Four Warning Letters Issued By FDA


March 16, 2010

Four Warning Letters Issued By FDA

The FDA rarely has the needs to issue more than one warning letter in order for a drug company to comply. This is because the warning letters received from the FDA can affect a company’s stock sales or be used in litigation against the company. The FDA has recently issued 4 warnings to Shire. The company makes a treatment for end stage kidney failure.

One brochure issued by Shire about Fosrenol their kidney treatment drug contained 4 different faux pas that the FDA jumped on. The warning letter issued in 2009 was brought to light in early 2010 and details the exact warnings given to Shire. The warning letter detailed these very important facts that were falsified, exaggerated or left out entirely from the brochure.

1. The Fosrenol brochure didn’t include risk warnings, leaving patients clueless about the risk of Crohn’s disease and bowel obstruction. Frankly that’s something I would want to be aware of.
2. The brochure claimed that Fosrenol is safer and more effective than other drugs on the market for end stage kidney failure. The FDA claims there is not enough evidence to make that claim. You’d think that a drug company touting the safety of their product would include the risk warnings to show that their risks are lower than other drugs.
3. The brochure says that Fosrenol can prevent bone disease, heart disease and death. There is no evidence to support this claim and the FDA has called the company on it. Sure some of the ingredients may help in preventing those problems but by no means should the company be claiming Fosrenol is a wonder drug- to really entice people to use their drug. The people at Shire need to be touting the real abilities of Fosrenol.
4. Related to #3 is the warning that Shire broadened the approved uses of the drug outside end stage renal failure.

Based on these warnings from the FDA you may be wondering what truth can be found on the Fosrenol brochure, well is seems that this drug has been approved by the FDA so Shire didn’t commit the infraction of marketing without FDA approval.

Researching drugs thoroughly instead of relying on brochures given to physicians by drug companies is so important to making the best choice in treatments, and in knowing what to expect from the drugs you take. Mis-marketing is the fault of overzealous drug companies, not knowing enough about what you are taking is the fault of the consumer.

Publisher: Salient News


1 comment on “Four Warning Letters Issued By FDA”

[…] All the way back in 1999 the FDA told Johnson and Johnson that their marketing material for Risperdal, an antipsychotic, was incorrect. The marketing materials overstated the benefits and minimized the risks involved with Risperdal. However Risperdal itself was approved by the FDA for antipsychotic use. Here we are in 2010 and guess what? Johnson and Johnson have continued to push Risperdal to the elderly even after the warning from the FDA. […]

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