Tighter Accutane restrictions announced by FDA

-November 23, 2004

The FDA announced today a national registry for women of childbearing age prescribed the drug Accutane has been set up. Accutane is a powerful acne medication that can cause serious birth defects, including brain and heart damage, even in small amounts. Ever since Accutane was introduced to the market in 1982, Accutane has been controversial.

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Bayer slow to pull Baycol from the market

-November 22, 2004

An editorial in the Journal of the American Medical Association is one of just several articles to appear in next week's edition that focuses on the FDA's ability to effectively monitor drug safety. Following the September Vioxx recall, more critics have been questioning the FDA's capability to adequately monitor drug safety considering its recent track record. The ability for drug companies to influence federal regulation has also come under intense scrutiny.

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Vioxx recall leaves arthritis treatment options in question

-October 25, 2004

The Vioxx recall has left many doctors with a need to decide what type of prescription practices to adopt for arthritis patients. The entire class of drugs that Vioxx belongs to, called the COX-2 inhibitors (which includes Pfizer's drugs Celebrex and Bextra), has been questioned in light of the Vioxx recall since many experts believe the adverse effects may be a class wide reaction. Since the focus of COX-2 inhibitors has always been on its effect on gastrointestinal bleeding, many experts believe more studies must be performed on the effects of cardiovascular risks.

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Antipsychotics linked to serious adulthood diseases

-October 25, 2004

Researchers have linked antipsychotic medications like olanzapine (Zyprexa or Zydis), quetiapine (Seroquel) and risperidone (Risperdal) to an increased risk of developing type 2 diabetes and heart disease in adulthood. The use of the newer antipsychotic drugs to treat conditions like bipolar disorder and schizophrenia appeared to cause insulin resistance in the children taking the drugs.

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COX-2 drugs under review by Europeans following Vioxx recall

-October 25, 2004

Following the Vioxx recall, the European Medicines Agency, the regulator based in London that monitors pharmaceutical safety and consists of a network of 3,000 scientists and experts to conduct studies and make decisions, is now reviewing all COX-2 inhibitor drugs. COX-2 inhibitors are the anti-inflammatory class of drugs that includes Vioxx and Pfizer's Celebrex and Bextra.

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New safety tests to begin on Celebrex

-October 18, 2004

Just days after Pfizer, Inc. warned doctors to be aware of possible links between its COX-2 arthritis and pain-relief drug Bextra and cardiovascular events, the company has announced it will begin new safety tests on its second COX-2 arthritis drug on the market, Celebrex. Both of Pfizer's arthritis drugs have been cast in negative light following the recall announcement of Vioxx, Merck & Co.'s COX-2 inhibitor drug.

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Bextra may have higher risk of stroke and heart attack

-October 18, 2004

Pfizer, Inc. announced two small clinical trials showed heart bypass surgery patients taking its anti-inflammatory drug Bextra had a higher risk of stroke and heart attack. Bextra is a COX-2 inhibitor drug, part of the same class of drug as Merck & Co.'s recently recalled arthritis and pain relief drug Vioxx.

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