Science Forums 2

[Michaelangelica]

Great links DVK
A full time job to keep up with it all!
the FDA is now publishing alist of drugs they are rewiwng for safty info
their resons and links to reports are here
http://www.fda.gov/Drugs/GuidanceCom...ects/UCM082196
This is the latest list although formatting will not paste over

Product Name: Active Ingredient (Trade)
or Product Class Potential Signal of Serious Risk/New Safety Information

Additional Information

(as of May 7, 2009)
Apomorphine (Apokyn) Psychiatric events FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Choriogonadotropin alfa (Ovidrel) Anaphylactic reactions FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Clomiphene citrate (Clomid) Visual disorders FDA is evaluating this issue to determine if the labeling, which includes visual disorders in the Warnings and Adverse Reactions sections, is adequate.
Clozapine orally disintegrating tablet (FazaClo) Deaths This issue relates to a finding, based on AERS reports, that the proportion of death events versus all events is higher for FazaClo than for other clozapine products. The reported events in the death cases are similar for FazaClo and other clozapine products. FDA is continuing to evaluate this issue.
Darifenacin (Enablex) and Solifenacin (Vesicare) Angioedema and other allergic reactions FDA is continuing to evaluate these issues to determine the need for any regulatory action.
Drospirenone/ethinyl estradiol (Yasmin) Pancreatitis FDA is evaluating this issue to determine if the labeling, which includes pancreatitis, is adequate.
Efavirenz (Sustiva) Birth defects involving the eye and face This issue stemmed from a case of anophthalmia in AERS that was originally reported to the Antiretroviral Pregnancy Registry (APR). The labeling was updated in March 2009 to include a description of this case.
Efavirenz (Sustiva) labeling
Fibrin sealant, human (Evicel) Air embolism FDA is evaluating this issue to determine if labeling is adequate.
Hydrochlorothiazide in combination products Skin reactions FDA is evaluating this issue to determine if labeling is adequate for the various hydrochlorothiazide-containing combination products.
Imiquimod cream (Aldara) Dysuria due to severe local reactions during use in the genital area

This issue was identified during a review of imiquimod adverse events as required by the Best Pharmaceuticals for Children Act and was presented at the November 18, 2008 Pediatric Advisory Committee meeting: One Year Post-Exclusivity Adverse Event Review: Imiquimod Pediatric Advisory Committee Meeting November 18, 2008 (PDF - 83 KB) (refer to Slide 24).

The labeling will be updated to include this event.
Modafinil (Provigil) and Armodafinil (Nuvigil) Serious skin reactions

This issue was originally identified from AERS reports and added to labeling in 2007. An FDA Drug Safety Newsletter article featured this issue in Fall 2007: Modafinil (marketed as Provigil): Serious Skin Reactions.

FDA is continuing to evaluate this issue to determine the need for any further regulatory action.
Orlistat (Xenical, Alli) Hepatotoxicity FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Polyethylene glycol oral laxative (various trade names) Neuropsychiatric events FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Raltegravir (Isentress) Psychiatric events The Adverse Reactions section of labeling (postmarketing experience) was updated to include psychiatric events.
Raltegravir (Isentress) labeling
Selegiline (Emsam) Hypertension FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Sumatriptan/naproxen (Treximet) Myocardial infarction FDA evaluated case reports in AERS and determined that the current labeling, which includes a Boxed Warning addressing myocardial infarction, is adequate.
Testosterone gel (Androgel, Testim) Adverse events from accidental exposure May 2009 FDA News Release, Testosterone Gel Safety Concerns Prompt FDA to Require Label Changes, Medication Guide, describes the addition of a Boxed Warning to the labeling addressing adverse events in children and women due to accidental exposure to testosterone gel.
Tolterodine tartrate (Detrol) Stevens-Johnson syndrome FDA is continuing to evaluate this issue to determine the need for any regulatory action.
Varenicline (Chantix) Angioedema, serious skin reactions, visual impairment, accidental injury FDA is continuing to evaluate these issues to determine the need for any regulatory action.

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Page Last Updated: 06/04/2009

http://www.fda.gov/Drugs/GuidanceCom.../ucm161063.htm