 Seizure risk for multiple sclerosis patients who take malignancies (new types of cancer) in patients with newly- Dalfampridine. diagnosed multiple myeloma who received Lenalidomide. July 23, 2012 - The U.S. Food and Drug Administration (FDA) is Clinical trials conducted after lenalidomide was approved updating health care professionals and the public about the risk of showed that newly-diagnosed patients treated with the drug had seizures in patients with multiple sclerosis (MS) who are starting an increased risk of developing second primary malignancies dalfampridine. Using information received from post-market compared to similar patients who received a placebo. A New Ink On Pharma Life adverse event reports, FDA recently evaluated seizure risk in MS Specifically, these trials showed there was an increased risk of patients taking dalfampridine. The majority of seizures developing acute myelogenous leukemia, myelodysplastic A Quarterly News Letter from Dept. of Pharmacy Practice, AL SHIFA COLLEGE OF PHARMACY syndromes, and Hodgkin lymphoma. happened within days to weeks after starting the recommended Vol. 2, Issue : 3 July - Sept 2012 dose and occurred in patients having no history of seizures.  Updated information on drug interactions between boceprevir and certain boosted HIV protease inhibitor drugs  New information regarding QT prolongation with L Various academic activities of the department promotes a various diseases by safe drug use. The arena of pharmacy practice ondansetron (Zofran) April 26, 2012 - The U.S. Food and Drug Administration (FDA) is department and as a part of the expansion programs of Pharmacy is expanding tremendously worldwide. It is interesting to note

notifying the public that co-administration of boceprevir, a A practice, We announce the addition of two new column in news that our country is also contributing heavily to this field. I hope June 29, 2012 - The U.S. Food and Drug Administration (FDA) is letter titled ADR Bulletin and Drug safety update. Adverse that ADR bulletin and Drug updates will surely help the doctors informing healthcare professionals and the public that hepatitis C virus (HCV) protease inhibitor, along with certain I ritonavir-boosted human immunodeficiency virus (HIV) Drug Reactions (ADRs) result in 0.3% to 7% of hospital and healthcare professionals to keep abreast with the latest preliminary results from a recently completed clinical study admissions and form 4th to 6th leading cause of death among knowledge in Drug safety. protease inhibitors, is not recommended at this time because of R suggest that a 32 mg single intravenous dose of ondansetron may hospitalized patients. Practicing doctors do not report ADRs due the possibility of reducing the effectiveness of the medicines, I congratulate Mrs Shinu, 2nd M Pharm student, who has affect the electrical activity of the heart (QT interval to their busy schedule. Hence there is a need for alternative secured second rank in M Pharm pharmacy practice in the permitting the amount of HCV or HIV virus in the blood (viral O prolongation), which could pre-dispose patients to develop an approach to identify, analyze and report the ADRs in order to University of Calicut. abnormal and potentially fatal heart rhythm known as Torsades load) to increase. Ritonavir-boosted HIV protease inhibitors minimize the incidence. This can be fulfilled only by creating T My heartfelt appreciation for First M Pharm students for de Pointes. include ritonavir-boosted Reyataz (atazanavir), ritonavir-boosted awareness among the doctors, hence there is a need to promote Prezista (darunavir), and Kaletra (lopinavir/ritonavir). I vigorous Pharmacovigilance activities across the country. The securing 100% result in First year M pharm pharmacy practice.  Cefepime and risk of seizure in patients not receiving I profusely thank Managing trustee, Alshifa group  New Warning and Contraindication for blood pressure objective of this new column ADR bulletin and Drug safety dosage adjustments for kidney impairment D Mr. P. Unneen and Dr R.Saraswathi, Director, Alshifa college medicines containing aliskiren update is to propagate the information regarding the side effects, June 26, 2012 - The U.S. Food and Drug Administration (FDA) is safe drug use to prescribers, pharmacists, other health of pharmacy for their wholehearted support, Infectious optimism reminding health care professionals about the need to adjust the April 20, 2012 - The U.S. Food and Drug Administration (FDA) is E professionals, other potential information about the drugs and and continuous encouragement. dosage of the antibacterial drug cefepime in patients with renal warning of possible risks when using blood pressure medicines