Post-marketing surveillance studies

The FDA may also require manufacturers to conduct post-market surveillance studies for Class II and III devices that meet the following criteria ... 

ROCK C L, THORNQUIST M D, KRISTAL A R, PATTERSON R E, COOPER D A, NEUHOUSER M L, neumark-sztainer D and cheskin l j (1999), Demographic, dietary and lifestyle factors differentially explain variability in serum carotenoids and fat-soluble vitamins baseline results from the sentinel site of the Olestra Post-Marketing Surveillance Study , J Nutr, 129(4), 855-64. rodale (1996), The Prevention Index - a report card on the nation s health, 1996 summary report. Rodale Press, Inc, Emmaus, Pennsylvania. SANDLER R S, ZORICH N L, FILLOON T G, WISEMAN H B, LIETZ D J, BROCK M H, ROYER M G and MIDAY R K (1999), Gastrointestinal symptoms in 3181 volunteers ingesting snack foods containing olestra or triglycerides , Annals Internal Med, 130, 253-61. 

Some large, multicentre post-marketing surveillance studies, in which a comparison of the newly marketed drug and standard therapy is made... 

These deliberations may result in several outcomes. Clinical development may continue as planned, but additional vigilance with more frequent visits and special tests may be added. The dose may be reduced or certain at-risk subjects may be excluded from further trials. The drug may proceed to registration, but the authorities may stipulate that a post-marketing surveillance study be conducted. The drug may even be withdrawn from further clinical development. 

Wilton LV, Heeley El, Pickering RM, et al. Comparative study of mortahty rates and cardiac dysrhythmias in post-marketing surveillance studies of sertindole and two other atypical antipsychotic drugs, risperidone and olanzapine. J Psychophar-macol 2001 15 120-6. 

Market research activities, post-marketing surveillance studies, clinical assessments and the like must not be disguised promotion. 

Phase 4, post-marketing surveillance studies. Often organised by drug manufacturers, they can provide valuable additional information from large numbers of patients. 

Schramm G, Steffens D. Contraceptive efficacy and tolerability of chlormadinone acetate 2 mg/ethinylestradiol 0.03 mg (Belara) results of a post-marketing surveillance study Chn Drug Invest 2002 22 221-31. 

In a post-marketing surveillance study in 27 803 patients with diabetes mellitus (94% type 2), data were reported after 12 weeks. The doses of acarbose were low 4.1% took less than 100 mg/day, 64% 100-250 mg/day, 32% 250-300 mg/day, and 0.1% more than 300 mg/day. Only 2.1% stopped therapy, mainly because of gastrointestinal adverse events. Tolerability appeared to be good and independent of age. Abnormal liver function was reported in 0.01%. The difference between these results and those of many controlled trials may in part be explained by the fact that higher doses have been used in most trials (14). 

In a post-marketing surveillance study of 1142 patients in whom acarbose was added to insulin therapy for type 2 diabetes mellitus, HbAlc improved by 0.9% and there were 108 adverse effects in 6.9% of the patients (45). Most of the complaints were gastrointestinal (flatulence, abdominal pain, diarrhea) and more than half were reported in the first week of acarbose therapy. 

Spengler M, Schmitz H, Landen H. Evaluation of the efficacy and tolerability of acarbose in patients with diabetes mellitus. A post marketing surveillance study Clin Drug Invest 2005 25 651-9. 

In a post-marketing surveillance study in 8760 patients for 16 weeks the most common serious adverse effect was weight gain, followed by edema of the legs, nausea, headache, and dizziness (26). 

Lombardi C Safety of sublingual immunotherapy with monomeric allergoid in adults Multicenter post-marketing surveillance study. Allergy 2001 56 989-992. 

Di Rienzo V Post-marketing surveillance study on the safety of sublingual immunotherapy in children. Allergy 1999 54 1110-1113. 

In a post-marketing surveillance study there were some cases in which fluoxetine alone appeared to have precipitated hepatitis, which remitted when treatment was withdrawn (27). Fluoxetine can cause mild increases in liver enzymes, with a rate in clinical trials of about 0.5%. Rarely this can progress to hepatitis. 

Duloxetine has recently been marketed as an antidepressant in Europe. It inhibits the re-uptake of serotonin and noradrenaline, with minimal effects on other neurotransmitter mechanisms. It is therefore classified as a serotonin and noradrenaline re-uptake inhibitor (SNRI) and is grouped with venlafaxine. The adverse effect profile of duloxetine appears to be similar to that of the SSRIs and venlafaxine. In placebo-controlled trials the most common adverse effects were nausea (37%), dry mouth (32%), dizziness (22%), somnolence (20%), insomnia (20%), and diarrhea (14%). Sexual dysfunction has also been reported. Current data suggest that, unlike venlafaxine, duloxetine does not increase the blood pressure, but further post-marketing surveillance studies will be needed to confirm this (1). 

A group of 14 US epilepsy centers has published the results of a post-marketing surveillance study of 701 patients taking topiramate (633). Although 41% of the patients reported cognitive adverse events at any time during treatment, only 5.8% of them discontinued for... 

Engst R, Schiewe U, Hobel W, Machka K, Meister W. Famciclovir in treatment of acute Herpes zoster results of two post-marketing surveillance studies in Germany. Acta Derm Venereol 2001 81(l) 59-60. 

Wilton LV, Shakir SA. A post-marketing surveillance study of formoterol (ForadU) its use in general practice in England. Drug Saf 2002 25(3) 213-23. 

Colin-Jones DG, Langman Ml, Lawson DH, Vessey MP. Cimetidine and gastric cancer preliminary report from post-marketing surveillance study. BMJ (Qin Res Ed) 1982 285(6351) 1311-13. 

Nossol S, Schwarzbold M, Stadler T. Treatment of pain with sustained-release tramadol 100, 150, 200 mg results of a post-marketing surveillance study. Int J Clin Pract 1998 52(2) 115-21. 

Conduct of Post-marketing Surveillance study (PMS) is a regulatory stipulation. Usually the protocol and centres need to have an approval of the DCGI before initiation of the PMS study. 

Promotional material and activities must not be disguised. Market research activities, post-marketing surveillance studies, clinical assessments and the like must not be disguised promotion and must be conducted with a primarily scientific or educational purpose. 

Post-marketing surveillance studies should have scientific or medical merit and objectivity and not be designed for, or conducted as, a promotional exercise. 

Post-marketing surveillance studies must have a formal protocol and a requirement for data collection, and generate a report. 

When a company is intending to carry out a post-marketing surveillance study it must advise the Adverse Drug Reactions Advisory Committee (ADRAC) of its intention. 

Only patients being treated for approved indications of the product are to be included in the post-marketing surveillance study. 

No starter packs or free trade packs should be distributed as part of the post-marketing surveillance study. 

Post-marketing surveillance studies, pharmacoeconomic studies, non-interventional trials, clinical audit programmes and the like, which have been commissioned, undertaken or provided by companies, must never be promotional in nature and must be conducted primarily with a scientific or educational purpose. This clause does not preclude the use of the data generated from such studies to support claims in promotion. 

The requirements for conducting post-marketing surveillance studies also apply to market research studies. 

It is typical before conducting a post-marketing surveillance study to obtain the view of the regulatory authorities on its design. The study may have been a condition of product approval, and it is both reasonable and wise to ensure that the study design can be expected to provide the information that is needed both by the sponsor and the regulators. Unblinded designs that imitate the ordinary clinical situation are the norm. 

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