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Public Citizen 19 articles

FDA refuses Public Citizen’s request to ban transvaginal mesh from market

The U.S. Food and Drug Administration (FDA) has rejected the request made by Public Citizen in 2011 to recall existing surgical mesh products, specifically transvaginal mesh, and ban them from the market. The FDA says that a rigorous review is sufficient enough. The FDA said it “may consider future action against individual products or this product type as appropriate.” Transvaginal mesh is used to repair conditions such as pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The mesh is implanted through the vagina and is used to shore up pelvic organs that have become displaced due to age, childbirth, ... Read More

FDA rejects consumer group’s request for black box warning on statin drugs

Cholesterol-lowering statin medication will not carry a black box warning for a deadly muscle disorder, the Food and Drug Administration (FDA) announced. The agency was petitioned by the consumer watchdog group Public Citizen, urging the FDA to force drug makers to alert consumers of the risk of rhambdomyolysis, a condition in which muscle cells break down and enter the bloodstream where they can damage the kidneys. Public Citizen filed its petition in 2001, not long after Bayer pulled its statin drug Baycol (cerivastatin) off the market after mounting reports of patients dying from the condition while taking the medication. The ... Read More

Controversy surrounds upcoming FDA decision on long-acting testosterone drug

The Food and Drug Administration (FDA) is expected to decide this week the fate of a long-acting testosterone product made by Endo Health Solutions, Inc. Aveed, indicated to boost testosterone in men with low levels of the hormone, has been rejected by the agency twice before based on health risks. Aveed, sold in other countries under the brand name Nebido, received mixed reactions from FDA advisors last year. The panel was split 9-9 on whether to recommend approval of the drug. Some advisors said the drug offers a valuable alternative to existing shorter-acting products, such as AndroGel, Testim and Axiron. ... Read More

Public Citizen urges FDA to add warnings of heart attack, stroke, death to testosterone treatments

Consumer advocacy group Public Citizen is petitioning the Food and Drug Administration (FDA) to require manufacturers of testosterone treatments to add black box warnings on the labels about the increased risk of heart attacks, stroke and death in men who use the treatment. Black box warnings are the strongest given by drug regulators and signify that medical studies indicate that a particular drug carries a significant risk of serious or even life-threatening adverse events. Testosterone supplements, including AndroGel, Testim and Axiron, are approved by the FDA to treat hypogonadism, a medical condition in which the testes produce little to no testosterone. ... Read More

Consumer watchdog wants strong warnings placed on blood thinner Plavix

Consumer watchdog group Public Citizen is lobbying federal drug regulators to place a black box warning on the anticoagulant Plavix notifying that patients with drug-delivering coronary artery stents could die from a major bleeding event if they take the medication for more than a year. A black box warning is the strongest warning placed on prescription medication and is given to products that, based on medical studies, pose a serious or life threatening risk for adverse events. More than 25 million prescriptions for Plavix, and its generic equivalent clopidogrel, were written during the past year. The blood thinner is used alone ... Read More

Public Citizen petitions FDA to ban diabetes drug Victoza due to thyroid cancer risk

Public watchdog group Public Citizen is petitioning the U.S. Food and Drug Administration (FDA) to pull the type 2 diabetes drug Victoza off the market because it puts patients at higher risk for thyroid cancer, pancreatitis, serious allergic reactions, and kidney failure that, the group says, “outweighs any documented clinical benefits.” Victoza, made by Novo Nordisk, was approved in January 2010 by the Food and Drug Administration (FDA). Six months later, the FDA issued new warnings about the drug that it had been linked to cases of pancreatitis, thyroid cancer, and renal failure. There are roughly a dozen classes of ... Read More

FDA advisor warns ‘do not use’ Yaz, Yasmin

When Dr. Sidney Wolfe was asked in 2009 by the Food and Drug Administration (FDA) to join the agency’s Risk Management Advisory Committee for a 4-year term, the head of the Washington, DC-based watchdog group Public Citizen took the task to heart. He championed the removal of the longstanding painkiller Darvocet/Darvon, calling the drug “extremely dangerous” based on reports of more than 2,000 accidental deaths since 1981. He also pushed for stronger warnings on prescription drugs, including the type 2 diabetes drug Avandia, which has been linked to fatal heart attacks. What he has yet to accomplish is the removal ... Read More

FDA panel member stripped of voting rights in Yaz-blood clot safety review

Sid Wolfe, head of the Public Citizen Health Research Group, was stripped of his voting rights on a Food and Drug Administration (FDA) advisory panel just before the committee was to review the safety of the popular birth control pills Yaz and Yasmin. Wolfe’s consumer advocacy group has waged a campaign warning women about what it perceives to be the dangerous risk of blood clots with oral contraceptives containing the hormone drospirenone, such as Yaz and Yasmin. The FDA cited “intellectual conflict of interest” when it pulled Wolfe’s voting power from the agency’s Drug Safety and Risk Management Advisory Committee. ... Read More

Watchdog group urges FDA to ban transvaginal mesh products

The watchdog group Public Citizen is taking aim at a type of surgical mesh used to repair pelvic floor conditions, arguing that the Food and Drug Administration (FDA) should ban the devices because they offer no significant benefits and that they expose patients to serious risks and the potential for permanent life-altering harm. Public Citizen is a national nonprofit consumer advocacy organization that is most recently known for petitioning the FDA to remove the painkillers Darvon and Darvocet based on data that showed the drugs were dangerous to consumers. The drugs were subsequently banned from the U.S. market earlier this ... Read More

Public Citizen warns against latex medical gloves

It took decades for the Food and Drug Administration (FDA) to be swayed, but consumer watchdog group Public Citizen was at the helm of the movement to persuade the FDA to ban the prescription painkillers Darvocet and Darvon (propoxyphene) due to serious health risks. The FDA rejected both petitions submitted by Public Citizen over the years, but new studies that showed the drugs caused dangerous heart rhythm abnormalities finally convinced the federal agency that the risks associated with Darvocet and Darvon far outweighed the benefits. Now the watchdog group is taking aim at another medical product – latex medical gloves. ... Read More