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The Food and Drug Administration (FDA) has recently approved Palforzia, a peanut allergy drug for children aged 4 to 17.
Dr. Peter Marks, the FDA’s Center for Biologics Evaluation and Research director, said that there are about one million children with peanut allergies in the United States. People with this diagnosis strictly avoid peanuts because there was previously no medication that can prevent allergic reactions. According to the FDA, even a small trace of peanuts can cause serious reactions to allergic individuals.
Some people allergic to peanuts have relied on the EpiPen, an auto-injectable device that releases an allergy-reversing chemical. Unlike the EpiPen, which is used to treat sudden severe allergic reactions, Palforzia cannot be used during emergencies. Instead, it is taken as a maintenance drug.
Treatment with Palforzia is divided in three phases. In the first phase, a medical professional administers the medicine to the patient. Then, in the second phase, the patient will take 11 doses over the course of several months. The start of phase two will also be supervised by a doctor who will check for potential allergic reactions. If the first two phases have been successfully completed, the patient may begin phase three, which involves taking a maintenance dose daily.
To evaluate the effectiveness and safety of Palforzia, the FDA tested it on nearly 500 people with peanut allergies. Results showed that the medication may have side effects, such as breathing problems, throat swelling, unconsciousness, and extremely low blood pressure. Therefore, the FDA requires doctors who carry out the treatment to be aware of the potential side effects of the new drug.
Because of possible risks, only patients who are registered in the FDA’s drug safety program can take the new medication. In addition, only certified healthcare providers, health care centers, and pharmacies can distribute it.