FDA names riskiest drugs
Sunday, June 7th, 2009
The FDA has just released its most recent quarterly report on “potential signals of serious risks” for certain drugs, identified between October and December of last year.
While being named in the report does not mean the FDA has confirmed a causal relationship between the drug and the risk, it does mean that the agency has identified a potential safety issue and is continuing to investigate it.
This doesn’t mean you shouldn’t take the drug — only that you should do your research and ask your physician before doing so.
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Drug: Side Effect or Adverse Effect
- Apomorphine (Apokyn): Psychiatric events
- Choriogonadotropin alfa (Ovidrel): Anaphylactic reactions
- Clomiphene citrate (Clomid): Visual disorders
- Clozapine orally disintegrating tablet (FazaClo): Deaths
- Darifenacin (Enablex) and Solifenacin (Vesicare): Angioedema and other allergic reactions
- Drospirenone/ethinyl estradiol (Yasmin): Pancreatitis
- Efavirenz (Sustiva): Birth defects involving the eye and face
- Fibrin sealant, human (Evicel): Air embolism
- Hydrochlorothiazide in combination products: Skin reactions
- Imiquimod cream (Aldara): Dysuria due to severe local reactions during use in the genital area
- Modafinil (Provigil) and Armodafinil (Nuvigil): Serious skin reactions
- Orlistat (Xenical, Alli): Hepatotoxicity
- Polyethylene glycol oral laxative (various trade names): Neuropsychiatric events
- Raltegravir (Isentress): Psychiatric events
- Selegiline (Emsam): Hypertension
- Sumatriptan/naproxen (Treximet): Myocardial infarction
- Testosterone gel (Androgel, Testim): Adverse events from accidental exposure
- Tolterodine tartrate (Detrol): Stevens-Johnson syndrome
- Varenicline (Chantix): Angioedema, serious skin reactions, visual impairment, accidental injury
View previous quarterly reports and background information on this FDA program here.
