazone (Avandia®, Avaglim®, Avandamet®): marketing suspension.
6. Somatropin: review of the safety profile in Europe.
7. Endotoxins in Baxter's Peritoneal Dialysis Solutions.
8. Inhaled or intranasal corticosteroids: psychiatric and systemic adverse reactions.
9. Osteonecrosis of the jaw-bevacizumab (Avastin®) or with sunitinib (Sutent®).
10. Tocilizumab (RoActemra): hypersensitivity/anaphylactic reactions.
11. Altellus® (self-injectable adrenaline): administration errors.
12. Orally administered bisphosphonates and risk of oesophageal cancer: insufficient evidence.
13. Formoterol and salmeterol: review of their safety in the treatment of asthma.
14. Benzidamine: administration errors due to oral ingestion of gynecological topical preparations.
15. Colchicine: overdose due to medication errors.
16. Octagamocta® (human immunoglobulin): recalled from all batches.
17. Tamoxifen: Reduced therapeutic response in CYP2D6 poor metabolisers or with CYP2 inhibitors.

Volume 17 No. 3. Download pdf (336KB)

1. Hospital pharmacovigilance program by CMBD.
2. Serious haematological, neurological and metabolic reactions with linezolid.
3. Etonorgestrel (Implanon®) and levodopa-carbidopa (Duodopa®): Device safety.
4. Drug Safety News.

Volume 17 No. 2. Download pdf (349KB)

1. Hospital pharmacovigilance program by laboratory signals.
2. Results in FEDRA and interview with the authors.
3. Drug Safety News:
   1. Antidepressants: Risk of bone fractures.
   2. Serotonergic antidepressants: pulmonary hypertension in neonates.
   3. Isotretinoin and erythema multiforme.
   4. Lamotrigine: risk of fatal liver failure is not confirmed.
   5. Perfalgan®-paracetamol 10 mg/ml solution for infusion: Risk of overdose in infants due to dosage error.
   6. Oral contraceptives with drospirenone and ethinylestradiol and risk of venous thromboembolism.
   7. DNA of a porcine circovirus in the Rotarix® vaccine.
   8. Fluoxetine and risk of congenital cardiac malformations.
   9. Becaplermin (Regranex®) and contraindication in patients with current or previous cancer.
   10. Valproic: interaction with carbapenems.
   11. Sibutramine and cardiovascular risk. Marketing suspension.
   12. Update: Natalizumab (Tysabri®) and LMP. Epoetins and risk of pure red cell aplasia.

Volume 17 No. 1.  Download pdf (460KB)

1. Communication on drug risks. News.
2. Alice in the country of Pharmacovigilance.
3. Drug Safety News:
   1. Gadolinium contrasts and nephrogenic systemic fibrosis.
   2. Cyproterone acetate and meningioma.
   3. Phenytoin and Stevens-Johnson syndrome.
   4. Statins and sleep disturbances, memory loss, sexual dysfunction, depression, interstitial lung disease.
   5. Propylthiouracil and severe liver toxicity.
   6. Beta-adrenergic agonists and risk of myocardial ischemia.
   7. Antipsychotics and venous thromboembolic disease.
   8. Finasteride and male breast cancer.
   9. Etravirine (Intelence®) and severe hypersensitivity reactions.
   10. Apomorphine and QT prolongation.
   11. Ceftriaxone and calcium precipitates.
   12. Vigabatrin and movement disorders.
   13. Prevention of osteonecrosis of the jaw associated with treatment with bisphosphonates.

Volume 16 No. 3. Download pdf (192KB)

1. Quinolone tendinopathy.
2. Peripheral neuropathy due to statins.
3. Vasospastic peripheral arterial ischemia due to methysergide in HIV patients.
4. Drug Safety News:
   1. Safety of Insulin glargine (Lantus®) (29/06/2009 and 01/09/2009).
   2. (Deprancol®): proposal to suspend marketing in Europe (25/06/2009).
   3. Possible interaction of clopidogrel with proton pump inhibitors (03/06/2009).

