The US Food and Drug Administration is planning to raise
awareness on possible side effects of drugs on quarterly basis. More exactly,
the agency will begin posting a list of drugs that present the risk of giving
strange “adverse events” every three months in order to give consumers and
health-care professionals early indications on what the FDA is investigating.
“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,” Dr. Janet Woodcock, who
heads the FDA's Center for Drug Evaluation and Research, said.
The decision came after the FDA had been criticized as slow
to alert people about serious heart risks with Merck & Co’s withdrawn
arthritis pill Vioxx and reports of suicidal behavior in children taking
antidepressants. There were also complaints by the public and physicians that
they aren’t being told soon enough of potential safety problems reported to the
FDA. Sometimes, clinical trials undergone before marketing a drug do not reveal
all the information people need. It is only when the drug is in wide use that a
problem emerges.
The first such list of the FDA was posted on Friday and
includes 20 medications and the potential issue for each, without indicating
though of how widespread or serious the problems might be. However, just
because a certain drug is on the list doesn’t mean it isn’t safe.
“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.
The first quarterly report, reported between Jan. 1 to March
31 to the FDA’s Adverse Event Reporting System (AERS), can be found on the FDA Web
site. The AERS collects reports from patients, hospitals, doctors and drug
companies about suspicious problems that might or might not be related to a
medication.
The report contains four drugs that were being investigated
for problems already announced to the public: heparin and severe allergic
reactions; Definity and cardiopulmonary reactions; Cymbalta and urinary
retention; and tumor necrosis factor inhibitors and cancer in children and
young adults.
The other 16 drugs and their potential side effects are as
follows: Arginine Hydrochloride Injection (R-Gene 10) and pediatric overdose
due to labeling / packaging confusion; Desflurane (Suprane) and cardiac arrest;
Etravirine (Intelence) and hemarthrosis; Fluorouracil Cream (Carac) and Ketoconazole
Cream (Kuric) and adverse events due to name confusion; Icodextrin (Extraneal)
and hypoglycemia; Insulin U-500 (Humulin R) and dosing confusion; Ivermectin
(Stromectol) and Warfarin and drug interaction; Lapatinib (Tykerb) and
hepatotoxicity; Lenalidomide (Revlimid) and Stevens-Johnson syndrome;
Natalizumab (Tysabri) and skin melanomas; Nitroglycerin (Nitrostat) and
overdose due to labeling confusion; Octreotide Acetate Depot (Sandostatin LAR)
and ileus (bowels not moving); Oxycodone Hydrochloride Controlled-Release (OxyContin)
and drug misuse, abuse and overdose; Phenytoin Injection (Dilantin) and purple
glove syndrome (discoloration, pain, and swelling of the hand that may lead to
amputation); Quetiapine (Seroquel) and overdose due to sample pack labeling
confusion; and Tebivudine (Tyzeka) and Peripheral neuropathy (tingling or
numbness in the extremities).
Dr. Paul Seligman, who is responsible for the FDA's safety
communications, hopes the list “will serve not only as a means of communication
to the public, but that it will also serve to encourage (medical) providers to
provide us with additional reports should they see similar kinds of adverse
events with the drugs that are on the list.”
