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U.S. Food & Drug Administration 12 articles

Health officials blame Indiana cantaloupes for deadly salmonella outbreak

Federal health authorities are warning consumers to avoid eating cantaloupe grown in southwestern Indiana after a salmonella outbreak that has sickened nearly 200 people in 21 states was traced to a farm in that area. Last week, the U.S. Centers for Disease Control and Prevention (CDC) identified Chamberlain Farms in Owensville, Indiana as the source for the latest salmonella outbreak, which the health agency blames for sickening 178 people since early July. At least 62 of those people were hospitalized and two have died as a result of their illness. Investigators haven’t ruled out other possible sources of the contamination, ... Read More

Abbott to pay $1.5 billion for illegally promoting Depakote, thanks to whistleblower lawsuits

Abbott Laboratories has pleaded guilty and agreed to pay $1.5 billion to resolve criminal and civil charges for fraudulently promoting its anti-seizure drug Depakote for a number of unapproved, off-label purposes. The near-record payout, the second largest by a drug company according to the U.S. Justice Department, also resolves four whistleblower lawsuits brought against Abbott Laboratories under the False Claims Act, which allows private citizens to sue on behalf of the United States and share a percentage of funds recovered. Deputy U.S. Attorney General James M. Cole said Monday’s settlement “shows further evidence of our deep commitment to public health ... Read More

Actos linked to serious psychiatric impairments, medical reviewer alleges

The diabetes drug Actos is linked to higher rates of suicide, schizophrenia, epilepsy, and grand mal seizures compared to other drugs in the same class, such as Avandia, says Dr. Helen Ge, a former medical reviewer in Takeda Pharmaceuticals’ pharmacovigilance department. Dr. Ge has filed a whistleblower lawsuit against Takeda under the False Claims Act, alleging the company fired her for objecting to its practices of concealing, downplaying, and whitewashing data that linked Actos to serious adverse side effects. She alleges Takeda required her and other medical reviewers to “change their professional opinion regarding adverse event classifications and assessments.” Her ... Read More

Listeria outbreak widens, FDA and cantaloupe farms search for answers

The deadly listeria outbreak that federal inspectors say is linked to Colorado-grown cantaloupe continues to expand, leaving many consumers across the country gripped with fear over the bacteria that can incubate within a person for 2 months before any signs of illness appear. The Associated Press has reported that an elderly woman from the Baton Rouge, Louisiana, area died during the weekend after being diagnosed with listeria. Although it will take at least a week to test whether the strain of bacteria found in the woman matches the strain found on the recalled cantaloupes, the woman’s family says that she ... Read More

Sunscreen labels to include level of protection against cancer-causing UVA rays

In a landmark move, the Food and Drug Administration (FDA) is requiring sunscreens to show on their labels how well the product protects users against cancer- causing ultraviolet A (UVA) light as well as sunburn-causing UVB light. Sunscreens are already required to list a Sun Protection Factor (SPF) level on their bottles that lets users know how well the product protects against UVB light. The new regulations, which will go into effect by next summer, will add the UVA rating. UVA rays can be more damaging than UVB rays because they penetrate deeper into the skin and cause the skin ... Read More

Bayer tests Google’s new ad format for Yaz promotion

A new ad format developed by Google for prescription drugs attaches a fixed link to sponsored results. When clicked, the link takes the browser to a page announcing  the drug’s side effects, risks, and other important information, much the same way as it is printed on the drug label or inside the product’s packaging. Bayer was the first company to sign up for the new format, which it now uses for its beleaguered birth control pill Yaz. When customers go to Google’s search engine and perform a search for information on Yaz or “the pill,” they will see this simple new ad format appear ... Read More

Off-label marketing boosts drug company profits

Off-label marketing is an illegal yet commonly employed sales strategy that some big pharmaceutical companies practice to broaden the appeal of a drug and boost sales. One of the most blatant examples of off-label marketing involved Bayer Healthcare’s blockbuster birth control pill Yaz. Bayer promoted the drug as a treatment for premenstrual dysphoric disorder (PMDD) symptoms and to clear up moderate cases of acne when the FDA approved it as birth control only. Bayer stopped the deceptive marketing of Yaz when the FDA cited it for false and misleading advertising. After Bayer was admonished over its Yaz ads, attorneys general ... Read More

Comedian lampoons the absurdity of drug ads

Writer-comedian Sarah Haskins has produced another segment of her popular satire on Current TV’s Target: Women, this time calling out the absurdity of television advertising in marketing drugs to women. “Even though I’m old, I don’t want the horrifying side effects of aging to prevent me from doing what I love,” Haskins, who just turned 30, jokes. “I want to walk with canoes, peel oranges, play fetch with my pup, and do stuff with horses,” she says while a montage of images pulled from actual television drug ads plays. In one of the ads Haskins shows, anatomy takes the form ... Read More

Yaz testing and marketing raises ethical red flag

A new report in the New York Times about Bayer Healthcare’s bestselling oral contraceptive Yaz brings to light some serious ethical questions surrounding the company’s testing and marketing of what some studies suggest is a potentially dangerous drug for many women. Earlier this year, the U.S. Food and Drug Administration sent a letter to Bayer Healthcare questioning the company’s ability to handle active pharmaceutical ingredients (API) testing. Bayer acknowledged the FDA’s concerns in an April response to the agency, but said that it had analyzed all relevant batches using its own testing standards and found that the quality of the ... Read More

Yaz lawsuits consolidated in Pennsylvania

Yaz and Yasmin lawsuits filed against Bayer Healthcare in Pennsylvania state courts were consolidated into a mass tort last week by Philadelphia Court of Common Pleas judge Sandra Mazer Moss, who appointed 3 Pennsylvania attorneys to serve as liaison counsel for the plaintiffs. All of the lawsuits allege that Yaz and Yasmin caused adverse events attributable to the ingredient drospirenone (DRSP), which has been linked to blood clots, strokes, heart attacks, gall bladder disease, deep vein thrombosis, pulmonary embolism, and other serious reactions, including sudden death. The suits assert that Bayer knew about the risks but failed to disclose them ... Read More