thevaccinereaction--2020-01-10--Tamiflu on Track to Be an Over-The-Counter Drug

In July 2019 , drug and French vaccine manufacturer Sanofi signed a deal with Roche Pharmaceuticals to obtain exclusive over-the-counter ( OTC ) rights for Tamiflu ( oseltamivir ) , an antiviral drug licensed for the treatment of influenza infections .
Genentech , a member of the Roche Group , currently sells Tamiflu in the United States only for prescription use.1 Tamiflu is a neuraminidase inhibitor given orally and the drug is rapidly absorbed by the gastrointestinal tract and processed by the liver .
In 1999 , the U.S. Food and Drug Administration ( FDA ) gave Roche licensing approval @ @ @ @ @ @ @ type A and B influenza in adults.2 In 2000 , the FDA approved use of oseltamivir for children one year and older , and Japan licensed it for adolescents and adults .
In 2002 , the European Medicines Agency ( EMA ) approved it for patients over age one .
By 2012 , the FDA had licensed Tamiflu ’ s use in infants as young as two weeks old .
Roche sponsored 40 clinical trials on oseltamivir during the 1990s and also funded post-marketing trials .
However , questions have been raised about @ @ @ @ @ @ @ evaluating oseltamivir were methodologically sound and of high enough quality to adequately determine effectiveness.3 4 In a 2014 report published in the British Medical Journal , researchers analyzed evidence for osteltamivir ’ s effectiveness and stated , “ In the treatment of adults , oseltamivir reduced the time to first alleviation of symptoms by 16.7 hours.
” 5 They also found that use of osteltamivir in children had “ no significant effect on admissions to hospital , ” adding that the drug ” does not affect asymptomatic influenza and there is no evidence @ @ @ @ @ @ @ spread.
“ The researchers concluded : Given that oseltamivir is now recommended as an essential medicine for the treatment of seriously ill patients or those in higher risk groups with pandemic influenza , the issues of mode of action , lack of sizeable benefits , and toxicity are of concern .
This is made worse by the record and stated intentions of governments to distribute oseltamivir to healthy people to prevent complications and interrupt transmission on the basis of a published evidence base that has been affected by reporting bias , ghost authorship @ @ @ @ @ @ @ these findings provide reason to question the stockpiling of oseltamivir , its inclusion on the WHO list of essential drugs , and its use in clinical practice as an anti-influenza drug .
Since 2005 , there have been reports in Japan , U.K. and the U.S. that Tamiflu is associated with serious side effects , including neurological dysfunction , psychiatric symptoms and death.6 A 2015 report in Clinical Psychopharmacology and Neuroscience observed that:7 The Tamiflu package insert label lists serious skin/hypersensitivity reactions and neuropsychiatric events in the warning and precaution section and advises @ @ @ @ @ @ @ allergic-like reactions.8 The drug ’ s package inserts states : U.S. Market Largest OTC Market in the World Sanofi has not announced an exact date of availability of OTC Tamiflu .
Under the agreement , Sanofi will head the clinical program and fund all studies needed to support the U.S. licensing switch of Tamiflu from prescription only to an OTC drug.1 According to Sanofi , “ The U.S. market is the largest OTC market in the world , and a successful switch of Tamiflu to OTC would support our global cough and cold @ @ @ @ @ @ @ sustainable point of difference in the market.
” 1 The global over the counter drug market was valued at U.S. $ 300B in 2018 and is estimated to grow to $ 491B by 2024 .
A recent market forecast report by Morder Intelligence stated:9 North America currently dominates the market for over the counter drugs and is expected to continue its stronghold for a few more years .
This region is expected to increase its market share in the future , owing to the leading trend among pharmaceutical companies to switch from Rx @ @ @ @ @ @ @ National Institute of Health has stated that 93 % of adults in the United States prefer to treat their minor ailments with OTC medicines before seeking professional care , and 85 % of parents in the United States prefer to treat their children ’ s minor ailments with an OTC medicine before seeking professional care .
This is resulting in the formation of the bigger market .
The U.S Centers for Disease Control and Prevention ( CDC ) has conducted qualitative research into clinician knowledge , attitudes , and practices related to prescribing @ @ @ @ @ @ @ many possible factors involved in clinician hesitancy to prescribe antivirals like Tamiflu , including different perceptions about how well the drugs work and lack of awareness of the CDC ’ s antiviral use recommendations.1 Sanofi ’ s executive vice president of consumer healthcare Alan Main expressed confidence in the popularity of Tamiflu after it becomes an OTC drug , He said , “ Tamiflu will offer a significant public health benefit once switched by providing increased access to a safe and efficacious treatment for the prevention and treatment of flu.
” 10 Main @ @ @ @ @ @ @ to either reduce their chances of getting the flu or , at the first signals , appropriately treat as early as possible during the crucial first 48 hours without having to wait for a doctor ’ s appointment.
” 3

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