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Posted: September 09, 2008

Caregiver Alert: FDA Investigates 20 Drugs for Possible Side Effects


The Food and Drug Administration says it is investigating 20 drugs for potential patient side effects as part of a new effort by the federal agency to warn patients and health care professionals as early and thoroughly as possible.


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The FDA released a list of the drugs in question and said they were chosen for study based on a review of the drug agency’s Adverse Event Reporting System (AERS), which contains millions of reports of adverse events submitted to the FDA by drug manufacturers, health care professionals and patients.


The list represents a wide range of drugs in the market, from Eli Lilly & Co.'s antidepressant Cymbalta to Purdue Pharma LP's powerful but controversial painkiller Oxycontin. The FDA is examining these and the other 18 drugs for numerous potential adverse patient reactions, including cardiac arrest, cancer and what it called Purple Glove Syndrome, which can result in patients having their arms amputated.


The FDA list, which focuses on adverse events reported between January and March this year, will be updated and released to the public on a quarterly basis, the agency said.


At the same time, FDA stressed that just because a drug is on the list and under scrutiny is not a reason for any patient to stop taking a medication as prescribed by their doctor. Instead, the intention is for patients and doctors to use the list to be aware of potential adverse events and to encourage the reporting of any problems with the drugs to the FDA. The list doesn't represent a comprehensive list of drugs the FDA is investigating, a spokesman emphasized.


Some drugs on the list have been the subject of FDA attention for a while. For example, the FDA has already sent out warnings on a handful of the drugs, including TNF blockers, such as Johnson & Johnson's Remicade, which the agency said in June it was investigating to determine whether the drug may be associated with cancer in children.


There are first-time mentions of certain drugs on the list, too. The list includes the multiple sclerosis treatment Tysabri as potentially being associated with skin cancer, for example. Its inclusion follows reports in medical journals of cases of melanoma in patients taking the drug, but the FDA didn’t say it was investigating the drug for this side effect until now.


Here is a complete list of the 20 drugs under investigation, along with the reason for investigation:


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)


Fluorouracil Cream (Carac) and Ketoconazole Cream (Kuric)

Adverse events due to name confusion


Anaphylactic-type reactions

Icodextrin (Extraneal)


Insulin  U-500 (Humulin R)

Dosing confusion

Ivermectin (Stromectol) and Warfarin

Drug interaction

Lapatinib (Tykerb)


Lenalidomide (Revlimid)

Stevens Johnson Syndrome

Natalizumab (Tysabri)

Skin melanomas

Nitroglycerin (Nitrostat)

Overdose due to labeling confusion

Octreotide Acetate Depot (Sandostatin LAR)


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

Tumor Necrosis Factor (TNF) Blockers

Cancers in children and young adults


The full list and further information can be found on the FDA's website at this location:

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