Not of Standard Quality Drugs - Safety Alerts - Drug Alert -CENTRAL DRUGS STANDARD CONTROL ORGANIZATION

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Sl. No.	Name of Drugs/Medical Device/Cosmetics	Batch No./Date of Manufacture/Date of Expiry/Manufactured By	Reason for failure with Report No. (in Form-13)& Date	Drawn By	From
1	FLEXON TABLETS	B. No. MM26F493, D/Mfg. Jun, 2013 , D/Exp. May, 2016, Mfg. By. M/s Aristo Pharmaceuticals, Plot 208, New Industrial Area No. 2, Mandideep, Dist-Raisen, Madhya Pradesh.	Disintegration 09395/2014-15 Dated 07-07-2014	CDSCO, East Zone	RDTL, Guwahati
2	MERICOL – 500 TABLETS	B. No. WSZ 1309, D/Mfg. Jun, 2013, D/Exp. May, 2016, Mfg. By. M/s Shivek Labs Ltd., Village-Kishanpura, Baddi-Nalagarh Road, Dist-Solan, Himachal Pradesh-174101.	Dissolution 09420/2014-15 Dated 15-07-2014	CDSCO, East Zone	RDTL, Guwahati
3	MERICOL – 500 TABLETS	B. No. WSZ1311, D/Mfg. Jan, 2013, D/Exp. Dec, 2016, Mfg. By. M/s Shivek Labs Ltd., Village-Kishanpura, Baddi-Nalagarh Road, Dist-Solan, Himachal Pradesh-174101.	Dissolution 09452/2014-15 Dated 21-07-2014	CDSCO, East Zone	RDTL, Guwahati
4	CEFVERT – 100 DT TABLETS	B. No. CPMKA-3541, D/Mfg. Oct, 2013, D/Exp. Sep, 2015, Mfg. By. M/s J. M. Remedies, Mamoore Complex, Saproon, Solan, Himachal Pradesh-173211.	Uniformity of Weight 09451/2014-15 Dated 21-07-2014	CDSCO, East Zone	RDTL, Guwahati
5	SANOFLOX –OZ TABLETS	B. No. DMT-038, D/Mfg. Apr, 2013, D/Exp. Mar, 2015, Mfg. By. M/s Mittal Laboratories Pvt. Limited, Sara Industrial Estate Ltd., Village-Rampur, Selaqui, Dehradun, Uttarakhand.	Disintegration 09458/2014-15 Dated 23-07-2014	CDSCO, East Zone	RDTL, Guwahati
6	PARACETAMOL TABLETS	B. No. 300414, D/Mfg. Apr, 2014, D/Exp. Mar, 2017, Mfg. By. M/s Veejay Laboratories, EPIP Zone, Amingaon, Guwahati, Assam-781031.	Dissolution 09467/2014-15 Dated 25-07-2014	CDSCO, East Zone	RDTL, Guwahati
7	PARACETAMOL TABLETS	B. No. 180414, D/Mfg. Apr, 2014, D/Exp. Mar, 2016, Mfg. By. M/s Veejay Laboratories, EPIP Zone, Amingaon, Guwahati, Assam-781031.	Dissolution and Uniformity of Weight 09468/2014-15 Dated 25-07-2014	CDSCO, East Zone	RDTL, Guwahati
8	RABMOL – 500 TABLETS	B. No. RAB-110, D/Mfg. Apr, 2014, D/Exp. Mar, 2016, Mfg. By. M/s Regent Ajanta Biotech, 86-87, Village-MakhiyaliDundi, Peerapura Road, Roorkee, Uttarakhand.	Dissolution 09472/2014-15 Dated 25-07-2014	CDSCO, East Zone	RDTL, Guwahati
9	PARACETAMOL TABLETS	B. No. 190414, D/Mfg. Apr, 2014, D/Exp. Mar, 2016, Mfg. By. M/s Veejay Laboratories, EPIP Zone, Amingaon, Guwahati, Assam-781031.	Dissolution 09473/2014-15 Dated 25-07-2014	CDSCO, East Zone	RDTL, Guwahati
10	PARACETAMOL TABLETS	B. No. 260414, D/Mfg. Apr, 2014, D/Exp. Mar, 2017, Mfg. By. M/s Veejay Laboratories, EPIP Zone, Amingaon, Guwahati, Assam-781031.	Dissolution 09474/2014-15 Dated 25-07-2014	CDSCO, East Zone	RDTL, Guwahati
11	Bupivacaine Heavy (Bupivacaine Hydrochloride & Dextrose Injection USP)	B. No.: I-3864                                     Mfgdt: 05/2013, Expdt: 04/2015, Mfd by: M/s. Jackson Laboratories Pvt. Ltd., Bye Pass, Majitha Road, Amritsar 143004	Description, Particulate Matter & Assay 32-1/2014-SS/DCA(N)-01/846            Dt. 21.07.2014	CDSCO, North Zone	CDL, Kolkata
