Topic:

Drug Safety

Latest Headlines

Latest Headlines

New hurdle for DPP-4 diabetes meds: FDA spotlights risk of 'disabling' joint pain

As if last week's Jardiance news wasn't enough to worry makers of DPP-4 diabetes drugs, the FDA has now issued a warning that the class of meds might cause "severe and disabling" joint pain.

No change in CV risk for ACS patients on Sanofi's Lyxumia

Back in June, researchers unveiled details of the ELIXA trial, which put Sanofi's Lyxumia in the clear as far as cardiovascular safety risks go. Now, a new analysis of the study shows that in Type 2 patients with acute coronary syndrome, the diabetes med didn't increase the rate of cardiovascular events--but it didn't decrease it, either.

UPDATED: It's confirmed: 'No signal' of heart failure risk with Merck's Januvia

The good news keeps rolling in for Merck when it comes to the cardiovascular safety of its DPP-4 inhibitor, Januvia. According to a new analysis of the TECOS trial, patients with Type 2 diabetes and cardiovascular disease--even those with a history of heart failure--can take the drug without an increased risk of CV complications.

Germany lists 54 GVK suspensions as EU comes down on Indian CRO

A few months ago, the European Medicines Agency followed through on a threatened continental marketing halt affecting about 700 drugs in Indian CRO GVK Biosciences' generic lineup due to allegations of manipulated trial results. Now, Germany's regulators have suspended another 54 drugs tested by GVK in accordance with the EMA's recommendations.

Allergan pulls 55 lots of eye drugs after consumers find particulate in their eyes

Allergan Monday said it was going to pull some of its eye drugs from the market because of a problem with particles shedding from the tube cap which led to a "small number of customer complaints." The small number is nearly two dozen, including 12 consumers who said they had a foreign object in their eye as well as one report of swelling and another of blurred vision.

GSK recalls 3.9M tubes of toothpaste that may have wood fragments in them

With its deal last year to combine consumer health operations with Novartis in a joint venture that GlaxoSmithKline will run, GSK CEO Andrew Witty bet a big piece of the drugmaker's future on products like OTC pain meds and toothpaste. While Witty has lauded the future of that operation, it has stumbled in that market with the recall of nearly 4 million tubes of toothpaste products that may give users splinters.

Takeda Actos settlement seems shaky as plaintiffs give it the sniff test

Takeda's new CEO, Christophe Weber, thought the Japanese drugmaker had freed itself of the drag from thousands of lawsuits tied to cancer risks from its diabetes drug Actos with a $2.37 billion settlement offer made in April. But despite an average promised payout of $250,000, many plaintiffs have not signed on, perhaps because the rewards of suing seem so much more enticing.

WuXi advances edible bar codes, a novel approach to counter-counterfeiting

Chinese CRO WuXi PharmaTech, alongside partner TruTag Technologies, is developing tiny, edible bar codes designed to prevent drug counterfeiting, and the technology cleared its first hurdle.

Roche scores Accutane victory with reversal of $25M verdict

Roche has been on a legal roller coaster with its acne drug Accutane. Facing thousands of claims that the drug triggers inflammatory bowel disease, the Swiss drugmaker is now enjoying a high point, as an appeals court reversed a $25 million verdict against the company.

Lilly chalks up a win for Cymbalta in first U.S. trial over withdrawal symptom claims

Eli Lilly scored a victory in the first U.S. trial over claims of withdrawal symptoms linked to its blockbuster antidepressant, Cymbalta, as a federal jury found the drugmaker was not responsible for side effects such as brain zaps and suicidal ideations in a patient who quit the med.