Roche probed over faulty drug-safety reporting
Swiss pharmaceutical giant Roche is under investigation over a failure to properly report adverse drug side-effects, the European Medicines Agency (EMA) said on Thursday.
Inspectors at the Basel-based company's British site in Welwyn found deficiencies related to Roche's global process of detecting and reporting the adverse effects of medicines.
At the time of the inspection, 80,000 reports for medicines marketed by Roche in the US had been collected through a Roche-sponsored patient support programme, but had not been evaluated to determine whether they should be reported to the EU authorities as suspected adverse reactions.
"These included 15,161 reports of death of patients and it is not known whether the deaths were due to natural progression of the disease or had a causal link to the medicine," the EMA said in the statement.
"There is at present no evidence of a negative impact for patients and while the investigations are being conducted there is no need for patients or healthcare professionals to take any action," added the EMA.
A Roche spokesman said the company "acknowledges it did not fully comply with regulations and appreciates the concerns that can be caused by this issue for people using its products.
"Roche is committed to actively pursuing corrective and preventative actions to address this matter expeditiously," it added. "The non-reporting of these potentially missed adverse events was not intentional."
The EMA is the equivalent of the US Food and Drug Administration and regularly carries out inspections to ensure correct adverse drug reporting.
This is meant to identify problems with drugs by recording when a patient dies or has a medical setback, even if they have an underlying disease.
(c) 2012 AFP
- Effects of Tamiflu still uncertain, warn experts, as Roche continues to withhold key trial data Jan 18, 2012 | not rated yet | 0
- Roche warns of counterfeit cancer drug in US Feb 14, 2012 | not rated yet | 0
- Roche extends its hostile takeover bid for Illumina Feb 27, 2012 | not rated yet | 0
- FDA warns of heart risk with HIV drug combination Feb 23, 2010 | not rated yet | 0
- EU approves skin cancer fighting drug: Roche Feb 20, 2012 | not rated yet | 0
- Motion perception revisited: High Phi effect challenges established motion perception assumptions Apr 23, 2013 | 3 / 5 (2) | 2
- Anything you can do I can do better: Neuromolecular foundations of the superiority illusion (Update) Apr 02, 2013 | 4.5 / 5 (11) | 5
- The visual system as economist: Neural resource allocation in visual adaptation Mar 30, 2013 | 5 / 5 (2) | 9
- Separate lives: Neuronal and organismal lifespans decoupled Mar 27, 2013 | 4.9 / 5 (8) | 0
- Sizing things up: The evolutionary neurobiology of scale invariance Feb 28, 2013 | 4.8 / 5 (10) | 14
Why is zone 1 in liver more prone to ischemic injury?
May 23, 2013 Hi, Is it because around central vein, there is only deoxygenated blood from the vein where as in the periphery there is hepatic artery. Also why...
How can there be villous adenoma in colon, if there are no villi there
May 22, 2013 As title suggest. Thanks :smile:
How can there be a term called "intestinal metaplasia" of stomach
May 21, 2013 Hello everyone, Ok Stomach's normal epithelium is simple columnar, now in intestinal type of adenocarcinoma of stomach it undergoes "intestinal...
Pressure-volume curve: Elastic Recoil Pressure don't make sense
May 18, 2013 From pressure-volume curve of the lung and chest wall (attached photo), I don't understand why would the elastic recoil pressure of the lung is...
If you became brain-dead, would you want them to pull the plug?
May 17, 2013 I'd want the rest of me to stay alive. Sure it's a lousy way to live but it beats being all-the-way dead. Maybe if I make it 20 years they'll...
MRI bill question
May 15, 2013 Dear PFers, The hospital gave us a $12k bill for one MRI (head with contrast). The people I talked to at the hospital tell me that they do not...
- More from Physics Forums - Medical Sciences
More news stories
(AP)—Department of Justice lawyers have again asked a federal appeals court in New York to delay lifting age restrictions and prescription requirements on an emergency contraceptive popularly known as the morning-after ...
Medications 3 hours ago | not rated yet | 0
(AP)—Merck & Co. says it is ending development of an experimental Parkinson's disease drug because the drug wasn't working.
Medications May 23, 2013 | 1 / 5 (1) | 0
(AP)—Johnson & Johnson is developing what could eventually be game-changing treatments for depression and pain, and it's aiming to apply for approval of more than 10 new medicines by 2017, executives said Thursday during ...
Medications May 23, 2013 | 5 / 5 (1) | 0
An independent panel of experts on Wednesday recommended US approval of a new Merck sleeping pill called suvorexant, but expressed concerns over the highest dosage and risks of drowsy daytime driving.
Medications May 22, 2013 | not rated yet | 0
Coenzyme Q10 decreases all cause mortality by half, according to the results of a multicentre randomised double blind trial presented today at Heart Failure 2013 congress. It is the first drug to improve heart failure mortality ...
3 hours ago | not rated yet | 4
Women at a particular stage in their monthly menstrual cycle may be more vulnerable to some of the psychological side-effects associated with stressful experiences, according to a study from UCL.
22 hours ago | 3.7 / 5 (3) | 3 |
Heart failure accelerates the aging process and brings on early andropausal syndrome (AS), according to research presented today at the Heart Failure Congress 2013. AS, also referred to as male 'menopause', was four times ...
3 hours ago | not rated yet | 1
Two mutations central to the development of infantile myofibromatosis (IM)—a disorder characterized by multiple tumors involving the skin, bone, and soft tissue—may provide new therapeutic targets, according to researchers ...
19 hours ago | 3 / 5 (2) | 0 |
Biological processes are generally based on events at the molecular and cellular level. To understand what happens in the course of infections, diseases or normal bodily functions, scientists would need to ...
23 hours ago | 5 / 5 (5) | 0 |
Mortality and length of stay are highest in heart failure patients admitted in January, on Friday, and overnight, according to research presented today at the Heart Failure Congress 2013. The analysis of nearly 1 million ...
3 hours ago | not rated yet | 0