pharmacovigilance activities to the doctors of Alshifa hospital I thank Associate editors Mr. Linu Mohan, Mrs. Shamna, (kidney) impairment. There have been cases of a specific type of containing aliskiren with other drugs called angiotensin and thereby creating awareness among the medical professionals. and Ms. Tina Thomas, for their effort in making this a success. Pharmacists are dedicated to the preservation and advancement seizure called nonconvulsive status epilepticus associated with converting enzyme inhibitors (ACEIs) and angiotensin receptor Happy reading ! of the public health. Their efforts enhance the quality of our lives the use of cefepime, primarily in patients with renal impairment blockers (ARBs) in patients with diabetes or kidney (renal) Dilip. C. impairment. by helping us to live as free as possible from disease pain and who did not receive appropriate dosage adjustments of cefepime. suffering. Evidence from many countries now demonstrates that Editor in Chief Cases of nonconvulsive status epilepticus associated with The following recommendations are being added to the drug success is already being achieved in preventing and treatment of [email protected] cefepime are documented in the medical literature and have been labels for aliskiren-containing products as of 4/20/12: identified in FDA's Adverse Event Reporting System (AERS) A new contraindication against the use of aliskiren with ARBs or POSTER PRESENTATION database .Most cases occurred in patients with renal impairment ACEIs in patients with diabetes because of the risk of renal st who did not receive appropriate dosage adjustment. impairment, hypotension, and hyperkalemia. ON WINGS OF SUCCESS P1RIZE  Revised recommendations for cardiovascular monitoring A warning to avoid use of aliskiren with ARBs or ACEIs in CHINNU P.B (2nd Yr. PHARM D) and use of multiple sclerosis drug Fingolimod patients with moderate to severe renal impairment (i.e., where Alshifa is always be a spot on inspiration and motivation to A prospective evaluvation of Anti Diabetic May 14, 2012 - The U.S. Food and Drug Administration (FDA) glomerular filtration rate [GFR] < 60 mL/min). all its members especially to the new generations. It's this Drugs in a Tertiary Care Referral Hospital has completed its evaluation of a report of a patient who died after  Updated information about the risk of blood clots in women motivation that took the name and fame of our college to the the first dose of multiple sclerosis drug Fingolimod. The agency taking birth control pills containing drospirenone heights of success. Once again with the sparkling performance of nd ORAL PRESENTATION our students the history was rewritten. P2RIZE also has evaluated additional clinical trial and postmarket data for April 10, 2012 - The U.S. Food and Drug Administration (FDA) fingolimod, including reports of patients who died of It was an honour for our students to be a part of the national has completed its review of recent observational (epidemiologic) SHINU.M (Senior Lecturer) cardiovascular events or unknown causes. However, based on its studies regarding the risk of blood clots in women taking level seminar conducted in PSG college on the topic National Conference on Experimental Pharmacology and Drug ADR Monitoring in a Tertiary Care Hospital reevaluation of the data, FDA remains concerned about the drospirenone-containing birth control pills. Drospirenone is a cardiovascular effects of fingolimod after the first dose. Data Evaluation. We consider it as a great opportunity to meet the synthetic version of the female hormone, progesterone, also rd show that, although the maximum heart rate lowering effect of eminent personality in the field of pharmacy practice. It was an 3 referred to as a progestin. Based on this review, FDA has PRIZE ultimate proud for us to attend and participate in different fingolimod usually occurs within 6 hours of the first dose, the concluded that drospirenone-containing birth control pills may be SHAMNA .M (Senior Lecturer) maximum effect may occur as late as 20 hours after the first dose . competition conducted there .Our happiness went to an extend by Effectiveness of Clinical Pharmacist associated with a higher risk for blood clots than other progestin- d k grabbing different position. The motivation we attained from this in some patients. p Intervention on Smoking Cessation

containing pills. FDA is adding information about the studies to , s s will be a fuel for attending future upcoming events In Tertiary Care Referral Hospital

 e

Safety review update of cancer drug Lenalidomide and risk the labels of drospirenone-containing birth control pills. r p .

of developing new types of malignancies v .

