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<< Previous   of   Next >>   ADVERTISEMENT   On the watch list Drugs under investigation by the Food and Drug Administration, what they are used for and the potential problem: R-Gene 10, a growth hormone, pediatric overdose because of labeling or 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 because of 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 because of sample package labeling confusion. Tyzeka, for chronic hepatitis B, nerve damage. Tumor Necrosis Factor (TNF) blockers, for juvenile arthritis, cancers in children and young adults.   CONTACT THE HERALD Do you have a news tip? newstips@heraldnet.com | 425.339.3400   Published: Sunday, September 7, 2008 FDA to post concerns about drugs Officials say making the list doesn't mean the drug is unsafe. The Washington Post WASHINGTON -- The Food and Drug Administration will begin posting every three months a list of drugs whose safety is under investigation because of complaints brought to the agency's attention by drug companies, physicians and patients. The FDA will name the drug and the nature of the "adverse events" but will not describe their seriousness or the number of complaints received, officials said Friday. Being on the list doesn't mean the drug is unsafe, only that FDA is looking into that possibility. FDA officials said they realize that the new policy, required by changes to federal law enacted last year, may unintentionally alarm some patients. The agency's Adverse Event Reporting System last year received 482,154 unsolicited reports of potential reactions to drugs. The vast majority were false alarms, with the reported problem having nothing to do with the medication a patient was taking. Presumably, many of the investigations that FDA will now announce will not find any new problem with the drug in question. "The risk is that people will read more into this than what it is, which is a statement that an evaluation is underway," said Paul Seligman of the agency's Center for Drug Evaluation and Research. He said he hoped patients would not stop taking a medicine simply because they saw it on the list. Another official, Gerald Dal Pan, said that FDA's "post-­market surveillance" system is not changing, only the timing and extent to which the public is informed. "I think the public has told us in recent years that 'we want to know what you are working on.' We are telling the public at pretty much the earliest stage what we are working on," he said. A drug is evaluated for safety in many ways in the long process leading to FDA's decision to approve or reject it for sale. Nevertheless, rare side effects and interactions sometimes are not recognized until after a drug is on the market and taken by many more people -- and people with more health problems -- than those in pre-market studies. In the last decade, the pain-killer drug Vioxx was found to increase the risk of heart attack and stroke; the diabetes drug Avandia to increase the risk of congestive heart failure; and numerous anti-epilepsy drugs to increase the risk of suicide. In each case, the hazard was not fully recognized until years after the drug was approved. The quarterly list, which can be found on the FDA Web site, will name only drugs being reviewed because of reports to the reporting program. The agency also starts investigations because of data from clinical trials and other studies. Those will not be on the list. When the FDA finds a drug has newly recognized hazards, it can add warnings to the official directions for the drug's use ("the label"), send warning letters to physicians, require patients taking the drug to be monitored closely, or take the medicine off the market. FDA officials said they had not yet decided how to inform the public when an investigation exonerates a drug. The first quarterly report, covering Jan. 1 to March 31, listed 20 drugs. Four were being investigated for problems that were already announced to the public -- heparin and severe allergic reactions; the diagnostic contrast agent Definity and cardiopulmonary reactions; Cymbalta and urinary retention; and tumor necrosis factor inhibitors and cancer in children and young adults. Some of the newly revealed investigations involve confusing names or packaging, not novel side effects. For example, FDA regulators are looking into problems caused when a cream with the trade name Carac used to treat pre-cancerous skin conditions is confused with a cream called Kuric prescribed for fungal infections. READER COMMENTS Be the first to comment. You must be a registered user and verify your e-mail address to post comments to blogs or articles on HeraldNet. To register, click here. To read other terms and conditions, click here. Log out

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