safety
Eisai’s weight loss drug lorcaserin found safe in major study
August 28, 2018Manufacturing and Production, Research and Development, Sales and Marketing Eisai, lorcaserin, safety, study, weight loss
Eisai’s weight loss drug lorcaserin does not increase people’s risk of major cardiovascular events according to a study of 12,000 …
FDA announces strongest warnings for opioid pain medications
March 23, 2016Medical Communications, Research and Development FDA, abuse, addiction, boxed, label, misuse, opioids, public health, restrictions, safety, warnings
The US Food and Drug Administration has announced class-wide safety labelling changes for immediate release (IR) opioid pain medications. The …
FDA criticised for safety data flaws
January 18, 2016Sales and Marketing FDA, US Government Accountability Office, pharmacovigilance, post-marketing data, safety
The US FDA is failing to meet its ‘statutorily required’ obligations to track safety data for drugs post-marketing and publish …
FDA bans drug imports from Indian plant
July 21, 2015Manufacturing and Production Emcure, FDA, GMP, Good Manufacturing Practices, India, compliance, manufacturing, production, safety
The FDA has blocked US imports from the manufacturing plants of a major Indian pharmaceutical firm over safety fears. The …
UK government launches ‘Sign up to Safety’ initiative
March 26, 2014Sales and Marketing Francis, Hunt, Mid Staffs, NHS, safety, sign up
A new ambition to reduce avoidable harm in the NHS by half over the next three years, cut costs and …
No cancer link with Lantus, says Sanofi
December 7, 2011Sales and Marketing Cancer, Lantus, Sanofi, diabetes, insulin, safety
Sanofi has presented a new meta-analysis which suggests its insulin blockbuster Lantus does not raise the risk of cancer. A …
Avandia withdrawn in Europe, but remains in US
September 24, 2010Sales and Marketing Avandia, FDA, pharmacovigilance, safety
GSK’s diabetes drug Avandia is to be withdrawn from the market in Europe because of high levels of heart attack, …
Safety First
September 22, 2009Research and Development, Sales and Marketing EU, US, reg, safety
A series of high-profile drug withdrawals in recent years has brought safety concerns to the fore, prompting more rigorous monitoring …
Avandia hit by further restrictions
January 25, 2008Sales and Marketing reg, safety
GlaxoSmithKline has strengthened the safety warnings on its diabetes drug Avandia following recommendations from European regulators. The drug was hit …
Europe unites with Canada on safety regulation
January 15, 2008Sales and Marketing reg, safety
European and Canadian regulators have forged a transatlantic agreement to exchange confidential information about the authorisation and safety of medicines. …
Champix linked to depression and suicidal thoughts
November 22, 2007Sales and Marketing reg, safety
Pfizer has alerted US regulator the FDA to cases of depression and suicidal thoughts in patients taking its smoking cessation …
Merck to pay $4.9 billion to end Vioxx claims
November 15, 2007Sales and Marketing Vioxx, safety
Merck looks set to pay $4.9 billion in a settlement for the thousands of people claiming injury after taking its …
Liver problems delay Galvus launch
November 9, 2007Sales and Marketing reg, safety
The European launch of new diabetes drug Galvus could be delayed by up to six months after small but significant …
FDA rejects painkiller Prexige
October 3, 2007Sales and Marketing reg, safety
Novartis has received a "not approvable" letter from the FDA for its painkiller Prexige because of concerns about potential liver …
