FDA expands approval for osteoporosis drug in effort to boost doctor access

The FDA expanded its approval for one type of older osteoporosis drug as part of a plan to improve doctors’ access to treatment for bone fractures caused by falls.

The US Food and Drug Administration expanded the use of Pfizer’s Lyrica and added another dose to its approved list for the drug, an injectable for the treatment of advanced osteoporosis.

The FDA also increased the dosages of other other older osteoporosis drugs.

FDA Commissioner Dr. Scott Gottlieb said in a statement, “By extending the evidence base to allow physicians to use increased doses of an injectable medication, it provides relief for patients experiencing accelerated bone loss, an issue that commonly leads to hospitalization.”

Lyrica is an extended-release medication that is designed to increase the strength of bone in the legs, hip and spine. The company previously added an older version of the drug to its approved list after the FDA’s Advisory Committee found it had safety concerns.

The FDA said the added dose allows physicians to prescribe two doses of the medication to people who have additional risks, such as weight gain and medication-induced constipation. The prescribing information to take into account these risks is currently in the document prescribed by health care professionals to treat the patient.

Another therapy on the FDA’s list that was expanded is Sumatriptan, which is commonly used to treat migraines. The drug is a combined dose of levetiracetam and triptans, which are two of the most common migraine treatments. The additional dose allows doctors to prescribe twice as much per dose for patients whose migraines are more severe.

Lingotron and Dysport, which treat pulmonary arterial hypertension, were also added to the new list. The agency said the new approval is for a three-month continuous course of treatment for use in adults who are candidates for regular treatment for high blood pressure who have not yet received treatment.

“I applaud the FDA for developing and using this additional information to strengthen the safety of these approved medications for osteoporosis treatment in patients,” said Dr. Carl Gerrish, a preventive cardiologist at Vanderbilt University Medical Center and past president of the American College of Cardiology.

“In some patients with advanced osteoporosis, this expanded label provides additional information to mitigate the risks associated with high-dose medications,” he said.

“Adding these new indications and doses and enhancing education for prescribers is extremely important in keeping more patients with osteoporosis healthy and in helping to prevent the loss of bone mass that can lead to fractures,” Gerrish said.

“Lingotron, Sumatriptan and Dysport help patients with lower-risk conditions remain healthy for years or decades, so its important that we find new and efficient ways to make these important medications available and available to more patients.”

FDA officials said an estimated 21 million adults are estimated to be living with osteoporosis in the United States, including 17 million men and 4 million women ages 65 and older.

The FDA said it encouraged additional interactions and discussions among doctors and pharmacists to discuss the new information.

Leave a Comment