ADR Monitoring Centre, PGIMS, Rohtak

30/03/2016

Your comments are invited :)

30/03/2016

17/03/2016

Here is the complete and authentic list of Fixed Doze Combinations (FDCs) banned by CDSCO (March 10, 2016)

1. Aceclofenac + Paracetamol + Rabeprazole
2. Nimesulide + Diclofenac
3. Nimesulide + Cetirizine + Caffeine
4. Nimesulide + Tizanidine
5. Paracetamol + Cetirizine + Caffeine
6. Diclofenac + Tramadol + Chlorzoxazone
7. Dicyclomine + Paracetamol + Domperidone
8. Nimesulide + Paracetamol dispersible tablets
9. Paracetamol + Phenylephrine + Caffeine
10. Diclofenac + Tramadol + Paracetamol
11. Diclofenac + Paracetamol + Chlorzoxazone + Famotidine
12. Naproxen + Paracetamol
13. Nimesulide + Serratiopeptidase
14. Paracetamol + Diclofenac + Famotidine
15. Nimesulide + Pitofenone + Fenpiverinium + Benzyl Alcohol
16. Omeprazole + Paracetamol + Diclofenac
17. Nimesulide + Paracetamol injection
18. Tamsulosin + Diclofenac
19. Paracetamol + Phenylephrine + Chlorpheniramine + Dextromethorphan + Caffeine
20. Diclofenac + Zinc Carnosine
21. Diclofenac + Paracetamol + Chlorpheniramine Maleate + Magnesium Trisillicate
22. Paracetamol + Pseudoephedrine + Cetrizine
23. Phenylbutazone + Sodium Salicylate
24. Lornoxicam + Paracetamol + Trypsin
25. Paracetamol + Mefenamic Acid + Ranitidine + Dicyclomine
26. Nimesulide + Dicyclomine
27. Heparin + Diclofenac
28. Glucosamine + Methyl Sulfonyl Methane + Vitamin D3 + Manganese + Boron + Copper+ Zinc
29. Paracetamol + Tapentadol
30. Tranexamic Acid + Proanthocyanidin
31. Benzoxonium Chloride + Lidocaine
32. Lornoxicam + Paracetamol + Tramadol
33. Lornoxicam + Paracetamol + Serratiopeptidase
34. Diclofenac + Paracetamol + Magnesium Trisilicate
35. Paracetamol + Domperidone + Caffeine
36. Ammonium Chloride + Sodium Citrate + Chlorpheniramine Maleate + Menthol
37. Paracetamol + Prochlorperazine Maleate
38. Serratiopeptidase (enteric coated 20000 units) + Diclofenac Potassium & 2 tablets of Doxycycline
39. Nimesulide + Paracetamol Suspension
40. Aceclofenac + Paracetamol + Famotidine
41. Aceclofenac + Zinc Carnosine
42. Paracetamol + Disodium Hydrogen Citrate + Caffeine
43. Paracetamol + DL Methionine
44. Disodium Hydrogen Citrate + Paracetamol
45. Paracetamol + Caffeine + Codeine
46. Aceclofenac (SR) + Paracetamol
47. Diclofenac + Paracetamol injection
48. Azithromycin + Cefixime
49. Amoxicillin + Dicloxacillin
50. Amoxicillin 250 mg + Potassium Clavulanate Diluted 62.5 mg
51. Azithromycin + Levofloxacin
52. Cefixime + Linezolid
53. Amoxicillin + Cefixime + Potassium Clavulanic Acid
54. Ofloxacin + Nitazoxanide
55. Cefpodoxime Proxetil + Levofloxacin
56. Combikit of Azithromycin, Secnidazole and Fluconazole
57. Levofloxacin + Ornidazole + Alpha Tocopherol Acetate
58. Nimorazole + Ofloxacin
59. Azithromycin + Ofloxacin
60. Amoxycillin + Tinidazole
61. Doxycycline + Serratiopeptidase
62. Cefixime + Levofloxacin
63. Ofloxacin + Metronidazole + Zinc Acetate
64. Diphenoxylate + Atropine + Furazolidone
65. Combikit of Fluconazole Tablet, Azithromycin Tablet and Ornidazole Tablets
66. Ciprofloxacin + Phenazopyridine
67. Amoxycillin + Dicloxacillin + Serratiopeptidase
