UP Ibalon Bicol: For safety, FDA monitors 20 drugs in the market

For safety, FDA monitors 20 drugs in the market

9/08/2008 | Posted by mesiamd | Edit Post

A 2007 federal law requires the Food and Drug Administration (FDA) to disclose reports from doctors, patients, hospitals, nurses and pharmaceutical companies problems surrounding a particular drug---from simple drug labelling concerns to serious side effects. The list doesn’t automatically imply that the drugs are unsafe and patients don't necessarily have to stop their medications.

Product Name:
Active Ingredient (Trade)
or Product Class----------------------------Potential Serious Risk/New Safety Info.

Arginine Hydrochloride Injection (R-Gene 10)----Pediatric overdose due to labeling
Desflurane (Suprane)----------------------------Cardiac arrest (heart stops working)
Duloxetine (Cymbalta)---------------------------Urinary retention
Etravirine (Intelence)-----------------------------Hemarthrosis (blood in a joint)
Fluorouracil Cream (Carac)
and Ketoconazole Cream (Kuric)---------------Adverse events due to name confusion
Heparin -------------------------------------anaphylactic-type allergic reactions

Icodextrin (Extraneal)---------------------------Hypoglycemia (low blood sugar)
Insulin U-500 (Humulin R)----------------------Dosing confusion
Ivermectin (Stromectol) and Warfarin---------Drug interaction
Lapatinib (Tykerb)-------------------------------Hepatotoxicity (liver toxicity)
Lenalidomide (Revlimid)--------------------------Stevens-Johnson syndrome
Natalizumab (Tysabri)----------------------------Skin melanomas (deadly skin cancer)

Nitroglycerin (Nitrostat)--------------------------Overdose due to labeling confusion
Octreotide Acetate Depot (Sandostatin LAR)----Ileus (bowels not moving)
Oxycodone Hydrochloride
Controlled-Release (OxyContin)-------------------Drug misuse, abuse, and overdose
Perflutren Lipid Microsphere (Definity)----------Cardiopulmonary reactions
Phenytoin Injection (Dilantin)----------------------Purple glove syndrome
Quetiapine (Seroquel)------------------------------Overdose due to labeling confusion
Tebivudine (Tyzeka)---------------------------------Peripheral neuropathy
Tumor Necrosis Factor (TNF) Blockers----------Pediatric cancers

For the first time, a quarterly report covering January 1 to March 31 2008 is issued scrutinizing certain medicines for their safety. Once the result of the drug evaluation is out, whether the drug has adverse effects or is confirmed safe, it will be reported in the Adverse Event Reporting System (ARES)to alert the public. Part of a drug safety initiative, the report evaluates the seriousness of a side-effect or if there is something unknown for a particular medicine which can pose a health problem. Source: WebHealthNews (09/05/08, DeNoon, DJ/Chang,L)=0=

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Supreme Court Courage Needed

"Intelligence can be inherited, education can be bought, expertise can be trained but courage is one thing that cannot be taught. And it is courage that is utterly lacking in our Supreme Court for a long time now. It a virtue Senators Diokno and Joker Arroyo had in abundance."---MyTy, Philippines

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Labels: Bicol Regional Training and Teaching Hospital, doctor as patient, drugs, FDA, Medicine, nurses, pharmaceuticals, side-effects, USA

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For safety, FDA monitors 20 drugs in the market

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