TAMIFLU : Side Effects, Risks and Benefits

SWINE FLU : TAMIFLU :  Side Effects, Risks and Benefits

According to the medicines watchdog more than 400 reports of side-effects of the antiviral drug Tamiflu have been received since the start of the swine flu outbreak, in the World.

Just as research suggested that the drug's harms may outweigh its benefits for some children, a total of 125 suspected adverse drug  reactions were reported to the Medicines and Healthcare products Regulatory Agency (MHRA) in the past week alone, In the UK.

In some isolated case, some of the patients who took Tamiflu, faced some respiratory problems.

One such case came out in Scotland, where the16-years-old daughter of GMTV presenter, Mr. Castle, took Tamiflu during an outbreak of Swine flu at her school, in May. His daughter, Georgina, suffered serious “ respiratory collapse and almost died “,as  he described.

But  the Governments, in many countries, maintained  that advice to parents to treat swine flu  with Tamiflu remained unchanged.

There had been received more than 418 reports of 686 and more suspected adverse reactions to Tamiflu between April 1 and August 6, in the World.  

The most common side-effects reported are allergies to Tamiflu, which is manufactured by Roche, and gastro-intestinal problems. Vomiting and nausea are listed as the drug's main side effects on its packaging.

And apart from the known side effects of Tamiflu, many  reports of side-effects of Relenza, another anti-viral, have been received since April 1 and the Officials said that most reports are in line with recognised side-effects of the drug.

In many countries, the Government Officials assured that  they were continuing to monitor reported side-effects of both drugs to establish any potential trends. And they further stated: "Tamiflu and Relenza are acceptably safe medicines and most people will not suffer any side-effects”.

"The balance of risks and benefits for Tamiflu and Relenza remains positive."

"We've got to keep things in proportion and people shouldn't worry unnecessarily. People shouldn't take Tamiflu unless they have got swine flu."

As the reports are coming out from the USA, Mexico, the UK, and many other countries seriously affected by the said disease, every case should be studied in isolation , and then only be given Tamiflu, otherwise not .

Many experts opined that the research, available, only dealt with seasonal flu, not swine flu, and added: "That's a very important distinction. Swine flu is a new virus. It is in its early days and we're adopting very much a safety-first approach to tackling the illness. Tamiflu is our only, and  our main line of defence against this new virus right now."

Another expert said: "The decision whether or not to prescribe a drug for a patient is always a matter for the clinical judgment of the prescriber concerned “

In relation to prescribing anti-virals there should be issued  proper guidance detailing clear advice on prescribing and on who to treat. That includes those who appear to have influenza A H1N1 virus and especially those who are at higher risk of complications.

Doctors should exercise their clinical judgment in deciding who should receive anti-virals based on an individual's needs.

However, Swiss pharma major Roche is making a killing on Tamiflu. By the end of the year, it expects to rake in £1.2 billion, or almost Rs 10,000 crore, through sales of its bestseller globally- Tamiflu in India alone !

 
In the last few weeks, sales of face masks, anti-bacterial hand washes, immunity builders, liquid hand sanitizers, surface cleaners and vitamin tablets have soared in most of the countries in the World.

In India, the Centre may be set to lift the ban on production and sale of the anti-H1N1 (oseltamivir) drug, and may allow desi manufacturers like Cipla, Ranbaxy and Hetero Drugs to launch more affordable, generic versions of the drug.

One of the biggest Pharma Companies-Ranbaxy produces the generic equivalent of Tamiflu, the API (active pharmaceutical ingredient) oseltamivir and its formulations. If allowed and required, Ranbaxy may provide more than a million capsules in the next few weeks to the Indian market.

There is a big rush in the World to develop a vaccine for swine flu whereas the oseltamivir may be curative while a vaccine would be preventive).

In India, the Industry sources opine that multinationals, Sanofi-Aventis, Novartis and GlaxoSmithKline amongst many others, in the run for making the swine flu vaccine, may be expected to charge around $6 (approx.  Rs 288) per dose although it may not and should not cost more than $1 (Rs 48) per dose to, actually, produce it in Indian Market.