New Study Contradicts FDA on Cholesterol Drug Crestor

Strategic Insights -

A recent study by Tufts University researchers has revealed that more people suffer serious side effects from the cholesterol-lowering drug Crestor than from other similar medications, despite the FDA's assertions that it is safe. The study's findings are likely to have significant implications for the millions of people who use Crestor, which was introduced in 2001 as the first cholesterol-lowering drug in a new class known as statins since the withdrawal of Baycol due to muscle problems.

The Tufts study contradicts the FDA's findings and those of Crestor's maker, AstraZeneca, which has played down the reports of side effects as "deceptively high" due to negative publicity surrounding Baycol. The FDA and AstraZeneca have maintained that Crestor is no more likely to cause adverse events than other statins.

Key Takeaways:

  • The Tufts University study found that more people suffered serious side effects from Crestor than from other statins, contradicting FDA and AstraZeneca's claims.
  • Crestor was introduced in 2001 as the first cholesterol-lowering drug in a new class of statins since Baycol's withdrawal.
  • The FDA has received a relatively high number of anecdotal reports of side effects through its Adverse Event Reporting system, despite playing down the risks.
  • AstraZeneca has rejected the Tufts study's implication that Crestor is riskier than other statins, saying its safety profile is in line with other marketed statins.
  • The study's leader, Richard Karas, emphasized that while Crestor may be less safe than other statins, the overall risks remain low and patients should consult their doctors before deciding whether to continue or stop taking the medication.

Statistics:

  • The number of people who suffer serious side effects from Crestor is significantly higher than from other statins.
  • The crestor is one of the most popular cholesterol-lowering medications on the market, with millions of people taking it.
  • The FDA has received a high number of reports of side effects through its Adverse Event Reporting system.
  • The number of people taking Crestor is not significantly higher than other statins, despite its popularity.
  • The overall risks of Crestor remain low, with most patients experiencing no adverse effects.

Sources:

  • "Tufts University study"
  • "FDA spokesperson Laura Alvey" by email on March 14
  • A statement by AstraZeneca
  • Tufts University study released on March 14
  • "The Philadelphia Inquirer", March 14, 2005
  • http://www.krtinfo.com/reprints/