68. Azithromycin + Cefpodoxime
69. Lignocaine + Clotrimazole + Ofloxacin + Beclomethasone
70. Cefuroxime + Linezolid
71. Ofloxacin + Ornidazole + Zinc Bisglycinate
72. Metronidazole + Norfloxacin
73. Amoxicillin + Bromhexine
74. Ciprofloxacin + Fluticasone + Clotrimazole + Neomycin
75. Metronidazole + Tetracycline
76. Cephalexin + Neomycin + Prednisolone
77. Azithromycin + Ambroxol
78. Cilnidipine + Metoprolol Succinate + Metoprolol Tartrate
79. L-Arginine + Sildenafil
80. Atorvastatin + Vitamin D3 + Folic Acid + Vitamin B12 + Pyridoxine
81. Metformin + Atorvastatin
82. Clindamycin + Telmisartan
83. Olmesartan + Hydrochlorothiazide + Chlorthalidone
84. L-5-Methyltetrahydrofolate Calcium + Escitalopram
85. Pholcodine + Promethazine
86. Paracetamol + Promethazine
87. Betahistine + Ginkgo Biloba Extract + Vinpocetine + Piracetam
88. Cetirizine + Diethyl Carbamazine
89. Doxylamine + Pyridoxine + Mefenamic Acid + Paracetamol
90. Drotaverine + Clidinium + Chlordiazepoxide
91. Imipramine + Diazepam
92. Flupentixol + Escitalopram
93. Paracetamol + Prochloperazine
94. Gabapentin + Mecobalamin + Pyridoxine + Thiamine
95. Imipramine + Chlordiazepoxide + Trifluoperazine + Trihexyphenidyl
96. Chlorpromazine + Trihexyphenidyl
97. Ursodeoxycholic Acid + Silymarin
98. Metformin 1000/1000/500/500mg + Pioglitazone 7.5/7.5/7.5/7.5mg + Glimepiride 1/2/1/2mg
99. Gliclazide 80 mg + Metformin 325 mg
100. Voglibose+ Metformin + Chromium Picolinate
101. Pioglitazone 7.5/7.5mg + Metformin 500/1000mg
102. Glimepiride 1mg/2mg/3mg + Pioglitazone 15mg/15mg/15mg + Metformin 1000mg/ 1000mg/1000mg
103. Glimepiride 1mg/2mg+ Pioglitazone 15mg/15mg + Metformin 850mg/850mg
104. Metformin 850mg + Pioglitazone 7.5 mg + Glimepiride 2mg
105. Metformin 850mg + Pioglitazone 7.5 mg + Glimepiride 1mg
106. Metformin 500mg/500mg+Gliclazide SR 30mg/60mg + Pioglitazone 7.5mg/7.5mg
107. Voglibose + Pioglitazone + Metformin
108. Metformin + Bromocriptine
109. Metformin + Glimepiride + Methylcobalamin
110. Pioglitazone 30 mg + Metformin 500 mg
111. Glimepiride + Pioglitazone + Metformin
112. Glipizide 2.5mg + Metformin 400 mg
113. Pioglitazone 15mg + Metformin 850 mg
114. Metformin ER + Gliclazide MR + Voglibose
115. Chromium Polynicotinate + Metformin
116. Metformin + Gliclazide + Piogllitazone + Chromium Polynicotinate
117. Metformin + Gliclazide + Chromium Polynicotinate
118. Glibenclamide + Metformin (SR)+ Pioglitazone
119. Metformin (Sustainded Release) 500mg + Pioglitazone 15 mg + Glimepiride 3mg
120. Metformin (SR) 500mg + Pioglitazone 5mg
121. Chloramphenicol + Beclomethasone + Clomitrimazole + Lignocaine
122. Clotrimazole + Ofloxaxin + Lignocaine + Glycerine and Propylene Glycol
123. Chloramphennicol + Lignocaine + Betamethasone + Clotrimazole + Ofloxacin + Antipyrine
124. Ofloxacin + Clotrimazole + Betamethasone + Lignocaine
125. Gentamicin Sulphate + Clotrimazole + Betamethasone + Lignocaine
126. Clotrimazole + Beclomethasone + Ofloxacin + Lignocaine
127. Becloemthasone + Clotrimazole + Chloramphenicol + Gentamycin + Lignocaine Ear drops
128. Flunarizine + Paracetamole + Domperidone
129. Rabeprazole + Zinc Carnosine
130. Magaldrate + Famotidine + Simethicone
