The FDA has removed prescribing and dispensing restrictions placed on rosiglitazone (Avandia, and others) in 2010 because of concerns about its cardiovascular safety.1 The removal of restrictions was based on the results of an independent reevaluation of the RECORD trial, which found no significant difference between rosiglitazone and metformin/sulfonylurea in the risk of cardiovascular (or unknown cause) death, myocardial infarction, or stroke.21. FDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes...

Moexipril hydrochloride (Univasc - Schwarz Pharma), an angiotensin-converting enzyme (ACE) inhibitor, was recently approved by the US Food and Drug Administration (FDA) for treatment of. It is the eighth ACE inhibitor to be marketed in the USA.

The results of a postmarketing study of its cardiovascular safety have led to the removal of the weightloss drug sibutramine (Meridia) from the market in the US and Canada. It has also been withdrawn in Europe and Australia, but remains on the market in many other countries. The study that led the FDA to ask Abbott Laboratories to withdraw the drug randomized 10,744 overweight patients with cardiovascular disease, diabetes or both to sibutramine or placebo for a mean duration of 3.4 years. The primary endpoint (non-fatal myocardial infarction, nonfatal stroke, cardiovascular death or...

Onychomycosis is caused most commonly by Trichophyton rubrum or T. mentagrophytes. About 10% of all persons worldwide and 40% of those ≥60 years old are believed to have the disease. Risk factors include older age, diabetes, poor peripheral circulation, smoking, HIV infection, psoriasis, and immunosuppression. Left untreated, onychomycosis can cause nail plate destruction, ingrown nails, and (particularly in patients with diabetes) secondary infections. Guidelines on treatment of onychomycosis have been published.

Trandolapril (tran doe la pril; Mavik - Knoll) has become the ninth angiotensin-converting- enzyme (ACE) inhibitor to be approved by the US Food and Drug Administration (FDA) for treatment of hypertension.

The FDA has approved the somatostatin analog pasireotide diaspartate (Signifor – Novartis) for treatment of adults with Cushing's disease (cortisol excess caused by an ACTH-secreting pituitary tumor) who are not candidates for pituitary surgery or for whom surgery has not been curative. Pasireotide is the first drug approved in the US specifically to treat Cushing's disease. The antiprogestin mifepristone (Korlym) was approved last year for control of hyperglycemia in patients with Cushing's syndrome, which includes other causes of hypercortisolism, such as exogenous steroids and...

Lonapegsomatropin-tcgd (Skytrofa – Ascendis), a long-acting prodrug of recombinant human growth hormone (rhGH), has been approved by the FDA for once-weekly subcutaneous (SC) treatment of growth failure due to inadequate secretion of endogenous growth hormone in children ≥1 year old who weigh ≥11.5 kg. It is the first once-weekly rhGH product to be approved in the US; other available rhGH formulations are administered more frequently.

Nonopioid drugs can be used in the treatment of many nociceptive and neuropathic pain conditions. For severe pain, especially severe chronic cancer pain, use of opioids may be necessary. Noninvasive nonpharmacologic treatments, including physical and psychological therapies, have been shown to improve pain and function in patients with some common chronic pain conditions and are unlikely to cause serious harms. A multimodal approach to analgesic therapy can increase pain control while reducing opioid use and adverse effects.

Octreotide acetate (Sandostatin - Sandoz), a synthetic octapeptide that mimics the actions of somatostatin, was recently approved by the US Food and Drug Administration for symptomatic treatment of patients with metastatic carcinoid or VIPomas (vasoactive intestinal peptide-secreting tumors).

The FDA recently announced that it was investigating 38 reports of loss of vision in men who took sildenafil (Viagra), which has been used to treat erectile dysfunction since 1998.