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Weekly Drug News Round Up - July 2, 2014

Afrezza Inhaled Insulin FDA-Approved for Type 1 and Type 2 Diabetics

In patients with asthma or chronic obstructive pulmonary disease, Afrezza may cause bronchospasm Read More...

The U.S. Food and Drug Administration (FDA) has approved Afrezza (insulin human) Inhalation Powder to improve glycemic control in adult diabetics. Afrezza is an ultra rapid-acting inhaled insulin that is administered with meals. Afrezza was evaluated in 24-week studies in both type 1 and type 2 diabetic patients. In type 1 patients also using long-acting insulin, Afrezza effectiveness to lower blood sugar (HbA1c) provided less HbA1c reduction than insulin aspart, and the difference was statistically significant. In type 2 patients using oral antidiabetic agents, Afrezza did significantly lower HbA1c compared to a placebo group. Exubera, another inhaled insulin, was withdrawn in 2007 due to lack of sales.

FDA Approves Vogelxo for Testosterone Replacement

Vogelxo is the second testosterone gel product approved in as many months Read More...

The U.S. Food and Drug Adminstration (FDA) has approved Upsher-Smith’s topical testosterone product Vogelxo for the treatment of male hypogonadism. Vogelxo is an androgen indicated for testosterone replacement therapy and is a Schedule III controlled substance. The gel will be available in tubes containing 50 milligram (mg) of testosterone and as an 88 gram metered-dose pump which delivers 12.5 mg testosterone per actuation. The launch date for Vogelxo gel is unknown but expected to be in the near future. Last month the FDA also approved Natesto, a nasal testosterone gel, even amid continuing concerns about venous clot formation with testosterone products.

Popular OTC Acne Products Linked with Serious, Rare Allergic Reactions

Before first using an OTC acne product, apply a small amount for 3 days to make sure you don’t develop any serious allergies Read More...

The U.S. Food and Drug Administration (FDA) is warning that some over-the-counter acne products can cause rare but potentially life-threatening allergic reactions or severe irritation. The warning applies to Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear, and others. Consumers should stop using these products and seek emergency medical attention immediately if they experience severe allergic reactions such as throat tightness, difficulty breathing, feeling faint, or swelling of the eyes, face, lips, or tongue; or if they develop hives or itching. It is not known if the reactions are due to benzoyl peroxide, salicylic acid, the inactive ingredients, or by a combination of both.

FDA Warns Parents About Topical Gum Medicines for Teething Babies

To sooth a child’s teething gums, gently massage with your finger and give the child a cool teething ring or a cool, clean washcloth to chew on Read More...

Teething is a normal part of the growth of a child that can be treated without drugs. The U.S. Food and Drug Administration (FDA) is warning that prescription drugs such as viscous lidocaine are not safe for treating teething in infants or young children, and have lead to harm. Benzocaine, found in such OTC products as Anbesol, Hurricaine, Orajel, Baby Orajel, and Orabase, should not be used in children under 2 years of age, unless recommended by your healthcare provider. Benzocaine may result in a serious and possibly fatal condition known as methemoglobinemia, where the amount of oxygen carried in the bloodstream in reduced.

Flu Nasal Spray Outperforms Flu Shots in Younger Kids

FluMist is more expensive than shots, but most insurance will pay Read More...

According to an expert medical group, children between 2 and 8 years of age who get the flu vaccine with the nasal spray (FluMist) instead of the shot are about half as likely to develop influenza. This comes from the Advisory Committee on Immunization (ACIP) -- the U.S. Centers for Disease Control and Prevention's vaccine advisory panel, and was determined based on a review of studies. FluMist is currently approved for use by people ages 2 to 49, but the new ACIP recommendation is restricted to children ages 2 to 8. FluMist is a live but weakened flu virus and may yield a better immune response in this age group than the regular flu shot, which is a killed virus.