Contributors : Vinod B, Ajmal M m May 07, 2012 - The U.S. Food and Drug Administration (FDA) is Second year M.Pharm w e informing the public of an increased risk of second primary n We encourage you to report all suspected adverse drug reactions to department of Pharmacy Practice. ADR forms are available at Patron Editorial Board Directors Editor in Chief Executive Editors all nursing stations, alternatively you may call : Mr. P. Unneen : Dr. R. Saraswathi : Mr. Dilip C : Mrs. Shamna.M, Dr. K.G. Ravikumar Mr. Linu Mohan, Ms. Tina Drug Information Centre on 468 CONTACT LENSES MEDICATE EYES Only about one to seven percent of eye drop medications are ADR BULLETIN PHARMA absorbed in to the eye, because most of it drips out. Moreover the patient finds use of eye drop is difficult and A new vista for health care professionals. often forgets to use it. A new medical invention has been Quarterly Bulletin from the Dept. of Pharmacy Practice - Alshifa College of Pharmacy - Concept : created by the scientist at Harvard Medical School. The new Dilip.C (Associate Prof.) PULS invention is a contact lens that can dispense a regular dose of antibiotics to the eye for more than a month. A bio CEFOPERAZONE SULBACTAM INJECTION Leap of Medicine degradable polymer film is mixed with a medication and coated with hydro gel, which is the same material used to ASSOCIATED RASHES IN A BABY make contact lenses. The films slowly release the - Concept : Linu Mohan (Asst Prof) medication in to the eye. Eye drops are used to dispense most eye medications but they are inefficient, which is why scientist believe this new medical invention will dispense eye medication more easily and effectively. EARLY DETECTION, KEY TO SURVIVAL Centre for materials for electronics and technology (C- MET), has developed a device to detect breast cancer easily. The device strapped to the breast may read temperature changes, which is the sign of malignancy. Studies show that the temperature of cancer tissues is different from that of a normal tissue. Cancer cell consumes more glucose than the normal healthy cells and discharge more heat. The pattern of temperature of cancerous tissue is also different. So the device works with thermal sensors which is small and bio compatible and can detect temperature with an accuracy of 0.001 degree centigrade. We report a case on rashes following the administration The company claims that, young women with dense breast tissue are the most difficult of cefoperazone sulbactam for neonatal sepsis in a 5 days old, to evaluate using breast palpitation, mammography and ultrasound examination. At least 10% of female baby breast cancers cannot be identified by mammography even when they are palpable. Most breast A 5 days old female baby weighing 2.75kg was admitted cancers do not become palpable until they are greater than one centimeter. By then 25% of them to peadiatric unit for presenting with lethargy and poor sucking would have been metastasized. The higher risk of developing breast cancer while young, can be for 3 days. On examination, the patient was shown to be febrile accurately detected with C MET`s system. due to fever post vaccination. The laboratory test reports of urine microscopy showed presence of puss cells in urine rating to 4- 6/hpf, RBCs to 10-12/hpf and epithelial cells 30-35/hpf. The CRITICAL TUMOR SUPPRESSOR IDENTIFIED SGPT and SGOT values were 22 IU/L and 68 IU/L respectively. Scientists from the Florida campus have identified a protein that impairs the development and maintenance of lymphoma (cancer The total bilirubin was 3.9mg/dl. The total leucocyte was found to of the lymph nodes), but is repressed during the initial stages of the disease, allowing for rapid tumor growth. be 8700 cells/cu mm and ESR of 5 mm/hr. she was prescribed with cefoperazone- sulbactam injection 100mg every 8th hourly, While the study, they largely focused on the role of this new tumor suppressor in lymphoma induced by Myc oncoproteins (the syrup Flora BC three times daily. Cefoperazone sulbactam is an cancer-promoting products of Myc oncogenes). The Myc family of oncoproteins (c-Myc, N-Myc, and L-Myc) regulates critical pathways antimicrobial agent which belongs to third generation that contribute to tumors; c-Myc expression, which is activated in human Burkitt lymphoma, is sufficient to induce the growth of several cephalosporins used to treat bacterial