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Cancer Risk; DRAP Advises Halt in Ranitidine Production

Food and Drug Regulatory Authority of the US made an announcement on September 13th, which alerted the pharmaceutical industry and public alike. FDA had determined that N-nitrosodimethylamine (NDMA) could be produced during the manufacturing of ranitidine drugs. Ranitidine (commonly marketed under ‘Zantac’) is a common heartburn medicine/antacid, which is easily available over the counter.

NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

The industry was roiled last year when it learned that NDMA and two other suspected carcinogens could form during the manufacturing of the commonly used “sartan” blood pressure meds valsartan, losartan and irbesartan.

But the industry only just learned that the same kind of production phenomenon also applied to ranitidine-containing drugs. Regulators and the industry were tipped off to the problem by online pharmacy Valisure, which discovered it during its own testing. The company then filed a Citizen Petition calling on the FDA to seek a market recall of all of the drugs and establish standards for testing and manufacturing.

Several pharma manufacturers have begun to voluntarily recall all Ranitidine drugs. Concerned countries are now placing ban on the import and distribution of these drugs as well.

Drug Regulatory Authority of Pakistan (DRAP) has issued notice to pharmaceutical companies across the countries to halt Ranitidine drugs production and to recall all such products already on the market.

The DRAP letter stated: FDA and Euro­pean Medicines Agency (EMA) are evaluating the risk associated with low levels of NDMA in Rani­tidine. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. Drap is closely working with international regulatory agencies to monitor the outcome of the investigations. However, in the greater public interest and in order to protect patients from probable risk associated with the detection of low levels of NDMA in Ranitidine, it is advised to suspend production for all dosage forms of Ranitidine-containing drugs till further orders; the stoppage of the release/distribution of all dosage forms of Ranitidine-containing drugs till further orders; and the stoppage of the sale/supply/utilisation of all dosage-forms of Ranitidine-containing drugs till further orders. Furthermore, it is requested to initiate the recall of the medicine available in sale outlets/distributors/hospitals/healthcare facilities.

Following are the brand names by which ranitidine is being marketed in Pakistan:

Brand Name Manufacturer/Mnf. Representative
ACEDONIL GLOBAL PHARMACEUTICALS
ACIDRAN VALOR PHARMACEUTICALS
ALTAL ALSON PHARMACEUTICALS
ANZOL INDUS PHARMA (PVT) LTD.
BIODINE TABS ALKEMY PHARMACEUTICAL LABORATORIES (PRIVATE) LTD.
CHASE SHROOQ PHARMACEUTICALS
DANITN MIRACLE PHARMACEUTICALS(PVT) LTD
DART MEDICAIDS PAKISTAN (PVT) LTD.
DEGUST HYGEIA PHARMACEUTICALS
DINETAC UNEXO LABS (PVT) LTD.
DINOLIVE OLIVE PHARMACEUTICALS
DUOTEC ASKARI PHARMACEUTICALS.
FESNIDINE ALFALAH PHARMA (PVT) LTD.
FOZAB PEARL & PEARL
GERTOCALM NOBLE PHARMA
GLAMET SPENCER PHARMA
H2 REC ZAFA PHARMACEUTICAL LABORATORIES (PVT) LTD.
HEALALSER LISKO PAKISTAN (PVT) LTD
KANTAC DRUG PHARM (PVT) LTD.
LOMADRYL MEEZAB INTERNATIONAL
MARIQUINE LISKO PAKISTAN (PVT) LTD
MONOCID WEBROS PHARMACEUTICALS
NAZDAC FYNK PHARMACEUTICALS
NIPODUR A.J. & COMPANY.
NITID DANAS PHARMACEUTICALS (PVT) LTD
NITISAF SAAAF PHARMACEUTICALS
NOULCE LOWITT PHARMACEUTICALS (PVT) LTD
NULCER BOSCH PHARMACEUTICALS (PVT) LTD.
OBATIDINE OBSONS PHARMACEUTICALS
PEPTAC MASS PHARMA (PRIVATE) LIMITED
PEPTICURE NABIQASIM INDUSTRIES (PVT) LTD.
PEPTINIL WILSONS PHARMACEUTICALS
PUROD CAYLEX PHARMACEUTICALS (PVT) LTD.
PYRAD GENOME PHARMACEUTICALS (PVT) LTD
RADICON MEDISURE LABORATORIES PAKISTAN (PVT.) LTD.
RAMAT BLOOM PHARMACEUTICALS (PVT) LTD.
RAMED-AC RAAZEE THERAPUTICS (PVT) LTD.
RANAX STANDPHARM PAKISTAN (PVT) LTD.
RANEXIN AKSON PHARMACEUTICALS (PVT) LTD.
RANI Siam Pharmaceuticals
RANIDIN FEROZSONS LABORATOIES LTD.
RANIGARD VEGA PHARMACEUTICALS LTD.
RANILOC ORTA LABS. (PVT) LTD.
RANIPEP DAVIS PHARMACEUTICAL LABORATORIES
RANISCOT SCOTMANN PHARMACEUTICALS
RANISON LIFE LINE PHARMACEUTICALS (PVT.) LTD.
RANIZAN MEDIZAN LABS (PVT) LTD
RANTAB JAWA PHARMACEUTICALS(PVT) LTD.
RANTAC SAPIENT PHARMA
RANTID CIBEX (PRIVATE) LIMITED
RANTIN MACTER INTERNATIONAL (PVT) LTD.
RANULCID MERCK PRIVATE LTD.
RATAC PARAMOUNT PHARMACEUTICALS
RATIDINE TABLET GRAY`S PHARMACEUTICALS
RELIANCE MEGA PHARMACEUTICALS (PVT) LTD
RENACID DRUGS INN PAKISTAN
RENATA PLATINUM PHARMACEUTICALS (PVT.) LTD.
RENATIL GOODMAN LABORATORIES
RENERA MEDERA PHARMACEUTICALS (PVT) LTD.
RENILOC ORTA LABS. (PVT) LTD.
RENOXID AXIS PHARMACEUTICALS
RESOTAC RASCO PHARMA
REXOTIDE REX PHARMACEUTICALS PAKISTAN
RINAI Z-JANS PHARMACEUTICAL (PVT) LTD.
RIO MACQUINS INTERNATIONAL
RITADINE CHAS. A. MENDOZA
STOMACID WERRICK PHARMACEUTICALS
TAGNA PANACEA PHARMACEUTICALS
TATIDINE DOSACO LABORATORIES
TIOBINE GRAY`S PHARMACEUTICALS
ULCEMED MEDICEENA PHARMA (PVT) LTD.
ULCENOR FLOW PHARMACEUTICALS (PVT) LTD.
ULCER OFF UNIPHARMA (PVT) LTD.
ULCERID MEDICRAFT PHARMACEUTICALS (PVT) LTD.
ULSFREE ZESION PHARMACEUTICAL (PVT) LTD
XETAC XENON PHARMACEUTICALS (PVT) LTD.
XETRON HIGH – Q INTERNATIONAL
ZANIATE MEDIATE PHARMACEUTICALS (PVT) LTD
ZANTAC GLAXOSMITHKLINE
ZENIT DR. RAZA PHARMA (PRIVATE) LIMITED
ZOMTIC ALLIANCE PHARMACEUTICALS (PVT) LTD.

 

September 25, 2019

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