Dangerous Drug Recalls

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Millions of prescriptions are written for drugs that will ultimately be recalled and withdrawn from the market. In some cases, pharmaceutical manufacturers knew about the dangers of their drugs but continued to market and sell them anyway.

More than 2 million serious adverse drug events occur each year in the U.S. and an estimate of drug-related deaths tops 100,000 people every year. Many of these serious side effects and life-threatening events occur in dangerous drugs that will be recalled from the market.

Why Are Drugs Recalled?

Each year in the U.S. about 1,400 drug recalls are listed by the FDA. Most of the recalls occur in the Class II category with about 5 to 10% of recalls in the Class I category. Some of these medications will return to the market after corrective action is performed to manufacturing or other processes. A few of these medications will be permanently withdrawn and no longer sold in the U.S.

Drugs may be recalled due to manufacturing, contamination, labeling or storage concerns but they may also be recalled due to safety concerns which may be harmful or even life-threatening. Drug recalls are classified according to severity of possible harm.

  • Class I Recall – the most serious type of recall in which there is concern that exposure to a drug product will cause serious harm or death
  • Class II Recall – a situation in which exposure to a drug product may cause temporary or medically reversible harm or where the likelihood of serious harm is small
  • Class III Recall – a situation in which exposure to a drug product is unlikely to cause harm or adverse health consequences

For every 100 new drugs that are approved in the U.S., about 27 will be recalled within 15 years of approval. In most cases, the average time for drugs that prove to be dangerous to be withdrawn from the market is about 5 years after introduction.

Approval of Drugs that Prove to be Dangerous

Even though the approval process in countries outside of the U.S. is technically faster, drug approval in Europe, Canada, Japan and other countries is more complex. With nationalized healthcare, drugs must go through a secondary review process in order to be reimbursed. In addition, most other countries forbid direct to consumer marketing which is known to increase the prescribing of new drugs, in some cases unnecessarily.

Because some health care professionals feel pressured to prescribe new medications that their patients are asking for, many Americans may be exposed to drugs which prove to be dangerous before risks are fully understood. Unfortunately, every year millions of patients get prescriptions for medications which turn out to cause severe side effects, permanent injury or death.

Drugs that were once best-selling, popular medications that were recalled and discontinued include:

  • Baycol
  • Bextra
  • Celebrex
  • Cylert
  • Darvon and Darvocet
  • Floxin
  • Meridia
  • Omniflox
  • Palladone
  • Permax
  • Propulsid
  • Raptiva
  • Rezulin
  • Serzone
  • Trasylol
  • Vioxx
  • Zelnorm

Seeger Weiss is aware of many more drugs which have shown a risk for serious side effects, some of which may be life-threatening and continuing to monitor the market for Dangerous Drug Recalls.

Sources:

Over 100 million prescriptions written before drug safety recalls, International Journal of Health Services (6/2016)

Drug Recalls by Class, U.S. Food and Drug Administration (12/2017)