Zyvox: FDA has received reports of serious CNS reactions when Zyvox is given to patients taking a selective serotonin reuptake inhibitor (SSRI) or a serotonin norepinephrine reuptake inhibitor (SNRI). Similar reports are cited between SSRI/SNRI. Linezolid is used to treat infections, including pneumonia, infections of the skin, and infections caused by a resistant bacterium (Enterococcus faecium). It is a reversible monoamine oxidase inhibitor (MAOI). Although the exact mechanism of this drug interaction is unknown, linezolid inhibits the action of monoamine oxidase A — an enzyme responsible for breaking down serotonin in the brain. It is believed that when linezolid is given to patients taking serotonergic psychiatric medications, high levels of serotonin can build up in the brain, causing toxicity. This is referred to as Serotonin Syndrome — signs and symptoms include mental changes (confusion, hyperactivity, memory problems), muscle twitching, excessive sweating, shivering or shaking, diarrhea, trouble with coordination and/or fever.

Methylene Blue:  Methylene blue is not an FDA-approved drug at this time, and limited data exist regarding its use in various settings, it is not known whether there is a risk of serotonin syndrome in patients taking serotonergic psychiatric medications who are given methylene blue by other routes (e.g., orally or by local tissue injection) or at intravenous doses lower than 1 mg/kg.

In addition, not all serotonergic psychiatric drugs have an equal capacity to cause serotonin syndrome with methylene blue. The cases of serotonin syndrome with methylene blue occurred in patients taking specific serotonergic psychiatric drugs, namely a selective serotonin reuptake inhibitor (SSRI), a serotonin norepinephrine reuptake inhibitor (SNRI), or clomipramine. It is unclear at this time whether intravenous methylene blue administration in patients receiving other psychiatric drugs with lesser degrees of serotonergic activity poses a comparable risk.

Orap (pimozide): The drug is metabolized by CYP 2D6; concomitant use with paroxetine or other strong CYP 2D6 inhibitors is contraindicated. Individuals with genetic variations resulting in poor CYP 2D6 metabolism (5 – 10% of the population) exhibit higher pimozide concentrations; alternative dosing strategies are recommended in such patients.  Possible risk factors for leukopenia/neutropenia include pre-existing low white blood cell count (WBC) and history of drug-induced leukopenia/neutropenia. Patients with a history of a clinically significant low WBC or drug-induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and discontinuation of Orap should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.

Risperdal (risperidone) tablets, oral solution, Risperdal M-Tab orally disintegrating tablets, Risperdal Consta injection :  Atypical antipsychotics have been associated with metabolic changes that may increase cardiovascular/cerebrovascular risk (hyperglycemia, dyslipidemia, weight gain). While all drugs in the class have been shown to produce metabolic changes, each drug has its own specific risk profile.

Chantix (varenicline) :  Monitor patients for neuropsychiatric symptoms. DA informed healthcare professionals of reports of suicidal thoughts and aggressive and erratic behavior in patient who have taken Chantix, a smoking cessation product. There are also reports of patients experiencing drowsiness that affected their ability to drive or operate machinery. FDA is currently reviewing these cases, along with other recent reports. A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in the cases had preexisting psychiatric illness and not all had discontinued smoking.

Sprycel (dasatinib): May increase the risk of pulmonary arterial hypertension.FDA notified healthcare professionals that Sprycel (dasatinib) may increase the risk of a rare but serious condition in which there is abnormally high blood pressure in the arteries of the lungs (pulmonary arterial hypertension [PAH]). Symptoms of PAH may include shortness of breath, fatigue, and swelling of the body (such as the ankles and legs). In reported cases, patients developed PAH after starting Sprycel, including after more than one year of treatment.

Nostrilla Nasal Decongestant: Bacterial contamination with Burkholderia cepacia: Insight Pharmaceuticals, LLC recalled one lot (lot #11G075, UPC Code 6373673005, 34,092 bottles) of Nostrilla Nasal Decongestant nasal spray to the consumer level, because it may contain the bacteria Burkholderia cepacia. Burkholderia cepacia may cause serious infection in individuals with a compromised immune system or chronic lung condition (i.e. cystic fibrosis).
Uprizing 2.0: Contains an undeclared drug ingredient, superdrol, a synthetic steroid. DA notified the manufacturer that lab analyses found that the product, sold as a testosterone booster, contains superdrol, a synthetic steroid, making it an unapproved new drug. Acute liver injury is known to be a possible harmful effect of using products containing synthetic anabolic steroids. In addition, use of synthetic anabolic steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death.