The once-monthly, subcutaneously injected calcitonin gene-related peptide (CGRP) receptor antagonist erenumab-aooe (Aimovig) was approved by the FDA in 2018 for preventive treatment of migraine in adults. Now the FDA has added a new warning to its labeling about a risk of new-onset hypertension and worsening of preexisting hypertension associated with use of the drug. CGRP is a potent microvascular vasodilator; blocking or deleting it has produced hypertensive effects in animals.

Teriparatide (ter i par' a tide; Forteo - Lilly), a recombinant segment of human parathyroid hormone, has been approved by the FDA for parenteral treatment of osteoporosis in post-menopausal women, and in men with idiopathic or hypogonadal osteoporosis, who are at high risk for fracture. Teriparatide is the first approved treatment for osteoporosis that stimulates bone formation. Other drugs approved for this indication inhibit bone resorption (Treatment Guidelines from the Medical Letter 2002;1:13).

View the Comparison Table: Some Drugs for Postmenopausal Osteoporosis

Etidronate (e ti droe' nate) disodium (Didronel - Norwich Eaton), an oral bisphosphonate available for many years for treatment of Paget's disease (Medical Letter, 20:78, 1978), recently has also been used for treatment of postmenopausal osteoporosis.

The FDA has approved changes to the labeling of erenumab-aooe (Aimovig)1, a once-monthly, subcutaneously injected calcitonin gene-related peptide (CGRP) blocker approved in 2018 for prevention of migraine. The new label contains a warning about hypersensitivity reactions, including rash, angioedema, and anaphylaxis, that have been reported with post-marketing use of the drug.According to the label, most of these reactions were not serious and occurred within hours after receiving the drug, but some occurred more than one week after administration. Because these reactions are voluntarily...

The FDA has approved zavegepant nasal spray (Zavzpret – Pfizer) for acute treatment of migraine with or without aura in adults. Zavzpret is the first nasal spray formulation of a calcitonin gene-related peptide (CGRP) receptor antagonist ("gepant") to become available in the US.

The FDA has approved two subcutaneously injected calcitonin gene-related peptide (CGRP) antagonists, fremanezumab-vfrm (Ajovy – Teva) and galcanezumab-gnlm (Emgality – Lilly), for migraine prevention in adults. Fremanezumab and galcanezumab are the second and third subcutaneously injected monoclonal antibodies that target the CGRP pathway to be approved by the FDA for this indication; erenumab-aooe (Aimovig), which targets the CGRP receptor, was the first.

Lasmiditan (Reyvow – Lilly), an oral serotonin (5-HT_1F) receptor agonist, and ubrogepant (Ubrelvy – Allergan), an oral calcitonin gene-related peptide (CGRP) receptor antagonist, have been approved by the FDA for acute treatment of migraine with or without aura in adults.

Since 2008, because of safety concerns, the FDA has mandated that long-term cardiovascular outcomes trials be conducted for all new drugs for type 2 diabetes. Reductions in the incidence of macrovascular complications in these trials with some sodium-glucose co-transporter 2 (SGLT2) inhibitors and glucagon-like peptide 1 (GLP-1) receptor agonists in patients at risk for cardiovascular disease (see Table 1) have led to new recommendations.

The FDA has approved Trudhesa (Impel Neuropharma), a new dihydroergotamine nasal spray product, for acute treatment of migraine with or without aura in adults. Another dihydroergotamine nasal spray (Migranal, and generics) has been available for many years for the same indication.