The FDA this month issued a warning to patients taking the antipsychotic drug Zyprexa, advising that they may be at a higher risk for a severe skin condition known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
The warning was issued after the agency compiled a higher-than-expected number of reports of patients suffering the potentially deadly condition.
The Food and Drug Administration recently added a strong warning to the yeast infection drug Diflucan for women who are pregnant, saying that even small doses have been associated with a higher risk of miscarriage.
Diflucan, taken orally, was approved by the FDA in 1990 and is sold by Pfizer. It is prescribed for a variety of fungal infections in the lungs, bladder, esophagus, mouth and blood, and is also indicated to fight infections in those with cancer or weakened immune systems. But it is used most often for vaginal yeast infections.
A jury in St. Louis, Missouri yesterday handed Johnson & Johnson its third loss in a growing number of lawsuits alleging the company’s baby powder products caused deadly ovarian cancer in users.
And, although this case didn’t reach the historic $72 million level awarded to the family of Jacqueline Fox in February, it’s still staggering as the jury ordered J&J to pay a whopping $55 million to a victim whose cancer has gone into remission.
The U.S. Food and Drug Administration took the unusual step this week of withdrawing its approval of four medications used to treat high cholesterol, based on studies that show the benefits of the drugs no longer outweighed the risks.
The change will affect drugs containing niacin, also known as vitamin B-3, and/or fenofibric acid, when the medications are combined with statins.
Just weeks after a St. Louis jury ordered Johnson & Johnson to pay $72 million to the family of a woman who died of ovarian cancer after years of using the company’s baby powder products, the second baby powder trial in the Missouri court has started.
This week, the trial began in a lawsuit filed by Gloria Ristesund, a woman diagnosed with ovarian cancer after using Johnson & Johnson’s talcum powder products for 40 years.
Two popular type-2 diabetes drugs are in the news after the FDA warned this week that patients taking them may face higher risks of heart failure.
The new warning, issued Tuesday, focuses on the DPP-4 inhibitors Onglyza (saxagliptin), sold by AstraZeneca, and Nesina (alogliptin), sold by Takeda. Together, these drugs are prescribed more than 3 million times each year.
A federal judge this week issued a ruling that pharmaceutical giant Bayer will have to face many of the growing lawsuits alleging its permanent birth control implant Essure caused serious patient side effects.
The decision comes in the wake of other significant Essure news: a recent study showed the FDA had underestimated the number of fetal deaths linked to the devices; and the FDA’s response of ordering new Essure clinical trials and a black box Essure warning label.
This past fall, news broke that a study published in the New England Journal of Medicine comparing the safety and effectiveness of Xarelto and warfarin may be tainted due to a faulty measuring device and missing data.
Now, questions are arising about whether the makers of Xarelto, Bayer and Johnson & Johnson, were complicit in keeping the data from the journal’s editors.
Last week, DrugNews reported on new warnings from the FDA, European Medicines Agency and consumer group Institute for Safe Medication Practices that the popular diabetes drugs Invokana and Jardiance may increase the risk of ketoacidosis.
Since patients taking the drugs weren’t warned by the manufacturers of these deadly risks before, those diagnosed with ketoacidosis or kidney failure have begun an Invokana class action lawsuit in Canada and are coordinating special lawsuits here in the United States.
U.S. drug maker Pfizer announced this week that it was recalling tens of thousands of packages of infant and children’s Advil from store shelves in Canada, after analysis showed ingredient spoiling may lead to higher or lower dosages than intended.
The move comes during the heart of cold and flu season, when parents rely most on the medications to prevent family illness.
Amid increased warnings that the anti-nausea drug Zofran may be linked to serious birth defects when used during pregnancy, a federal panel last year created a special court for victims to seek compensation from the drug’s maker, GlaxoSmithKline.
In January, with hundreds of lawsuits already filed, Glaxo filed a request to have them thrown out of court before families had a chance to prove their case.
Experts have cautioned for years that new-generation oral blood thinners like Xarelto may have similar internal bleeding risks as warfarin, the traditional drug they were designed to replace.
And, recent studies show the risks for gastro-intestinal bleeding in particular may even be higher with Xarelto than warfarin.