131. Cyproheptadine + Thiamine
132. Magaldrate + Ranitidine + Pancreatin + Domperidone
133. Ranitidine + Magaldrate + Simethicone
134. Magaldrate + Papain + Fungul Diastase + Simethicone
135. Rabeprazole + Zinc + Domperidone
136. Famotidine + Oxytacaine + Magaldrate
137. Ranitidine + Domperidone + Simethicone
138. Alginic Acid + Sodium Bicarbonate + Dried Aluminium Hydroxide + Magnesium Hydroxide
139. Clidinium + Paracetamol + Dicyclomine + Activated Dimethicone
140. Furazolidone + Metronidazole + Loperamide
141. Rabeprazole + Diclofenac + Paracetamol
142. Ranitidine + Magaldrate
143. Norfloxacin + Metronidazole + Zinc Acetate
144. Zinc Carnosine + Oxetacaine
145. Oxetacaine + Magaldrate + Famotidine
146. Pantoprazole (as Enteric Coated Tablet) + Zinc Carnosine (as Film Coated Tablets)
147. Zinc Carnosine + Magnesium Hydroxide + Dried Aluminium Hydroxide + Simethicone
148. Zinc Carnosine + Sucralfate
149. Mebeverine & Inner HPMC capsule (Streptococcus Faecalis + Clostridium butyricum + Bacillus mesentricus + Lactic Acid Bacillus)
150. Clindamycin + Clotrimazole + Lactic Acid Bacillus
151. Sildenafil + Estradiol Valerate
152. Clomifene Citrate + Ubidecarenone + Zinc + Folic Acid + Methylcobalamin + Pyridoxine + Lycopene + Selenium + Levocarnitine Tartrate + L-Arginine
153. Thyroxine + Pyridoxine + Folic Acid
154. Gentamycin + Dexamethasone + Chloramphenicol + Tobramycin + Ofloxacin
155. Dextromethorphan + Levocetirizine + Phenylephrine + Zinc
156. Nimesulide + Loratadine + Phenylephrine + Ambroxol
157. Bromhexine + Phenylephrine + Chlorepheniramine Maleate
158. Dextromethorphan + Bromhexine + Guaiphenesin
159. Paracetamol + Loratadine + Phenylephrine + Dextromethorphan + Caffeine
160. Nimesulide + Phenylephrine + Caffeine + Levocetirizine
161. Azithromycin + Acebrophylline
162. Diphenhydramine + Terpine + Ammonium Chloride + Sodium Chloride + Menthol
163. Nimesulide + Paracetamol + Cetirizine + Phenylephrine
164. Paracetamol + Loratadine + Dextromethophan + Pseudoepheridine + Caffeine
165. Chlorpheniramine Maleate+Dextromethorphan+Guaiphenesin+Ammonium Chloride + Menthol
166. Chlorpheniramine Maleate + Ammonium Chloride + Sodium Citrate
167. Cetirizine + Phenylephrine + Paracetamol + Zinc Gluconate
168. Ambroxol + Guaiphenesin + Ammonium Chloride + Phenylephrine + Chlorpheniramine Maleate + Menthol
169. Dextromethorphen + Bromhexine + Chlorpheniramine Maleate + Guaiphenesin
170. Levocetirizine + Ambroxol + Phenylephrine + Guaiphenesin
171. Dextromethorphan + Chlorpheniramine + Chlorpheniramine Maleate
172. Cetirizine + Ambroxol + Guaiphenesin + Ammonium Chloride + Phenylephrine +Menthol
173. Chlorpheniramine + Phenylephrine + Caffeine
174. Dextromethorphan + Triprolidine + Phenylephrine
175. Terpinhydrate + Dextromethorphan + Menthol
176. Dextromethorphan + Phenylephrine + Zinc Gluconate + Menthol
177. Chlorpheniramine + Codeine + Sodium Citrate + Menthol Syrup
178. Enrofloxacin + Bromhexin
179. Bromhexine + Dextromethorphan + Phenylephrine + Menthol
180. Levofloxacin + Bromhexine
181. Levocetirizine + Ranitidine
182. Levocetirizine + Phenylephrine + Ambroxol + Guaiphenesin + Paracetamol
