Recent Blog Posts in August 2010

The Financial Times reported on Thursday that the United States Department of Justice is conducting a corruption probe of several major pharmaceutical companies, including GlaxoSmithKline, Pfizer, Bristol-Myers Squibb, and Eli Lilly.  Specifically, the Department of Justice is investigating whether these and other companies have violated U.S. anti-bribery laws by making payments in other countries.

The Department of Justice is particularly interested in payments that may have been used to influence the reliability or integrity of clinical drug trials conducted in other countries.  This is significant because 80% of applications to the Food and Drug Administration for approval of drug marketing in the United States rely on at least one clinical drug trial conducted outside the U.S.

The FDA has issued a safety alert disclosing that Lamictal (lamotrigine) can cause aseptic meningitis.  Lamictal (lamotrigine) is a medication commonly used to treat seizures in children two years and older, and bipolar disorder in adults.  Symptoms of meningitis may include headache, fever, stiff neck, nausea, vomiting, rash, and sensitivity to light.  In cases of meningitis, it is important to rapidly diagnose the underlying cause so that the correct treatment can be promptly begun.

The label change to disclose the risk of aseptic meningitis came after the FDA identified 40 cases of aseptic meningitis in patients who took Lamictal between December 1994 and November 2009.

The Food and Drug Administration (FDA) today ordered the recall of the male enhancement supplement Prolactis because it contains an undeclared drug ingredient.  Lab analysis has found that Prolactis contains Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED).  This makes Prolatis' an unapproved drug.  The Prolactis label does not disclose this ingredient.

Sildenafil is the active ingredient in Viagra.  Sildenafil's analogue, Sulfoaildenafil, may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

The FDA has just accepted Bayer Schering Pharma's New Drug Application for Gadovist, a gadolinium-based contrast agent currently sold in Europe and other parts of the world, but not in the United States.  A New Drug Application is the procedure a drug company uses to formally request the FDA to allow it to sell a drug in the United States.

Although Bayer's application for Gadovist is new, Gadovist itself is not.  Gadovist has been approved for sale in the European Union since 1998.  However, until recently, Bayer has not sought approval for selling it in the United States.  This decision  --  whatever its basis  --  has put Americans at risk.

Gadovist has a macrocyclic molecular structure, which means the gadolinium ion is surrounded by an organic chelate.  In contrast, Magnevist, the Bayer contrast agent sold in the United States, has a linear ionic molecular structure.  Magnevist's molecular structure is less stable than Gadovist's macrocyclic structure.  As a result, European regulatory agencies recognize than Magnevist is less safe than Gadovist.  The EU equivalent of the FDA requires the Magnevist label to state that it is contraindicated (not recommended) for use on people with severe renal impairment.  Gadovist does not have this restriction.