Topic:

Drug Safety

Latest Headlines

Latest Headlines

Pfizer prevails in first court test of Zoloft birth-defect claims

Pfizer racked up an important win in the first trial over Zoloft's alleged links to birth defects. A St. Louis jury decided on Friday that the drug giant isn't liable for congenital abnormalities in a boy whose mother took Zoloft during her pregnancy.

Sanofi sues drug information startup over side effect info

Sanofi is suing startup Diagnosia over the publication of information about side effects and drug interactions in its physician decision support software.

KemPharm sets IPO price for up to $56M

Iowa's KemPharm, maker of abuse-resistant versions of painkillers, has set its price range for a possible IPO, seeking up to $56 million at $12 to $14 a share.

Zoloft lawyers accuse Pfizer of hiding birth-defect risks

Pfizer researchers found evidence last year that pregnant women using its Zoloft antidepressant had a higher risk of giving birth to a child with heart problems and other congenital anomalies, Bloomberg reports. Now, the internal report has surfaced in a lawsuit blaming Zoloft for a young boy's heart defect, the first such case to go to trial.

Baxter again having to recall saline solution as shortage persists

Just weeks after recalling three lots of 0.9% sodium chloride injection amounting to nearly 600,000 units, Baxter has recalled 8 more lots, adding further to the national shortage of saline. Last time the problem was leaky bags. This time the drugmaker says there is a problem with the chance for particulate in the bags. The FDA also announced the recall in a MedWatch notice.

Safety scare with AstraZeneca's diabetes drug could shake up the DPP-4 field

The FDA raised some alarming concerns tied to AstraZeneca's Onglyza ahead of a committee meeting to discuss the safety of so-called DPP-4 inhibitors, sounding a worrying note for a blockbuster class of drugs.

AZ's Onglyza has most to lose at FDA safety confab, analysts say

FDA experts will grill a couple of diabetes meds next Tuesday, and the outcome of that debate could put a damper on sales. The drugs: AstraZeneca's Onglyza and Takeda's Nesina, both DPP-4 blood sugar-fighters. The questions: Do they really increase the risk of heart failure? And if so, what's to be done about it?

AdverseEvents: Analysis of side-effect reports turns up troubling safety signals for Novartis, Eisai drugs

Drugs that treat brain-related diseases are often tied to troubling side effects. Now an analysis of FDA side-effects reports by healthcare informatics firm AdverseEvents has uncovered more potential safety problems for the meds.

North Carolina compounder is closed and its products are recalled

For more than two years, the FDA has been very clear about the standards its expects U.S. drug compounders to maintain and the very harsh penalties that can await those who don't comply. But some still haven't heeded the message, and last week North Carolina authorities closed one and the FDA warned providers not to use any of its products.

Under pressure, Zoetis pulls arsenic-based poultry drug from market

The FDA announced Wednesday that Zoetis has agreed to withdraw the arsenic-based drug Histostat (nitarsone) from the market by this fall. The move follows years of pressure from food safety groups concerned that the drug--used to prevent blackhead disease in poultry--could endanger human health.