Pharmacovigilance

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Indian Drug Regulator to investigate Glitazones
2007-06-13 06:52:00
The Indian drug regulator (Drug Controller General of India DCGI) will now investigate safety concerns on Avandia and Actos, two key diabetes medicines that could potentially be affecting 10 million diabetics in India.The move follows the US Food and Drug Administration (FDA) directive putting both the drugs, Rosiglitazone and Pioglitazone, under the strictest drug safety warnings (Black Box) following the publication of recent studies linking them to an increased risk of heart failures.Versions of Avandia are being sold by Indian companies such as Sun Pharmaceuticals Ltd, Cipla Ltd, Glenmark Pharmaceuticals Ltd and Torrent Pharmaceuticals Ltd, besides Glaxo’s GSK Pharmaceuticals Ltd unit.Source: http://www.livemint.com/2007/06/08002046/ DrugregulatorasksGSK-for-Av.html
More About: Zones , Tiga

FDA Asks for Black-Box Warning on Heart Failure Risk with Thiazolidinedione
2007-06-07 14:33:00
The US FDA commissioner revealed that the agency has requested the manufacturers of rosiglitazone (Avandia) and pioglitazone (Actos) to add black-box warnings about the risk for heart failure with these drugs.The FDA indicated that the request was made because although the drugs currently carry warnings about potential heart failure, they are still sometimes being prescribed to patients with this condition thus creating a need for stricter action.Reference: New York Times dated 7th June 2007http://www.nytimes.com/2007/06/07/hea lth/07drug.html?_r=1&hp=&adxnnl=1&ore f=slogin&adxnnlx=1181219366-DOm2snpHx ZbSZJFCCGfiqw
More About: Black , Heart , Failure , Warning , Risk

Interstitial Nephritis Associated with Omeprazole
2007-06-05 10:18:00
CaseA 62-year-old man presented with acute renal failure. On examination, there were no allergic features such as rash, fever or eosinophilia. Urine examination was normal. Previous renal function was normal. His creatinine peaked at 470 micromol/L. Investigations included tests for anti-neutrophil cytoplasmic and antinuclear antibodies, antibodies against extractable nuclear antigens, double-stranded DNA, complement, hepatitis serology, serum paraprotein concentration and renal ultrasound, all of which were normal. Renal biopsy showed florid interstitial nephritis. A few weeks earlier, he was diagnosed with Helicobacter gastritis and treated with triple therapy (omeprazole, amoxycillin, clarithromycin) followed by omeprazole 40 mg daily. He had previously been taking pantoprazole for dyspepsia. Other medical history included a knee injury six months earlier. This had been treated with diclofenac, which was associated with the development of a rash and was substituted with rofecoxib...
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FDA Warns on Chinese-Manufactured Toothpaste
2007-06-05 10:15:00
The FDA is warning consumers to throw out any Chinese toothpaste after it found a component of antifreeze in several products.Because diethylene glycol (DEG) is not always listed in the ingredients on the package, the FDA says people should examine their toothpaste and discard any imported from China. So far there have been no reports of injuries from DEG-contaminated toothpaste, but there have been deaths in several countries from DEG-contaminated products like cough syrup. The FDA is concerned about chronic exposure to DEG, particularly to vulnerable populations like children and people with kidney or liver disease.Source: Physician's First Watch June 4 2007Reference: http://www.fda.gov/bbs/topics/NEWS/2007/N EW01646.html
More About: Toothpaste , Manu , Paste

Rosiglitazone
2007-05-29 14:10:00
FDA NewsFOR IMMEDIATE RELEASEP07-88May 21, 2007Media Inquiries:Susan Cruzan, 301-827-6242Consumer Inquiries:888-INFO-FDAFDA Issues Safety Alert on AvandiaThe U.S. Food and Drug Administration (FDA) is aware of a potentialsafety issue related to Avandia (rosiglitazone) , a drug approved totreat type 2 diabetes. Safety data from controlled clinical trialshave shown that there is a potentially significant increase in therisk of heart attack and heart-related deaths in patients takingAvandia. However, other published and unpublished data from long-termclinical trials of Avandia, including an interim analysis of data fromthe RECORD trial (a large, ongoing, randomized open label trial) andunpublished reanalyses of data from DREAM (a previously conductedplacebo-controlled, randomized trial) provide contradictory evidenceabout the risks in patients treated with Avandia.Patients who are taking Avandia, especially those who are known tohave underlying heart disease or who are at high risk of ...