12	Compound Sodium Lactate Injection IP 500 ml,	B. No.: P13D-612                               Mfgdt: 01/2013, Expdt: 12/2015, Mfd by: M/s. Parentral Drugs (I) Ltd., Vill: Sura, Suranusi, Jalandhar 144027	Assay of Sodium         32-1/2014-SS/DCA(N)-72/923            Dt. 25.07.2014	CDSCO, North Zone	CDL, Kolkata
13	Mefcin Forte (Mefanamic Acid &Paracetamol Tablets)	B. No.: MCF-020                                 Mfgdt: 07/2012, Expdt: 06/2014, Mfd by: M/s. Suzikem Drugs Pvt. Ltd., Plot No. 205/2A, IDA, Cherlapalli, Phase II, RR Dist 500051	Disintegration  32-12/2014-SS/DCA(H)-180/873            Dt. 23.07.2014	CDSCO, SubZone Hyderabad	CDL, Kolkata
14	Combipack of Artesunate Injection, Sodium Bicarbonate & Sodium Chloride Injection IP,	B.No: P2284,P2246,P2247Mfgdt: 10/2012, 09/2012, 09/2012, Expdt: 09/2014, 08/2015, 08/2015, Mfd by: M/s. Bharat Parenterals Ltd., Haripura, Tal. Savli, Vadodara 391520	Particulate Matter & Clarity of Solution         32-9/2014-SS/DCA(W)-09/872           Dt. 23.07.2014	CDSCO, West Zone	CDL, Kolkata
15	Numbcaine Heavy 20mg/4ml (Bupivacaine Hydrochloride in Dextrose Injection USP),	B. No.: 2NUB12                                 Mfgdt: 01/2014, Expdt: 12/2015, Mfd by: M/s. Samarth Life Science Pvt. Ltd., Unit-II, Plot No. 2, Industrial Area, Lodhimajra, Baddi, H.P. 173205.	Description & Particulate Matter             32-20/2014-SS/DCA(J)-04/771            Dt. 03.07.2014	CDSCO, Sub-Zone, Jammu	CDL, Kolkata
16	Flexon (Ibuprofen &Paracetamol Tablets),	B. No.: D26C112                                   Mfgdt: 03/2012, Expdt: 02/2015, Mfd by: M/s. Aristo Pharmaceuticals Pvt. Ltd., Survey No. 371, KunbarFalia, Dabhel, Nani Daman 396210.	Disintegration 32-8/2014-SS/DCA(E)-123/911         Dt. 25.07.2014	CDSCO, East Zone	CDL, Kolkata
17	Niclo (Diclofenac Sodium Injection IP 3ml)	B. No.: L13D04017                                    Mfgdt: 08/2013, Expdt: 07/2016, Mfd by: M/s. N.I. Pharmaceutical Works (P) Ltd., Boral Main Road, PaschimNischintapur, BagherGhole, Kolkata 700 103, W.B.	Extractable Volume & Particulate Matter                   32-8/2014-SS/DCA(E)-05/868                  Dt. 22.07.2014	CDSCO, East Zone	CDL, Kolkata
18	Rifampicin Capsules BP 300 mg (RIFAMLIFE)	Batch No – RFM001                                 D/Mfg.    ­– 05/2012, D/Exp.    – 05/2015, Mfd. By- M/s. EUROLIFE HEALTHCARE PVT.LTD., 69-A, Mittal Chambers, Nariman Point,  Mumbai-400 021.	Dissolution RDTL/897/13-14                 Date:- 14-07-14	CDSCO, North Zone	RDTL, Chandigarh
19	C-Biotic Ear Drop	Batch No – ULO-4419                           D/Mfg.    ­– SEP./13, D/Exp.    – AUG./15, Mfd. By-M/s. UltratechParmaceuticals,(An ISO 9001:2000 & GMP Certified Company) Vill.Tipra, P.O.:Barotiwala, Distt.Solan (H.P.)	Assay of Clotrimazole and Lignocaine Hydrochloride RDTL/629/13-14 Date:- 25-07-14	CDSCO, Sub-Zone, Chandigarh	RDTL, Chandigarh
20	FLUCONAZOLE CAPSULES (FLZ-150)	Batch No – CE1106                            D/Mfg.    ­– 10/2012, D/Exp.    – 10/2015, Mfd. By- M/s. GRACURE PHARMACEUTICALS LTD., Bhiwadi,  (Raj)	Uniformity of filled weight & Dissolution RDTL/885/13-14 Date:- 22-07-14	CDSCO, North Zone	RDTL, Chandigarh
21	Maxclave 625 (Amoxycillin&Clavulanate Potassium tablets IP)	Batch No –MLT-033,                             D/Mfg. -07/2013, D/Exp. – 12/2014, Mfd. By- M/s. MaxmedLifesciencesPvt Ltd., Plot-No. 5, Sec. IIDC, Sidcul, Rudrapur (Uttarakhand)	Assay of Clavulanic Acid	CDSCO, Goa	CDTL, Mumbai

