Serious Health Problems Arise from Kaletra
Serious health problems have been reported in premature babies receiving Kaletra oral solution. Manufactured by Abbott Laboratories, Kaletra is an anti-HIV protease inhibitor approved by the FDA when used as part of an HIV treatment program. Approximately 5 million Kaletra prescriptions are filled annually.
According to the FDA, two of the main ingredients in Kaletra, propylene glycol and alcohol, are harmful to premature babies due to their inability to eliminate propylene glycol. A review of the Adverse Events Reporting System (AERS) database from the approval of Kaletra oral solution in September 2000 through September 2010 was conducted. Ten life-threatening events such as cardiomyopathy, lactic acidosis, acute renal failure, central nervous system (CNS) depression, and respiratory complications were reported in neonates. In addition, one death due to cardiogenic shock was also reported.
On March 8, 2011, Abbott Laboratories announced that they would be revising the label to address the increased risk of side effects in babies. "The use of Kaletra oral solution should be avoided in premature babies until 14 days after their due date, or in full-term babies younger than 14 days of age unless a healthcare professional believes that the benefit of using Kaletra oral solution to treat HIV infection immediately after birth outweighs the potential risks. In such cases, FDA strongly recommends monitoring for increases in serum osmolality, serum creatinine, and other signs of toxicity."
FDA Issues Warning for Terbutaline Due To Risk of Serious Heart Problems and Death
The Food and Drug Administration is requiring stronger safety warnings for a popular treatment to prevent pregnant women from prematurely giving birth.
Women should not be given injections of the drug terbutaline for more than three days "because of the potential for serious maternal heart problems and death," the FDA said Thursday. It is now requiring a boxed warning — the FDA's most serious type of warning — be added to the drug's label.
The FDA also warned doctors against prescribing a pill form of the drug for "any treatment of preterm labor" because it has not been shown to be effective and carries similar risks.
Baby Monitors Recalled After 2 Deaths
Based out of Woonsocket, R.I., Summer Infant recalled 1.7 million video baby monitors on February 11, 2011, after the product had been linked to two infant strangulation deaths. According to the Consumer Product Safety Commission, a 10-month old girl died in addition to a 6-month old boy. Many near death strangulation accidents have also been reported.
Commission chairman Inez Tenembaum states “I urge all parents and caregivers to put at least 3 feet between any video or audio baby monitor cords and a child in a crib,” she said. “This simple step can save your child's life.”
The video monitors which were sold between 2003 and 2011 will now come packaged with warning labels and instructions about proper product placement. The commission, which first warned about the potential dangers of monitor cords in October of 2010, says that since 2004, seven children have been strangled with baby cords placed too close to cribs.
Summer Infant has announced that they will also be recalling the rechargeable batteries in another 58,000 video monitors sold exclusively at Babies R Us due to the potential of overheating and rupture, which can cause severe burns. The company has received five reports of ruptured batteries, including three cases of property damage.
Birth Defects Caused by Prescription Drug Use
While some birth defects stem from naturally occurring causes or medical malpractice, many arise due to prescription drug exposure. Women of childbearing age commonly experience mood disorders, such as depression and anxiety, and are prescribed medications such as Paxil, Prozac, and other SSRI’s. An SSRI (selective serotonin reuptake inhibitor) eases the side effects of depression by affecting certain neurotransmitters, such as serotonin. Changing the balance of serotonin seems to help brain cells send and receive chemical messages, which in turn boosts mood. According to MayoClinic, SSRIs approved by the Food and Drug Administration to treat depression, with their generic names followed by brand names in parentheses, include:
- Citalopram (Celexa)
- Escitalopram (Lexapro)
- Fluoxetine (Prozac, Prozac Weekly, Sarafem)
- Paroxetine (Paxil, Paxil CR, Pexeva)
- Sertraline (Zoloft)
- Fluoxetine combined with the atypical antipsychotic olanzapine (Symbyax)
The American College of Obstetricians and Gynecologists (ACOG) has recommended that women avoid Paxil during pregnancy, and the Food and Drug Administration (FDA) has designated Paxil a Class D drug, indicating that it has been shown to cause birth defects when taken during pregnancy. Although many dangerous birth defects can arise after the use of any of the above-mentioned drugs, two common birth defects are congenital heart defects and persistent pulmonary hypertension of the newborn.
A congenital heart defect refers to a problem with the structure of the heart. According to Medline of the National Institutes of Health, these defects can involve the walls of the heart, the valves of the heart, and the arteries and veins near the heart. Congenital heart defects can disrupt the normal flow of blood through the heart by causing it to slow down, be blocked or go in the wrong direction or to the wrong place. The most common forms of heart defects are ventricular septal defect and atrial septal defect (VSD and ASD).