septicemia caused by tumor types in animal models. susceptible organisms. Cefoperazone is administered paren- This circuit is apparently operational in all human tumors with MYC involvement, which is more than half of all human tumor terally. On the days of therapy she developed maculopapular types. This opens a new therapeutic avenue to exploit for cancers with Myc involvement including relapsed metastatic tumors and rashes on the IV injection site on her right foot. This is suspected refractory tumors, those that have not responded to treatment. to be the adverse reaction of cefoperazone as it has a very high incident rate. The drug was not withdrawn and fusidic acid was prescribed for topical application. EQUIPMENT MAKES DRAWING BLOOD EASIER The causality of the event, assessed as per WHO-UMC system for A blood test is a laboratory analysis performed on a blood sample that is usually extracted from a vein standard case causality assessment criteria can be considered as in the arm using a needle. Blood tests are used to determine physiological and biochemical states, such as probable. Analyzed by the Naranjo's ADR probability scale, the disease, mineral content, drug effectiveness, and organ function. Usually it makes the visit of patient to the score was 5, which also make it a probable adverse drug reaction. clinic unpleasant if he is asked to draw his blood. It becomes bad, if the person drawing the blood can not seem REFERENCE: to find the vein, there by having to stick the patient with a needle couple of times. 1. B.D Miglani, K G Ravikumar, A textbook of Pharmacy AccuVein LLC has developed a device that offers hand-held, Practice, first edition, page 250-1. non-contact vein illumination, which shows the person drawing your blood where exactly they 2. K D Tripathi, Essentials of medical pharmacology, fifth should stick that needle. The device, weighing only 10 ounces, works by detecting and highlighting edition, page 663-6. hemoglobin, and also scans up to 8mm below the skin's surface. 3. Joseph T Dipiro, Pharmacist Drug Handbook, page 247-9 The device enables healthcare professionals to see a vein map on the skin, which represents Ibrahimkutty, 1st year M.Pharm an exciting medical innovation striving to improve the time, comfort and cost of care and also Linu Mohan,Asst prof improves patient satisfaction. Danisha,Ist Mpharm. Please report potential ADR to : [email protected]

2 3 Month wise ADR details In a tertiary care referral Hospital. DRUG UPDATE A Complete update on Drugs for Doctors.. JUNE 45 Carbidopa 25 mg + Concept : Shamna M, Sr. lecturer levodopa 250 mg Severe drowsiness NEW DRUG APPROVALS 1 Nifedipine Headache 46 Moxifloxacin 400 mg Itching 2 Furosemide Hypokalemia 47 Fosphenytoin Hyperglycemia 3 Artesunate Diarrhea and abdominal pain Aflibercept - August 3, 2012 Aflibercept, an angiogenesis increase the production of neutrophils. It is administered as an 48 Omeprazole 20 mg Constipation 4 Moxifloxacin Allergy severe itching inhibitor (Anti VEGF) has been approved by the US Food and injection beginning 24 hours after chemotherapy treatment. 49 Rifampicin, INH, Drug Administration (FDA) for use in the treatment of metastatic 5 Ethamsylate Severe headache FDA Approves Vaccines for the 2012-2013 Influenza Season Pyrazinamide Drug induced hepatitis colorectal cancer. The indication is for use in combination with 6 Racecadotril Nausea, vomiting 50 Atenolol 50 mg + the conventional FOLFIRI regimen (leucovorin, irinotecan, 5- August 13, 2012 - Each year experts from the FDA, the 7 Metaxalone 400 mg, amlodipine 5 mg Sinus bradycardia fluorouracil). World Health Organization, the Centers for Disease Control and Diclofenac 50 mg Gastritis 51 Potassium supplement Nausea and vomiting Prevention (CDC), and other public health experts study 8 Olanzapine 25 mg Hyperglycemia Enzalutamide - August 31, 2012 Enzalutamide, an anti influenza virus samples and global disease patterns to identify 52 Cefuroxime 500 mg Severe diarrhea androgen has been approved by US Food and Drug 9 Metoclopramide Dizziness, confusion, nausea 53 Valproic acid 500 mg Alopecia virus strains likely to cause the most illness during the upcoming Administration (FDA) to treat men with metastatic castration- flu season. Based on that information and the recommendations 10 Nifedipine Headache 54 Nifedipine 20 mg Dizziness resistant prostate cancer that has