Specification and Criteria for Acceptance for test performed on blood glucose test strip and analyzer based glucose reagents

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IDMA launches its 7th state board in Telegana Our Bureau, Chennai Saturday, August 09, 2014, 08:00 Hrs [IST]

The Telengana state board (chapter) of the Indian Drug Manufacturers’ Association (IDMA) was launched by the deputy chief minister of the state, Dr T Rajaiah on August 3. This is the 7th state branch of IDMA in the country.

At the inaugural meeting, the deputy CM said the government of Telengana plans to launch an International Pharma City near Hyderabad in a land area of 7000 acres, with an outlay of Rs.5000 crore. The pharma city will comprise cluster units of all manufacturing plants of the bulk drug industries and formulations. 

IDMA president S V Veeramani said the Telengana government has a number of projects and programmes for the promotion of pharma industry. The pharma industry in Telengana contributes 25per cent of the total pharmaceutical exports from India.

The launch meeting was attended by 180 people from various bulk drugs and formulation industries. The new state board of IDMA has already got membership strength of 50 manufacturing units, said Veeramani. The new branch will act in Telengana in association with bulk drug manufacturers association and other pharmaceutical manufacturers associations there.

The licencing and controlling authority of the drugs control department in Talengana, M Amrutha Rao was the guest of honour in the meeting. S V Veeramani presided.

http://www.pharmabiz.com/NewsDetails.aspx?aid=83440&sid=1

New AP govt plans to transform state into next medical hub of India A Raju, Hyderabad Saturday, August 09, 2014, 08:00 Hrs [IST]

By strengthening Vishaka Institute of Medical Sciences (VIMS) in Visakhapatnam and Sri Venkateshwara Institute of Medical Sciences (SVIMS) in Tirupati and establishing a new All India Institute of Medical Sciences (AIIMS) in Krishan-Guntoor, the state government of Andhra Pradesh is planning to make AP as the next medical hub of India. 

Government of Andhra Pradesh (AP) is drafting a comprehensive plan to make the new state of AP the next medical hub of India. In view of this, the government has divided the entire state of 13 districts of AP into 3 clusters North, Central and Southern and establishing one AIIMS like instate in each cluster. 

In each cluster, apart from strengthening the infrastructure in the government hospitals, the state government is also planning to establish one AIIMS like institute to meet the quality healthcare needs of the state. For this, the state government has already earmarked to strengthen the already existing VIMS in the northern cluster at Visakhapatnam and SVIMS in Tirupati in the Southern cluster. While in the central cluster in between Guntoor and Krishna districts, the state government has already sent a proposal to the central government to establish new AIIMS and the proposal has already been accepted by the central government. 

“We want to make Andhra Pradesh the next medical hub of India. We have not only ordered to take all measures to improve and strengthen existing healthcare infrastructure in all the government hospitals, but our plan is also to establish AIIMS like world class standard institutes in all the 3 clusters across the state. VIMS will serve in the North, AIIMS will serve in the central and SVIMS will serve the southern cluster of districts in the state,” said Chandrababu Naidu, chief minister of Andhra Pradesh.

The state government is also planning to link all the government hospitals and the state level healthcare institutes with top notch and advanced medical institutes in the country. By this the state government plans to provide the best of best medical facilities to the people and make the state the medical hub of the country.

Prior to bifurcation, the entire healthcare infrastructure was developed and concentrated only in Hyderabad, because of which, people had to come from far away districts like srikakulam, chittoor to Hyderabad for availing advanced treatment of chronic disease. But now AP has formed into a new state, the state government wants to create its own healthcare infrastructure on par with world standards. 

