Clopidogrel gets new warning


Warnings and label changes

A boxed warning added to clopidogrel (Plavix) to warn of reduced effectiveness in patients who are poor metabolizers of the drug. Tests are available to identify genetic differences in CYP2C19 function and health care professionals should consider use of other anti-platelet medications or alternative dosing strategies in patients identified as poor metabolizers.

A labeling change on sibutramine hydrochloride (Meridia) stating that it is contraindicated in patients with a history of cardiovascular disease because the drug has been associated with an increased risk of heart attack and stroke in these patients.

Changes to the label and medication guide for natalizumab (Tysabri) to note that the risk of developing progressive multifocal leukoencephalopathy (PML) increases with the number of infusions received. Information about the occurrence of Immune Reconstitution Inflammatory Syndrome in patients who have developed PML and subsequently discontinued natalizumab has also been added.

A warning added to the label of didanosine (Videx/ Videx EC) of an association between use of the drug and development of non-cirrhotic portal hypertension.

New prescribing information for bortezomib (Velcade) noting that patients with hepatic impairment should be treated at reduced starting doses and closely monitored for toxicities.

A boxed warning added to WinRho SDF (Rho(D) Immune Globulin Intravenous) after cases of intravascular hemolysis (IVH), including fatalities, were reported in patients treated for immune thrombocytopenic purpura. The warning calls for 8 hours of monitoring after administration, patient education about symptoms of IVH, and multiple dipstick urinalyses.

A warning about the potential for increased risk of muscle injury from the cholesterol-lowering medication simvastatin (Zocor) 80 mg. Although myopathy is a known side effect with all statins, patients face a greater risk of developing muscle injury, including rhabdomyolysis, when they are prescribed and use higher doses of the drug.

Recalls

Recalls of insulin syringes and infusion needle sets by manufacturer Nipro Medical Corporation. Glucopro syringes may have needles that detach and then become stuck in the insulin vial, push back into the syringe, or remain in the skin after injection. Inspections revealed coring in the needles of Exel/Exelint Huber needles, Exel/Exelint Huber Infusion Sets and Exel/Exelint “Securetouch+” Safety Huber Infusion Sets.

A class I recall of Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical and the Transseptal Sheath Introducer Kit because the sheath tip may break off and separate while the sheath is inside a blood vessel.

A recall of eight lots of OneTouch SureStep Test Strips because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.

An expanded voluntary recall of all lots of Arrow custom intravenous administration products (IV tubing sets and accessories) and certain Arrow arterial embolectomy catheters distributed prior to February 19, 2010 after testing revealed pin holes in product packaging, which could affect the sterility of the items.

A Class 1 recall of certain lots of the BD Q-Syte Luer Access Split Septum device and other finished products, including kits and trays, in which the Q-Syte Luer Access device is a component. These lots of the devices are defective and may result in air bubbles leaking into the infusion system or leakage of therapy or blood, resulting in serious injuries or death.

Approvals

A new indication for rosuvastatin (Crestor) for the primary prevention of cardiovascular disease in individuals who have no clinically evident heart disease but are at an increased risk of heart disease due to the combined effect of older age, high CRP levels and the presence of at least one additional risk factor.

Collagenase clostridium histolyticum (Xiaflex), the first drug approved to treat Dupuytren's contracture, a progressive hand disease. It is a biologic drug which works by breaking down the excessive buildup of collagen in the hand.

Dalfampridine extended release tablets (Ampyra) to improve walking in patients with multiple sclerosis. The most common adverse reactions reported include urinary tract infection, insomnia, dizziness, headache, nausea, weakness, back pain, balance disorder, swelling in the nose or throat, constipation, diarrhea, indigestion, throat pain, and burning, tingling or itching of skin. It should not be used in patients with moderate to severe kidney disease.

Morphine sulfate oral solution for the relief of moderate to severe, acute and chronic pain in opioid-tolerant patients in doses of 100 milligrams per 5 mL or 20 milligrams per 1 mL. Although the use of this medicine to manage pain has been common practice for many years, this form and concentration of morphine was not FDA-approved until now.

The first generic version of tamsulosin hydrochloride (Flomax), to treat benign prostatic hyperplasia, in which an enlarged prostate gland causes problems with urination.