Volume 16 No. 2. Download pdf (175KB)

1. HPV vaccine safety.
2. Medication errors with damage reported in 2008.
3. Drug Safety News:
   1. Medication error due to administration of salbutamol for intravenous nebulization (20/04/09).
   2. Efalizumab (Raptiva®): Marketing suspension (16/02/09).

Volume 16 No. 1. Download pdf (350KB)

1. HPV vaccine safety.
2. Insomnia and other sleep disturbances with statins.
3. When is it useful to notify the batch of a drug?
4. Drug Safety News:
   1. Methylphenidate: update of the conditions of use.
   2. Classic antipsychotics and increased mortality in elderly patients with dementia.
   3. Rimonabant (Acomplia®): precautionary suspension of marketing.
   4. Dopamine ergot agonists: update on restrictions of use.
   5. Hormone therapy in menopause: update of the information.
   6. Natalizumab (Tysabri®) and progressive multifocal leukoencephalopathy.
   7. Update of the information related to the contamination of Viracept® (nelfinavir): the toxicological studies indicate that there is no risk.

Volume 15 No. 2. Download pdf (356KB)

1. Mania associated with clarithromine.
2. New contraceptives (vaginal, transdermal, oral) and risk of THROMBOSIS.
3. Heart failure associated with pregabalin.
4. Safety of rota-virus vaccines.
5. Drug Safety News:
   1. Ergot Dopamine Agonists in Parkinson's Disease: Update on the Risk of Heart Valve Fibrosis.
   2. Tumor progression, reduced survival and cardiovascular risks associated with epoetins: new recommendations for use.
   3. New safety information on Exubera® (inhaled insulin).
   4. Risks of using angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor antagonists (ARAII) during pregnancy.
   5. Possible liver disorders associated with the consumption of HERBALIFE® products.
   6. Evaluation of the association of abacavir and didanosine with increased risk of myocardial infarction.

Volume 15 No. 1. Download pdf (980KB).

1. Medication errors in Madrid.
2. News in the notification of ADR suspicions.
3. Drug Safety News:
   1. Intranasal desmopressin in primary nocturnal enuresis (PNE) and risk of hyponatremia: new restrictions on use (28/03/2008).
   2. Moxifloxacin (Actira®, Proflox®, Octegra®): risk of liver damage and severe skin reactions (21/02/2008).
   3. Rosiglitazone and cardiovascular risk: new contraindications and restrictions of use (28/01/2008).
   4. Varenicline (Champix®): Review of safety information in Europe (09/01/2008).
   5. Marketing suspension of carisoprodol (Mio-relax®, Relaxibys®) (effective June 1, 2008) (4/12/2007).

       

Volume 14 No. 3. Download pdf (508KB)

1. News in Pharmacovigilance.
2. Electronic notification of ADR suspicions.
3. Drug Safety News:
   
   1. Strontium ranelate (Protelos®, Osseor®): risk of serious hypersensitivity reactions (16/11/2007).
   2. Interim suspension of the marketing of Trasylol® (aprotinin) (5/11/2007).
   3. Pioglitazone and Rosiglitazone: conclusions of the evaluation of the benefit-risk balance in Europe (19/10/2007).
   4. Piroxicam: updated information on the conditions of use as a hospital diagnostic drug (29/08/2007).
   5. Botulinum toxin: (Botox®, Dysport®, Neurobloc®, Vistabel®): risk of serious adverse effects due to toxin dissemination (6/07/2007).

