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Drugs Approved by the FDA on February 2010


Drugs Approved by the FDA on February 2010

The Food and Drug Administration (FDA) is the agency that is responsible for protecting and promoting public health through the regulation and supervision of prescription and over-the-counter pharmaceutical drugs and medications among other things.

VPRIV

Velaglucerase alfa for injection (VPRIV) is a drug that has been approved by the FDA to treat children and adults with a form of Gaucher disease, which is a rare genetic disorder. People who don’t produce enough of an enzyme called glucocerebrosidase develop Gaucher disease. Harmful amounts of a certain fatty substance (lipid) could build up in the liver, bones, spleen, nervous system and bone marrow if this enzyme isn’t present, preventing organs and cells from working as they should. Gaucher disease occurs in about 1 in 50,000 to 1 in 100,000 people.

 

The most common form of this disease is Type 1 Gaucher disease, and VPRIV provides long-term enzyme replacement for this type. Yet another enzyme replacement therapy is Cerezyme (imiglucerase), which is currently in short supply, to which VPRIV is an alternative. Allergic reactions are the most common adverse reactions to VPRIV. Some of the other adverse reactions that have been observed with the use of VPRIV include:

 

  • Fatigue and weakness
  • Nausea
  • Dizziness
  • Headache
  • Prolongation of activated partial thromboplastin time, which is a measure of clotting time.
  • Joint pain
  • Fever
  • Back pain
  • Abdominal pain

 

PREVNAR 13 PNEUMOCOCCAL DISEASE VACCINE

Prevnar 13 has been approved by the FDA, which is a pneumococcal 13-valent conjugate vaccine for infants and young children between 6 weeks and 5 years of age. Prevnar is the predecessor of Prevnar 13; it is a pneumococcal 7-valent conjugate vaccine that was licensed in 2000 by the FDA to prevent otitis media and invasive pneumococcal disease (IPD). The protection provided by the new vaccine extends to six additional types of the bacteria that cause disease.

 

To prevent the invasive disease caused by 13 different serotypes of the bacterium Streptococcus pneumoniae, Prevnar 13 has been approved. It has also been approved to prevent otitis media that is caused by the seven serotypes shared with Prevnar. Pneumonia, as well as infections of the middle ear, blood and the membrane that covers the brain and spinal cord can be caused by this bacterium.

 

CAYSTONE (AZTREONAM FOR INHALATION SOLUTION)

To improve respiratory symptoms in cystic fibrosis (CF) patients who also have pseudomonas aeruginosa (P. aeruginosa), the FDA has granted marketing approval for Cayston (aztreonam for inhalation solution). However, in patients with forced expiratory volume in one second (FEV1) of less than 25% or greater than 75% predicted, in pediatric patients below the age of 7, and in patients colonized with Burkholderia cepacia, the safety and efficacy of Cayston have not been established.

 

Cayston is administered at a dose of 75 mg, three times a day, over a 28-day period, followed by 28 days off of Cayston therapy. Cayston should ONLY be used with an Altera Nebulizer System, and is administered by inhalation. Before administrating Cayston, patients should use a bronchodilator.

 

Worldwide, about 70,000 people have cystic fibrosis, which is a chronic debilitating genetic condition that affects the respiratory and digestive systems. The decline in pulmonary function, which is usually associated with morbidity and mortality among CF patients, is contributed to by chronic respiratory tract infection with P. aeruginosa.

 

MENVEO MENINGITIS VACCINE

Bacterial meningitis has four common types, to which menveo is a vaccine. Swelling of the membrane that covers the brain or spinal cord is caused by this disease, which can prove to be fatal within 48 hours.

 

XIAFLEX FOR TREATING DUPUYTREN’S CONTRACTURE

When a “cord” can be felt in adults with Dupuytren’s contracture, the prescription medication Xiaflex can be used. The patient won’t be able to straighten his/her fingers if the thickening of this cord in the hand over time causes one or more fingers to bend toward the palm. A healthcare provider experienced in injection procedures of the hand and treating people with Dupuytren’s contracture can inject Xiaflex into the patient’s cord. This medicine helps “break” the cord that is causing the finger to be bent.

 

Important safety information:

Some of the serious side effects that can be caused by Xiaflex include:

 

  • Damage of tendon or ligament, which may be caused when receiving an injection of Xiaflex, causing it to weaken or break. To fix the damaged tendon or ligament, surgery may be required. If the patient has trouble bending the injected finger towards the wrist after the swelling goes down or if he/she has problems using the treated hand after the follow-up visit, the doctor should be called immediately.
  • Injury to the nerve or other serious injury of the hand. If the patient feels numbness, tingling or increased pain in the treated hand or finger after injection or after the follow-up visit, the doctor should be called.
  • Allergic reactions. People who have received injections of Xiaflex may experience allergic reactions because it contains foreign proteins. Chest pain, hives, trouble breathing and swollen face are some of the allergic reactions that should be immediately reported to the doctor.

