The Therapeutic Goods Administration (TGA) is investigating whether a prescription drug containing sildenafil, a medication used to treat erectile dysfunction (ED) and pulmonary arterial hypertension (PAH), can be sold under a different name.
The TGA is currently investigating whether it may be sold under the trade name, which means ‘all’.
The TGA is investigating whether it may be sold under the trade name, which means ‘all’.
The TGA has set up an investigation team, following which the TGA will determine whether it has received the necessary formalities of a prescription before the drug can be sold under a different name.
This investigation is ongoing, but information on the TGA is now being collected.
The TGA has sent a request to the Department of Health for a report on the investigation to be made public, following which this report can be published, in English and in a more appropriate language.
The TGA is seeking from patients to report on whether the prescription drug sildenafil, a medication used to treat ED and PAH, may be sold under a different name, the TGA will report on this.
The drug was originally registered in the UK in 2003.
The TGA is currently investigating the sale of the drug under the trade name.
Sildenafil, a drug that is sold under the brand name Viagra, is sold under a different name.
The TGA will also determine whether it may be sold under the name, which means ‘all’.
The TGA is currently seeking patients to report whether the prescription drug sildenafil, a medication used to treat erectile dysfunction (ED) and pulmonary arterial hypertension (PAH), may be sold under a different name. Patients will need to provide them with a full copy of the prescription from their GP, to which they must be informed as soon as possible.
The TGA is also seeking information on whether patients should receive written guidance on the sale of the drug under the trade name.
The TGA is currently seeking information on the sale of the drug under the trade name.
Find out morePatients will need to provide their GP information as soon as possible
Patients with a health condition such as heart, lung, liver or kidney disease should not be taking sildenafil, as it can be dangerous for people with these conditions.
Sildenafil is not currently registered in the NHS and is therefore not available for patients with any other health conditions.
Patients are advised that if they meet the above criteria and request it from their GP, they should provide their GP a copy of their health condition to which they are seeking sildenafil, or their GP may be able to provide a referral letter explaining the condition to them.
If the patient requests sildenafil, they will need to provide their GP with a letter from their GP stating that they are ‘under a health condition’.
Patients who are currently taking sildenafil will not need to provide their GP information to ensure it is for the patient.
For more information on the prescription drug sildenafil, please read the following article, which contains a list of approved medications and information on their sales.
References:
1. Fugh-Wald/Jardin/Waldmann (2005). ‘Sildenafil tablets (Viagra).’ Pharmaceutical Journal of Australia, 24, p. 895.
2. Brickell, F., & Stoner, D. (2006). ‘Sildenafil tablets (Viagra).’ Pharmaceutical Journal of Australia, 29, p. 1325.
3. ‘Sildenafil tablets (Viagra).’ Pharmaceutical Journal of Australia, 25, p. 845.
4. Fugh-Wald/Jardin/Waldmann (2006). ‘Sildenafil tablets (Viagra).’ Pharmaceutical Journal of Australia, 27, p. 815.
5. ‘Sildenafil tablets (Viagra).’ Pharmaceutical Journal of Australia, 28, p. 927.
The Food and Drug Administration (FDA) has received an email from India’s National Health Organisation (NHA), which indicates the company was informed of an issue with the medication VIAGRA. The FDA has issued a notice of exclusion in this matter.
The NHA said the company was not aware of any complaints about the medication, and that the product contained a generic version of VIAGRA.
The FDA stated that there was “no evidence that the medication was intended to treat an underlying condition”. The company was directed to submit to the NHA and other healthcare professionals for a review before the review process is complete.
The FDA stated that the product “is in compliance with all regulatory and safety standards and product monographs, and has not been shown to cause adverse effects or interactions with other drugs, including the use of VIAGRA”. The product was packaged in blister packs.
The FDA issued an alert letter advising that the product should not be sold to consumers who have purchased it from online pharmacies, because such sales are illegal. A statement issued on the same day stated the following about VIAGRA:
VIAGRA was originally developed as a medication for erectile dysfunction (ED). VIAGRA is a non-hormonal treatment for ED.
It was developed by a company called Eli Lilly which is based in the US and has been in business since 1998.
The NHA said: “VIAGRA is a medication specifically designed to treat erectile dysfunction. The drug has been approved by the FDA for sale in the US, Canada, Australia and New Zealand.
“The product was originally developed for treating erectile dysfunction.
Sildenafil citrate, commonly known by the brand name, is a prescription-only medicine used to treat erectile dysfunction (ED) in adult men. It works by improving blood flow to the penis, helping to achieve and maintain an erection during sexual activity.
Sildenafil is available in 25mg, 50mg, and 100mg strengths.
Sildenafil has been shown to be effective in up to 80% of men with ED, with effects typically noticeable within 30 to 60 minutes, and lasting for up to 4–5 hours.
Common side effects include:
Less common but serious effects include visual disturbances, hearing changes, or prolonged erections. Seek medical attention if severe or persistent side effects occur.
Sildenafil should not be used by those:
Inform your doctor of all medications and supplements before use. Interactions may occur with:
Avoid excessive alcohol while taking sildenafil, as it can lower blood pressure and increase side effect risk. Use with caution if you have any heart-related conditions.
Sildenafil is available by prescription only in the UK.
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Less common side effects but serious side effects include vision changes, hearing changes, or prolonged erections.
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