What “off-label” use of a drug really is, and why you need to know about it
When your doctor prescribes a drug for you, you probably assume — and with good reason — that it is an FDA-approved treatment for your condition.
That may or may not be the case.
On average, one in five prescriptions are written for an “off-label” use of a drug. That means your doctor believes that the drug will help you even if it has not been approved specifically for your illness or symptoms.
Off-label prescribing of drugs is legal and common, and can be beneficial for patients. For example, beta blockers (drugs approved to lower blood pressure and treat heart disease) can also help some people with migr...
Source: New Harvard Health Information - September 4, 2015 Category: Consumer Health News Authors: Gregory Curfman, MD Tags: Drugs and Supplements off-label use of a drug Source Type: news
Why taking smart drugs just isn't very clever
As medical advances endow us with superhuman abilities, we are in danger of losing our humanity (Source: Telegraph Health)
Source: Telegraph Health - August 20, 2015 Category: Consumer Health News Tags: university provigil oxbridge narcolepsy modafinil students oxford smart drugs cambridge Source Type: news
The Truth About This So-Called 'Smart Drug'
By: Laura Geggel Published: 08/19/2015 07:55 PM EDT on LiveScience The "smart drug" modafinil actually does work for some people, improving their performance on long and complex tasks, also enhancing decision-making and planning skills, a new review of studies finds. Modafinil, also known by its brand name Provigil, is approved by the Food and Drug Administration to treat people with sleep disorders such as narcolepsy. But the majority of the drug's users — such as students who take it to study for exams — use it off-label, believing it may help them focus. This is despite the lack of strong evidence to date sh...
Source: Science - The Huffington Post - August 20, 2015 Category: Science Source Type: news
Narcolepsy medication modafinil is world's first safe 'smart drug'
Increasingly taken by healthy people to improve focus before exams, after a comprehensive review researchers say modafinil is safe in the short-term Modafinil is the world’s first safe “smart drug”, researchers at Harvard and Oxford universities have said, after performing a comprehensive review of the drug. They concluded that the drug, which is prescribed for narcolepsy but is increasingly taken without prescription by healthy people, can improve decision- making, problem-solving and possibly even make people think more creatively.While acknowledging that there was limited information available on the effects of lo...
Source: Guardian Unlimited Science - August 19, 2015 Category: Science Authors: Helen Thomson Tags: Drugs Science Neuroscience Source Type: news
Narcolepsy medication modafinil is world's first safe 'smart drug'
Increasingly taken by healthy people to improve focus before exams, after a comprehensive review researchers say modafinil is safe in the short-termModafinil is the world ’s first safe “smart drug”, researchers at Harvard and Oxford universities have said, after performing a comprehensive review of the drug. They concluded that the drug, which is prescribed for narcolepsy but is increasingly taken without prescription by healthy people, can improve decision- ma king, problem-solving and possibly even make people think more creatively.While acknowledging that there was limited information available onthe effects of lo...
Source: Guardian Unlimited Science - August 19, 2015 Category: Science Authors: Helen Thomson Tags: Drugs Science Neuroscience Source Type: news
Exclusive: DH funds private prescriptions for drug denied to NHS patients
Taxpayers’ money is being used by the Department of Health to pay for private prescriptions for a £12,000 a year drug to treat narcolepsy, HSJ has learned. (Source: HSJ)
Source: HSJ - July 20, 2015 Category: UK Health Source Type: news
Did swine flu jabs give scores of children a sleeping sickness?
Scottish 16-year-old Chloe Gasson, pictured with mum Sandy Young, is one of 100 Britons believed to have been affected by narcolepsy as a result of receiving the Pandemrix vaccination for swine flu. (Source: the Mail online | Health)
Source: the Mail online | Health - July 17, 2015 Category: Consumer Health News Source Type: news
Woman who developed narcolepsy after swine flu jab had 'no quality of life'
Family of 23-year-old Katie Clack, who took her own life after struggling with the terrible effects of her incurable sleep disorder, vows to fight for justiceA 23-year-old nursery assistant who developed narcolepsy after receiving a swine flu vaccine took her own life last year, telling her family that living with the incurable sleep disorder had become unbearable.Katie Clack’s death raises fresh questions about the government’s long refusal to compensate about 80 people who developed narcolepsy as a rare side-effect of the vaccine, on the basis that the condition is not serious enough to merit payouts. Continue readin...
