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FDA warning 703 articles

GAO to investigate cancer risks linked to gynecological surgical tool

The U.S. Government Accountability Office (GAO) will launch an investigation into a gynecological surgical tool that was used for hysterectomies and uterine fibroid removals for two decades before the Food and Drug Administration warned it could spread uterine cancer and worsen a woman’s odds of survival. The announcement came after a dozen lawmakers wrote the GAO asking the agency to investigate laparoscopic power morcellators. The surgical tools are fitted with a long blade that minces entire uteruses or uterine growths inside the uterine cavity and removes them through a small incision in the abdomen. Power morcellation has been favored by ... Read More

FDA warns consumers about homeopathic OTC asthma treatments

Consumers should be aware that the safety and effectiveness of asthma treatments labeled as homeopathic and sold over the counter cannot be guaranteed, and asthma symptoms that are not appropriately treated and managed could lead to life threatening consequences, the Food and Drug Administration (FDA) said in a safety communication. “Asthma is a serious, chronic lung condition,” the agency warned. “If asthma is not appropriately treated and managed, patients may have wheezing, shortness of breath, and coughing, and could be at risk for life-threatening asthma attacks that may require emergency care or hospitalization.” There is no cure for asthma, but ... Read More

Abbott, AbbVie face varying lawsuits with AndroGel

Abbott Laboratories and AbbVie skirted racketeering claims alleging the companies made health plans pay unnecessarily for the arthritis drug Humira and the testosterone replacement AndroGel instead of less expensive generics. U.S. District Judge Robert Dow said plaintiffs New England Carpenters Health and Welfare Fund failed to show that the defendants teamed up with pharmacies and intermediaries to illegally increase sales of the drugs by offering savings cards or coupons to reduce copayments. The fund also accused Abbott and AbbVie of insurance fraud, alleging the companies instructed pharmacies to hid subsidies by processing them as secondary insurance rather than discounts. “While ... Read More

Panel recommends more studies on cardiovascular risks with testosterone drugs

Makers of testosterone replacement drugs should collect data on heart attacks and strokes in men who use their products, and the labels on the treatments should have stronger language to restrict intended uses to reduce over-prescribing, a Food and Drug Administration (FDA) advisory panel recommended. The FDA asked an outside panel of experts to address whether there is a risk of major cardiovascular events such as stroke, heart attack and death in men who used testosterone replacement therapies. The agency also asked the panel whether current evidence still supports the use of the drugs in certain patients. The FDA is ... Read More

Judge refuses to throw out $9 billion judgment against Actos makers

A Louisiana federal judge refused to throw out a $9 billion judgment against Takeda Pharmaceuticals and Eli Lilly & Co., alleging the companies hid bladder cancer risks with its blockbuster type 2 diabetes drug Actos. The April verdict was in favor of plaintiffs Terrence and Susan Allen, who claimed the drug companies withheld from doctors and patients information about bladder cancer risks associated with Actos. It was the first U.S. trial of its kind, setting the stage for thousands of other similar lawsuits against Takeda and Eli Lilly involving Actos and bladder cancer. Japan-based Takeda was ordered to pay $6 billion ... Read More

Major depressive disorder drugs add warning for risk of rare eye disease

Drugs to treat major depressive disorder have been linked to angle-closure glaucoma, a rare type of the eye disease in which eye pressure rises very quickly, causing symptoms such as headache, eye pain, nausea, rainbows around lights at night, and very blurred vision. An updated warning for angle-closure glaucoma has been added to the following medication labels: Anafranil (clomipramine) Capsules Aptryxol (desvenlafaxine) extended-release Tablets Brintellix (vortioxetine) Tablets Celexa (citalopram hydrobromide) Tablets Cymbalta (duloxetine hydrochloride) Capsules Desvenlafaxine Fumarate Extended-Release Tablets Desyrel (trazodone hydrochloride) Tablets Effexor XR (venlafaxine hydrochloride) extended-release tablets Fetzima (levomilnacipran) extended-release capsules Fluoxetine Tablets Forfivo XL (bupropion hydrochloride Extended-Release ... Read More

Lipitor diabetes lawsuits mount since FDA warning five months ago

Lawsuits against Pfizer by women who say the company’s cholesterol-lowering statin Lipitor caused them to develop type 2 diabetes have skyrocketed in recent months, shooting up from 56 to nearly 1,000 in the past five months, according to a Reuters review of federal court filings. The lawsuits allege Pfizer knew of the possible side effect but failed to adequately warn the public. In 2012, the Food and Drug Administration (FDA) warned that Lipitor and other statins could increase blood sugar levels which could lead to a “small increased risk” of type 2 diabetes. Studies show the risk is higher among ... Read More

FDA warns of side effects from unapproved use of Expressions product as dermal filler

The Food and Drug Administration (FDA) is warning doctors that Expression brand injectable product made by Enhancement Medical should not be used as a dermal filler because the product has not been approved for this use and adverse events have been reported. These events include swelling, tenderness, firmness, lumps, bumps, bruising, pain redness, discoloration, itching, and the development of hard nodules. Expression is a hyaluronic acid, and is approved by the FDA only as an intranasal splint, and is intended to minimize bleeding and swelling and to prevent the septum and the nasal cavity from sticking together. Intranasal splints are ... Read More

Teen’s death prompts FDA warning for consumers to avoid pure caffeine powder

Logan Stiner was just days away from his high school graduation when he died after consuming a lethal dose of powdered caffeine. The teen’s death prompted a Food and Drug Administration (FDA) investigation resulting in the agency issuing a warning to consumers to avoid pure caffeine products, especially those sold in bulk bags over the internet. “A single dose is essentially 100 percent caffeine. A single teaspoon of pure caffeine is roughly equivalent to the amount in 25 cups of coffee,” the FDA warning stated. “Pure caffeine is a powerful stimulant and very small amounts may cause accidental overdose. Parents ... 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