2007 federal law requires the FDA to disclose all its investigations into allegations of drugs, possibly associated with side effects. Today, the list of the first of this series of quarterly reports. The list includes the adverse events reported between 1 and 31 January in March 2008. FDA officials said that they would be "several weeks or months" before the recent reports are accepted.
All reports from the FDA on the list of early warning systems for drugs already on the market. This Adverse Events Reporting System (AERS) collects reports of patients, hospitals, doctors and pharmaceutical companies, the suspects may have problems - or not - in connection with drugs.
The fact that drugs in the list does not mean that it is not safe - or even suspicion that causes problems. No one should stop receiving the drug just because it is on the list, said, FDA.
"If the drug on the list, it means that we have already begun to analyse see if there is security gap, further evaluation", Gerald Dal Pan, MD, MPH, director of FDA surveillance and epidemiology, said in a press conference.
If the evaluation, FDA without any further warnings or all-clear, Dal Pan said.
Here is a list of drugs and "adverse events" - side effects - reported to the AERS database:
Report did not say how many people were affected by the possible reaction of drugs, and did not give any indication of its seriousness.Product Name: Active Ingredient (Trade) or Product Class Potential Signal of Serious Risk/New Safety Information Arginine Hydrochloride Injection (R-Gene 10) Pediatric overdose due to labeling / packaging confusion 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 (life-threatening 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 (a deadly drug reaction) 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 (lung/heart problems) Phenytoin Injection (Dilantin) Purple glove syndrome (discoloration, pain, and swelling of the hand that may lead to amputation) Quetiapine (Seroquel) Overdose due to sample pack labeling confusion Tebivudine (Tyzeka) Peripheral neuropathy (tingling or numbness in the extremities) Tumor Necrosis Factor (TNF) Blockers Cancers in children and young adults
"Our security measures, experts see the seriousness of the case, when we see more than a certain type of event, we should not expect, if there is anything new and did not know about drugs, or whether it is known, but may require refinement of our Knowledge ", Dal Pan said.
"This expands our commitment to the public and health care in the community abreast of what we appreciate," Paul Seligman, MD, MPH, FDA deputy director of security policy and communications, said at a press conference.
Source : http://www.medscape.com/viewarticle/580145?src=rss
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