Heparin, saline solutions recalled for possible contamination

Warnings, recalls, label changes

A recall of all lots of heparin and saline pre-filled flushes manufactured by AM2 PAT Inc. due to possible contamination with Serratia marcescens, which can lead to life-threatening injuries or death. The products are distributed under the brand names Sierra Pre-Filled Inc. and B. Braun Medical Inc. and are sold in 3 ml and 5 ml sizes for heparin, and 3 ml, 5 ml and 10 ml sizes for normal saline. Facilities with any of the recalled pre-filled syringes should stop using them immediately and return leftovers to the distributor.

A voluntary recall of certain lots of heparin sodium injection in 1,000 units/mL, 10 mL vials and 30 mL vials manufactured by Baxter Health care Corp. due to reports of adverse reactions including abdominal pain, decreased blood pressure, tachycardia and nausea. For lot numbers, go here.

An FDA review of 199 placebo-controlled trials of 11 antiepileptic drugs yielded a .43 percent patient risk of suicidal thoughts and behaviors compared to a .22 percent risk for placeboes. The higher risk was observed one week after starting the drug and persisted to at least 24 weeks. All antiepileptics are expected to carry this risk, and health care providers should inform patients, families and caregivers of the risk so patients can be carefully observed.

A label revision for varenicline (Chantix) warning doctors to monitor patients for changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior.

Nicotine withdrawal may have complicated some reports of symptoms, but other patients have experienced symptoms without having stopped smoking. Some patients with pre-existing psychiatric illness saw a worsening of their conditions, as well.

Patients have died when they were mistakenly given edetate disodium (Endrate) instead of edetate calcium disodium (calcium disodium versenate) or when edetate disodium was used in ways not approved by the FDA. Both are commonly referred to as EDTA. Health care professionals should take extra care when prescribing, dispensing and administering these drugs.

A Class I recall of All Fire Star and Dura Star balloon catheters, lots 13173912 through 13315455, plus 52 additional lots above 13315455. The products may deflate slowly or not at all, which can cause injury or death.

Market withdrawal of the current liquid formulation of Leukine (sargramostim) because of an upward trend in reports of adverse reactions, including fainting. The trend hasn't been seen with lyophilized Leukine.

Biphosphonates may bring severe bone, joint and musculoskeletal pain that occurs within days, months or years of starting the drugs. Health care professionals should consider discontinuing the drugs temporarily or permanently in patients with pain. The risk factors for, and incidence of, this pain are unknown.

A label revision for Ortho Evra Contraceptive Transdermal (Skin) Patch to reflect a new study that found patch users age 15-44 were at higher risk of developing venous thromboembolism (VTE) than women who used birth control pills. Doctors should discuss this risk with patients.

Approvals

ProFlu+, a test that detects influenza A virus, influenza B virus, and respiratory syncytial virus A and B (RSV) from a throat culture in as few as three hours. Other respiratory tests are fast but not as accurate or accurate but not as fast.

xTAG Respiratory Viral Panel, a rapid test that detects and identifies 12 different respiratory viruses from a single sample. The test, taken from throat secretions, differentiates influenza A subtypes H1 and H3, human metapneumovirus (hMPV), influenza A, influenza B, respiratory syncytial virus subtype A and B, parainfluenza 1, 2 and 3, rhinovirus and adenovirus. Results are available within a few hours.

Natalizumab (Tysabri) for moderate-to-severe Crohn's disease in patients with evidence of inflammation who can't tolerate, or didn't respond to, other therapies. Patients must enroll in a special restricted distribution program called the Crohn's Disease-Tysabri Outreach Unified Commitment to Health (CD TOUCH) Prescribing Program, because the drug carries serious risks, like anaphylaxis and infections.

Etravirine (Intelence) tablets for adults with HIV who have failed treatment with other antiretrovirals. The drug is approved for use in combination with other anti-HIV medications. Adverse events may include nausea and rash.

Erectile dysfunction drug tadalafil (Cialis) for daily use in 2.5 milligram or 5 mg tablets, which will allow men to attempt sexual activity at any time. Men who are taking organic nitrates shouldn't use tadalafil. The drug recently underwent a label change to highlight potential risk of sudden hearing loss.

Use of Evicel (liquid fibrin sealant) to help control bleeding during general surgery. The sealant was already approved for use during liver and vascular surgery.

TOP2A FISH pharmDx, a genetic test to assess the risk of tumor recurrence and long-term survival for patients with higher-risk breast cancer. The test is suitable for premenopausal patients or those whose tumor size or lymph node involvement suggest a higher likelihood of tumor recurrence or lower survival.

Miscellaneous

The FDA will review the final trial results of the ENHANCE study that preliminarily found the combination of ezetimibe/simvastatin (Vytorin) was no more effective than simvastatin alone (Zocor) in preventing atherosclerosis progression. Once the drugs' makers submit a final report, the FDA may take up to six months to evaluate the data to determine if action is needed on these drugs and/or LDL cholesterol-lowering drugs in general.