183. Cetirizine + Dextromethorphan + Phenylephrine + Zinc Gluconate + Paracetamol +Menthol
184. Paracetamol + Pseudoephedrine + Dextromethorphan + Cetirizine
185. Diphenhydramine + Guaiphenesin + Ammonium Chloride + Bromhexine
186. Chlorpheniramine + Dextromethorphan + Phenylephrine + Paracetamol
187. Dextromethorphen + Promethazine
188. Diethylcabamazine Citrate + Cetirizine + Guaiphenesin
189. Pseudoephedrine + Dextromethorphan + Cetirizine
190. Chlorpheniramine + Phenylephrine + Dextromethophan + Menthol
191. Ambroxol + Terbutaline + Dextromethorphan
192. Dextromethorphan + Chlorpheniramine + Guaiphenesin
193. Terbutaline + Bromhexine + Guaiphenesin + Dextromethorphan
194. Dextromethorphan + Tripolidine + Phenylephirine
195. Paracetamol + Dextromethorphan + Chlorpheniramine
196. Pholcodine + Phenylephrine + Promethazine
197. Codeine + Levocetirizine + Menthol
198. Dextromethorphan + Ambroxol + Guaifenesin + Phenylephrine + Chlorpheniramine
199. Cetirizine + Phenylephrine + Dextromethorphan + Menthol
200. Roxithromycin + Serratiopeptidase
201. Paracetamol + Phenylephrine + Triprolidine
202. Acetaminophen + Loratadine + Ambroxol + Phenylephrine
203. Cetirizine + Acetaminophen + Dextromethorphan + Phenyephrine + Zinc Gluconate
204. Diphenhydramine + Guaifenesin + Bromhexine + Ammonium Chloride + Menthol
205. Chlopheniramine Maleate + Codeine Syrup
206. Cetirizine + Dextromethorphan + Zinc Gluconate + Menthol
207. Paracetamol + Phenylephrine + Desloratadine + Zinc Gluconate + Ambroxol
208. Levocetirizine + Montelukast + Acebrophylline
209. Dextromethorphan + Phenylephrine + Ammonium Chloride + Menthol
210. Dextromethorphan + Bromhexine + Guaiphenesin + Menthol
211. Acrivastine + Paracetamol + Caffeine + Phenylephrine
212. Naphazoline + Carboxy Methyl Cellulose + Menthol + Camphor + Phenylephrine
213. Dextromethorphan + Cetirizine
214. Nimesulide + Paracetamol + Levocetirizine + Phenylephrine + Caffeine
215. Terbutaline + Ambroxol + Guaiphenesin + Zinc + Menthol
216. Codeine + Chlorpheniramine + Alcohol Syrup
217. Dextromethorphan + Phenylephrine + Guaifenesin + Triprolidine
218. Ammomium Chloride + Bromhexine + Dextromethorphan
219. Diethylcarbamazine + Cetirizine + Ambroxol
220. Ethylmorphine + Noscapine + Chlorpheniramine
221. Cetirizine + Dextromethorphan + Ambroxol
222. Bromhexine + Dextromethorphan + Ammonium Chloride + Menthol
223. Ambroxol + Guaifenesin + Phenylephrine + Chlorpheniramine
224. Paracetamol + Phenylephrine + Chlorpheniramine + Zinc Gluconate
225. Dextromethorphan + Phenylephrine + Cetirizine + Paracetamol + Caffeine
226. Dextromethophan + Chlorpheniramine + Guaifenesin + Ammonium Chloride
227. Levocetirizine + Dextromethorphan + Zinc
228. Paracetamol + Phenylephrine + Levocetirizine + Caffeine
229. Chlorphaniramine + Ammonium Chloride + Sodium Chloride
230. Paracetamol + Dextromethorphan + Bromhexine + Phenylephrine + Diphenhydramine
231. Salbutamol + Bromhexine + Guaiphenesin + Menthol
232. Chlorpheniramine + Ammonium Chloride + Noscapine + Sodium Citrate
233. Cetirizine + Dextromethorphan + Bromhexine + Guaifenesin
234. Diethyl Carbamazine + Chlorpheniramine + Guaifenesin
