According to an analysis by the Institute for Safe Medication Practices, Pradaxa drug (Dabigatran) topped the list of direct reports to the FDA for serious adverse drug events in 2011. Pradaxa took the lead with 817 direct reports, followed by Coumadin (Warfarin) with 490 direct reports, Levaquin (Levofloxacin) with 393, […]
Author: Cal Warriner
It seems sort of nonsensical to blame the victim for his or her condition but that is what medical device maker Stryker appears to be doing in an April Field Safety Notice (FSN). In the United Kingdom, medical device manufacturers are required to report to the MHRA, their version of our […]
Even though more than 93,000 patients have been implanted with the now recalled DePuy metal-on-metal hip, the U.S. Food and Drug Administration wants to start a conversation. It seems a little like the proverbial “closing the barn door after the horse has already escaped”. The federal agency will convene a […]
According to a study published June 11, the users of Actos (pioglitazone) or Avandia (rosiglitazone) may face an increased risk of developing macular edema. Published in the Archives of Internal Medicine, British researchers collected data on more than 100,000 patients with type 2 diabetes who were enrolled in the British […]
In its June 4th announcement that it is taking four synthetic vaginal meshes off the market, Ethicon acts like it is in charge of the FDA. First, the division of Johnson & Johnson (J&J) requests it be given 120 days to “cease commercialization” which essentially means allowing the four defective […]
On Monday, June 4, in a letter to two different courts, Ethicon, a division of Johnson & Johnson (J&J) announced it was removing four synthetic surgical meshes from the market. All four fall under the Gynecare division – the TVT Secur, Prosima, Prolift and the Prolift+M. In doing so it […]
Late last night, June 4th comes news from Bloomberg, that medical device maker, Johnson & Johnson (J&J) plans to stop selling four transvaginal mesh implants in the face of hundreds of lawsuits and more to come. Ethicon, a unit of J&J, told a federal judge in West Virginia that it […]
Consumers Union has posted an ad in the online news source, Politico, Monday, May 21, asking “Should medical device makers be allowed to sell new devices based on manufacturer-recalled products – without ever having to prove that the safety flaws were fixed?” Sounds like the answer should be a resounding […]
The U.S. Food and Drug Administration (FDA) announced on Wednesday, May 9, that patients taking the osteoporosis drug, Fosamax, or any of the bone-building class of drugs known as bisphosphonates, should be reevaluated every three to five years to determine if it is safe for them to remain on the […]
Pradaxa, an anti-coagulant drug marketed by Boehringer Ingelheim Pharmaceuticals, enjoyed an unusually smooth (and quick) ride towards FDA approval. Rather than spending months pouring over clinical studies and safety data, FDA employees instead approved Pradaxa based primarily on a single study and did so in just six months. Below are […]
