WASHINGTON – The Food and Drug Administration has approved the first prescription drug designed to boost sexual desire in women, a milestone long sought by a pharmaceutical industry eager to replicate the blockbuster success of impotence drugs for men.
But stringent safety measures on the daily pill called Addyi mean it will probably never achieve the sales of Viagra, which has generated billions of dollars since the late 1990s.
The drug’s label will bear a boxed warning – the most serious type – alerting doctors and patients to the risks of dangerously low blood pressure and fainting, especially when the pill is combined with alcohol. The same problems can occur when taking the drug with other commonly prescribed medications, including anti-fungals used to treat yeast infections.
“Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment,” said Dr Janet Woodcock, director of the FDA’s drug centre, in a statement announcing the approval on Tuesday.
Under an FDA-imposed safety plan, doctors will only be able to prescribe Addyi after completing an online certification process that requires counseling patients about Addyi’s risks. Pharmacists will also need certification and will be required to remind patients not to drink alcohol while taking the drug.
Opponents of the drug say it’s not worth the side effects, which also include nausea, drowsiness and dizziness. They point out that the FDA rejected the drug twice, in 2010 and 2013, due to these risks.
“This is not a drug you take an hour before you have sex. You have to take it for weeks and months in order to see any benefit at all,” said Leonore Tiefer, a psychologist and sex therapist who organized a petition last month calling on the FDA to reject the drug.
Patients should stop taking the drug after eight weeks if they do not see any improvement, says the FDA release.
Sprout Pharmaceutical’s drug is intended to treat women who report emotional stress due to a lack of libido. Its approval marks a turnaround for the FDA, which previously rejected the drug twice due to lacklustre effectiveness and side effects. The decision represents a compromise of sorts between two camps that have publicly feuded over the drug for years.
On one side, Sprout and its supporters have argued that women desperately need FDA-approved medicines to treat sexual problems. On the other side, safety advocates and pharmaceutical critics warn that Addyi is a problem-prone drug for a questionable medical condition.
Beginning with the drug’s launch in mid-October, doctors who see patients complaining about a loss of sexual appetite will have a new option.
* Associated Press
Ain Dubai in numbers
126: The length in metres of the legs supporting the structure
1 football pitch: The length of each permanent spoke is longer than a professional soccer pitch
16 A380 Airbuses: The equivalent weight of the wheel rim.
9,000 tonnes: The amount of steel used to construct the project.
5 tonnes: The weight of each permanent spoke that is holding the wheel rim in place
192: The amount of cable wires used to create the wheel. They measure a distance of 2,4000km in total, the equivalent of the distance between Dubai and Cairo.
ABU%20DHABI%20CARD
%3Cp%3E%3Cstrong%3E5pm%3A%20%3C%2Fstrong%3EWathba%20Stallions%20Cup%20%E2%80%93%20Handicap%20(PA)%20Dh70%2C000%20(Turf)%202%2C200m%0D%3Cbr%3E%3Cstrong%3E5.30pm%3C%2Fstrong%3E%3A%20Rub%20Al%20Khali%20%E2%80%93%20Maiden%20(PA)%20Dh80%2C000%20(T)%201%2C400m%0D%3Cbr%3E%3Cstrong%3E6pm%3A%20%3C%2Fstrong%3EAl%20Marmoom%20Desert%20%E2%80%93%20Maiden%20(PA)%20Dh80%2C000%20(T)%201%2C600m%0D%3Cbr%3E%3Cstrong%3E6.30pm%3A%20%3C%2Fstrong%3ELiwa%20Oasis%20%E2%80%93%20Handicap%20(PA)%20Dh80%2C000%20(T)%201%2C400m%0D%3Cbr%3E%3Cstrong%3E7pm%3A%20%3C%2Fstrong%3EAl%20Khatim%20Desert%20%E2%80%93%20Handicap%20(PA)%20Dh80%2C000%20(T)%201%2C600m%0D%3Cbr%3E%3Cstrong%3E7.30pm%3A%3C%2Fstrong%3E%20Al%20Quadra%20Desert%20%E2%80%93%20Handicap%20(TB)%20Dh80%2C000%20(T)%201%2C600m%3C%2Fp%3E%0A
UAE currency: the story behind the money in your pockets
The Florida Project
Director: Sean Baker
Starring: Bria Vinaite, Brooklynn Prince, Willem Dafoe
Four stars
RIDE%20ON
%3Cp%3EDirector%3A%20Larry%20Yang%3C%2Fp%3E%0A%3Cp%3EStars%3A%20Jackie%20Chan%2C%20Liu%20Haocun%2C%20Kevin%20Guo%3C%2Fp%3E%0A%3Cp%3ERating%3A%202%2F5%3C%2Fp%3E%0A
Singham Again
Director: Rohit Shetty
Stars: Ajay Devgn, Kareena Kapoor Khan, Ranveer Singh, Akshay Kumar, Tiger Shroff, Deepika Padukone
Rating: 3/5
Final scores
18 under: Tyrrell Hatton (ENG)
- 14: Jason Scrivener (AUS)
-13: Rory McIlroy (NIR)
-12: Rafa Cabrera Bello (ESP)
-11: David Lipsky (USA), Marc Warren (SCO)
-10: Tommy Fleetwood (ENG), Chris Paisley (ENG), Matt Wallace (ENG), Fabrizio Zanotti (PAR)
if you go
The flights
Air France offer flights from Dubai and Abu Dhabi to Cayenne, connecting in Paris from Dh7,300.
The tour
Cox & Kings (coxandkings.com) has a 14-night Hidden Guianas tour of Guyana, Suriname and French Guiana. It includes accommodation, domestic flights, transfers, a local tour manager and guided sightseeing. Contact for price.
How to tell if your child is being bullied at school
Sudden change in behaviour or displays higher levels of stress or anxiety
Shows signs of depression or isolation
Ability to sleep well diminishes
Academic performance begins to deteriorate
Changes in eating habits
Struggles to concentrate
Refuses to go to school
Behaviour changes and is aggressive towards siblings
Begins to use language they do not normally use
Which honey takes your fancy?
Al Ghaf Honey
The Al Ghaf tree is a local desert tree which bears the harsh summers with drought and high temperatures. From the rich flowers, bees that pollinate this tree can produce delicious red colour honey in June and July each year
Sidr Honey
The Sidr tree is an evergreen tree with long and strong forked branches. The blossom from this tree is called Yabyab, which provides rich food for bees to produce honey in October and November. This honey is the most expensive, but tastiest
Samar Honey
The Samar tree trunk, leaves and blossom contains Barm which is the secret of healing. You can enjoy the best types of honey from this tree every year in May and June. It is an historical witness to the life of the Emirati nation which represents the harsh desert and mountain environments