Roche probed over faulty drug-safety reporting

June 21, 2012

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 .

"These included 15,161 reports of death of patients and it is not known whether the deaths were due to 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 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.

Explore further: Effects of Tamiflu still uncertain, warn experts, as Roche continues to withhold key trial data

Related Stories

Effects of Tamiflu still uncertain, warn experts, as Roche continues to withhold key trial data

January 18, 2012
Two years after pharmaceutical giant Roche promised the BMJ it would release key Tamiflu trial data for independent scrutiny, the safety and effectiveness of this anti-influenza drug remains uncertain, warn experts today.

Roche warns of counterfeit cancer drug in US

February 14, 2012
(AP) -- The maker of the best-selling cancer drug Avastin is warning doctors and patients about counterfeit vials of the product distributed in the U.S.

Roche extends its hostile takeover bid for Illumina

February 27, 2012
Swiss pharmaceutical group Roche said Monday it is sticking by its hostile $5.7-billion (4.2 billion euros) bid for US gene mapper Illumina and is extending it for a month.

EU approves skin cancer fighting drug: Roche

February 20, 2012
Swiss drug giant Roche said on Monday it had been given European Union approval for its treatment to fight a highly aggressive form of skin cancer.

US wants more information from Roche on Illumina bid

March 13, 2012
Swiss pharmaceutical group Roche said Tuesday the US Federal Trade Commission had requested additional information on its hostile $5.7-billion (4.2 billion euros) bid for US gene mapper Illumina.

Recommended for you

Mind-body therapies immediately reduce unmanageable pain in hospital patients

July 25, 2017
Mindfulness training and hypnotic suggestion significantly reduced acute pain experienced by hospital patients, according to a new study published in the Journal of General Internal Medicine.

Study suggests ending opioid epidemic will take years

July 20, 2017
The question of how to stem the nation's opioid epidemic now has a major detailed response. A new study chaired by University of Virginia School of Law Professor Richard Bonnie provides extensive recommendations for curbing ...

Team-based model reduces prescription opioid use among patients with chronic pain by 40 percent

July 17, 2017
A new, team-based, primary care model is decreasing prescription opioid use among patients with chronic pain by 40 percent, according to a new study out of Boston Medical Center's Grayken Center for Addiction Medicine, which ...

Private clinics' peddling of unproven stem cell treatments is unsafe and unethical

July 7, 2017
Stem cell science is an area of medical research that continues to offer great promise. But as this week's paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, ...

Popular heartburn drugs linked to higher death risk

July 4, 2017
Popular heartburn drugs called proton pump inhibitors (PPIs) have been linked to a variety of health problems, including serious kidney damage, bone fractures and dementia. Now, a new study from Washington University School ...

Most reproductive-age women using opioids also use another substance

June 30, 2017
The majority of reproductive-age and pregnant women who use opioids for non-medical purposes also use at least one other substance, ranging from nicotine or alcohol to cocaine, according to a University of Pittsburgh Graduate ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.