Navigation Links
FDA Imposes New Restrictions On Roche's Accutane

Women taking Roche Inc's popular acne treatment Accutane (isotretinoin) will soon have to submit to new restrictions aimed at preventing unwanted pregnancies while on the drug. The US Food and Drug Administration (FDA) said that it has approved significant changes to the drugmaker's pregnancy prevention programme. The pregnancy prevention programme was adopted about 13 years ago, when Accutane was conclusively linked to birth defects and even faetal death.//

But in recent years, case reports have demonstrated that some women on the drug continued to get pregnant despite these well-document side effects. The FDA said that the new restrictions will include requiring women to take a pregnancy test every month to prove that they are not pregnant as well as to sign a consent form, showing that they are aware of the potential risks. The FDA added that pharmacists would now be restricted to dispensing a one-month supply to ensure that these restrictions are followed. The typical treatment period is about six months.

In order to make the programme work, the FDA said that physicians wishing to prescribe the drug would receive yellow "Accutane Qualification Stickers'' that must be placed on the prescription as a means of verifying the negative pregnancy test and that the patient received the appropriate counseling. ''This sticker will indicate to the pharmacists that the patient is 'qualified,' the FDA said in a statement.
'"/>




Page: 1

Related medicine news :

1. Bird Flu Restrictions To Be Lifted In Scotland
2. Restrictions Imposed on Sale of Edible Common Salt
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:6/26/2016)... Viejo, California (PRWEB) , ... June 26, 2016 , ... ... Final Cut Pro X. , "Film editors can give their videos a whole new ... said Christina Austin - CEO of Pixel Film Studios. , ProSlice Levels contains ...
(Date:6/26/2016)... Clarkston, Michigan (PRWEB) , ... June 26, 2016 ... ... respect to fertility once they have been diagnosed with endometriosis. These women need ... but they also require a comprehensive approach that can help for preservation of ...
(Date:6/25/2016)... ... June 25, 2016 , ... The temporary closing of Bruton Memorial Library on June 21 due ... up a new, often overlooked aspect of head lice: the parasite’s ability to live away ... a common occurrence, but a necessary one in the event that lice have simply gotten ...
(Date:6/25/2016)... ... 25, 2016 , ... As a lifelong Southern Californian, Dr. Omkar Marathe earned ... the David Geffen School of Medicine at UCLA. He trained in Internal Medicine at ... fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had the opportunity ...
(Date:6/25/2016)... ... ... Conventional wisdom preaches the benefits of moderation, whether it’s a matter of ... too high can result in disappointment, perhaps even self-loathing. However, those who set the ... Research from PsychTests.com reveals that behind the tendency to set low expectations ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... Research and Markets has announced the ... report to their offering. ... favourable commercial environment for MedImmune to enter. The US ageing ... serve to drive considerable growth for effective anti-influenza medications. The ... sales considerably, but development is still in its infancy. ...
(Date:6/23/2016)... -- , , , WHEN: , ... , , , LOCATION: , , , Online, with free ... EXPERT PANELISTS:  , , , Frost & Sullivan,s Global Vice President ... Industry Analyst, Divyaa Ravishankar and Unmesh Lal, Program Manager , ... is witnessing an exceptional era. Several new demand spaces, such as ...
(Date:6/23/2016)... announced the establishment of Astellas Farma Colombia (AFC), a new affiliate with operations headquartered in Bogota. Colombia ... ... ... ... Astellas is a pharmaceutical ...
Breaking Medicine Technology: