HIV/AIDS News & Information

Metformin tablet. Hypoglycemia does not usually occur in patients receiving metformin alone, but it can occur when caloric intake is deficient, when patients do not compensate for strenuous exercise with caloric supplementation, or during concomitant use with other glucose-lowering agents (e.g., sulfonylureas and insulin) or ethanol. Elderly, debilitated, or malnourished patients and those with adrenal or pituitary insufficiency or alcohol intoxication are particularly susceptible to hypoglycemic effects. Hypoglycemia may be difficult to recognize in older patients and in patients taking beta-adrenergic blocking drugs.

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Impaired hepatic function. Impaired hepatic function has been associated with some cases of lactic acidosis. In general, sitagliptin/metformin should be avoided in patients with evidence of hepatic disease.

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Sitagliptin/Metformin drug HCl Tablets (Janumet)

Manufacturer: Merck, Inc., Whitehouse Station, NJ Indication: Sitagliptin/metformin HCl tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type-2 diabetes mellitus when glucose levels are not adequately controlled with generic metformin (Glucophage generic, Bristol-Myers Squibb) or sitagliptin (Januvia, Merck) alone or in patients who are already using a sitagliptin/metformin combination.

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The agency’s own statistics for 2006 show that drug companies failed to initiate more than 70% of post-marketing studies that they committed to performing during that year; 899 of the 1,259 post-marketing studies (71%) promised had not begun as of September 30, 2006. This was an increase of 5% over fiscal year 2005. When that report first came out, Representative Rosa DeLauro (D-Conn.), Chairman of the House Appropriations subcommittee, which approves the FDA’s annual budget, said:

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When Caroline Loew, PhD, Senior Vice President of Scientific and Regulatory Affairs at the Pharmaceutical Research and Manufacturers of America (PhRMA), appeared before a House committee in May 2007, she gave a more expansive analysis of MedWatch’s flaws:

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When the Food and Drug Administration (FDA) approved Merck’s quadrivalent human papillomavirus vaccine (Gardasil) on June 8, 2006, the agency extracted some post-approval commitments from the company, as it frequently does when it “green-lights” an important new drug around which questions still revolve. Those commitments involved additional testing of Gardasil after it went on the market, particularly in girls 11 to 12 years of age. Only a small number of girls in this age group had participated in Merck’s clinical trials, and these trials were submitted as evidence of the drug’s efficacy and safety. That patient population would loom large in the months after the FDA’s approval as Merck mounted a political campaign to convince states to require the vaccination for sixth-grade girls.

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In studies evaluating PPIs as a risk factor for CDAD, results have been mixed. This relationship has been somewhat ambiguous, and the exact mechanism of action is only speculative. C. difficile is a gram-positive, spore-forming anaerobic bacillus. The spores are acid-resistant, and they are not affected by the gastric pH. By contrast, a vegetative inoculum of C. difficile is easily destroyed by stomach acid. Suppressing gastric acid secretion may allow actively growing bacteria and ingested spores that germinate in the stomach to survive until they pass into the bowel, increasing the likelihood of colonization. PPIs have also been implicated in diminishing neutrophil activity, thereby further increasing the risk of an infectious disease. Overall, it has been proposed that PPIs either suppress the body’s natural barrier defense to infection or alter the immune response to infection.

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