Gardasil approved for expanded use; House investigates Centrum Cardio claims; Pfizer warned for online Viagra push; and more
For the week of September 15:
Gardasil’s story continues to evolve, with the FDA granting approval to Merck for use against two more cancers but insisting on new information for the HPV vaccine’s label.
The additional label information includes reports about serious side effects like seizures and paralysis. Recent news reports have covered the backlash against Gardasil, which is approved for women, aged 9 to 26.
At the beginning of the summer, the FDA did not approve use of the vaccine for women between the ages of 27 and 45.
Also:
House representatives John Dingell and Bart Stupak are investigating claims that Wyeth markets its Centrum Cardio vitamin as cholesterol lowering.
The FDA addresses Pfizer’s online marketing tactics for Viagra, sending a warning letter about a Web video and pushing the drug company to shut down an “advergame” earlier this month.
Allergan said that it will apply with the FDA next year for expanded use of Botox for treatment of migraines, with the announcement sending the company’s shares up 11%.