Volume 14 No. 2. Download pdf (2.920KB) 

1. Access to Safe Use of Medicines and Health Products
2. Drug Safety News:

1. Information note on the withdrawal of Viracept (nelfinavir) (6/6/2007),
2. Cardiac risk associated with rosiglitazone: AEMPS communication on recently published data (24/5/2007),
3. Linezolid (Zyvoxid®): restriction of indications in complicated skin and soft tissue infections (26/4/2007),
4. Cabergoline and risk of heart valve disease (20/4/2007),
5. Rosiglitazone and pioglitazone: increased risk of fractures in women (10/4/2007),

Volume 14 No. 1. Download pdf (949KB) 

1. New medicines for pediatrics.
2. Psychiatric reactions in children with montelukast.
3. Drug Safety News:
   1. Use Restrictions and Warnings for Telithromycin (Ketek®) (30/3/2007).
   2. Nephrogenic systemic fibrosis and gadolinium contrasts for magnetic resonance imaging (8/2/2007).
   3. Ketorolac: change to medication for hospital use (7/2/2207).
   4. Alpha-1 adrenergic blockers and intraoperative floppy iris syndrome (IFIS)(23/1/2007).
4. Access to Safe Use of Medicines and Health Products.

December 2006 Volume 13 No. 3.  Download pdf (685KB) 

1. Pharmacovigilance in the CMBD.
2. Drug-associated hyponatremia.
3. Drug Safety News:

1. Extract of the root of "cimicifuga racemosa" and liver lesions (20/07/2006).
2. Update on atherothrombotic risks of coxibs and traditional NSAIDs (26/10/2006).

August 2006 Volume 13 No. 2. Download pdf (518KB)

• IMO-AP and RAM notification.
• VI Conference on Pharmacovigilance:

1. The prevention of the risk of medication in the elderly.
2. Risk prevention in children.
3. Prevention of teratogenicity by drugs.

• Drug Safety News:

1. Lamotrigine use during pregnancy: risk of oral clefts (30/06/2006).
2. Fluoxetine in the treatment of major depression: Extension of the indication for children and adolescents (6/06/2006).

May 2006 Volume 13 No. 1.  Download pdf (470KB)

1. VI Conference on Pharmacovigilance.
2. Risk prevention from hospitals.
3. Drug Safety News:

1. Elidel®/Rizan® (pimecrolimus) and Protopic® (tacrolimus) and risk of tumors (update of the informative note 2005/07 April 2005) (29/03/2006).
2. Risk of renal alterations associated with the use of tenofovir (21/03/2006).
3. Use of the amoxicillin-clavulanic acid association and risk of hepatotoxicity (13/03/2006).

December 2005 Volume 12 No. 3.  Download pdf (496KB)

1. Uveitis and scleritis associated with bisphosphonates.
2. Tacrolimus and apraxia.
3. Drug Safety News:
   1. Parenteral administration of bisphosphonates and osteonecrosis of the jaw (8/11/2005).
   2. Galantamine (Reminyl®): mortality in patients with mild cognitive impairment. Updated information from the informative note 2005/02 of the Spanish Agency for Medicines and Health Products (24/10/2005).
   3. Precautionary suspension of the marketing authorization for Hexavac® (hexavalent vaccine) (20/09/2005).

September 2005 Volume 12 No. 2. Download pdf (862KB)

1. Risk communication to physicians.
2. Drug Safety News:
   1. Prohibition of magistral formulas with anorexigenic products and central nervous system stimulants: benfluorex, prolintane, pemoline, phenylpropanolamine and tiratricol (30/06/2005).
   2. Carisoprodol (MIO-RELAX®, RELAXIBYS®): risk of abuse and dependence (29/06/2005).
   3. Selective COX-2 inhibitor anti-inflammatory drugs: cardiovascular risk. Update of the informative note 2005/05 February (29/06/2005).
   4. Marketing suspension of veralipride (Agreal®), effective June 15, 2005 (20/05/2005).
   5. Corticosteroids with B vitamins for parenteral administration: modification of the authorization conditions (13/05/2005).
   6. Use of selective serotonin reuptake inhibitors (SSRIs) and other antidepressants in children and adolescents (update of the information notes 2004/06 and 2004/June 14 and December 2004) (26/04/2005).
   7. Risks of the use of growth hormone in healthy people and change to "hospital use" (22/04/2005).

