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Asthma drug linked to serious cardiovascular, cerebrovascular events

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The asthma drug Xolair (omalizumab) for children and adults 12 years of age and older can cause problems with the heart and blood vessels supplying the brain, the Food and Drug Administration (FDA) announced after a review of safety studies. As a result, new warnings of an elevated risk of serious cardiovascular and cerebrovascular adverse events will be added to the drug’s label. The review also investigated rates of cancer between patients using Xolar and found no difference compared to patients not being treated with Xolair. However, due to limitations in the five-year study, the agency cannot rule out the ... Read More

Drug company to seek FDA approval for first ‘female Viagra’

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Sprout Pharmaceuticals says it will resubmit an application for Food and Drug Administration (FDA) approval for its “female Viagra” pill by the end of the year in hopes of having the first marketed pill to treat hypoactive sexual desire disorder, or HSDD, in women. HSDD is the most commonly reported female complaint and is characterized by a decreased libido that causes personal distress or personal difficulties. An estimated 1 in 10 women are affected by the disorder. Filbanserin is a 5-HT1A receptor agonist and 5-HT2A receptor antagonist that was initially investigated as an antidepressant. Preclinical studies suggest that fibanserin targets ... Read More

Panel recommends more studies on cardiovascular risks with testosterone drugs

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Makers of testosterone replacement drugs should collect data on heart attacks and strokes in men who use their products, and the labels on the treatments should have stronger language to restrict intended uses to reduce over-prescribing, a Food and Drug Administration (FDA) advisory panel recommended. The FDA asked an outside panel of experts to address whether there is a risk of major cardiovascular events such as stroke, heart attack and death in men who used testosterone replacement therapies. The agency also asked the panel whether current evidence still supports the use of the drugs in certain patients. The FDA is ... Read More

Breast reduction third most common cosmetic surgery for men

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In 2013, nearly 23,000 procedures – including liposuction and mastectomies – were performed on men to remove enlarged breast tissue, a condition known as gynecomastia. The procedure is the third most common cosmetic surgery performed for men behind rhinoplasty (nose reshaping) and blepharoplasty (eye lift). Gynecomastia can be embarrassing leaving lingering emotional scars. It can also be painful, causing breasts to become swollen and tender. In some cases, the breasts can lactate. The condition may go away after a few months or years, or symptoms may persist for a lifetime, in which case surgical intervention may be considered. “Surgical treatment ... Read More

Risperdal with stimulant often prescribed off-label to treat children with ADHD

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A combination of two medications – a stimulant and the antipsychotic Risperdal – may be a helpful treatment for children with attention-deficit/hyperactivity disorder (ADHD) and severe aggression, but the amount of additional benefit appears to be moderate, according to new research published in the Journal of the American Academy of Child and Adolescent Psychiatry. Risperdal, also known as risperidone, is approved to treat adults and children with schizophrenia, bipolar disorder, and autism with irritability. It is not approved as a treatment for ADHD or ADD, but it is often prescribed by doctors off-label for those conditions and in many cases ... Read More

Erectile dysfunction drug Strenda given new ‘fast acting’ status by FDA

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Auxillium and Vivus’ erectile dysfunction drug Strenda has been granted a new designation by the Food and Drug Administration (FDA) that may help it compete against the dominating pills in the market, Pfizer’s Viagra and Eli Lilly’s Cialis. Strenda has been granted “fast-acting” status, allowing the pill to be taken just 15 minutes before sex, instead of 30 minutes as previously stated on its label. Comparatively, Cialis must be taken daily while Viagra must be taken one to two hours before sex. Strendra contains the active ingredient avanafil, which is in a class of drugs called phosphodiesterase inhibitors. Other drugs in ... Read More

FDA panel recommends severely limiting testosterone drug prescriptions

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A U.S. Food and Drug Administration (FDA) advisory panel voted 20-1 Wednesday to impose strict new limitations on testosterone-replacement drugs, recommending changes to labeling that would limit FDA-approved prescription indications to men who have abnormally low testosterone levels due to injury or disease, but not aging. The changes, triggered by conflicting studies and a lack of evidence showing the efficacy of testosterone drugs for treating common age-related issues, would exclude millions of American men who currently use the drugs as antidotes for low libido, muscle loss, and lack of energy. The panel’s recommendations, which the FDA usually accepts, could also ... Read More

Anti-abuse drug sickens hundreds of children each year

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Medical safety specialists are concerned at the growing number of young children who are sickened or die from accidentally swallowing a relative’s prescription for a medication used to treat opioid drug addiction. For every 100,000 patients who are prescribed buprenorphine, 200 children are hospitalized – a rate more than four times higher than the second-most accidentally ingested medication, blood pressure mediation. The research is published in the current issue of the journal Pediatrics. Buprenorphine is a narcotic much like the drugs it is designed to help patients wean off, such as heroin or prescription painkillers. While it can produce typical ... Read More

FDA recalls potassium chloride injection due to labeling error

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Baxter International, Inc., is recalling one lot of potassium chloride injection because the drug packaging may contain units of gentamicin sulfate instead. Potassium chloride injection is used to treat potassium deficiency. Gentamicin sulfate is an antibacterial drug. This labeling error could result in a medication error or delay in therapy for patients who require high concentration of potassium chloride, the Food and Drug Administration (FDA) warned. The recall involves Lot #P318220, NDC # 0338-079-48 of potassium chloride Injection 10mEq per 100mL, with the product code 2B0826. Shipping cartons labeled for this specific lot number of potassium chloride injection may contain units ... Read More

FDA approves new diet pill Contrave

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A new prescription diet pill has been given clearance by the Food and Drug Administration (FDA) for marketing in the United States. Contrave, made by Orexigen Therapeutics, is a combination of bupropion, an antidepressant that is also used for smoking cessation, and naltrexone, a drug used to treat drug and alcohol dependence. Contrave is approved for overweight or obese patients with a body mass index (BMI) of 30 or higher, as well as people with a BMI of 27 or higher with at least one other health issue such as diabetes. Patients treated with Contrave lost an average of 4.2 ... Read More