The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for March 2009. This issue contains a hot topic about the public perception of herbal medicines, a yellow card update that focusses on the rare adverse drug reaction of progressive multifocal leukoencephalopathy (PML) and drug safety updates in the following areas:
Drug safety advice
Methylphenidate: updated guidance on safe and effective use in ADHD
Atomoxetine: risk of psychotic or manic symptoms
Antipsychotics: use in elderly patients with dementia
Exenatide (Byetta): risk of severe pancreatitis and renal failure
Bisphosphonates: atypical stress fractures
Yellow Card scheme update
Adverse drug reactions in focus: progressive multifocal luekoencephalopathy
Hot topic
Public perception of herbal medicines
Stop press
Efalizumab (Raptiva): recommendation to suspend marketing authorisation
Patient-controlled analgesia extension sets: risk of inadequate pain relief
Effects of MRI on implantable drug pumps
Oral bowel cleansing solutions: risk of harm
Other information from the MHRA
Patient Information Leaflets of the month: smoking-cessation aids
Consultation: changes to legislation and working during an influenza pandemic
Drug Safety Update: Volume 2 Issue 8, March 2009
http://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/CON041211
Senator Grassley on Tuesday asked the drug maker Pfizer to provide details of its payments to at least 149 faculty members at Harvard Medical School. The senator, an Iowa Republican who is investigating the drug industry’s influence on the practice of medicine, also asked for any Pfizer e-mail, faxes, letters or photos regarding Harvard medical students who have protested drug company influence.
Mr. Grassley, in a letter to Pfizer, wrote that he was “greatly disturbed” to read an article in The New York Times on Tuesday describing a Pfizer representative taking cellphone photos of the medical students last October at a campus demonstration against industry influence. “I find this troubling as I have documented several instances where pharmaceutical companies have attempted to intimidate academic critics of drugs,” he wrote.
The request for information about Pfizer payments to Harvard Medical faculty members in the last two years expands Mr. Grassley’s investigation of industry payments to three Harvard psychiatrists who had promoted antipsychotic medicines for children. According to records Mr. Grassley obtained from drug companies, the professors were accused of not properly reporting at least $4.2 million in payments from 2000 to 2007. One of them has been suspended from conducting clinical trials.
A Pfizer spokesman said on Tuesday that the company “will fully cooperate with Senator Grassley’s request for information.” The spokesman, Ray Kerins, said Pfizer regrets if the photograph taken by the sales representative “was offensive to anyone involved,” but believes the company has acted legally and ethically and that collaboration with medical schools is “a valuable source of innovation and scientific advancement.”
3/2/9, New York Times
http://www.nytimes.com/2009/03/04/business/04pfizer.html?_r=2
Eli Lily has mailed an apology to all Australian doctors after being caught out making misleading claims about a controversial new anti-depressant.Duloxetine, sold as Cymbalta, went on the Pharmaceutical Benefits Scheme last July despite official warnings linking it to suicide and liver damage. It has been prescribed more than 82,000 times since, 23,000 in Victoria alone.
A Medicines Australia review has found that Eli Lilly made a “concerted effort” at the time of the PBS listing to spruik “off-label” use of the drug at up to twice the approved dose, as a treatment for physical pain associated with depression.
In January in the US, the company agreed to pay a $US1.42 billion settlement over its marketing of the anti-psychotic drug Zyprexa after pleading guilty to a federal misdemeanour.
4/3/9, http://www.watoday.com.au/national/apology-for-misleading-drug-claims-20090304-8oii.html