spread or recurred. of the FDA's Vaccines and Related Biological Products Advisory 11 Hydroxyzine CNS depression 55 Pantoprazole + Fingolimod, sphingosine - 1-phosphate receptor modulator is Committee, the strains selected for inclusion in the 2012-2013 flu 12 Gentamycin Tinnitus, vestibular imbalance Domperidone Headache indicated for the treatment of patients with relapsing forms of vaccines are: 13 Alprazolam Vertigo and dizziness 56 Levofloxacin 500 mg Constipation multiple sclerosis (MS). Recommended dose is 0.5md once daily, 14 Ceftriaxone Diarrhea  A/California/7/2009 (H1N1)-like virus with/without food. 15 Codeine + acetaminophen Insomnia  A/Victoria/361/2011 (H3N2)-like virus JULY Linaclotide - August 30, 2012 Linaclotide, guanylate cyclase 16 Acyclovir Diarrhea  type C agonist (GCC agonist) has been approved by US Food and B/Wisconsin/1/2010-like virus. 17 Cefoperazone 1 Duloxetine 20 mg Intense somnolence and Drug Administration (FDA) for the treatment of chronic While the H1N1 virus is the same as what was included in the + sulbactum Rashes at IV injection site drowsiness idiopathic constipation and irritable bowel syndrome with 2011-2012 influenza vaccines, this year's influenza H3N2 and B 18 Diltiazem hydrochloride Hypotension and abnormal 2 Nifedipine 20 mg Drastic hypotension constipation (IBS-C) in adults. viruses differ from those in the 2011-2012 influenza vaccines. ECG 3 Spironolactone 100 mg Gynaecomastia Pertzumab - Pertuzumab, a humanized monoclonal antibody, 19 Vitamin+iron supplement 4 Lorazepam 2 mg Constipation and tiredness Qsymia (Phentermine and Topiramate extended-release) (t.eido ) Nausea which inhibits HER 2 (Human epidermal growth factor receptor) 5 Risperidone 2 mg Amenorrhea FDAapproved Qsymia (Phentermine and Topiramate extended- has been approved by US Food and Drug Administration (FDA) 20 Losartan 50 mg + release) as an addition to a reduced-calorie diet and exercise for furosemide 40 mg Postural hypotension 6 Syp.Kcl Severe diarrhea for the treatment of HER 2 positive breast cancer. chronic weight management. The drug is approved for use in 21 Isosorbidedinitrate 5mg Severe headache, fainting 7 Vitamin K Itching 8 Carboplatin 400 mg Hypokalemia Glucarpidase - January 17, 2012 Glucarpidase, a recombinant adults with a body mass index (BMI) of 30 or greater (obese) or 22 Metoprolol Hypotension enzyme, has been approved as a treatment for the rapid and 9 Piracetam + cefotaxim Red skin rashes adults with a BMI of 27 or greater (overweight) who have at least 23 Piroxicam 20 mg Wheezing and asthma sustained reduction of toxic methotrexate levels due to impaired one weight-related condition such as high blood pressure 10 Inj.tenicteplase 30mg Hematuria 24 Rifampicin 200 mg Heart burn renal function. (hypertension), type 2 diabetes, or high cholesterol 11 Iron tab Vomiting 25 Nicorandil 5 mg Headache Mirabegron - June 28, 2012- Mirabegron is a beta-3 adrenergic (dyslipidemia). 26 Cholestyramine 5 mg Abdominal discomfort 12 Valproic acid 300 mg Pedal edema & lowered platelet count agonist indicated for the treatment of overactive bladder (OAB) 27 Pantoprazole Abdominal and constipation 13 Syp.KCl Severe diarrhea with symptoms of urge urinary incontinence, urgency, and 28 Nifedipine Edema urinary frequency. 14 Cefoperazone+ sulbactum Diarrhea NEW DOSAGE FORM FOR EXISTING DRUGS 29 Cefoperazone+sulbactum Diarrhea 15 Amoxicillin clavulanate Severe diarrhea Everolimus - An mTOR (mammalian target of rapamycin) has Afinitor Disperz - First Drug Formulated for Children with 30 Phenytoin 100 mg Insomnia 16 Moxifloxacin Constipation been approved for the treatment of breast cancer in females. Rare Brain Tumor 31 Nifedipine Dizziness Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir 32 Ceftriaxone 1 g Rashes August 29, 2012 -- The U.S. Food and Drug Administration disoproxil fumarate) - Aug. 28, 2012 - Stribild (elvitegravir, 33 Levofloxacine 5000 mg Diarrhea AUGUST approved Afinitor Disperz (everolimus tablets for oral cobicistat, emtricitabine, tenofovir disoproxil fumarate) has been suspension), a new pediatric dosage form of the anti-cancer drug 34 Inj. Ampicillin Vaginal discharge and itching 1 Mannitol Dry mouth approved by the U.S. Food and Drug Administration to treat Afinitor (everolimus) used to treat a rare brain tumor called 35 Cefoperazone+sulbactum Diarrhea 2 Cefixime Loose stool adults with HIV, the virus that causes AIDS. The combination subependymal giant cell astrocytoma (SEGA). Afinitor Disperz 36 Nifedipine Constipation drug, which only has to be taken once a day interferes with 3 Lorazepam Drowsiness is the first approved pediatric-specific dosage form developed for 37 H.mixtard Hypoglycemia enzymes that are needed for the virus to multiply. 