The US Food and Drug Administration has warned 14 major drugmakers over Internet adverts for their drugs, including 19 which carry “black box” warnings of serious side effects, for failing to include risk information for patients.
The ads, which relate to company-sponsored links on Internet search engines such as Google, also in some cases included information on uses of the drugs which have not been approved by the FDA.
During routine surveillance by the agency’s Division of Drug Marketing, Advertising and Communications (DDMAC), officials found that sponsored links had made representations and/or suggestions for the efficacy of a total 48 drugs without communicating any risk information about their use, thus misleading patients.
One of the Division’s most strongly-worded subsequent warning letters went to Biogen Idec concerning the sponsored links for its multiple sclerosis drug Tysabri (natalizumab). The links’ failure to communicate any risk information, and “their casual approach” to treatment with Tysabri “is extraordinary in light of the potentially lethal risks of the drug and the stringent controls over its distribution,” regulatory review officer Dr Sharon Watson told the company.
“By omitting the most serious and frequently-occurring risks associated with the drug, the sponsored links misleadingly suggest that Tysabri is safer than it is known to be,” she adds.
Warning letters about sponsored links’ failure to supply risk information have also gone to:
Sanofi Aventis for Plavix (clopidogrel);
GlaxoSmithKline for Avandia (rosiglitazone), Avandamet (rosiglitazone and metformin), Avandaryl (rosiglitazone and glimepiride), Avodart (dutasteride), Coreg CR (carvedilol) and Tykerb (lapatinib);
Forest Laboratories for Bystolic (nebivolol), Campral (acamprosate), Lexapro (escitalopram) and Namenda (memantine);
Cephalon for Fentora (fentanyl) and Treanda (bendamistine);
Bayer Healthcare Products for Levitra (vardenafil), Yaz (drospirenone and ethinyl estradoil) and Mirena (levonorgestrel-releasing intrauterine system);
Johnson & Johnson for Prezista (darunavir);
Pfizer for Aromasin (exemestane), Caduet (amlodipine besylate/atovastatin), Chantix (varenicline), Detrol LA (tolterodine tartrate), Lyrica (pregabalin) and Celebrex (celecoxib);
Novartis for Femara (letrozole), Diovan (valsartan), Exforge (amlodipine and valsartan), Exjade (deferasirox) and Gleevec (imatinib mesylate);
Genentech for Avastin (bevacizumab), Lucentis (ranibizumab), Rituxan (rituximab), Xolair (omalizumab), Herceptin (trastuzumab) and Pulmozyme (dornase alfa);
Boehringer Ingelheim for Spiriva HandiHaler (tiotropium bromide inhalation powder), Flomax (tamsulosin) and Mirapex (pramipexole);
Merck & Co for Januvia (sitagliptin), propecia (finasteride), Singulair (montelukast sodium) and Emend (aprepitant);
Hoffmann-LaRoche for Boniva (ibandronate), Pegasys (peginterferon alfa-2a) and Xeloda (capecitabine); and
Eli Lilly for Cymbalta (duloxetine), Evista (raloxifene) and Gemzar (gemcitabine).
Warning letters mainly relating to generic products have also been issued to Glenmark Generics, Lannett, Lehigh Valley Technologies, Mallinckrodt, Xanodyne, Physicians Total Care, Boehringer Ingelheim Roxane and Cody Labs.
The FDA has not communicated with any of the search engines because of its policy not to contact third parties carrying drug advertisements, even if these are in violation of agency rules.
