Canadian regulators are warning that combining the blood thinner Plavix and the diabetes drug Prandin could lead to extremely low blood sugar levels, which may endanger the health of patients.
In a letter to healthcare professionals sent on July 31, Health Canada announced new contraindications about the use of Plavix (clopidogrel) together with the drug repaglinide, sold in the U.S. as Prandin and in Canada as Gluconorm.
According to the warning, administering the two drugs together could cause a significant decrease in blood glucose levels.
The Health Canada decision to contraindicate use of the two drugs together came as a result of a study published last year in the medical journal Clinical Pharmacology & Therapeutics.
“Repaglinide when taken by itself is intended to lower blood sugar to a normal level. However, when both medications are taken together, there is a greater risk of the blood sugar becoming too low, also known as hypoglycemia,” the Health Canada warning states. “Severe hypoglycemia can cause loss of consciousness, seizure, brain damage and even death.”
Both of the drug warning labels in that country are being updated to include the new contraindications. However, it appears no similar move has yet been made in the United States.
Prandin is a type 2 diabetes drug by Novo Nordisk that was approved in the United States in December 1997. It belongs to a class of drug known as meglitinides, which includes Starlix and Glufast.
Plavix (clopidrogrel) is a blockbuster medication that has been used by millions of people in the United States and is commonly prescribed to prevent blood platelets from sticking together and forming clots. There are between 2.5 million and 3 million Plavix prescriptions handed out each month in the U.S.
In recent years, some concerns have emerged about the potential side effects of Plavix and whether many of these prescriptions may have been unnecessary due to genetic resistance to the medication.
In August 2009, researchers from the University of Maryland identified a gene variant found in about one-third of the population that may signal a reduced effectiveness of Plavix. People with the CYP2C19 variant have reduced functioning of a liver enzyme that is supposed to convert Plavix from its inactive form to its active form, potentially making Plavix ineffective at reducing the risk of blood clots.
Unnecessary use of Plavix may expose individuals to an increased risk of gastrointestinal bleeding, severe ulcers, a rare blood disorder known as thrombotic thrombocytopenic pupura (TTP) and other injuries.
Bristol-Myers Squibb and Sanofi-Aventis currently face hundreds of Plavix injury lawsuits filed in state and federal courts throughout the United States, alleging that the drug makers have placed their desire for profits before the safety of consumers by aggressively marketing the medication while failing to adequately warn consumers or the medical community about the health risks associated with the medication.
In 2013, the U.S. Judicial Panel on Multidistrict Litigation (JPML) centralized all Plavix cases filed in the federal court system before U.S. District Judge Freda L. Wolfson in the District of New Jersey for coordinated handling during pretrial proceedings.