Tagged Articles

drug makers 6 articles

New meta-analysis raises serious questions about SSRI use during pregnancy

There is not enough research to provide a clear guidance on the risks or benefits of antidepressant use during pregnancy, however there are serious concerns regarding the drugs’ affects on newborns that should be addressed, a new meta-analysis has found. The analysis on antidepressant use during and after pregnancy was conducted by U.S. Department of Health and Human Services’ Agency for Healthcare Research and Quality. The study focused on a class of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs, which include the brand names Zoloft, Prozac, Lexapro, Celexa, and Paxil. Researchers reported finding evidence that SSRI use during ... Read More

Man says his stroke was caused by AndroGel testosterone treatment

Ed Downes’ stroke seemed to come out of nowhere. Ed, who was in his upper 40s at the time, was taking medication for hypertension and attention deficit disorder (ADD), but was otherwise healthy. When he began to lose interest in sex and his energy level plummeted, he, like hundreds of thousands of other men, followed the advice of a drug company’s television commercial and had a “conversation with his doctor” to see if he was suffering from low testosterone, or, as the advertisement called it, “Low T.” Ed was prescribed AndroGel, a testosterone replacement gel, which he took for two years. ... Read More

FDA revises guidelines for off-label drug use

The Food and Drug Administration (FDA) is amending its policies for drug makers and medical device manufacturers to help better define how scientific studies for unapproved uses can be shared with physicians without legal implications. Drugs are granted approval by the FDA for specific indications, and drug makers are banned from promoting their medications for unapproved, or off-label, uses. However, doctors have the authority to prescribe medications for off-label uses. The updated policies do not change basic positions, such as requiring that shared articles of studies are from peer-reviewed medical journals and have not been edited to hone in on ... Read More

Takeda gives up on diabetes drug candidate due to liver damage risk

Takeda Pharmaceuticals, Asia’s largest drug maker, has halted development of its new diabetes treatment, known as TAK-875 or fasiglifam, because the drug was linked to liver damage. Takeda tried to find a silver lining in the cloud of data, hoping that the drug’s efficacy profile would outweigh the liver risks. However, after consulting with three independent panels on clinical trials results, the writing was on the wall. “The company has reached the conclusion that, on balance, the benefits of treating patients with fasiglifam do not outweigh the potential risks,” Takeda said. “Takeda is working with trial investigators and local regulatory ... Read More

Alabama court rules that makers of brand name drugs can be sued by generic drug users

Generic drugs should carry the same warnings as the brand name drug and, if not, then users of the generic drug can sue the name-brand drug maker for fraudulent misrepresentation, the Alabama Supreme Court ruled. The ruling comes as a response to a certified question from a U.S. District Court, which arose during a case where a plaintiff alleged that a generic version of the prescription heartburn drug Reglan caused him to develop a movement disorder called Tardive Dyskinesia. The plaintiff sued the brand name maker, Wyeth, alleging that the company failed to warn both doctors and patients of the ... Read More

Johnson and Johnson seeks FDA approval for new type 2 diabetes treatment

Johnson & Johnson’s Janssen Research & Development is hoping to win approval for its new type 2 diabetes treatment, a fixed-dose therapy combining canagliflozin and immediate release metformin. Canagliflozin is a selective sodium glucose co-transporter 2 (SGLT2) inhibitor that works by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels. Metformin, an older medication, is a biguanide that lowers blood glucose levels by decreasing the amount of glucose made by the liver. In its New Drug Application (NDA) to the Food and Drug Administration (FDA), Janssen provided data from the comprehensive global Phase ... Read More