April 2005 Volume 12 No. 1. Download pdf (766KB)

1. The safety of drugs under debate.
2. Drug Safety News:
   1. Elidel® (pimecrolimus) and Protopic® (tacrolimus) and risk of tumors (4/04/2005).
   2. Administration of didanosine and tenofovir: new efficacy and safety data advise against their concomitant use (2/03/2005).
   3. Selective COX-2 inhibitor anti-inflammatories and cardiovascular risk: new restrictions on use (18/02/2005).
   4. Hepatitis induced by combination treatment of rifampicin with saquinavir/ritonavir: data from a clinical trial (11/02/2005).
   5. Possible confusion in the change of a rapid human insulin (Actrapid®, Humulina®, Humaplus®) for a rapid insulin analogue (Novorapid®, Humalog®) (3/02/2005).
   6. Galantamine (Reminyl®): increased mortality in patients with mild cognitive impairment. Preliminary data from two clinical trials (26/1/2005).
   7. Suspension of commercialization of the pharmaceutical specialty Meleril® (thioridazine) (18/01/2005).
   8. Atazanavir (Reyataz®): pharmacokinetic interaction with omeprazole (29/12/2004).
   9. Parecoxib (Dynastat®): cardiovascular risk in coronary bypass surgery and severe dermatological reactions (27/12/2004).
   10. Laxatives with a high phosphate content: risk of hyperphosphatemia (21/12/2004).
   11. New data on cardiovascular safety of celecoxib (Celebrex®) (20/12/2004).
   12. Use of selective serotonin reuptake inhibitors (SSRIs) in the treatment of depressive disorders in children and adolescents (17/12/2004).
   13. Cisapride: marketing suspension (22/11/2004).
3. VI Conference on Pharmacovigilance.

December 2004 Volume 11 No. 3. Download pdf (717KB)

1. Drug-associated suicide.
2. Notification cluster of local reactions with the Infanrix® vaccine, in 4-year-old children, in the Community of Madrid.
3. Drug Safety News:
   1. Pergolide: risk of valvulopathy (November 10, 2004).
   2. Multi-organ failure and yellow fever vaccine (October 28, 2004).
   3. Marketing suspension of rofecoxib (Vioxx® and Ceoxx®) (September 30, 2004).
   4. Possible Dosage Confusion of Orally Administered Methotrexate (July 27, 2004).

September 2004 Volume 11 No. 2.  Download pdf (2.622KB)

1. Safety of new antiepileptics.
2. Drug Safety News:
   1. Use of selective serotonin reuptake inhibitor drugs in the treatment of depressive disorders in children and adolescents (June 29, 2004).
   2. Sulfuric hexafluoride (Sono Vue®): Restriction of therapeutic indications due to serious adverse reactions of an allergic and cardiac type (May 20, 2004).
   3. Risperidone: Risk of cerebral ischemic events in patients with dementia. Restriction of Terms of Use (May 10, 2004).

April 2004 Volume 11 No. 1. Download pdf (631KB)

1. Results of the Spontaneous Notification Program in the Community of Madrid, year 2003.
2. Drug Safety News:
   1. New safety data on the antipsychotics olanzapine and risperidone in the treatment of elderly patients with psychosis or conduct disorder associated with dementia (March 9, 2004).
   2. Restriction of the use of benzbromarone (Urinorm®) and suspension of the marketing of benziodarone (Dilafurane®) and benzbromarone-allopurinol associations (Acifugan®, Facilit®) (February 10, 2004).
   3. Restriction of therapeutic indications for hormone replacement therapy (January 23, 2004).

December 2003 Volume 10 No. 3.  Download pdf (58KB)

1. Safety of antidepressants.
2. Drug Safety News:
   
   1. Premature Virological Failure in HIV-Infected Patients Treated with Tenofovir in Combination with Lamivudine and Abacavir.
   2. Lack of virological response in patients with HIV infection treated with the combination of Tenofovir, Didanoside and Lamivudine.