Moreover, the state government has also enhanced the limit of Aarogyasri healthcare scheme from Rs.2 lakh to Rs.2.5 lakh, under which the poor patients can avail high quality healthcare and treatment for various diseases. To make the Aarogyasri scheme more transparent and accountable, the state government has decided to link with Aadhaar cards of all white ration card holders with Aarogysri cards. For this, the state health department is planning to issue fresh Aarogysri cards called NTR Aarogyasri cards in the next one month.

http://www.pharmabiz.com/NewsDetails.aspx?aid=83439&sid=1

CCI imposes Rs.1.41 cr penalty on chemist association Ferozepur for anti-competitive practices Shardul Nautiyal, Mumbai Saturday, August 09, 2014, 08:00 Hrs [IST]

The Competition Commission of India (CCI) has imposed a fine of Rs.1.41 crore against Chemists and Druggists Association, Ferozepur (CDAF), Punjab alleging inter alia contravention of the provisions of sections 3 and 4 of the Competition Act. As per sources, copy of the order was received by CDAF on 31 July, 2014. 

Earlier in February last year, the CCI had also directed AIOCD to cease and desist from indulging in and following practices which have been found anti-competitive in violation of Section 3 of the Competition Act. The Commission had also imposed a penalty of Rs.47 lakh on the trade body and directed it to file an undertaking that the practices carried on by it and its members regarding grant of NOC for appointment of stockists, fixation of trade margins, collection of PIS (product information service) charges and boycott of products of pharmaceutical companies have been discontinued within 60 days from the date of receipt of this order.

The case against CDAF was filed by Arora Medical Hall, a registered partnership firm engaged in the business of wholesale trade of medicines in Ferozepur, Punjab through its partner Rajesh Arora under section 19(1) (a) of the Competition Act, 2002 against CDAF and its office - bearers alleging inter alia contravention of the provisions of sections 3 and 4 of the Act. 

Arora Medical Hall holds the wholesale dealership of a number of companies like Ranbaxy, Abbott Solvey, Abbott Piramal, Abbott India, Ozone, Sun Pharma, Alkem, Alkem Gencare, Hetero, Johnson & Johnson, Pfizer, Pfizer Pharmacia, Cutic, Leeford, Canvarzys, Inuida, Apex Labs, Organon, MSD, Fullford, Biocon, Macleods etc and accordingly, it distributes and sells medicines of these companies to the retailers in Ferozepur District.

Arora Medical Hall has alleged that CDAF has made it mandatory for any chemist or druggist, who wishes to take distributorship for medicines of a company in Ferozepur city, to take a No Objection Certificate (NOC) and Letter of Credit (LOC) from it by making a payment of Rs.2100 per company. It further states that it objected to the said rule in 2010, because of which it was expelled from the primary membership of CDAF.

In view of the above discussion, the Commission has directed CDAF to cease and desist from indulging in such anti competitive practices which have been found to be anti competitive in terms of the provisions of section 3 of the Act. 

As per the findings of the Commission, it is evident that CDAF, because of its position, is able to continuously engage in limiting and controlling the supply and market of the drugs and pharmaceutical products by insisting upon NOC for appointment of stockists etc. It cannot be doubted that had these practices not been there, the consumers or patients at large would have been benefited from the competition and consequential attended benefits arising therefrom in the markets.

Considering the totality of facts and circumstances of the present case including the nature of contravention, the Commission decides to impose a penalty on CDAF and its office bearers at the rate of 10 per cent of their respective average turnover which has been calculated as per the financial statements of income/receipts filed by the association/office bearers.

http://www.pharmabiz.com/NewsDetails.aspx?aid=83444&sid=1

Academicians hail govt's decision to introduce Pharm D in govt medical colleges to improve pharmacy education Peethaambaran Kunnathoor, Chennai Saturday, August 09, 2014, 08:00 Hrs [IST]

Academicians of pharmaceutical sciences from various educational institutions have welcomed the decision of the Union government to improve pharmacy education in the country by introducing Pharm D course in government medical colleges and increasing the number of institutions and the students intake there.

Hailing the announcement of health minister, Dr Harshvardhan, in this regard as a welcome move, the pharmacy teachers have commented that the minister’s dynamic initiative is an exemplary step towards the profession of pharmacy. Prof P Suresh, Principal of the Institute of Pharmacy & Technology, Cuttack, Orissa, said a need-based market driven dynamic curriculum for B. Pharm and M. Pharm with public-private partnership of industry-academia interaction process should be developed with an in-built provision for employability, skills/employment opportunities for all pharmacy graduates in the country.  

Likewise, the government should explore possibilities to discourage the practice of recruiting unqualified/under qualified persons of other streams in pharma industry as this will hinder the job opportunities for the pharmacy graduates.

