Cymbalta Under FDA Investigation

Cymbalta, which is used to treat Fibromyalgia and ME/CFS patients, is one of 20 drugs currently under investigation by the FDA. It is under investigation due to the possibility of urinary retention.

To better inform the health care world and patients, the FDA is now posting quarterly an online list of all new drugs under investigation. This new procedure was implemented after Congress passed a law in 2007 requiring the FDA to publish any new safety warnings or potential serious risks based on their review of the adverse event report.

The FDA warns that the drugs on their quarterly list do not conclude that the drug has the listed risk. It is on the list because the FDA has identified a “potential safety issue”.

Here are the 20 drugs currently listed, along with the listed risks for each one:

• 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

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