Citing risks of liver damage and stomach bleeding, the U.S. Food and Drug Administration (FDA) has called for new warnings to be added to the labels of popular over-the-counter pain relievers. The warnings apply to users of acetaminophen, as well as nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, naproxen, and ketoprofen.

For products containing acetaminophen, the FDA has proposed adding a label warning to reflect “the potential for liver toxicity, particularly when using acetaminophen in high doses, when taking more than one product with acetaminophen, and when taken with moderate amounts of alcohol.” For products containing NSAIDs, the label warning would emphasize “the potential for stomach bleeding in persons over age 60, in persons who have had prior ulcers or bleeding, in persons who take a blood thinner, when taking more than one product containing an NSAID, when taken with moderate amounts of alcohol, and when taking for longer time than directed.”
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Fearing that the Environmental Protection Agency (EPA) isn’t doing enough to protect our air quality, 13 states plus the District of Columbia filed suit last week against the agency in D.C. federal court. The plaintiffs are calling for stricter regulation on toxic emissions, claiming that the new airborne pollution standards are too lax and violate the Clean Air Act. In addition, a petition has been filed by Earthjustice on behalf of the American Lung Association, Environmental Defense, and the National Parks Conservation Association.

At issue is what’s known as fine particulate matter, including dust and soot that is emitted from factories, power plants, and cars. This type of pollution has been strongly connected to respiratory disease and heart ailments; even a small reduction in emissions may save thousands of unnecessary deaths.
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Inciting a major controversy over one of the world’s best-selling drugs, the New York Times has accused Eli Lilly of questionable, unethical, and possibly illegal marketing with regard to Zyprexa. After receiving thousands of internal Lilly documents and emails from a lawyer who represents mentally ill patients, the Times filed two potentially damaging reports this past weekend. The first report claimed that the drug maker intentionally downplayed the risks of obesity and increased blood sugar associated with Zyprexa. The second claimed that Lilly encouraged unapproved (off-label) use of Zyprexa (olanzapine), which is approved only for the treatment of schizophrenia and bipolar disorder.

According to Lilly documents received by the Times, the company has been aware of Zyprexa’s links to obesity for at least a decade, but deliberately minimized the significance of the risk factor–fearing that the drug’s sales would be jeopardized. Apparently, Lilly told its sales representatives to downplay the risk in their conversations with doctors, even though the company’s published data indicates that 30 percent of Zyprexa patients gain 22 or more pounds within one year of treatment–and some patients were reported to have gained more than 100 pounds.
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In an alert issued today, the U.S. Food and Drug Administration connected Rituxan with a fatal viral infection of the central nervous system. According to the FDA, two Rituxan patients have died after developing progressive multifocal leukoencephalopathy (PML), which is a rare virus that attacks the brain.

While the drug is approved for treatment of non-Hodgkin’s lymphoma and rheumatoid arthritis, both of the patients who died were being treated for systemic lupus erythematosus (SLE), a condition for which Rituxan has not been approved.
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Breast cancer rates in the United States dropped 7.2 %, dramatically reversing previous trends which consistently showed rising rates. While the turnaround is surprising news to most, it does not surprise critics of hormone replacement drugs. In 2003, a large federal study linked HRT drugs like Prempro and Premarin, to an increased risk of breast cancer. Within months, millions of women stopped taking estrogen and progestin pills.

Medical researchers has exected about 200,000 cases of breast cancer in 2003; but only 14,000 were actually diagnosed with the disease. Because breast cancer takes years to form, experts think that withdrawing hormones mostly caused small tumors that had been growing to stop or shrink, making them no longer detectable on mammograms. Whether this is true or will result in fewer cases over the long run will take more time to tell.
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A report in this week’s edition of the International Breastfeeding Journal has warned pregnant women that receiving epidural pain relief during labor may affect their subsequent attempts at breastfeeding. According to the Australian study, women who receive epidurals during childbirth are more likely to experience difficulties with breastfeeding in the first postpartum week and are also more likely to halt breastfeeding within the first 24 weeks after the birth.

Though the reasons for the connection are unclear, researchers believe it relates to the presence of fentanyl, an opioid commonly found in epidural treatments. The study’s authors suggest that the “association between breastfeeding and intrapartum analgesia is due to the pharmacological effect of the analgesic agents. There is a growing body of evidence that the fentanyl component of epidurals may be associated with sleepy infants and difficulty establishing breastfeeding.” The study also contends that type of birth (ie. Caesarian section) may affect breastfeeding patterns as well.
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Citing a range of severe adverse effects, the U.S. Food and Drug Administration (FDA) has called for the removal of unapproved quinine drugs from the market. Currently only one quinine drug has been approved by the FDA–for the treatment of malaria–but quinine drugs are often prescribed “off-label” for the treatment of leg cramps. The FDA issued a stern warning to consumers that quinine drugs are potentially dangerous and should not be used to treat leg cramps.

“Because malaria is life-threatening, the risks associated with quinine use are justified for that condition,” reads the FDA’s statement. “But because of the drug’s risks, FDA believes it should not be used to prevent or treat leg cramps.”
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Trying to resolve a controversial, complicated, long-standing issue, the U.S. Food and Drug Administration (FDA) has proposed significant rule changes that would make experimental drugs more accessible to critically ill patients. According to the agency, the regulatory changes would offer “expanded access for experimental drugs … to individual patients, small patient groups, and larger populations under a treatment plan when there is no satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition.”

“This proposed reform is carefully designed to balance several objectives,” said Dr. Andrew C. von Eschenbach, Acting FDA Commissioner. “One goal is to enable many more patients who lack satisfactory alternatives to have access to unapproved medicines, while balancing the need for safeguarding the individual patient. Another equally important goal is to ensure the continued integrity of the scientific process that brings safe and effective drugs to the market.”
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As consumers are inundated with reports of E. coli outbreaks and Salmonella contamination, the U.S. Congress has promised to make food safety a high priority when it reconvenes next year. In fact, some lawmakers and watchdog groups are considering whether to create an independent federal food-safety agency to deal with the issue. 

“The food safety process is collapsing,” Rep. Rosa DeLauro told the New York Times. The Connecticut Democrat is among those championing a single food-safety regulatory body that would combine related parts of the FDA and the Department of Agriculture (USDA) into a stand-alone agency. Even Dr. David Acheson, the chief medical officer for the FDA’s Center for Food Safety and Applied Nutrition, agrees that the current system is flawed, telling the Times, “I think it’s fairly clear that something needs to change.”
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In what could be a serious blow to drug maker Amgen, a Congressional panel recommended changing the way Medicare pays for Amgen’s Epogen, a wildly popular–some say overused–drug used in the treatment of anemic kidney patients. The House Ways and Means Committee held a two-hour hearing earlier this week to discuss the issue. Anemia drugs are currently Medicare’s largest drug expenditure and account for approximately $6 billion in revenue and $2 billion in profit for Amgen.

At issue is the fact that Medicare has separate reimbursement methods for dialysis treatments and drug prescriptions. Dialysis centers can currently charge a 6 percent premium on Epogen, raising fears that doctors are over-prescribing the anemia drugs in order to increase profits. Panel members suggested bundling dialysis and drug reimbursement together into a single fee so that the incentive for overusing the drug is diminished. The Government Accountability Office offered a similar recommendation.
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