August 2003 Volume 10 No. 2.  Download pdf (342KB)

1. Low molecular weight heparins and severe bleeding. Dose adjustment recommendation in renal failure.
2. Rofecoxib, celecoxib and arterial hypertension: some preventive considerations.
3. Drug Safety News:

1. Suspension of marketing of pharmaceutical specialties with acetylsalicylic acid/salicylates for systemic administration and exclusively for children, which do not require a prescription.
2. Contraindication to the concomitant use of Repaglinide and Gemfibrozil.
3. Telithromycin (Ketek®): Worsening of Myasthenia Gravis.
4. Suspension of marketing of pharmaceutical specialties containing Astemizole.
5. Marketing suspension of the pharmaceutical specialty Exolise®: ethanolic extract of Camelia Sinensis (green tea).

​​March 2003 Volume 10 No. 1. Download pdf. (198KB)

1. Ten years of operation of the Pharmacovigilance Center of the Community of Madrid.
2. Drug Safety News:
   1. Suspension of the marketing of pharmaceutical specialties containing Nefazodone, effective March 1, 2003.
   2. Amifostine (Ethyol®): Serious dermatological adverse reactions.

September 2002 Volume 9 No. 2.  Download pdf (62KB)

• Regulations and recommendations on pharmacovigilance in Spain: information for health professionals.
• Drug Safety News:
  • Risks and benefits of hormone replacement therapy with estrogens associated with progestins: New data.
  • Epoetin alfa: Administer intravenously to patients with chronic renal failure.
  • Re-evaluation of the benefit-risk ratio of phlebotonic agents for oral administration.

 May 2002 Volume 9 No. 1.  Download pdf (70KB)

• Results of the spontaneous notification program in the Community of Madrid during the year 2001.
• The safety of medicines managed with OMI-AP.
• Important local adverse reactions reported to the Pharmacovigilance Center of the Community of Madrid after vaccination of diphtheria, tetanus and acellular pertussis.
• Drug Safety News:
  • Nimesulide (Guaxan®, Antifloxil®): Precautionary suspension of marketing.
  • Tetrabamate (Sevrium®): Soon to be withdrawn from the market. Available in pharmacies until July 31, 2002, only to finish treatments in progress.
  • Tolerance, dependence and withdrawal syndrome with Zolpidem (Inclusion in the list of psychotropic substances and products).
• Adverse reactions associated with moxifloxacin.

September 2001 Volume 8 No. 1.  Download pdf (100KB)

• Results of the program during the year 2000.
• Drug Safety News:
  • Cerivastatin and rhabdomyolysis.
  • Leflunomide Arava®): severe liver reactions.
  • Information note on safety of bupropion.
  • Bupropion and risk of seizures: changes in product safety information.
  • Information on the risk of tuberculosis infection associated with infliximab (Remicade®).
  • Mitoxantrone in the adjuvant treatment of breast cancer. indication restriction.

September 2000 Volume 7 No. 1.  Download pdf (48KB)

• Drug photosensitivity reactions.
• Drug Safety News: 
  • Vigabatrin (Sabrilex®) and visual field defects.
  • Information note on Cisapride.
  • Irreversible nephropathy due to the use of plant species of Aristolochia spp.
  • Blood dyscrasias (pancytopenia, aplastic anemia) in patients treated with ENBREL® (etanercept).

Volume 6 No. 3 

• Results of the Spontaneous Notification Program (Yellow Card) during 1999. 
• Queries:

1. What CPK elevations justify the withdrawal of statin treatment?
2. Arrhythmias with H1 antihistamines.
3. Treatment of tuberculosis in patients with liver disease due to tuberculostatic agents.

Volume 6 No. 2 

• Severe pulmonary adverse reactions reported to the Spanish Pharmacovigilance System (SEFV).
• Generic Drugs and Bioequivalence.
• Brief notices: 

1. Grepafloxacin
2. Pramipexole
3. Trovafloxacin.

Volume 6 No. 1

• Adverse reactions common to the quinolone group. Review of spontaneous notifications collected in FEDRA.
• Results of the Spontaneous Notification Program during 1997 in the Community of Madrid.

