Here are some safety advisory and news for your speed update.
- HSA Alerts Public on Abbott’s Voluntary Recall of Medisense Optium™ Blood Glucose Test Strips
- HSA Warns Against Taking “Jianbu Huqian Wan”
- Safety Concerns of Paracetamol for Children Dispelled?
- FDA Starts Removal of Breast Cancer Indication for Avastin
- HSA Alerts Public on Abbott’s Voluntary Recall of Medisense Optium™ Blood Glucose Test Strips
The Health Sciences Authority (HSA) is overseeing the voluntary market recall of 43 affected lots of Abbott MediSense Optium™ Blood Glucose Test Strips by Abbott Laboratories (S) Pte Ltd. The blood monitoring device is not affected by this recall. For more info, click here.
- HSA Warns Against Taking “Jianbu Huqian Wan”
The Health Sciences Authority (HSA) has detected an adulterated health product labelled “JianBu HuQian Wan”, which was tested by HSA's Pharmaceutical Laboratory to contain two undeclared potent western medicinal ingredients, namely dexamethasone and chlorpheniramine, which are controlled under the Poisons Act. Read here for full details.
- Safety Concerns of Paracetamol for Children Dispelled?
Children are not mini-adults. This has always been the principle in modern pharmacotherapy. Health experts around the world have been scrutinizing causality of paracetamol use and the risk of acute liver injury. Though most experts view paracetamol as a safe drug when used as directed, there have been rare reports of toxicity occurring even when used with recommended doses. Dr. Eric J. Lavonas and colleagues of Rocky Mountain Poison and Drug Center systematically reviewed the medical literature to assess the rate at which liver injury has been reported for children prescribed therapeutic doses of paracetamol, defined as up to 75 mg/kg per day orally or intravenously or up to 100 mg/kg per day rectally. The results from 62 studies that enrolled 32,414 children were included. No child (0% [95% confidence interval: 0.000-0.009]) was reported to have exhibited signs or symptoms of liver disease, to have received an antidote or transplantation, or to have died. The review concluded that hepatoxicity after therapeutic dosing of paracetamol in children is rarely reported in defined-population studies. Case reports suggest that this phenomenon may occur, but few reports contain sufficient data to support a probable causal relationship.
- FDA Starts Removal of Breast Cancer Indication for Avastin
On 16-Dec-2010, US FDA notified healthcare professionals and patients that it is recommending removing the breast cancer indication for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use. The drug itself is not being removed from the market and today’s action will not have any immediate impact on its use in treating breast cancer. Today’s action will not affect the approvals for colon, kidney, brain, and lung cancers.
BACKGROUND: FDA is making this recommendation after reviewing the results of four clinical studies of Avastin in women with breast cancer and determining that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. None of the studies demonstrated that patients receiving Avastin lived longer and patients receiving Avastin experienced a significant increase in serious side effects. These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.
For full reporting, click here.
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