Seeking the attention of the health minister in matters related to industry-academia interaction, Dr Suresh said the government should make it mandatory that the pharma industry needs to extend its support to the pharmacy educational institutions to upgrade their standards in tune with the requirements of the industry. In the same line, the Drugs & Cosmetics Act must be suitably amended in a profession friendly manner, emphasising on the need to recruit duly qualified pharmacy graduates in adequate numbers for its various operations.

Welcoming the union government’s supportive measures to pharmacy education, Dr K G Revikumar, director –research, Alshifa College of Pharmacy, Perinthalmanna in Kerala, said the union health ministry should take steps to constitute a competent and capable committee in order to study the present system of pharmacy education and its various components in the country and suggest measures to revamp the system on par with the global scenario.  

He said efforts are needed to create a strong coordination among AICTE, PCI and UGC because these agencies/authorities are controlling the pharmacy education. According to him, there were only four pharmacy colleges in the country till 1947, the number has increased to 1500 today.

http://www.pharmabiz.com/NewsDetails.aspx?aid=83443&sid=1

MAC Pune offers common branding & marketing platform for Ayurveda MSMEs Shardul Nautiyal, Mumbai Saturday, August 09, 2014, 08:00 Hrs [IST]

Aimed at implementing the concept of Health for All through the concept of Ayurveda, the second Ayurveda industry cluster namely Maharashtra Ayurved Centre Pvt Ltd (MAC) at Pune under the Centre's Ayush scheme has launched an online e-commerce portal - www.ayurways.biz to offer a common marketing platform for farmers, traders,  doctors, researchers, pharmacists and other stakeholders across the state.

The project will benefit around 900 Micro, Small and Medium Enterprises (MSMEs) through interventions like exhibition, production, contract manufacturing, raw material processing and will translate into 50 per cent cost saving in the respective businesses of the stakeholders.

Says Dr Sunita Belgamwar, chairperson of MAC, "The online business platform will not only help 49 members of MAC Pune but will also serve as a common interface for our distribution channels like Ayurveda Healthstore, Cafetaria, Exhibition and Pharmacy which will facilitate display of over 700 ayurvedic products under different brands."

The project cost of MAC Pune cluster which is the second Ayurveda cluster after Konkan in the state is Rs.17 crore of which an installment of Rs.4 crore is being awaited from the central government. Pune cluster will house a ayurvedic cafe for the development of Ayurveda cuisine, a dedicated raw material processing centre for supply of standardised, graded, certified and processed raw materials in bulk to the ayurvedic manufacturers.

The procurement of the raw materials will be done by the cluster from the farmers growing herbal and medicinal plants across the country by setting up backward linkages. 

Spanning an area of 45,000 square feet built up facility, the cluster will have a common facility centre at Kolewadi with its corporate office at Pune. The project is also estimated to give employment to 108 people directly and 1000 people indirectly. It is also envisaged to establish EU/USA FDA approved manufacturing facilities in three years, setting up advanced teaching institutes, create exclusive exports division in five years, establish 15 exclusive herbal and Ayurveda products distribution centres (Ayurways stores) by 2015 across Maharashtra. 

http://www.pharmabiz.com/NewsDetails.aspx?aid=83442&sid=1

Indian Pharmaceutical Association unveils postal stamp as part of Platinum jubilee celebrations Our Bureau, Bengaluru Saturday, August 09, 2014, 08:00 Hrs [IST]

The Indian Pharmaceutical Association (IPA)  has released a postal stamp on the occasion of the Platinum jubilee celebrations here in Bengaluru. We need to commemorate the 75 years of the Association.   The stamp is priced at Rs.5. The landmark effort of Platinum jubilee needs to be remembered and observed, said Dr. TV Narayana, vice president IPA and chairman Education Division, IPA. The event also saw the release of a Guide to Medication by a Pharmacist. The handy booklet was brought out by Co-Pharma Trust, a 45-year old not-for-profit venture working to promote the importance of pharmacists. The initiative is the brainchild of Dr. DA Gundu Rao, president, Karnataka Pharmacy Council. The 64-page booklet was complied by Dr Gundu Rao, PS Bhagawan, Samson P George and Y Veranarayana Gowda. It provides an informative details on mediation and methods of use, general medication discipline, storage, procurement, disposal, dosage and use. It also provided addresses of the regulatory departments that consumers could access in the event of a doubt on the medicine quality. A section of the booklet has also highlighted the importance of  pharmacy as a career along with details of how to apply for admissions in the college. The comprehensive booklet is targeted to the common man and efforts are on to release the edition in Kannada which will be useful to a layman in the state. In fact this is a first of its kind booklet providing useful information, said Dr Gundu Rao. The day-long platinum jubilee celebrations, evolved around the theme of ‘Excellence in quality- Applying learning to practice’, had regulatory officials, industry professionals, academia and community pharmacists as participants. Karnataka drugs controller Raghurama Bhandary who is the president, IPA Karnataka chapter said in his opening remarks that the event was a platform to network with the regulatory authorities, industry and academia. The event organised by IPA and IPA Karnataka branch was important when the pharma industry being at the cross roads and had to put up with the increasing expectations from global regulators. Therefore, it is the right time for the industry to attend and understand all the learnings and apply it, said Dr Rao V S V Vadlamudi, president, Indian Pharmaceutical Association and director, St Peter's Institute of Pharmaceutical Sciences. http://www.pharmabiz.com/NewsDetails.aspx?aid=83441&sid=1

