This morning on KSEV-700, Steve Drake, of KSEV’s “Financial Desk,” said that the FDA ordered Pfizer to pull its “Wild Thing” Viagra ad because the ad was too suggestive. That is NOT the reason why the FDA ordered the ad pulled:
“The TV ads omit the indication for the drug (namely, treatment of erectile dysfunction) and fail to provide information relating to the major side effects and contraindications of the drug, as required,” Christine Hemler Smith, a Food and Drug Administration regulatory review officer, informed Pfizer in a letter posted on the agency’s Web site.
[snip]
“The TV ads claim that Viagra will provide a return to a previous level of sexual desire and activity,” Smith wrote to Robert B. Clark, a Pfizer vice president. “FDA is not aware of substantial evidence or substantial clinical experience demonstrating this benefit for patients who take Viagra,” Smith wrote.
[snip]
Men who already have heart disease can risk further heart woes when they have sex, Smith’s letter said. Viagra, approved to treat erectile dysfunction, should not be used by men with heart conditions whose doctors have warned them not to have sex. Also, patients taking drugs that contain nitrates have been warned not to take Viagra because of sudden, unsafe drops in blood pressure.
What Drake said is just flat-out wrong, according to the FDA letter to Pfizer.
