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20 Drugs the FDA is Watching


The FDA (Food and Drug Administration) is the United States government agency that enforces laws on the manufacturing, testing, and use of medical drugs. They are also responsible for protecting and promoting the nation's public health. The FDA must approve a drug before it is made available to the public and they continue to monitor drugs once they are on the market.

 In 2007 a law was passed that required the FDA to allow consumers access to their reports on drug-related adverse reactions.

The information is gathered through a reporting program called The Adverse Event Reporting System (AERS)  The Adverse Event Reporting System (AERS) collects information from doctors, hospitals, patients and drug companies about problems that may (or may not) be related to a certain drug.

If a patient complains of a side effect, has trouble (confusion) with a label or name or if any other complaints are made about a certain drug, it is reported to The Adverse Event Reporting System.
 
The following drugs are on the list with the potential risk stated:

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

Duloxetine (Cymbalta)

Urinary retention

Etravirine (Intelence)

Hemarthrosis

Fluorouracil Cream (Carac) and Ketoconazole Cream (Kuric)

Adverse events due to name confusion

Heparin

Anaphylactic  type reactions

Icodextrin (Extraneal)

Hypoglycemia

Insulin  U 500 (Humulin R)

Dosing confusion

Ivermectin (Stromectol) and Warfarin

Drug interaction

Lapatinib (Tykerb)

Hepatotoxicity

Lenalidomide (Revlimid)

Stevens Johnson Syndrome

Natalizumab (Tysabri)

Skin melanomas

Nitroglycerin (Nitrostat)

Overdose due to labeling confusion

Octreotide Acetate Depot (Sandostatin LAR)

Ileus

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 sample pack labeling confusion

Telbivudine (Tyzeka)

Peripheral neuropathy (tingling in the extremities)

Tumor Necrosis Factor (TNF) Blockers

Cancers in children and young adults


The FDA has stated that just because a drug is on the list does not mean you should stop taking the drug if it has been prescribed to you or that doctors should stop prescribing the drug.  It only means that the drug and its potential risks are being investigated.

"If a drug is listed, it means we have begun an analysis to see if there is a safety problem that requires further evaluation," Gerald Dal Pan, MD, MPH, director of the FDA office of surveillance and epidemiology, said at a news conference.

Once the investigation is complete the FDA will issue further warnings, require name or label changes to eliminate any confusions or issue an all clear if the drug is deemed safe.

"This extends our commitment to keep the public and the health care community informed of what we are evaluating," Paul Seligman, MD, MPH, FDA associate director of safety policy and communication, said at the news conference.

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This article has been contributed by an Alternative Health Journal community member. It reflects the views of the author and only the author. The Alternative Health Journal makes no claims to the accuracy of the information contained within.

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