NSAID use may mask early pneumonia symptoms By Joanna Lyford, Senior medwireNews Reporter 04 August 2014 J Crit Care 2014; Advance online publication

medwireNews: People with pneumococcal pneumonia who are taking nonsteroidal anti-inflammatory drugs (NSAIDs) at the point of diagnosis tend to develop more severe disease despite being younger and healthier than those not using these drugs, shows research.

The team behind the finding hypothesises that NSAID use may mask initial symptoms and delay antimicrobial therapy.

“Our data support the need for a prospective and multicenter study to determine if early NSAID use may predispose to worse outcomes in young adults with pneumococcal pneumonia”, write Jean-Damien Ricard (CHU Louis Mourier, Colombes, France) and team in the Journal of Critical Care.

For this study, Ricard and his team retrospectively identified all adults with a confirmed diagnosis of pneumococcal community-acquired pneumonia (CAP) who were admitted to an intensive care unit (ICU) over a 12-year period.

Of 106 patients, 20 had taken an NSAID in the 4 days prior to hospital admission. Usually, NSAIDs had been prescribed by the patient’s general practitioner (GP) for symptoms of lower respiratory tract infection (LRTI) such as fever, chest pain or cough.

Interestingly, patients who had taken NSAIDs were younger, on average, than those who had not taken NSAIDs, at 43.3 versus 62.2 years. They were also healthier, with just 40% having one or more comorbid condition, versus 75% of those who were not taking NSAIDs.

Despite this, the course of pneumonia was more severe in NSAID-exposed patients. They had a significantly higher frequency of new-onset pleuropulmonary complications (45 vs 12%) and complicated pleural effusions (20 vs 2%) compared with non-exposed patients.

All pleural effusions were strongly exudative, and multivariate analysis identified NSAID use as the only significant independent predictor of pleural effusion/pulmonary abscess (odds ratio [OR]=4.04), whereas the presence of at least one comorbidity was protective (OR=0.29).

The length of stay in intensive care and mortality were similar irrespective of NSAID use, however.

Ricard et al say their data “highlight the potential danger of NSAID consumption at the early stage of undiagnosed pneumococcal CAP, which leads mostly young, active, and otherwise healthy adults to the ICU.”

They write: “Because mortality in this population is not null, we believe that GPs should be alerted on the risks of providing NSAIDs without antibiotics in patients with LRTI symptoms that runs the risk of blunting general signs, thus delaying seeking medical care with consequently worse symptoms at presentation.”

medwireNews (www.medwirenews.com) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2014

http://www.medwirenews.com/43/105784/Infectious_Diseases/NSAID_use_may_mask_early_pneumonia_symptoms_.html

Inadequate management common in young-onset Type 2 diabetes By Laura Cowen, medwireNews Reporter 08 August 2014 Lancet Diabetes Endocrinol 2014; Advance online publication

medwireNews: Patients with young-onset Type 2 diabetes have worse metabolic control than those with late-onset disease, but they are less likely to receive organ-protective drugs, show data from the Joint Asia Diabetes Evaluation (JADE) cohort.

These findings “suggest an impending epidemic of young-onset diabetic complications”, write Juliana Chan (The Chinese University of Hong Kong) and study co-authors in The Lancet Diabetes and Endocrinology.

The researchers found that 18% of 41,029 patients with Type 2 diabetes, enrolled from 245 institutions in nine countries across Asia over a 5-year period, were diagnosed with the disease before the age of 40 years. The mean age at diagnosis for these patients was 32.9 years compared with 53.9 years for patients with late-onset diabetes (diagnosed at 40 years or older).