235. Ketotifen + Cetirizine
236. Terbutaline + Bromhexine + Etofylline
237. Ketotifen + Theophylline
238. Ambroxol + Salbutamol + Theophylline
239. Cetririzine + Nimesulide + Phenylephrine
240. Chlorpheniramine + Phenylephrine + Paracetamol + Zink Gluconate
241. Acetaminophen + Guaifenesin + Dextromethorphan + Chlorpheniramine
242. Cetirizine + Dextromethorphan + Phenylephrine + Tulsi
243. Cetirizine + Phenylephrine + Paracetamol + Ambroxol + Caffeine
244. Guaifenesin + Dextromethorphan
245. Levocetirizine + Paracetamol + Phenylephirine + Caffeine
246. Caffeine + Paracetamol + Phenylephrine + Chlorpheniramine
247. Ketotifen + Levocetrizine
248. Paracetamol + Levocetirizine + Phenylephirine + Zink Gluconate
249. Paracetamol + Phenylephrine + Triprolidine + Caffeine
250. Caffeine + Paracetamol + Phenylephrine + Cetirizine
251. Caffeine + Paracetamol + Chlorpheniramine
252. Ammonium Chloride + Dextromethorphan + Cetirizine + Menthol
253. Dextromethorphan + Paracetamol + Cetirizine + Phenylephrine
254. Chlorpheniramine + Terpin + Antimony Potassium Tartrate + Ammonium Chloride + Sodium Citrate + Menthol
255. Terbutaline + Etofylline + Ambroxol
256. Paracetamol + Codeine + Chlorpheniramine
257. Paracetamol+Pseudoephedrine+Certirizine+Caffeine
258. Chlorpheniramine+Ammonium Chloride + Menthol
259. N-Acetyl Cysteine + Ambroxol + Phenylephrine + Levocertirizine
260. Dextromethorphan + Phenylephrine + Tripolidine + Menthol
261. Salbutamol + Certirizine + Ambroxol
262. Dextromethorphan + Phenylephrine + Bromhexine + Guaifenesin + Chlorpheniramine
263. Nimesulide + Certirizine + Phenylephrine
264. Naphazoline + Chlorpheniramine + Zinc Sulphate + Boric Acid + Sodium Chloride + Chlorobutol
265. Paracetamol + Bromhexine + Phenylephrine + Chlorpheniramine + Guaifenesin
266. Salbutamol + Bromhexine
267. Dextromethorphan + Phenylephrine + Guaifenesin + Certirizine + Acetaminophen
268. Guaifenesin + Bromhexine + Chlorpheniramine + Paracetamol
269. Chlorpheniramine + Ammonium Chloride + Chloroform + Menthol
270. Salbutamol + Choline Theophylinate + Ambroxol
271. Chlorpheniramine + Codeine Phosphate + Menthol Syrup
272. Pseudoephedrine + Bromhexine
273. Certirizine + Phenylephrine + Paracetamol + Caffeine + Nimesulide
274. Dextromethorphan + Cetirizine + Guaifenesin + Ammonium Chloride
275. Ambroxol + Salbutamol + Choline Theophyllinate + Menthol
276. Paracetamol + Chlorpheniramine + Ambroxol + Guaifenesin + Phenylephrine
277. Chlorpheniramine + Vasaka + Tolubalsm + Ammonium Chloride + Sodium Citrate + Menthol
278. Bromhexine + Cetrizine + Phenylephrine IP+Guaifenesin + Menthol
279. Dextromethorphan + Ambroxol + Ammonium Chloride + Chlorpheniramine + Menthol
280. Dextromethorphan + Phenylephrine + Cetirizine + Zinc + Menthol
281. Terbutaline + N-Acetyl L-Cysteine + Guaifenesin
282. Calcium Gluconate + Levocetirizine
283. Paracetamol + Levocetirizine + Pseudoephedrine
284. Salbutamol + Choline Theophylinate + Carbocisteine
285. Chlorpheniramine + Vitamin C
286. Calcium Gluconate + Chlorpheniramine + Vitamin C
287. Chlorpheniramine + Paracetamol + Pseudoephedrine + Caffeine
