FDA Highlights Potential Negative Health Effects from new Asthma Drug

Dangerous drug lawyers at Pintas & Mullins Law Firm report that the FDA recently issued a safety warning about the potential for adverse side effects from Asthmanefrin (racepinephrine), an over-the-counter asthma drug. The FDA has received an abundance of complaints about the inhaled solution this past year.

Asthmanefrin is manufactured by Nephron Pharmaceuticals Corp., and was approved for OTC sales just over a year ago in late 2012. Among the reports of adverse health events associated with the asthma drug, patients have reported severe chest pain, increased blood pressure, nausea, and rapid heart rate among other side effects.

The drugs’ labels indicate that patients experiencing difficulty sleeping, rapid heartbeat, and tremors or seizures should immediately stop Asthmanefrin use and see a doctor. Labels also state that use of this inhaled solution may cause blood pressure to increase, which could heighten the risk of stroke or heart attack and even cause death in high-risk patients.

In light of these severe risks, the FDA decided to reconsider the approval process of inhaled drugs for treatment of asthma. The agency plans to hold a new drug application (NDA) evaluation in early 2014. Currently, since they are sold over-the-counter, drugs like Ashmanefrin are not subjected to the NDA process of evaluation.

Asthmanefrin can be purchased at most pharmaceutical retail chains, such as Walgreens and CVS. Earlier in 2013 a component of the drugs’ starter kit, the EZ Breathe Atomizer, was recalled due to manufacturing defects. The Taiwan-made component could become dislodged during use, posing a choking risk.

Medications to treat asthma are critical to managing the symptoms of the disease, and there are many different types available either as over-the-counter or prescriptions. One class of medications, known as long-acting beta agonists (LABAs), are taken regularly to control chronic symptoms and prevent attacks. Unfortunately, LABAs have also been associated with an increased risk of experiencing a life-threatening asthma attack.

The risk of such an event is greatest when LABA medications are taken alone, without also taking an inhaled corticosteroid. The FDA has warned patients prescribed to LABAs that they should never be taken without an inhaled corticosteroid. Prescription medications in the LABA class include Brovana, Foradil, Perforomist, and Serevent. Some drugs, such as Advair and Dulera, combine both a LAVA and corticosteroid.

Unfortunately, the FDA also noticed an abundance of complaint reports from patients taking the combined drugs, and in 2010 the agency issued a warning urging physicians not to prescribe them. The FDA recommended that patients take LABAs only for the shortest amount of time possible and, as mentioned, only take them in conjunction with an inhaled corticosteroid.

These federal warnings and recommendations were in response to clinical trials which proved the link between LABAs and severe, even fatal aggravation of asthma symptoms that often led to hospitalization. Advair and Serevent, drugs that combine LABAs and corticosteroids, were both relabeled with a Black Box Warning, the FDA’s most severe caution, indicating the risk of asthma-related deaths in some patients. According to the Warning, about 13 out of every 13,000 patients will suffer a fatal asthma attack while taking these drugs.

The FDA later affirmed that these warnings may also apply to Foradil (formoterol). A clinical professor of medicine at Stanford’s School of Medicine estimated that about 4,000 of the 5,000 asthma deaths in the United States each year are caused by LABAs. She and other esteemed physicians have urged the FDA to take these medications off market completely.

Asthma drug lawyers at Pintas & Mullins Law Firm have decades of experience in pharmaceutical litigation, particularly with excessively dangerous classes of drugs like LABAs. If you or a loved one was hospitalized or killed from a dangerous asthma medication, you may be entitled to compensation for your medical bills, and should contact an experienced asthma drug lawyer today for a free legal consultation.


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