• Defective Drug Side Effects

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Vioxx and Celebrex were used for years and were so popular they both became blockbuster drugs. In recent months, a major turn of events has forced people to look at the drug industry and the drug agency overseeing it with a critical eye.

Merck & Co. announced in September that its popular arthritis drug Vioxx was linked to increased cardiovascular risk that was considered so significant it was being taken off the market. Vioxx''s cardiovascular risks raised questions about the entire safety of Cox-2 inhibitors, the drug class to which Vioxx and Pfizer Inc.''s Celebrex and Bextra belongs.

Shortly after the Vioxx recall, safety warnings for both Bextra and Celebrex were announced. Similar findings found in Vioxx users surfaced regarding Celebrex, but the drug still remains on the market. The quickly tarnished reputation of Cox-2 inhibitors left millions of patients without a method of pain relief and set off major criticism of the FDA''s ability to adequately protect the public.

Just as Cox-2 users began to switch to over-the-counter drugs like naproxen and brand name Aleve, more cardiovascular concerns were raised putting the spotlight on the Cox-1 inhibitor drug as well. The FDA has since ordered a review of trial data on Celebrex and Bextra while continuing to battle its critics, which includes agency whistleblower Dr. David Graham. Graham has claimed the agency pressured him to downplay results of a study reviewing the safety of Vioxx, and as well he has pointed out other drugs on the market that he feels presents major safety concerns.

Though the news has been consumed with stories involving Cox-2 inhibitors in recent months, other stories throughout the year have been controversial and are forcing regulators to look at the inadequacies of drug regulation. These include the new warnings from the FDA on heightened suicide risks in children taking antidepressants, the flu vaccine shortage and other major headlines. As the FDA and regulators try to win back public confidence, proposed changes in the way drug oversight is followed have already been made.