288. Guaifenesin + Bromhexine + Chlorpheniramine + Phenylephrine + Paracetamol + Serratiopeptidase (as enteric coated granules) 10000 SP Units
289. Paracetamol + Pheniramine
290. Betamethasone + Fusidic Acid + Gentamycin + Tolnaftate + lodochlorhydroxyquinoline (ICHQ)
291. Clobetasol + Ofloxacin + Miconazole + Zinc Sulphate
292. Clobetasole + Gentamicin + Miconazole + Zinc Sulphate
293. Levocetirizine + Ambroxol + Phenylephrine + Paracetamol
294. Permethrin + Cetrimide + Menthol
295. Beclomethasone + Clotimazole + Neomycin + lodochlorohydroxyquinone
296. Neomycin + Doxycycline
297. Ciprofloxacin + Fluocinolone + Clotrimazole + Neomycin + Chlorocresol
298. Clobetasol + Ofloxacin + Ketoconazol + Zinc Sulphate
299. Betamethasone + Gentamicin + Tolnaftate + lodochlorhydroxyquinoline
300. Clobetasol + Gentamicin + Tolnaftate + lodochlorhydroxyquinone + Ketoconazole
301. Allantoin + Dimethieone + Urea + Propylene + Glycerin + Liquid Paraffin
302. Acriflavine + Thymol + Cetrimide
303. Betamethasone + Neomycin + Tolnaftate + lodochlorohydroxyquinoline + Cholorocresol
304. Clobetasol + Neomycin + Miconazole + Clotrimazole
305. Ketoconazole + Tea Tree oil + Allantion + Zinc Oxide + Aloe Vera + Jojoba oil + Lavander oil + Soa noodels
306. Clobetasol Propionate + Ofloxacin + Ornidazole + Terbinafine
307. Clobetasol + Neomycin + Miconazole + Zinc Sulphate
308. Beclomethasone Diproprionate + Neomycin + Tolnaftate + lodochlorhydroxyquinoline + Chlorocresol
309. Betamethasone + Gentamycin + Zinc Sulphate + Clotrimoazole + Chlorocresol
310. Borax + Boric Acid + Naphazoline + Menthol + Camphor + Methyl Hydroxy Benzoate
311. Bromhexine + Dextromethorphan
312. Dextromethophan + Chlopheniramine + Bromhexine
313. Menthol + Anesthetic Ether
314. Dextrometharphan + Chlopheniramine + Ammonium + Sodium Citrate + Menthol
315. Ergotamine Tartrate + Belladona Dry Extract+Caffeine + Paracetamol
316. Phenytoin + Phenobarbitone
317. Gliclazide 40mg + Metformin 400mg
318. Paracetamol + Ambroxol + Phenylephrine + Chlorpheniramine
319. Oflaxacin + Ornidazole Suspension
320. Albuterol + Etofylline + Bromhexine + Menthol
321. Albuterol + Bromhexine + Theophylline
322. Salbutamol+Hydroxyethyltheophylline (Etofylline) + Bromhexine
323. Paracetamol+Phenylephrine+Levocetirizine+Sodium Citrate
324. Paracetamol + Propyphenazone + Caffeine
325. Guaifenesin + Diphenhydramine + Bromhexine + Phenylephrine
326. Dried Alumnium Hydroxie Gel + Prophantheline + Diazepam
327. Bromhenxine + Phenylephrine + Chlorpheniramine + Paracetamol
328. Beclomethasone + Clotrimazole + Gentamicin + lodochlorhydroxyquinoline
329. Telmisartan + Metformin
330. Ammonium Citrate + Vitamin B 12 + Folic Acid + Zinc Sulphate
331. Levothyroxine + Phyridoxine + Nicotinamide
332. Benfotiamine + Metformin
333. Thyroid + Thiamine + Riboflavin + Phyridoxine + Calcium Pantothenate + Tocopheryl Acetate + Nicotinamide
334. Ascorbic Acid + Manadione Sodium Bisulphate + Rutin + Dibasic Calcium Phosphate + Adrenochrome mono Semicarbazone
335. Phenylephrine + Chlorpheniramine + Paracetamol + Bromhexine + Caffeine
336. Clotrimazole + Beclomethasone + Lignocaine + Ofloxacin + Acetic Aicd + Sodium Methyl Paraben + Propyl Paraben