4 Glimepiride Hypoglycemia the treatment of a pediatric tumor. It is recommended to treat 38 Escitalopram 5 mg Increase of appetite, nausea, 5 Salbutamol Tremor tbo-filgrastim - August 29, 2012 - The U.S. Food and Drug patients ages 1 year and older with tuberous sclerosis complex sleep disturbances (TSC) who are diagnosed with SEGA that cannot be treated with 6 Furosemide Hypokalemia Administration approved tbo-filgrastim to reduce the time certain 39 Tramadol+ rabeprazole Nausea and vomiting surgery. Prior to approval of this new dosage form, Afinitor was 7 Cefoperazone+sulbactum Diarrhea patients receiving cancer chemotherapy experience severe 40 Chlordiazepoxide 10 mg Sedation and drowsiness neutropenia, a decrease in infection-fighting white blood cells recommended for use only in patients ages 3 years old and older. 8 Cefotaxim Pain at injection site 41 Hydroxychloroquine called neutrophils. It is intended for use in adults who have Afinitor was granted accelerated approval in 2010 to treat SEGA 9 Levofloxacine Headache 200 mg Retinopathy and blurred vision cancers other than blood or bone marrow cancers (non-myeloid in patients with TSC. 10 Ondansetron Dizziness 42 Betahistine 8 mg Dizziness malignancies) and are taking chemotherapy drugs that cause a FDA Approves Nucynta ER (tapentadol) Extended-Release 11 Diclofenac+ gentamycin ATN 43 Tramadol 37.5 mg + substantial decrease in the production of neutrophils in the bone Oral Tablets for the Management of Neuropathic Pain paracetamol 32.5 mg Nausea and vomiting 12 Deflazacort GI disturbances marrow. This reduction in neutrophils may lead to infection and Associated with Diabetic Peripheral Neuropathy 44 Moxifloxacin 400 mg Diarrhea and GI disturbances 13 Ciprofloxacin seizure fever (febrile neutropenia). It stimulates the bone marrow to

4 5 Aug. 29, 2012 -- U.S. Food and Drug Administration (FDA) has aid chronic disease management. Researchers have very recently came up with VITAMIN K2, may reduce outbreaks by almost 50 percent in people with a type approved the supplemental New Drug Application (sNDA) for The sensor resembles a grain of sand in size, is made primarily of which can cease the progression of Parkinson's' disease. of hard-to-treat asthma, an early study finds. The researchers Nucynta ER (tapentadol) extended-release tablets, an oral silicon, and can be integrated into an inert pill or any other Parkinsonism is a slowly progressive neurological disorder explained that about a third of people with severe asthma have analgesic taken twice daily, for the management of neuropathic ingestible object (such as a pharmaceutical). The Proteus Digital characterized by progressive dementia with several known eosinophilic asthma, in which eosinophils cause swelling of lung pain associated with diabetic peripheral neuropathy (DPN) in Health feedback system integrates wearable and ingestible etiologies. It is also postulated that disruption of energy airways. Standard asthma treatment with inhaled steroids isn't adults when a continuous, around-the-clock opioid analgesic is sensor technologies to detect medication intake and physiologic production in mitochondria can also be a causative factor. This effective, so these patients take oral steroids, which have many needed for an extended period of time. It is the first and only data. energy is generated by transferring of electrons. In Parkinson side effects. Mepolizumab blocks the production of eosinophils opioid approved by the FDA for neuropathic pain associated with patients, the transportation of electron and mitochondrial activity and reduces the frequency of severe asthma outbreaks, which DPN. In addition to this new indication, Nucynta ER is currently A disposable patch is worn on the body to capture and relay the is disrupted resulting in insufficient production of energy for the may reduce the need for steroids. approved for the management of moderate to severe chronic pain body's physiological response and behaviors. In addition to cell. This leads to the death of