 

The patient should inform the healthcare provider before receiving Xiaflex if he/she has had an allergic reaction to a previous Xiaflex injection, or if he/she has a bleeding problem or other medical conditions. If the patient takes any medicines, including vitamins, herbal supplements, and prescription and non-prescription medications, he/she should tell the doctor about them. Additionally, if the patient uses prasugrel hydrochloride (Effient), clopidogrel (Plavix), warfarin sodium (Coumadin), aspirin, or any other blood thinning medications, the doctor should also know about them. Some of the common side effects of Xiaflex are:

 

  • Pain in the underarm
  • Tenderness or pain at the injection site or the hand
  • Swelling of the injection site or hand
  • Redness or warmth of the skin
  • Itching
  • Bleeding or bruising at the injection site
  • Swelling of the lymph nodes in the elbow or underarm
  • Breaks in the skin

 

OLEPTRO

For treating major depressive disorder (MDD) in adults, the FDA has approved Oleptro (trazodone hydrochloride) Extended Release Tablets, which is a novel once-daily formulation of the antidepressant trazodone. A combination of social and somatic symptoms is one of the characteristics of MDD which is a common mental illness. Worldwide, MDD is the chief cause of disability. Oleptro offers physicians who treat MDD another therapeutic alternative. MDD usually co-exists with other illnesses and it occurs in women twice as much as in men. According to some of the researches done on this subject, only about 65% of people with MDD are diagnosed and 90% of those are treated with medication.

 

There are significant differences in the way patients respond to antidepressant drug therapy, which makes treating MDD with antidepressant medications quite challenging. Research shows that within the first four weeks of treatment, as many as 28% of patients being treated with antidepressants stop taking their medication, and within the first 12 weeks, as many as 44% stop taking their medication. Suboptimal efficacy, adverse effects such as weight gain, and the exacerbation of symptoms such as sexual dysfunction, sleep disturbance and agitation are some of the reasons that make patients discontinue their antidepressant treatment.

 

BLACK BOX WARNING:

Oleptro isn’t approved for use in pediatric patients.

 

Suicidality and antidepressant drugs:

Increased risk of suicidal thinking and behavior in children, adolescents and young adults who take antidepressants for major depressive disorder and other psychiatric disorders.

 

WARNING AND PRECAUTIONS:

Major depressive disorder patients, both adult and pediatric, whether they’re taking antidepressant medications or not, may experience emergence of suicidal ideation and behavior or unusual change in behavior, and/or worsening of their depression. These patients should be monitored and their families and caregivers should be notified about the need to monitor them; they should be monitored for:

 

  • Suicidality
  • Clinical worsening
  • Panic attacks
  • Hypomania
  • Hostility
  • Mania
  • Anxiety
  • Akathisia
  • Insomnia
  • Aggressiveness
  • Irritability
  • Agitation
  • Impulsivity

 

Antidepressant use has been linked with the development of a possibly life-threatening serotonin syndrome, or neuroleptic malignant syndrome (NMS)-like reactions, which could occur with Oleptro, especially if its use is preceded by other serotoninergic drugs. If this occurs, supportive treatment should be initiated and treatment with Oleptro and any concomitant serotonergic or antidopaminergic agents including antipsychotics should be immediately discontinued.

 

Oleptro isn’t approved for use in treating bipolar depression. A major depressive episode could be the initial symptom of bipolar disorder. Patients should be adequately screened to determine if they are at risk of bipolar disorder and they should also be monitored for mania/hypomania before starting treatment with Oleptro.

 

An increased risk for QT interval prolongation may arise in the case of administration of immediate-release trazodone products, as experience shows. People with hypokalemia, hypomagnesemia, or a genetic predisposition to prolonged QT/QTc are some of the susceptible individuals in whom QT prolongation may lead to Torsades de pointes and even death.

 

The risk of arrhythmias may increase in patients with pre-existing cardiac disease. The risk of cardiac arrhythmia may increase in these patients by the concomitant administration of drugs that prolong the QT interval or that are inhibitors of CYP3A4. Patients receiving trazodone hydrochloride have reported syncope and orthostatic hypotension. The risk of bleeding events may increase when taking drugs that interfere with serotonin reuptake, including trazodone hydrochloride. This risk may become even greater in the case of concomitant use with NSAIDs, aspirin or other drugs that affect coagulation.

 

When serotonergic drugs are used in combination with monoamine oxidase inhibitors, serious, and sometimes even fatal reactions have been reported. Because of this, Oleptro shouldn’t be used concomitantly or within 14 days of monoamine oxidase inhibitors. In men receiving trazodone, cases of priampism may occur in some rare cases. Additionally, men who have predisposing conditions should use Oleptro with caution. Using antidepressants puts individuals at risk of hyponatremia. Elderly patients, patients taking diuretics or those who are volume-depleted are at greater risk.

 

Oleptro has the potential of impairing thinking, judgment and motor skills. The physician who is prescribing Oleptro should advise his/her patients to use caution when operating machinery or driving. Sleep disturbance, anxiety and agitation are some of the discontinuation symptoms that may occur when Oleptro is discontinued abruptly. In the case of discontinuing Oleptro, it should be tapered off slowly, and the patient should be monitored for the symptoms mentioned above.

 

ADVERSE REACTIONS:

Dizziness, blurred vision, somnolence/sedation and constipation are some of the most common adverse reactions of Oleptro which have occurred greater than or equal to 5% and twice more than that of placebo. However, Oleptro has yet other side effects and the ones mentioned above are only some examples.

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Prepared By: Dr. Mehyar Al-khashroum
Edited By: Miss Araz Kahvedjian




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