Patients with young-onset diabetes also had longer disease duration than those with late-onset diabetes (median 10 vs 5 years), and were more likely to be men (57 vs 52%), obese (35 vs 26%), have a family history of diabetes (67 vs 53%), use alcohol occasionally or regularly (33 vs 27%) and be a current smoker (17 vs 14%).

In terms of disease control, patients with young-onset diabetes had significantly higher concentrations of glycated haemoglobin (HbA1c) than those with late-onset diabetes (mean 8.32 vs 7.69%) and were significantly less likely to achieve HbA1c concentrations lower than 7% (27 vs 42%), despite being more likely to be receiving insulin (24 vs 15%).

Young-onset Type 2 diabetes was also associated with higher low-density lipoprotein cholesterol levels (2.78 vs 2.74 mmol/L) and a higher prevalence of diabetic retinopathy (20 vs 18%).

However, patients with young-onset disease were less likely than those with late-onset diabetes to receive statins (31 vs 37%), antihypertensives (31 vs 38%) and renin-angiotensin-system inhibitors (25 vs 29%).

“These data are concerning in view of the proven benefits of early control of cardiometabolic risk factors on long-term risk of complications,” say the researchers.

After adjusting for disease duration and other major confounders, Chan and team found that younger age at diagnosis was still significantly and independently associated with poor glycaemic control. And this finding was “consistent across all countries despite the wide range of clinical practices, health-care systems, and coverage for insurance and medication”, they note.

In an accompanying editorial, Soon Song, from Northern General Hospital in Sheffield, UK, says that the study findings have several important clinical ramifications. Principally, “they emphasise that suboptimum treatment of risk factors is widespread, affecting individuals with young-onset disease across different age groups”.

He concludes that, if the future of these young patients is going to improve, immediate changes are required at all levels “from the restructuring of health-care systems to the changing of clinicians’ mind-set”.

medwireNews (www.medwirenews.com) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2014

http://www.medwirenews.com/42/105792/Endocrinology_and_metabolism/Inadequate_management_common_in_young-onset_Type_2_diabetes.html

EMA accepts Pfizer's application seeking new indication for Prevenar 13 for prevention of pneumococcal pneumonia in adults New York Saturday, August 09, 2014, 09:00 Hrs [IST]

The European Medicines Agency (EMA) has accepted Pfizer’s application seeking to expand the indication for Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) in adults to include the prevention of pneumonia caused by the 13 pneumococcal serotypes contained in the vaccine.

“Pneumococcal pneumonia continues to be a serious health problem, causing significant illness and mortality in older adults,” said Dr. Emilio A. Emini, senior vice president, vaccine research and development, Pfizer. “The results of the Community-Acquired Pneumonia Trial in Adults study underscore the potential benefits of Prevenar 13 in preventing disease in this age group.”

This application is based on the positive results of the landmark Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), which demonstrated statistically significant reductions in vaccine-type pneumococcal community-acquired pneumonia (CAP), including non-invasive/non-bacteremic CAP, and invasive pneumococcal disease (IPD) in adults aged 65 and older. Prevenar 13 is currently approved for adults in Europe for the prevention of invasive pneumococcal disease.

Pfizer also recently submitted a supplemental Biologics Licence Application to the US Food and Drug Administration (US FDA) seeking to add efficacy data regarding the use of Prevnar 13 in older adults to the prescribing information and to meet its commitment under FDA's accelerated approval program. A decision regarding acceptance of this supplement for review by the FDA’s Center for Biologics Evaluation and Research (CBER) is expected by the end of September 2014. Pfizer plans to submit applications in other major markets, including Australia, Canada and Japan, later this year.

Pneumococcal disease refers to a group of illnesses caused by S. pneumoniae bacteria. Invasive pneumococcal disease occurs when bacteria enter the bloodstream or another site that is normally sterile. Non-invasive pneumococcal pneumonia occurs when the bacteria cause infection in the lungs but are not detected in the blood concurrently. In adults, pneumonia is the most common presentation of pneumococcal disease. For every one case of invasive pneumococcal pneumonia in adults, it is estimated that at least three cases of non-invasive pneumococcal pneumonia occur. While non-invasive forms of pneumococcal disease are typically more common, the invasive types of disease are generally more severe.