cells in certain parts of brain in adults when a continuous, around-the-clock opioid analgesic is recording information from the sensor, the patch records heart disrupting communication between neurons. The consequences needed for an extended period of time rate, temperature, activity, and rest patterns. The patch lasts are the typical symptoms' of Parkinson's: Muscle stiffness, Tofacitinib Appears Effective, Safe for approximately 7 days and is operated by a battery, which also tremors and lack of movement (akinesia). lasts approximately 7 days. Ulcerative Colitis: Study Although the exact root of Parkinson's diseases is unknown, NEW INDICATION FOR EXISTING DRUGS A mobile device is then carried in the pocket or purse to display scientists are successful in unfolding several genetic defects Aug. 15, 2012 -- An experimental drug called Tofacitinib reduces data in context and support care. (mutations) found in Parkinson's patients, including PINK1 and the symptoms of ulcerative colitis, at least in the short term. The Linagliptin - FDA approves updated prescribing information for Parkin mutations, both of which lead to reduced mitochondrial drug appears relatively safe, with few serious side effects, a new Linagliptin tablets for add-on therapy to insulin in adults with The sensor can be used to detect the exact time medication is activity. By studying these mutations, scientists hope to untangle study found. More than three-quarters of those taking the highest type 2 diabetes. taken, as well as the unique identity of the medication. The information is controlled by the patient. the mechanisms underlying the disease process. dose of the drug -- which is given as a pill -- had a response to the Gabapentin enacarbil - The US Food and Drug Administration medication, and 41 percent of these patients achieved a (FDA) has approved gabapentin enacarbil extended-release The IEM does not contain a battery. Instead, the fluids in the remission, according to the study. tablets for the management of post herpetic neuralgia in adults. stomach power the sensor, and the body transmits the digital signal generated by the sensor. The IEM is the only ingestible Experimental Drug May Cut Severe FDA Approves Auvi-Q (Epinephrine injection, USP) - Aug. sensor that is powered by the body. The sensor passes through the Asthma Attacks: Study 13, 2012 -- FDA has approved Auvi-Q (Epinephrine injection, body similar to fiber. USP) for the emergency treatment of life-threatening allergic Aug. 16, 2012 -- An experimental drug known as Mepolizumab reactions in people who are at risk for or have a history of Vascular Endothelial Growth Factor Inhibitors (Anti- anaphylaxis. Auvi-Q is the first-and-only compact epinephrine VEGF) in the Management of Diabetic Macular Oedema auto-injector with audio and visual cues that guide patients and As an alternative treatment for DMO, anti-vascular endothelial RUG AFETY OMMUNICATION caregivers step-by-step through the injection process. growth factors (anti-VEGF) have been introduced. Different D S C types of anti-VEGF are available, all of which inhibit VEGF FDA Safety Changes: Statin Label Revised With New June 1, 2012. Other reports include liver injury, severe bleeding, angiogenic activity by binding to the VEGF protein and thus Warning sudden worsening of glucose (sugar) control, weight gain, GENERIC APPROVALS preventing its receptor activation. The US Food and Drug Administration (FDA) has approved class swelling, leg cramps and withdrawal syndrome, and adrenal Pegaptanib (PG) is a pegylated aptamer that targets only the safety labeling changes for statins, including removal of the suppression. FDA Approves Generic Versions of Actos VEGF 165 isoform and is currently approved for the treatment of recommendation for routine monitoring of liver enzymes and the  Codeine use in certain children after tonsillectomy and/or Aug. 17, 2012 -- The first generic versions of Pioglitazone neovascular age-related macular degeneration (AMD). addition of new information about reversible cognitive adverse adenoidectomy may lead to rare, but life-threatening adverse (Actos) have been approved by the U.S. Food and Drug Bevacizumab (IVB) is a full-length humanised antibody that effects and reports of increased blood glucose and glycosylated events or death Administration to help adults with type 2 diabetes control blood binds to all types of