17/03/2016

Here is the list of Drug safety alerts with regards to Pregnant population.

Use of medicine in Pregnancy- Safety information

1. Isotretinoin induced psychiatric and female reproductive disorders (Teratogenic effects like serious craniofacial, cardiovascular, thymic and CNS malformation)
2. Ciprofloxacin induced foetal death
3. Phenytoin induced congenital anomaly
4. Carbamazepine induced multiple joint contractures of new born
5. Sodium valproate induced congenital anomaly

17/03/2016

It is request to All Healthcare Professionals inculding Clinicians, Nurses, Clinical Pharmacists, Pharmacists, General Practitioners and Consumers (Patients), kindly update yourself with the following Drug Safety alerts.
SO whenever you prescribe or see any of the drug given below kindly be aware about the possible reaction given below.

Here is the list of Adverse drug reactions caused by the drugs reached to IPC from ICSRs received from across the country:

Drug alerts from PvPI

1. Pipracillin + Tazobactum induced Bronchospasm, Hypokalemia, loss of appetite
2. Ferrous sulphate induced Haematemesis
3. Ticagrelor induced Monoparesis
4. Ceftriaxone induced Hepatitis, peripheral neuropathy
5. Lohexol induced Eosinophilia
6. Carbimazole induced Appetite loss
7. Efavirenz induced granulomatous leisons
8. Cisplatin induced micturition painful
9. Hydroxychloroquine induced Melaena
10. Trihexiphenidyl hydrochloride induced SJS
11. Neomercazole induced Weight loss
12. Methotrexate induced Hepatotoxicity
13. Deferasirox induced pancreatitis
14. DPP-IV inhibitors Sitagliptin, saxagliptin, linagliptin, vildagliptin and alogliptin induced Joint pain/Arthralgia
15. Epoitin beta induced Retinopathy
16. SGLT2 inhibitors like Canagliflozin, dapagliflozin and empagliflozin) induced DKA
17. Leflunomide induced SJS, Hepatic disorder
18. Meropenem induced Ludwig angina (Cellulitis)
19. Sodium valproate induced slurred speech
20. Sildenafil induced cyanosis
21. Vecuronium induced cardio-respiratory arrest
22. Oseltamivir induced Photophobia
23. Ziprasidone induced DRESS syndrome
24. Ambroxol+ Bromhexine induced Skin reaction like SJS
25. Artemether+Lumefantrine induced SJS
26. Rota vaccine induced Intussusception
27. Bedaquiline induced neuropathy, NHL, Death, Fever, cough, dyspnea
28. Rabies vaccine induced Erythema multiforme
29. Mannitol induced hypokalemia
30. Sunitinib induced Hepatotoxicity (Monitor for ALT/AST, Billirubin, nausea, vomiting, severe stomach/abdominal pain, dark urine, pale stool, yellowish eyes/skin), Haemorrhage (Monitor for CBC, Platelets, PT/INR), CHF, IHD
31. Pazopanib hydrochloride induced Cardiac dysfunction, CHF, IHD (monitor for fast/irregular heartbeat, dizziness, fainting, radiating chest pain, SOB, )
32. Carbamazepine induced TEN, SJS
33. Nitrofurantoin is C/I in patients with estimated GFR less than 45ml/min/1.73m2

27/11/2015

What is the difference between side effect and ADR?

A side effect is any unintended effect of a pharmaceutical product occurring at doses normally used by a patient which is related to the pharmacological properties of the drug.
An adverse event or experience is defined as any untoward medical occurrence that may present during treatment with a medicine but which does not necessarily have a causal relationship with this treatment.

27/11/2015

What is an adverse reaction (AR)?

An adverse reaction is a noxious and unintended response to a marketed product that occurs at any dose used or tested for the diagnosis, treatment or prevention of a disease or for modifying an organic function

What is an adverse drug reaction (ADR)?

It is a noxious response to a drug which is unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function

27/11/2015

What is an adverse event (AE)?

An adverse event is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does necessarily have to have a causal relationship with this treatment

27/11/2015

What is Pharmacovigilance?

Pharmacovigilance, as defined by the World Health Organization, is the science and activities relating to the detection, assessment, understanding and prevention of adverse events or any other possible drug-related problems. Recent inclusions to this definition are: herbals, traditional and complementary medicines, blood products, biologicals, medical devices and vaccines.

27/11/2015