Volume 5 No. 2

• Hepatitis B vaccine. Suspected adverse reactions reported to the SEFV (Spanish Pharmacovigilance System).
• Psychiatric adverse reactions associated with macrolides.

Volume 5 No. 1

• Hematological adverse reactions with ticlopidine. Analysis of the notifications collected in the SEFV.
• Publications of adverse reactions by professionals of the Madrid Community. Year 1996.
• Informative Note of the National Pharmacovigilance Commission: Ticlopidine and hematological adverse reactions.

Volume 4 No. 3 

• Cardiovascular risk and use of dihydropyridines.
• Results of the “Yellow Card” Program. Year 1996.
• Physicians' attitude towards the Spontaneous Notification Program: About a survey.
• Brief: Change of name of the Actol® specialty for Niflactol®.

Volume 4 No. 2 

• Neuroleptic Malignant Syndrome. Review based on the notifications collected in FEDRA.
• Fulminant Hepatitis due to Phenelzine. Review of notifications of hepatic impairment due to MAOIs collected in FEDRA.
• Alterations in tooth pigmentation associated with treatment with amoxicillin and amoxicillin-clavulanate. Review of FEDRA notifications.
• Notes from the National Pharmacovigilance Commission:

1. Orgoteine
2. Amoxicillin-clavulanic acid
3. Calcium Antagonists
4. Withdrawal of flu vaccines.

Volume 4 No. 1

• Adverse reactions with hypocholesterolemic agents.
• Hypoglycemia due to interaction between insulin, ACE inhibitors and NSAIDs.
• Zipeprol an antitussive of abuse.

Volume 3 No. 3

• Editorial: The “Yellow Card” Program in the Madrid Community.
• Annual results of the Yellow Card Program.
• Drug-induced polyneuropathies.
• Debate on the new oral contraceptives: Recommendations of the Health Authorities.

Volume 3 No. 2 

• Withdrawal phenomena with antidepressant drugs.
• Adverse reactions to new drugs marketed during 1993.

Volume 3 No. 1 

• Drug-induced liver disease.
• Medication-induced gynecomastia.

Volume 2 No. 3 

• Oral contraceptives: side effects and interactions. 
• Results in 1994 of the “Yellow Card” Program.
• Cyproterone acetate and hepatic carcinogenesis.

Volume 2 No. 2 

• Adverse Effects Profile to Omeprazole and H2 antagonists through spontaneous reporting.
• Drug-induced Stevens-Johnson syndrome and toxic epidermal necrolysis.
• Drug nephrolithiasis.

Volume 2 No. 1 

• Adverse reactions produced by immunoglobulins.
• Drug-induced systemic lupus: Role of pharmacogenetics applied to antidepressants.
• Brief notices:

1. Sudden death and vaccination with DTP (Diphtheria-Tetanus and Whooping Cough).
2. Withdrawal of the pharmaceutical specialty Gammagard.

• Detection of adverse drug reactions.

Volume 1 No. 3 

• First Year Results.
• ECG changes associated with the use of non-cardiovascular drugs.
• Notification of suspected adverse reactions.

Volume 1 No. 2 

• Medication-associated agranulocytosis.
• Impotence and antihypertensive treatment. 
• Informative Notes: 

1. Clozapine
2. Capsules of Vogue.

• Notification of suspected adverse reactions.

Volume 1 No. 1

• Ketorolac: A nonsteroidal anti-inflammatory like the others.
• Quinolones and musculoskeletal disorders: Review.
• Derivatives of heterologous proteins.
• Adverse reactions reported to the Center.
• Notes from the National Pharmacovigilance Commission: 

1. bendazac
2. Droxicam
3. Piroxicam-Thiomersal.

• Brief News: Gangliosides, Centoxin.
• Detection of adverse drug reactions.

Volume 0 No. 0 

• Rationale for pharmacovigilance.
• Spontaneous Notification System. The Yellow Card.
• Spanish Pharmacovigilance System.
• Pharmacovigilance Center of the Community of Madrid.