U.S. posts drugs under safety probe
05.09.2008 21:02
Health
- Source: cbc.ca
Health officials in the U.S. on Friday began publishing a quarterly list of prescription drugs under investigation for potential side-effects, with the aim of keeping doctors and patients better informed. The drugs are under review based on complaints from the public. Inclusion on the list does not mean the U.S. Food and Drug Administration has concluded the drug is dangerous, officials stressed, but that safety reviewers think the reported problem needs to be looked at more closely. The first report of 20 drugs under review was released Friday. All of the drugs, except one, are approved for use in Canada. Health Canada's website includes similar warnings about the drugs. "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." The FDA is required to post quarterly lists of drugs under investigation under a drug safety bill passed in the U.S. last year. "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. The first table includes problems that have already been publicized, such as the blood thinner heparin, immune-suppressing medications that are being studied for a possible link to cancer in young people, and medications given at home or in hospitals that are linked to overdoses because of potentially confusing instructions. Consumer advocates called the posting a good first step but expressed reservations about the value of the table in its current form. "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." It's not yet clear how a suspected problem will be taken off the list if it is later deemed OK, a flaw Seligman acknowledged needs to be refined. A spokesperson for the Pharmaceutical Research and Manufacturers of America, the main industry lobbying group, also stressed the importance of not stopping medication abruptly. "One can't generalize with an emerging safety notice," said Alan Goldhammer, a vice-president of the organization. "It may affect half the patients, a quarter of the patients, or only a small subset of the patients." Product name or class | Potential risk |
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| Arginine hydrochloride injection (R-Gene 10) | Pediatric overdose due to labelling/packaging confusion | | Desflurane (Suprane) | Cardiac arrest | | Duloxetine (Cymbalta) | Urinary retention | | Etravirine (Intelence) | Hemarthrosis | | Fluorouracil cream and Ketoconazole cream | 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) - not approved for use in Canada | Hepatotoxicity | | Lenalidomide (Revlimid) | Stevens Johnson Syndrome (skin condition that causes blisters, shedding of skin) | | Natalizumab (Tysabri) | Skin melanomas | | Nitroglycerin (Nitrostat) | Overdose due to labelling confusion | | Octreotide Acetate Depot (Sandostatin LAR) | Ileus (temporary suspension of peristalsis, which can cause bowel obstruction) | | Oxycodone Hydrochloride controlled-release (Oxycontin) | Drug misuse, abuse and overdose | | Perflutren lipid microsphere (Definity) | Cardiopulmonary reactions | | Phenytoin injection (Dilantin) - an anticonvulsant | Purple Glove Syndrome | | Quetiapine (Seroquel) | Overdose due to sample pack labelling confusion | | Telbivudine (Tyzeka) - sold in Canada as Sebivo | Peripheral neuropathy | | Tumor Necrosis Factor (TNF) blockers | Cancers in children and young adults | | (Sources: FDA, Health Canada) |
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