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:6/20/2017)... ... June 20, 2017 , ... With certifications and experience that puts them at ... Adam and Hal Kimowitz are currently accepting new patients at their practice for these ... for some patients, which is why they offer the latest in modern dental techniques ...
(Date:6/20/2017)... Linda, Ca (PRWEB) , ... June 20, 2017 ... ... of alternative polyA sites. To understand their regulatory principles, the research team developed ... mRNA-Seq, iCLIP and RNA motif analyses. This reveals at nucleotide resolution the ‘RNA ...
(Date:6/20/2017)... ... June 20, 2017 , ... ... industry has been selected as the partner of choice by Amtrak to fulfill ... service that provides medium- and long-distance intercity service in the contiguous United States. ...
(Date:6/20/2017)... ... June 20, 2017 , ... Uniworld Boutique River ... aboard the line’s latest all-inclusive boutique ship, S.S. Joie de Vivre . What ... specifically for cruising France’s Seine River and designed small enough to dock directly in ...
(Date:6/20/2017)... , ... June 20, 2017 , ... The law firm ... on his installation as the president of the DuPage County Bar Association’s Board of ... Installation Dinner June 9 at the Drake in Oak Brook. Momkus McCluskey Roberts LLC ...
Breaking Medicine News(10 mins):
(Date:6/5/2017)... , June 5, 2017 Kohll,s Pharmacy ... the United States . The Raizer is ... a fallen person up to an almost-standing position ... and operated by one assistant and does not ... is simple enough that a child can operate it, ...
(Date:6/2/2017)...  NxStage Medical, Inc. (Nasdaq:  NXTM), a leading medical technology company ... demonstrating positive biochemical outcomes related to more frequent hemodialysis ... will be presented at the ERA-EDTA Congress being held ... . The research was conducted by ... Europe (KIHDNEy) Cohort team ...
(Date:5/30/2017)... DarioHealth Corp. (NASDAQ: DRIO), a leading global digital health ... it will be presenting at the 7th annual LD Micro Invitational ... Raphael , CEO, of DarioHealth will be giving the presentation and ... June 6th & 7th, 2017 at the Luxe Sunset Bel Air ... space. About LD Micro LD ...
Breaking Medicine Technology: