Tuesday, December 14, 2004

Vioxx type drug use limited in Germany

The Drug Commission of the German Medical Association (the equivalent of the Food & Drug Administration or FDA in the United States) is limiting the prescription of all drugs in the Cox-2 category. It may be noted that Vioxx is a Cox-2 inhibitor and it was recently recalled by Merck. Two other drugs Celebrex and Bextra that are gradually taking up the market share of Vioxx are also from the same Cox-2 category. There is no consensus among scientists in the United States if all drugs in the Cox-2 category are as dangerous as Vioxx though one study has shown that Vioxx was the most dangerous of all. (Related article: Vioxx recall focuses limelight on Cox-2 inhibitor drugs)

At this time, Celebrex is emerging as the most popular alternative to Vioxx and Bextra has been prescribed to some arthritis patients though it is expected that its share will go down as new safety warnings are added to Bextra. (Related article: Warning issued on Vioxx alternative Bextra)

According to German authorities, Cardiovascular complications are a side effect of all Cox-2 drugs. After the recall of Vioxx, they are questioning the safety of the remaining four drugs on the market: Celecoxib (Celebrex®); Valdecoxib (Bextra®), Parecoxib (Dynastat®) and Etoricoxib (Arcoxia®). The European drug approval authority is expected to deal with this question in the coming months.

The German Medical Association is recommending that doctors in Germany be very careful in prescribing Cox-2 drugs and prescribe it to only those patients that are likely to receive the most benefit and have the least susceptibility to cardiovascular complications:

  • Cox-2 drugs are not to be given to all cardiovascular risk patients.
  • Cox-2 drugs are to be used with patients over 65 years only during strict supervision by the doctor and with special precaution because the cardiovascular risks generally increase at the age.
  • The use of all Cox-2 drugs in general is to be limited till more data is available. The suggested time is only 3 months.

Recommended article: Alternatives to Vioxx are not totally safe