We present our unique timeline of the heparin scandal, from the initial recall right up to now.
Created by DNMPharma on 10/12/2008
Last updated: 12/03/10 at 11:07
Republican Joe Barton sent another letter to the FDA, following up on details that were sent to him by APP after his initial enquiry.
Following fresh criticism of the agency’s handling of the heparin case, in-PharmaTechnologist reports on a FDA official’s explanation of the what, the when and the why of the scandal, from first deaths to continued vigilance.
The US Food and Drug Administration has opened offices in three Chinese cities – Beijing, Shanghai and Guangzhou – to help improve the safety of medicines and ingredients imported into the US.
A member of the US Congress has called on the GAO to launch an investigation into the FDA’s handling of the heparin crisis, citing “unanswered questions concerning [the] deaths”.
Members of the Committee on Energy and Commerce have said that recent actions by the FDA have been politically motivated and insufficient, although they did acknowledge the moves were necessary.
The pharmaceutical industry’s vigilance in ensuring the safety of raw materials was criticised at this year’s AAPS, with significant, challenging alterations needed to improve the system.
US Marshals have entered Celsus Laboratories to seize 11 lots of heparin, which contain contaminated material from China according to the US Food and Drug Administration (FDA).
Tim Bölke, head of the excipient taskforce at the European Fine Chemicals Group, discusses certification and the heparin scandal.
A report has been published detailing the US Food and Drug Administration’s (FDA) failings in its inspection of overseas manufacturing facilities.
The pharmaceutical industry must adapt its processes and strategies to cope with a new, tougher operating environment, according to Stefan Borgas, CEO of Lonza.
The International Pharmaceutical Excipients Council (IPEC) of Europe has outlined the actions it is taking as it continues to develop awareness of the need for safe excipients.
A list of drugs currently being evaluated for potential safety issues by the US Food and Drug Administration (FDA) has been posted on its website.
APP Pharmaceuticals, currently the sole supplier of therapeutic heparin vials to the US market, has received FDA approval to manufacture three new formulations of the blood-thinner at its plant in Barceloneta, Puerto Rico.
US researchers have developed a chemoenzymatic strategy to synthesise the anticoagulant drug heparin and avoid the contaminant that has killed more than 80 people.
The heat is being turned up on Actavis Totowa as Federal lawsuits begin to pile up following the Digitek (digoxin) recall.
The Pharmacopeia has approved new monographs for heparin sodium and calcium as it seeks to prevent a repeat of the crisis that rocked the US.
The US Food and Drug Administration (FDA) is likely to receive a $275m budget boost to aid it in its ability to conduct foreign inspections.
The blood thinner heparin has been linked to 149 U.S. deaths in people who had allergic reactions after taking it, U.S. regulators said.
A US senator has asked the Food and Drug Administration (FDA) for a probe into outsourcing of production for pharmaceuticals, as well as ways to make drugmakers accountable for products which fail to meet quality standards.
The European Medicines Agency (EMEA) has urged for greater international cooperation as it outlined how to prevent a repeat of the heparin crisis.
Eleven deaths and 86 cases of harmful side effects this year have been linked to use of medical devices containing the blood thinner heparin, U.S. regulators said.
The Health Minister has confirmed the contaminated blood thinner Heparin is now affecting our health system.
The US Food and Drug Administration has declared the country's previously-tainted heparin supply to be "safe" due to stronger testing and controls that are now in place. Meanwhile, China continues to distance itself from the matter.
China is on course to having its own version of the International Pharmaceutical Excipients Council - joining its fellow organisations in Europe, the Americas and Japan.
Imports of a blood thinner linked to dozens of deaths in the United States are now safe because of tighter testing and controls, a top U.S. health official said Monday in China.
Major U.S. dialysis centers say the price of blood-thinner heparin has doubled since mid-April because of global recalls and tight supplies since the discovery of contaminated raw product from China.
Medtronic Inc said late Wednesday it was recalling selected devices coated with the blood-thinner heparin that was later found to be tainted.
China's drug safety agency accused the United States on Tuesday of stonewalling Beijing's investigation into a blood thinner linked to 81 deaths by refusing to provide details on victims and specifics about the later stages of drug production.
Federal drug regulators believe that a contaminant detected in a crucial blood thinner that has caused 81 deaths was added deliberately, something the Food and Drug Administration has only hinted at previously.
Swedish authorities have recalled Sanofi Aventis' low molecular weight injectable blood thinner Lovenox (enoxaparin), known locally as Klexane, after four batches of the blockbuster drug were found to contain oversulfated chondroitin sulphate.
International research suggests that a simple in vitro bioassay, in addition to procedures currently in place, would help secure the global supply chain for heparin and reduce the risk of patients being exposed to harmful contaminants.
The US Food and Drug Administration (FDA) has revealed evidence linking the heparin contaminant with the series of reported adverse reactions, and has also now issued a warning letter to the Chinese facility at the centre of the safety scare after completing its inspection.
Batches of Sanofi-Aventis's blood-thinning heparin injection Lovenox have been found to contain small amounts of impurity in Britain, Sweden, Spain and Australia, officials said on Thursday.
The US Food and Drug Administration (FDA) has revealed it will be operating on the ground in China imminently, while the Drug Information Association (DIA) has just planted itself in Asia's other pharma don, India.
Draft legislation has been put forward which would require the US Food and Drug Administration (FDA) to inspect foreign manufacturing plants every four years.
Chinese and American officials disagreed Monday about the possible cause of contamination of a blood thinner partly made in China.
The US Food and Drug Administration (FDA) believes that the contamination of Baxter's blood thinner heparin, which has been linked to 62 deaths in the US, may have been due to the deliberate replacement of some ingredients with cheaper alternatives.
The number of people whose deaths are associated with an allergic reaction to heparin has shot up as the US Food and Drug Administration (FDA) has updated its tally.
China's drug regulatory authority is finally responding to curb its damaged reputation by urging its local authorities to take a more proactive role in stemming what is fast becoming a global heparin contamination, sparked by material sourced in the country.
As the commonly used blood thinner heparin is recalled around the world and some doctors worry about shortages, researchers say the anti-clotting drug Angiomax works just as well.
France, Italy, and Denmark are the latest countries to recall heparin products as the contamination scare spreads over materials linked to China.
Australia warned doctors and patients about the safety of the blood thinner heparin after finding a contaminated sample distributed by AstraZeneca Plc, the U.K.'s second-largest drugmaker.
A drug company continued to market its heparin products in Canada even though it knew its supplier was implicated in a growing scandal involving tainted ingredients that have been linked to 19 deaths and hundreds of illnesses in the United States.
The heparin recall has widened after a lot of heparin sodium USP active pharmaceutical ingredient (API) produced by Scientific Protein Laboratories (SPL) was found to contain a heparin-like contaminant.
American Health Packaging unit issued a voluntary recall of heparin sodium injection vials as part of broader recall of heparin products made by Baxter International Inc.
Certain blood-thinning medications sold in Canada contain a contaminant that U.S. officials have suggested may be linked to 19 deaths, Health Canada said Friday
The US Food and Drug Administration (FDA) has now the contaminant found in samples of Baxter's recalled heparin and confirmed that it is indeed linked to a Chinese manufacturing plant.
The US Food and Drug Administration (FDA) has alerted the media that it has taken a significant step forward in its plans to establish a presence on the ground in China.
China and the United States are working together to investigate the blood-thinner heparin, which has been linked to 19 American deaths, China's food and drug administration said Sunday.
The Food and Drug Administration said Friday that all heparin products being imported into the United States would be stopped and tested for a possibly dangerous contaminant.