The move by the Food and Drug Administration (FDA) was 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 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 antifungals used to treat yeast infections.
Opponents of the drug say it is 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.
Patients should stop taking the drug after eight weeks if they do not see any improvement, notes 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 U-turn by the FDA, which previously rejected the drug twice due to lacklustre effectiveness and side effects.
Source: Times of Malta
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 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 antifungals used to treat yeast infections.
Opponents of the drug say it is 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.
Patients should stop taking the drug after eight weeks if they do not see any improvement, notes 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 U-turn by the FDA, which previously rejected the drug twice due to lacklustre effectiveness and side effects.
Source: Times of Malta
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