Vioxx, a non-steroidal anti-inflammatory (NSAID), was made by Merck & Co. Inc., and introduced to the American market in 1999. The company then voluntarily pulled the drug from the market in September 2004, after there were multiple reports of increased risk of heart attack and stroke associated with long-term, high-dose use.

Six investigators from the Mount Sinai School of Medicine analyzed 30 randomized placebo-controlled trials involving Vioxx  and 20,152 individuals. They published their findings in the November 23 issue of Archives of Internal Medicine.

What the researchers found is disturbing:

Their analysis showed that safety concerns arose almost four years before the drug was withdrawn from the market. Dr. [Joseph] Ross and his colleagues found that as of December 2000 — when 21 of the 30 studies had been completed — there was a strong concern that patients taking Vioxx were at a greater risk for adverse events or death from cardiovascular conditions or blood clots. Thereafter, collected data through June 2001 showed Vioxx to be associated with a 35 percent increase in risk of a cardiovascular event or death. The association with cardiovascular risk strengthened as more data became available. As of April 2002, the pooled analysis showed a 39 percent increased risk, and as of September 2004, a 43 percent increased risk.

If this is true, and it seems to be, how can the company have gotten away with this?

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Post from: Blisstree

Vioxx (Rofecoxib) Dangers Known Earlier

Today the Medicines and Healthcare products Regulatory Agency (MHRA) announces approval of naproxen 250mg tablets to be made available from pharmacies under the brand name Feminax Ultra for the treatment of period pain (primary dysmenorrhoea) for women aged between 15 and 50 years. Medicines containing naproxen are currently available on prescription only.

It is estimated that 40-70% of women of reproductive age experience period pain during their menstrual cycles. For up to 10% of women period pain can interfere with their daily activities.

Over-the-counter (OTC) naproxen provides an alternative to ibuprofen, which is the only non-steroidal anti-inflammatory drug (NSAID) currently available OTC for the treatment of primary dysmenorrhoea.

The Commission on Human Medicines (CHM) carefully considered the safety issues before recommending approval and concluded that in these women the benefits outweigh the risks. Pharmacists may check age and symptoms with the individual to make sure it is safe to supply this medicine.

Dr June Raine, Director of Vigilance and Risk Management of Medicines at the MHRA said, “Period pain is a condition which can be successfully managed by women themselves. OTC naproxen will expand the choice of treatments available for this common condition from pharmacies.”

This approval ties in with a wider MHRA initiative of widening availability of medicines for Women’s Health.

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Post from: Blisstree

Press release: UK approves Feminax Ultra for period pain as OTC