Melamine present in infant formula and other milk products has been associated with widespread illness and some deaths among infants in China. It was also identified in pet food sold in North America after a large number of pets became ill and some died. In both the infants and the pets, renal injury appeared to be the cause.1Melamine (C3H6N6) is a heterocyclic compound, two-thirds nitrogen by weight, that is slightly soluble in water. When combined with formaldehyde, it forms melamine resin, which has a wide variety of industrial applications including the manufacturing of kitchenware,...

Inhaled drugs for asthma are available in the US mainly in pressurized metered-dose inhalers (MDIs), which require a propellant, and dry powder inhalers, which do not. The chlorofluorocarbon (CFC) propellants in MDIs are being replaced by hydrofluoroalkane (HFA) propellants for environmental reasons: CFCs contribute to the depletion of the ozone layer. December 31, 2008 will be the last day that albuterol MDIs using CFC propellants can be sold in the US. The FDA is expected to announce a termination date for other CFC-containing products in the near future.Three HFA albuterol inhalers and one...

The FDA has added a boxed warning to fluoroquinolone package inserts about tendon injuries that may occur as a result of their use. Tendinitis or tendon rupture may occur rarely with systemic use of any fluoroquinolone, either while the drug is being taken or for up to several months afterwards.Fluoroquinolone-related tendon injury is rare; estimates for its incidence in the general population range from 0.14% to 0.4%. The risk is higher for patients >60 years old and for those taking corticosteroids. For patients with organ transplants, the incidence may be as high as 15%.1 A case-control...

A recent article in the New England Journal of Medicine confirms something that others, including The Medical Letter (Treat Guidel Med Lett 2008; 6:23), have been saying for years: no particular combination of protein, carbohydrate and fat in the diet offers any advantage in losing weight. This randomized 2-year trial followed 800 overweight and obese subjects on low fat/average protein, low fat/high protein, high fat/average protein, and high fat/high protein diets. Carbohydrate intake varied from 35% (in the high fat/high protein diet) to 65% (in the low fat/average protein diet). All...

The FDA has announced that it will lower the age for over-the-counter access to the emergency contraceptive Plan B1 from 18 to 17 years old. In a randomized, controlled trial, the two 0.75-mg levonorgestrel tablets in Plan B, taken 12 hours apart beginning within 72 hours after unprotected intercourse, decreased the overall pregnancy rate to 1.1% (11/976) of women who requested emergency contraception.2 The sooner the drug is taken after coitus, the more effective it is. Nausea and vomiting can occur with Plan B. Fetal malformations have not been associated with pregnancies that occurred...

Paliperidone palmitate (Invega Sustenna – Ortho-McNeil Janssen) has been approved by the FDA as a once-monthly injection for acute and maintenance treatment of schizophrenia in adults. An extended-release oral formulation (Invega) has been available since 2006.1 Long-acting injections of antipsychotic drugs typically are used to treat patients who cannot adhere to an oral regimen.2,3 Paliperidone is the primary active metabolite of risperidone (Risperdal), which is also available as a long-acting (every 2 weeks) injection. It is unclear whether either risperidone or paliperidone is a better...

Belimumab (Benlysta – Human Genome Sciences/GlaxoSmithKline) has been approved by the FDA for treatment of adults with active, autoantibody-positive, systemic lupus erythematosus (SLE). It is the first biologic agent approved for SLE and the first drug of any kind to be approved for this disease in >50 years.

The FDA has approved a sublingual spray formulation of fentanyl (Subsys – Insys) for management of breakthrough pain in adult cancer patients who are receiving and are tolerant to opioid therapy (taking ≥60 mg/day of oral morphine or the equivalent). Fentanyl is already available in the US for intravenous, intrathecal, epidural, transdermal and transmucosal use.

Electronic cigarettes, also called e-cigarettes, are battery-operated nicotine-delivery devices that resemble tobacco cigarettes. They deliver vapor containing a mixture of nicotine and either propylene glycol or glycerol. E-cigarettes are widely available in retail stores and on the internet in labeled strengths ranging from zero to high levels of nicotine and in flavors such as tobacco, mint, coffee, cherry, bubblegum, and chocolate. They are advertised as a healthier alternative to smoking a tobacco cigarette and, although not FDA-approved, as a smoking cessation tool.

The FDA has approved a once-daily, extended-release chewable tablet formulation of methylphenidate (QuilliChew ER – Pfizer) for treatment of attention-deficit/hyperactivity disorder (ADHD). It is the first long-acting chewable formulation of the drug to be marketed in the US. Immediate-release chewable methylphenidate tablets (Methylin, and generics) have been available since 2003.