Source: Guardian Unlimited Science - July 13, 2015 Category: Science Authors: Hannah Devlin science correspondent Tags: UK news Swine flu Health GlaxoSmithKline Pharmaceuticals industry Drugs Science Source Type: news
FDAVoice: Celebrating the 3rd anniversary of the FDA Safety and Innovation Act
By Stephen Ostroff, M.D.
Anniversaries are celebrated for many different reasons. Sometimes it is to recognize the enduring strength of an institution. Other times it offers an opportunity to gauge success or progress.
One commemoration that falls into the latter category is today’s third anniversary of the signing of the landmark Food and Drug Administration Safety and Innovation Act or, as it is known in the world of Washington acronyms, FDASIA.
FDASIA gave FDA authority to collect user fees from industry over five years, beginning in 2012, to fund reviews of innovator drugs, medical devices, generic drugs, and bio...
Source: Mass Device - July 10, 2015 Category: Medical Equipment Authors: MassDevice Tags: Blog Food & Drug Administration (FDA) Regulatory/Compliance Source Type: news
'Immunological Mistaken Identity' Led to Narcolepsy (CME/CE)
(MedPage Today) -- Tracking a link between H1N1 vaccine and narcolepsy (Source: MedPage Today Geriatrics)
Source: MedPage Today Geriatrics - July 5, 2015 Category: Geriatrics Source Type: news
On the Flu Vax?Narcolepsy Link
Researchers identify a peptide present in the swine-flu vaccine linked to narcolepsy that may be responsible for the sleep disorder. (Source: The Scientist)
Source: The Scientist - July 1, 2015 Category: Science Tags: Daily News Source Type: news
Swine flu jab and narcolepsy may be linked by autoimmune response
Vaccine may have caused narcolepsy by triggering the production of antibodies which destroy a sleep-regulating part of the brain, a new study suggestsScientists appear close to pinpointing why a swine flu vaccine given to six million people in Britain triggered the devastating sleep disorder, narcolepsy, in rare cases.The Pandemrix vaccine, made by GlaxoSmithKline (GSK), and which was recommended by the UK government to high-risk groups during the 2009-10 swine flu pandemic, was withdrawn after medical records showed a spike in the number of cases of narcolepsy presenting in doctors’ surgeries. Continue reading... (Sourc...
Source: Guardian Unlimited Science - July 1, 2015 Category: Science Authors: Hannah Devlin, science correspondent Tags: Swine flu Science Health Vaccines and immunisation Health policy UK news Source Type: news
Scientists find new evidence on GSK vaccine link to narcolepsy
LONDON, (Reuters) - Scientists investigating why a GlaxoSmithKline flu vaccine triggered narcolepsy in some people say they have the first solid evidence the rare sleep disorder may be a so-called "hit-and-run" autoimmune disease. (Source: Reuters: Health)
Source: Reuters: Health - July 1, 2015 Category: Consumer Health News Tags: healthNews Source Type: news
Stanford study: Immune response to a flu protein yields new insights into narcolepsy
(Stanford University Medical Center) An international team of researchers has found some of the first solid evidence that narcolepsy may be a so-called 'hit-and-run' autoimmune disease. (Source: EurekAlert! - Infectious and Emerging Diseases)
Source: EurekAlert! - Infectious and Emerging Diseases - July 1, 2015 Category: Infectious Diseases Source Type: news
My Q and A With William Dement, a True Sleep Studies Pioneer
Dr. William C. Dement, a professor at the Stanford Center for Sleep Sciences and Medicine, is considered the father of sleep medicine. In answer to my questions, he spoke about his early interest in sleep studies, the scientists who inspired him and how the study of sleep has evolved over half a century. Here is a transcript of our conversation. What led you to found the Stanford Sleep Disorders Clinic? Before I came to Stanford, I was a research fellow at Mount Sinai Hospital in New York City and worked with patients who had narcolepsy. After I went to Stanford, in 1963, I discovered that doctors were not recognizing th...
Source: Science - The Huffington Post - June 25, 2015 Category: Science Source Type: news
