FDA Begins Listing All Drugs Under Investigation

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 adverse event report is drawn from hospitals, patients, doctors, and drug companies in regard to any suspicious problems that could have been caused from a medication already on the market. The FDA states, "The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk, or that FDA has identified a causal relationship between the drug and the listed risk. It is on the list only because FDA has identified a potential safety issue." The head of The FDA's Center for Drug Evaluation and Research, Dr. Janet Woodcock, said "My message to patients is this: Don't stop taking your medicine. If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently."

The quarterly lists will not be cumulative. Instead each quarterly report will contain only new listings of the drugs the FDA is investigating since the previous list was published. Hopefully, this new procedure will better educate the population of what the FDA is investigating and help ease concerns of the public and physicians of not knowing potential safely problems with drugs soon enough. Even though drugs go through many trials and must pass different tests before being sold on the market, there are times where some side effects or medical concerns are not realized until after the drug is widely used. The FDA will evaluate all concerns with the drugs on the list and report each potential signal, issue or any new safety information to the public as appropriate.

The initial list that includes drugs under review for potential health concerns from January to March 2008 contains the names of 20 drugs and their potential concern. The list lacks detail and doesn't list what led the FDA to realize the concern or the number of cases affected by the drugs. There are some consumer advocates that are raising concerns as to the usefulness of the list, since it doesn't include specifics into how widespread or serious the problems associated with the drugs are.

The FDA continues to investigate concerns of drug interactions, side effects and potential health threats to aid patients in receiving the best possible treatments. When you hear of FDA concerns in regards to marketed drugs it isn't always viewed negatively. It proves that the FDA continuously has an eye on the situation and drugs are not just released from the radar once they are on the market. Dr. Gerald Dal Pan, head of the FDA's drug safety office, highlights the change in the FDA's procedures by stating, "What's new here is that we are telling the public really at the earliest stage what we are working on." The hope of the FDA per Dr. Paul Seligman, who is responsible for the FDA's safety communications, is to not only communicate what the FDA is working on to the public, but to also encourage health care providers to supply any information they may have in regards to similar adverse events as those published on the list.

To see the list of drugs under review, visit the U.S. Food and Drug Administration.

Below is the current list of 20 drugs and the adverse events that the FDA currently has under investigation.

(1) Arginine Hydrochloride Injection (R-Gene 10)

Pediatric overdose due to labeling / packaging confusion

(2) Desflurane (Suprane)

Cardiac arrest (heart stops working)

(3) Duloxetine (Cymbalta)

Urinary retention

(4) Etravirine (Intelence)

Hemarthrosis (blood in a joint)

(5) Fluorouracil Cream (Carac) and Ketoconazole Cream (Kuric)

Adverse events due to name confusion

(6) Heparin

Anaphylactic-type (life-threatening allergic) reactions

(7) Icodextrin (Extraneal)

Hypoglycemia (low blood sugar)

(8) Insulin U-500 (Humulin R)

Dosing confusion

(9) Ivermectin (Stromectol) and Warfarin

Drug interaction

(10) Lapatinib (Tykerb)

Hepatotoxicity (liver toxicity)

(11) Lenalidomide (Revlimid)

Stevens-Johnson syndrome (a deadly drug reaction)

(12) Natalizumab (Tysabri)

Skin melanomas (deadly skin cancer)

(13) Nitroglycerin (Nitrostat)

Overdose due to labeling confusion

(14) Octreotide Acetate Depot (Sandostatin LAR)

Ileus (bowels not moving)

(15) Oxycodone Hydrochloride Controlled-Release (OxyContin)

Drug misuse, abuse, and overdose

(16) Perflutren Lipid Microsphere (Definity)

Cardiopulmonary reactions (lung/heart problems)

(17) Phenytoin Injection (Dilantin)

Purple glove syndrome (discoloration, pain, and swelling of the hand that
may lead to amputation)

(18) Quetiapine (Seroquel)

Overdose due to sample pack labeling confusion

(19) Tebivudine (Tyzeka)

Peripheral neuropathy (tingling or
numbness in the extremities)

(20) Tumor Necrosis Factor (TNF) Blockers

Cancers in children and young adults