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FDA approves two new insulin drugs

Insulin degludec injection (Tresiba) and insulin degludec and insulin aspart injection (Ryzodeg 70/30) have been approved for adults with diabetes mellitus. Both drugs contain insulin degludec, a long-acting insulin analogue with a 25-hour half-life. Both medications are products of Novo Nordisk.

 

Tresiba contains only degludec as its active ingredient and is injected subcutaneously once a day to help control blood glucose levels in patients with diabetes. Patients do not need to take it at the same time every day due to its extended coverage. Tresiba is not recommended for the treatment of diabetic ketoacidosis.

 

Ryzodeg 70/30 is an insulin mixture that contains insulin degludec along with insulin aspart, a rapid-acting agent. It is also administered as a subcutaneous injection and is taken once or twice a day with any main meal. It is indicated to improve glycemic control in adults with diabetes mellitus. Ryzodeg is not recommended for the treatment of diabetic ketoacidosis.

 

There are similar adverse reactions and warnings for both Tresiba and Ryzodeg. Hypoglycemia is the most common adverse reaction associated with Tresiba and Ryzodeg. Other adverse reactions include allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, weight gain, headache, and nasopharyngitis. Patients who are taking Tresiba or Ryzodeg must have their potassium level monitored for hypokalemia because insulin may cause a cellular shift in potassium, resulting in life-threatening hypokalemia. Concomitant use of Tresiba or Ryzodeg with a thiazolidinedione increases the risk of fluid retention and heart failure. Stop or reduce the dose of the thiazolidinedione if signs and symptoms of heart failure develop.

 

Spiriva Respimat approved for new asthma indication

The FDA has approved a new indication for tiotropium bromide (Spiriva Respimat) inhalation spray as long-term maintenance treatment of asthma in patients ages 12 and over. The medication was previously approved for the maintenance treatment of chronic obstructive pulmonary disease.

  
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The new indication was approved based on efficacy and safety data from 12 clinical trials involving 5,000 adults and adolescents with mild, moderate, and severe symptomatic asthma who received at least an inhaled corticosteroid. The addition of tiotropium bromide significantly improved lung function and reduced asthma flares compared with placebo.

 

The most commonly reported adverse reactions associated with tiotropium bromide include pharyngitis, sinusitis, bronchitis, and headache in adults.

 

Spiriva Respimat is a product of Boehringer Ingelheim.

 

FDA evaluating risks of using tramadol in children 17 and younger

The FDA is investigating the use of tramadol in children ages 17 and younger because of the rare but serious risk of slowed or difficult breathing, which may be increased in children treated with tramadol for pain after tonsillectomies and/or adenoidectomies. Tramadol is not indicated for use in children, but the agency's data show it is being used off-label in the pediatric population. Healthcare providers should be aware of this and consider prescribing alternative FDA-approved pain medications for children, the agency cautions.

  
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Tramadol is converted in the liver to the active form of the opioid called O-desmethyltramadol. Some individuals have genetic variations that cause tramadol to be converted to the active form of the opioid faster and more completely than normal. These patients are known as ultra-rapid metabolizers and are more likely to have higher-than-normal amounts of the active form of the opioid in their blood after taking tramadol, which can result in respiratory depression and lead to death.

 

The FDA stated that a 5-year-old child in France, later identified as an ultra-rapid metabolizer of tramadol, experienced severely slowed and difficult breathing and required emergency intervention and hospitalization after only a single dose of tramadol oral solution after a tonsillectomy and adenoidectomy.