I gave my word to the many readers I heard from following my story on the dangers linked to the Gardasil cervical vaccine ( now being considered for approval for use in older women ) - that I would stay on top of this story.
With this in mind, I'm happy to report the FDA has taken steps towards better protection of women by issuing a stern warning letter to Merck, the makers of Gardasil, for deficiencies found in their West Point, Pennsylvania manufacturing plant.
Among the issues cited by the FDA included the fact that Merck failed to establish adequate written procedures describing the handling of all written and oral complaints about a drug product - including the complaints filed about Gardasil.
Also included in the warning letter was mention of " significant deviations from current good manufacturing practice ... in the manufacture of licensed biological vaccine products, bulk drug substances, and drug components" .
If you, a daughter, a sister, a friend ....or any woman you know has suffered ill effects following vaccination with Gardasil , make a report to your doctor and log on to the FDA's adverse events drug reporting page and make your voice heard!
Read the full story on the FDA letter in today's Wall Street Journal.
Wednesday, April 30, 2008
Follow Up- Cervical Vaccine Warnings
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