The FDA has added information about Kawasaki disease to the label for the rotavirus vaccine (RotaTeq), but has not issued new warnings or precautions about the vaccine's use and maintains that it is safe.
The updated label includes information about six cases of Kawasaki disease that occurred during the drug's clinical trials and three cases reported since the vaccine was licensed in February 2006. The number of cases reported is no greater than the number that would be expected by chance. There is no known cause-and-effect relationship between the vaccine and the disease.
The FDA will monitor for additional cases of Kawasaki disease, but says that the vaccine is safe and effective and the "best way to protect a child against rotavirus disease."
Source: Physician's First Watch June 18th 2007
Detailed FDA report: http://www.fda.gov/cber/label/rotateqLBinfo.htm
Friday, June 22, 2007
FDA Advisory Panel Rejects Obesity Drug
An FDA advisory panel has voted unanimously not to recommend sale in the U.S. of rimonabant, a widely anticipated antiobesity drug, the New York Times reports.
The drug, available in 37 countries, was rejected "because of worries that it causes neurological and psychiatric problems and increases the risk of suicide," according to the newspaper.
Rimonabant is a cannabinoid-receptor blocker. In clinical studies, it had shown favorable effects not only on weight loss but also on fasting glucose, HDL cholesterol, and triglycerides.
Source: Physician’s First Watch June 15th 2007
Link: http://www.nytimes.com/2007/06/14/business/14drugs.html?ex=1182657600&en=1879e8c6b01830c7&ei=5070
The drug, available in 37 countries, was rejected "because of worries that it causes neurological and psychiatric problems and increases the risk of suicide," according to the newspaper.
Rimonabant is a cannabinoid-receptor blocker. In clinical studies, it had shown favorable effects not only on weight loss but also on fasting glucose, HDL cholesterol, and triglycerides.
Source: Physician’s First Watch June 15th 2007
Link: http://www.nytimes.com/2007/06/14/business/14drugs.html?ex=1182657600&en=1879e8c6b01830c7&ei=5070
Wednesday, June 13, 2007
Indian Drug Regulator to investigate Glitazones
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
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
Thursday, June 7, 2007
FDA Asks for Black-Box Warning on Heart Failure Risk with Thiazolidinediones
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 2007
http://www.nytimes.com/2007/06/07/health/07drug.html?_r=1&hp=&adxnnl=1&oref=slogin&adxnnlx=1181219366-DOm2snpHxZbSZJFCCGfiqw
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 2007
http://www.nytimes.com/2007/06/07/health/07drug.html?_r=1&hp=&adxnnl=1&oref=slogin&adxnnlx=1181219366-DOm2snpHxZbSZJFCCGfiqw
Tuesday, June 5, 2007
Interstitial Nephritis Associated with Omeprazole
Case
A 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. The exact duration of treatment with rofecoxib was unclear.
Omeprazole was changed to ranitidine and the man was treated with tapering doses of prednisolone, commencing at 75 mg daily. On examination three years later, his creatinine had improved to 123 micromol/L.
Comment
Acute interstitial nephritis is due to a hypersensitivity reaction and is typically associated with reversible acute renal failure. Drugs account for 71% of cases of acute interstitial nephritis.Medicines commonly implicated include non-steroidal anti-inflammatory drugs (NSAIDs), penicillins, cephalosporins, sulfonamides and proton pump inhibitors. Drug-induced interstitial nephritis is not dose dependent and can recur with rechallenge. The classic triad for interstitial nephritis of fever, rash and eosinophilia occurs in less than 10% of cases.Urine examination including microscopy may show haematuria, proteinuria, white cells, casts and eosinophiluria, but may be unremarkable.
Interstitial nephritis may occur with all of the proton pump inhibitors, although most reports to the Australian Adverse Drug Reactions Advisory Committee (ADRAC) have been with omeprazole.To date (14 May 2007) ADRAC have 82 reports associated with proton pump inhibitors. Of these cases, 50 were associated with omeprazole, 12 with esomeprazole, 6 with pantoprazole and 14 with rabeprazole. The duration of proton pump inhibitor treatment before presentation is usually between two weeks and nine months.
The temporal relationship in this case suggests that omeprazole was the most likely cause of interstitial nephritis, although the possibility that amoxycillin, pantoprazole or the NSAID were implicated cannot be excluded.
For more detailed information refer to the source article
Interstitial Nephritis Associated with Omeprazole (Aust Prescr 2007;30:67)
http://www.australianprescriber.com/magazine/30/3/artid/884/
A 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. The exact duration of treatment with rofecoxib was unclear.
Omeprazole was changed to ranitidine and the man was treated with tapering doses of prednisolone, commencing at 75 mg daily. On examination three years later, his creatinine had improved to 123 micromol/L.
Comment
Acute interstitial nephritis is due to a hypersensitivity reaction and is typically associated with reversible acute renal failure. Drugs account for 71% of cases of acute interstitial nephritis.Medicines commonly implicated include non-steroidal anti-inflammatory drugs (NSAIDs), penicillins, cephalosporins, sulfonamides and proton pump inhibitors. Drug-induced interstitial nephritis is not dose dependent and can recur with rechallenge. The classic triad for interstitial nephritis of fever, rash and eosinophilia occurs in less than 10% of cases.Urine examination including microscopy may show haematuria, proteinuria, white cells, casts and eosinophiluria, but may be unremarkable.
Interstitial nephritis may occur with all of the proton pump inhibitors, although most reports to the Australian Adverse Drug Reactions Advisory Committee (ADRAC) have been with omeprazole.To date (14 May 2007) ADRAC have 82 reports associated with proton pump inhibitors. Of these cases, 50 were associated with omeprazole, 12 with esomeprazole, 6 with pantoprazole and 14 with rabeprazole. The duration of proton pump inhibitor treatment before presentation is usually between two weeks and nine months.
The temporal relationship in this case suggests that omeprazole was the most likely cause of interstitial nephritis, although the possibility that amoxycillin, pantoprazole or the NSAID were implicated cannot be excluded.
For more detailed information refer to the source article
Interstitial Nephritis Associated with Omeprazole (Aust Prescr 2007;30:67)
http://www.australianprescriber.com/magazine/30/3/artid/884/
FDA Warns on Chinese-Manufactured Toothpaste
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.
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 2007
Reference: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01646.html
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