VEGF. It is used in and licensed for tumour hemoglobin (HbA1c) levels. Aug 15, 2012 - The U.S. Food and Drug Administration (FDA) is glucose levels. License to produce the generic versions in 15 therapy. Ranibizumab (RBZ), it is a humanised monoclonal  FDA: Do Not Prescribe Sildenafil Off-label to Kids With reviewing reports of children who developed serious adverse milligrams (mg), 30 mg and 45 mg strengths was granted to antibody fragment that binds all active forms of VEGF-A and is PAH effects or died after taking codeine for pain relief after Mylan Pharmaceuticals. As with the brand name drug, generic currently approved for AMD and DMO. tonsillectomy and/or adenoidectomy for obstructive sleep apnea versions will contain a label warning that the drug could cause or August 31, 2012 - Clinicians should not prescribe sildenafil on an In summary, only RBZ has been approved for the treatment of syndrome. Recently, three pediatric deaths and one non-fatal but worsen heart failure in certain people. And there may be an off-label basis for children to treat pulmonary arterial DMO in Europe. RBZ and IVB were both developed by life-threatening case of respiratory depression were documented increased risk of bladder cancer in people who take the drug for hypertension (PAH) because low doses do not effectively Genentech (now part of Roche), but Roche-Genentech has not in the medical literature.These children (ages two to five) had more than a year. improve exercise ability, and high doses increase the risk for sought a licence for the use of IVB in the eye. However, due to the death, the US Food and Drug Administration (FDA) warned. evidence of an inherited (genetic) ability to convert codeine into very high price of RBZ, IVB has regularly been used off label life-threatening or fatal amounts of morphine in the body. All FDA Issues New Safety Alert on Reumofan Plus and children had received doses of codeine that were within the while experimental studies are underway. The therapeutic aim of Reumofan Plus Premium NEW DEVELOPMENTS IN MEDICARE FIELD anti-VEGF injections in patients with DMO is to improve and typical dose range. August 21, 2012 -- The U.S. Food and Drug Administration today FDA Approves Digestible Microchips to be Placed in Pills stabilise quality of vision and, ultimately, to improve quality of FDA is currently conducting a safety review of codeine to life which is severely threatened by visual loss (eg, increased risk issued a new warning to consumers about the potential health determine if there are additional cases of inadvertent overdose or August 3, 2012 The US Food and Drug Administration (FDA) of falls, severe limitation in daily activities like reading, watching risks of two products marketed as natural dietary supplements for death in children taking codeine, and if these adverse events has approved the first ingestible sensor. The Ingestion Event TV or driving a car). treating arthritis, muscle pain, osteoporosis, bone cancer, and occur during treatment of other kinds of pain, such as post- Marker (IEM), by Proteus Health, represents a new category of other conditions. The products, Reumofan Plus and Reumofan operative pain following other types of surgery or procedures. medical device: It is made entirely of ingredients found in food Plus Premium, contain several potentially harmful active New Hope for Parkinson's Patients: Two Antibiotics Linked to Liver Injury in Elderly and is activated on ingestion. pharmaceutical ingredients that are not listed on the product Vitamin K2 labels. Aug. 13, 2012 -- A new study finds that two antibiotics commonly The FDA validation represents a major milestone in digital used to treat respiratory and sinus infections -- moxifloxacin and medicine. Directly digitizing pills, for the first time, in Vitamin K2 plays a role in the energy production of defective The FDA has received dozens of additional adverse event reports, levofloxacin -- may boost the risk of severe liver injury in seniors. conjunction with wireless infrastructure, may prove to be the new mitochondria and that it potentially offers hope for a new including death and stroke, associated with the use of Reumofan standard for influencing medication adherence and significantly treatment for Parkinson's. Plus since the agency issued its first warning about the product on

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