First list released of 21 drugs under investigation

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First list released of 21 drugs under investigation

By Ricardo Alonso-Zaldivar
ASSOCIATED PRESS

September 6, 2008

WASHINGTON – The government yesterday 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 21 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're 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 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 received little attention involved Tysabri, a newer, widely used multiple sclerosis drug. The FDA said it's 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's been linked to a rare kind of brain infection that is often fatal. Manufacturer Biogen Idec Inc. said it doesn't 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.

The list isn't just a reflection of raw data, but more like what a police officer would call “probable cause.” Officials said a drug only will be listed if FDA safety reviewers determine that a reported problem deserves a closer look.

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.”

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 it worries some will be needlessly alarmed.

Drugs under review

R-Gene 10, a growth hormone, pediatric overdose due to labeling/packaging confusion.

Suprane, an anesthetic, cardiac arrest.

Cymbalta, for depression and other conditions, urinary retention.

Intelence, an HIV medication, bleeding into joints.

Carac and Kuric, creams for skin conditions and fungal infections, name confusion.

Heparin, a blood-thinner, serious allergic reactions.

Extraneal, used in kidney dialysis, low blood sugars.

Humulin R (U-500), insulin for diabetes, dosing confusion.

Stromectol and Warfarin, an anti-parasite drug and a blood thinner, drug interaction.

Tykerb, for advanced breast cancer, liver damage.

Revlimid, for multiple myeloma, severe skin blistering and bleeding.

Tysabri, for multiple sclerosis, skin melanomas.

Nitrostat, for angina, overdose due to labeling confusion.

Sandostatin LAR, for abnormal bone growth, bowel obstruction.

Oxycontin, a pain killer, drug misuse, abuse and overdose.

Definity, used in cardiac imaging, cardiopulmonary reactions.

Dilantin injection, for epileptic seizures, serious skin reaction.

Seroquel, for bipolar disorder, overdose due to sample pack labeling confusion.

Tyzeka, for chronic hepatitis B, nerve damage.

Tumor Necrosis Factor (TNF) Blockers, for juvenile arthritis, cancers in children and young adults.

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