As part of its regulatory commitments under the FDA’s accelerated approval program, Pfizer conducted the CAPiTA study (Community-Acquired Pneumonia Immunisation Trial in Adults), which was designed to evaluate the efficacy of Prevnar 13 in the prevention of vaccine-type pneumococcal pneumonia. The study showed that Prevenar 13 prevented a first episode of vaccine-type community-acquired pneumonia (CAP) in adults 65 years of age and older, the study’s primary objective. This is one of the largest double-blind, randomised, placebo-controlled vaccine efficacy trials ever conducted in older adults to clearly demonstrate a significant reduction in vaccine-type pneumococcal CAP, and importantly, non-bacteremic/non-invasive vaccine-type pneumococcal CAP. It involved approximately 85,000 subjects aged 65 years and older and was conducted by Julius Clinical, a spin-off of the Julius Center for Health Sciences and Primary Care, a division of the University Medical Center Utrecht in the Netherlands. Fifty-eight sentinel hospitals were used for the surveillance of CAP and IPD. The safety profile of Prevenar 13 observed in the study was consistent with studies previously conducted in adults.

Prevenar 13 was first introduced for use in infants and young children in December 2009 in Europe and is now approved for such use in more than 120 countries worldwide, including the United States and Japan. It is the most widely used pneumococcal conjugate vaccine (PCV) in the world, and more than 640 million doses of Prevenar 7-valent/Prevenar 13 have been distributed worldwide. In addition, Prevenar 13 is approved for use in adults 50 years of age and older in more than 90 countries, and is also approved in the United States and European Union (EU) for use in older children and adolescents aged 6 to 17 years. Recently, Prevenar 13 was also approved in the EU for use in adults 18 to 49 years of age.

Prevnar 13 is a vaccine approved for adults 50 years of age and older for the prevention of pneumococcal pneumonia and invasive disease caused by 13 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). This indication is based upon immune responses to the vaccine; For children 6 weeks through 17 years of age, Prevnar 13 is approved for the prevention of invasive disease caused by the 13 vaccine strains, and for children 6 weeks through 5 years for the prevention of otitis media caused by 7 of the 13 strains;  Prevnar 13 is not 100per cent effective and will only help protect against the 13 strains included in the vaccine; Effectiveness when given less than 5 years after a pneumococcal polysaccharide vaccine is not known.

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FMRI collaborates with Delhi & Gurgaon police to enable green corridor from IGI Airport to FMRI Our Bureau, Mumbai Saturday, August 09, 2014, 10:30 Hrs [IST]

Fortis Memorial Research Institute (FMRI) recently collaborated with the Delhi and Gurgaon traffic police to set up a corridor of life between the IGI Airport and the Institute to enable quick uninterrupted passage to airlifted organs meant for human transplant, and will go a long way in saving valuable lives. A test run providing uninterrupted privileged road access was carried out that cut transport time to 15.42 minutes for the 15.5 km run.

The test-run carried out by FMRI, Delhi & Gurgaon traffic police worked with clockwork precision because of the seamless coordination between the hospital and the traffic police. FMRI also conducted an on-line poll to gauge the readiness for a green corridor in the city. The survey revealed that 66 per cent of the people who travel by road felt that Delhi-NCR is not yet adequately equipped to make green corridor a reality. However, 100 per cent of the participants felt that it was the need of the hour and that they would not mind to wait for an ambulance to pass for organs to reach the hospital to save a valuable life. Of this, 60 per cent respondents said that they were willing to wait for more than 30 minutes, if there was is such halt.

Dr Avnish Seth, director Fortis Organ Retrieval and Transplant (FORT) said, “The majority of organ donations in India are by living related donors, often involving considerable risk. Deceased donation following brain death can bridge the huge gap between the requirement and availability of organs in India. It is estimated that there is a need for more than 1,75,000 kidneys, 100,000 livers, 50,000 hearts, and 20,000 lungs in a year. A robust deceased donor program could give many terminally ill patients a fresh lease of life. Fortis Organ Retrieval and Transplant endeavors to create awareness about the noble act of donating organs following brain death. We encourage individuals to pledge their organs during life and inform the family about their decision. Our well trained transplant coordinators counsel and assist families in exercising their choice about organ and tissue donation after the death of a loved one.  FORT provides a 24- hour referral service for assistance with documentation and procedures related to organ and tissue donation.”

Earlier this year, the police commissioner and 70 senior police officials had pledged their organs at a workshop held at FMRI to raise awareness about organ donation.  Organ donation after brain death is a concept that is gradually gaining ground in India. In brain death, damage occurs to the brain because of stroke or head injury, the brain dies but the heart continues to beat for a few hours or days and the vital blood supply to the organs is maintained. Once the diagnosis of brain death is confirmed by the doctors and the family consents to donation, organs like kidneys, liver, heart, lungs, small intestine and pancreas, the organ can be retrieved and transplanted in needy recipients.

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