A 55 years old male patient, who is planned for bronchoscopy developed central anti-cholinergic syndrome due to therapeutic dose of atropine. Withdrawal of atropine has improved the symptoms. Thereafter, instillation of atropine as eye drops leads to reappearance of symptoms. The reaction was definite according to Naranjo's algorithm. It was severe and definitely preventable according to Modified Hartwig and Siegel's scale and Modified Schumock and Thornton scale respectively. Central anti-cholinergic syndrome may be due to variation in the genetic susceptibility (Idiosyncrasy) to atropine. Idiosyncratic reaction on administration of atropine as a pre-anesthetic medication or eye drops should be kept in mind while prescribing.
Background: As per World Trade Organisation (WTO), from the year 2005, India granted product patent recognition to all new chemical entities (NCEs). This may affect the new drug approvals in India. The purpose of this study was to compare the new drug approvals in India with the United States (US) and the European Union (EU) regions. Methods: We obtained information about regulatory approval of new drugs in the US, EU, or India of last 5 years (from 2011 through 2015) from the publicly accessible databases of three regulatory agencies. For the drug products identified, the drugs were classified into fourteen main Anatomical Therapeutic Chemical (ATC) groups, review classification and approval date. Results: There were 509 new drugs approved from 2011 through 2015 by one or more of the three regulatory agencies. Total 182 new drugs were approved in US during the period of 2011 to 2015, with an average of 36.4 new drugs approved per year. For the same period a total of 257 new drugs were approved in the EU, with an average of 51.4 new drugs approved per year and in India a total of 70 new drugs were approved, with an average of 14 new drugs approved per year. There were more number of new drug approvals in antineoplastic and immunomodulating agents (L) ATC group in all the three regions (US= 66; EU= 61 and India= 17). Conclusions: For new drugs approved between 2011 and 2015, India has lagged behind the US and the EU in approval of new drugs. There was no difference in the patterns of new drug approvals with respect to the therapeutic areas.
The objective of this study was to see the trends of new drug approvals by the U.S. FDA in last 5 years and find the therapeutic areas with higher new drug approvals. METHODS We obtained information about regulatory approvals by the U.S. FDA from publicly accessible databases at Drugs@FDA. 3 The definition of "new drug" included ABSTRACT Background: The U.S Food and Drugs Administration (FDA) is the world's leading drug regulatory authority. There are reports of more product pipelines in oncology therapy area. The objective of this study was to see the overall trends of new drug approvals by the U.S. FDA in last 5 years and find the therapeutic areas with higher new drug approvals. Methods: New drug approvals data obtained from publicly available databases of the U.S. FDA from 2011 through 2015. For the drug products identified, the drugs were classified into fourteen main Anatomical Therapeutic Chemical (ATC) groups, single or combination products, New Drug Application (NDA) chemical types, review classification and approval date. Results: There were 182 new drugs approved from 2011 through 2015 by the U.S. FDA with a mean of 36.4 approvals per year. Out of these 182 new drug approvals, 149 (81.87%) approvals were for new molecular entity (NME) and 33 (18.13%) for biologics license application (BLA). There were more number of new drug approvals in antineoplastic and immunomodulating agents (L) ATC group (n=66; 36.26% of total new drug approvals). Conclusions: For new drugs approved between 2011 and 2015, the U.S. FDA was first to approve majority of new drugs. There was upward trend of new drug approvals in antineoplastic therapeutic area.
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