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The government on Friday began posting a list of prescription drugs under investigation for potential safety problems in an effort to better inform doctors and patients.
The first list is a bare-bones compilation naming 20 medications and the potential issue for each. It provides no indication of how widespread or serious the problems might be, leading some consumer advocates to question its usefulness, and prompting industry worries that skittish patients might stop taking a useful medication if they see it listed.
Food and Drug Administration officials said they are trying to walk a fine line in being more open to the public while avoiding needless scares. Congress, in a drug safety bill passed last year, ordered the agency to post quarterly listings of medications under investigation.
"My message to patients is this: Don't stop taking your medicine," said Dr. Janet Woodcock, who heads the FDA's Center for Drug Evaluation and Research. "If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently."
At least five of the drugs on the list had problems that already have been publicized. These included the blood thinner heparin, recalled earlier this year, and immune-suppressing medications being studied for a link to cancer in youngsters.
One emerging concern that previously got little attention involved Tysabri, a newer, widely used multiple sclerosis drug. The FDA said it is investigating a potential link to skin melanoma, a dangerous cancer. Doctors in Boston had reported two cases of melanoma in Tysabri patients in a letter to the New England Journal of Medicine in February. Tysabri suppresses the immune system, and it has also been linked to a rare kind of brain infection that is often fatal. Manufacturer Biogen Idec Inc. said it does not believe there is an increased risk of melanoma.
The FDA said drugs will be placed on the list based on reports it receives from hospitals, doctors and patients.
"What's new here is that we are telling the public really at the earliest stage what we are working on," said Dr. Gerald Dal Pan, head of the FDA's drug safety office. "I think the public told us, 'We want to know what you are working on.' And we are responding to that."
The list is not just a reflection of raw data, but more like what a police officer would call "probable cause." Officials said a drug will only be listed if FDA safety reviewers determine that a reported problem deserves a closer look.
"Our hope is that this 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," said Dr. Paul Seligman, who is responsible for the FDA's safety communications.
Consumer advocates called the listing a positive step, but said it needs to be fleshed out.
"It's a good thing to get started but it needs to have much more detail if it's to have significant safety value," said Thomas J. Moore, a senior scientist with the Institute for Safe Medication Practices. "A table with just a few words of description is quite limited."
"It's just the most basic warning system," said Diana Zuckerman, president of the National Research Center for Women and Families. "It's not going to say how many reports there were. It's not going to say how many died and how many were hospitalized."
Nor is it clear how drugs suspected of a problem will be removed from the list if later exonerated.
The Pharmaceutical Research and Manufacturers of America, the main industry lobbying group, said it supports giving more safety information to doctors and patients, but worries that some will be needlessly alarmed.
"Our reservation is that patients will be abruptly stopping therapy," said Alan Goldhammer, a vice president of the organization. "One can't generalize with an emerging safety notice. It may affect half the patients, a quarter of the patients, or only a small subset of the patients."
http://www.ksl.com/?nid=201&sid=4185459
Posted by Salt Lake City, Utah, Dangerous Drug Attorney, Dustin Lance
FDA drug evaluation and research: http://tinyurl.com/5bu2om
Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) January - March 2008
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 |
| Tumor Necrosis Factor (TNF) Blockers |
Cancers in children and young adults |
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