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Drug companies: mea culpa

01 June 1993

Drug manufacturer Glaxo is in trouble with the US Food and Drug Administration over its advertising of Zantac (ranitidine), a treatment for peptic ulcers.

The FDA cites a total of eight violations of the Federal, Food, Drug and Cosmetic Act, including unfairly knocking the competition, and promoting the drug's use for preventing stress ulcer, for which it is not approved.

Glaxo is likely to have to join another anti ulcer drug manufacturer, Marion Merrell Dow, in the ignominy of having to issue "Dear Doctor" letters correcting its earlier false claims.

Marion Merrell ran into strikingly similar problems over its advertising for Carafate (sucralfate).

It is currently having to run a series of ads in the medical press correcting its "false and/or misleading" earlier claims:

"Carafate has not been proven superior to histamine H2 receptor antagonists. . .Carafate has not been proven superior in effectiveness to other anti ulcer medications. . .Carafate has not been proven to offer equal duodenal ulcer healing rates. . . ."

Zantac - Zantac (ranitidine), the ulcer drug, is one of the world's top bestsellers. Consequently, the recent news that most ulcers are caused by the helicobac...

Ulcer drug linked to stomach bug - People taking the ulcer drug omeprazole face a 10 fold increased risk of developing gastroenteritis caused by the bug campylobacter, now a more common...

Zantac and ulcers - Q:Could you please tell me the side effects of Zantac? M D, London...... ...

New ulcer therapy urged - Peptic ulcers should be treated with acid reducing drugs and antimicrobial therapy, the US National Institutes of Health have recommended. ...

The use of Zantac for Maintenance Therapy - In Vol 4 No 4 you state that our product Zantac is not approved for maintenance therapy in the US but is in the UK.

Diet reduces ulcer risk - A diet high in fruit and vegetables can reduce the risk of developing a duodenal ulcer. Researchers believe it is the vitamin A and fibre content of t...

Fda fingers heart drug - The calcium blocker nifedipine used to treat high blood pressure has been singled out by the US's Food and Drug Administration (FDA) for increasing th...

Fda drug alerts - Crestor (rosuvastatin): The US Food and Drug Administration (FDA) has issued a Public Health Advisory notifying healthcare professionals that 22 membe...

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