Surveillances studies postmarketing

Kopp AF, Mortele KJ, Cho YD, et al Prevalence of acute reactions to iopromide postmarketing surveillance study of74,717 patients. Acta Radiol 2008 49 902-911. 

Postmarketing Surveillance Studies. Any surveillance of safety of a drug after marketing is postmarketing surveillance (PMS) (now often referred to as a postauthorization safety study). In practice the distinction between Phase TV studies and PMS is blurred (e.g., German drug experience studies). 

In this context, a decision on whether postmarketing surveillance studies should be built into the development programme must be taken. Such an observational study may signal the occurrence of adverse events or alternatively it may signal and quantify the frequency of adverse events. At this point in the life cycle of a new medicine, post-marketing surveillance is likely to involve cohort observational studies of 10-20 000 patients. The value of these studies is likely to be three-fold ... 

Waller PC, Wood SM, Langman MJS, et al. Review of company postmarketing surveillance studies. BMJ 1992 304 1470-2. 

HiU PL, Bridgman KM. A multicentre postmarketing surveillance study to evaluate the safety of bisoprolol in the treatment of hypertension and ischaemic heart disease. Br ] Clin Res 1992 3 85-98. 

Hannaford P. Postmarketing surveillance study of Norplant in developing countries. Lancet 2001 357(9271) 1815-6. 

Schofl C, Liibben G. Postmarketing surveillance study of the efficacy and tolerability of pioglitazone in insulin-resistant patents with type 2 diabetes mellitus in general practice. Clin Drug Invest 2003 23 725-34. 

Experimental Evidence Safety of SLIT in the Postmarketing Surveillance Studies... 

The information on safety provided by the controlled trials are of course valuable, but the populations are highly selected and the administration of SLIT is usually supervised this situation is profoundly different from that occurring in the clinical reality. Therefore, more consistent information on the safety should be obtained when SLIT is prescribed and administered in the everyday clinical practice, i.e. in postmarketing surveillance studies. 

As mentioned before, LNIT requires a particular administration technique after premedication, the allergenic extract (aqueous or powdered) has to be sprayed into a nostril while vocalizing. This fact, in addition to the efficacy limited to the nose, reduced the clinical use of LNIT therefore, no postmarketing surveillance studies are available. In conclusion, based on the clinical trials, LNIT appears safe and well tolerated. The EAACI/ESPACI position paper states that side effects do not represent a problem [12],... 

In a postmarketing surveillance study of artemotil in 300 patients, 294 (98%) were cured, five improved, and one did not show any change (9). The adverse effects were mild headache, nausea, vomiting, and giddiness. 

Painful eyes occurred in 14% of patients taking nifedipine compared with 9% in captopril-treated patients in a postmarketing surveillance study (61). The mechanism is unknown but is not via ocular vasodilatation (62). 

Etodolac, a pyranocarboxylic acid, was first marketed in the UK in 1986. By 1988, etodolac had been reported 27 times to the UK Committee on Safety of Medicines as being suspected of causing serious adverse reactions (1). In a French postmarketing safety study in 51 355 patients taking 200-600 mg/day, 10% of patients reported a total of 6236 adverse reactions and 9% dropped out because of adverse reactions, 21 of which were judged severe (2). In another four postmarketing surveillance studies in 8334 patients with rheumatic conditions who took 200-600 mg/day of etodolac for periods ranging from 4 weeks to 1 year, 23% reported adverse events and 9%... 

Adverse effects associated with famciclovir have been collected in over 6000 patients in two postmarketing surveillance studies (5). Only headache, abdominal symptoms, dizziness, vomiting, and diarrhea were associated with the drug. Two prospective trials have confirmed the low frequency of adverse effects, the more common ones being nausea, headache, vomiting, and diarrhea (6,7). 

Wilton LV, Shakir S. A postmarketing surveillance study of gabapentin as add-on therapy for 3,100 patients in England. Epilepsia 2002 43(9) 983-92. 

None of the postmarketing surveillance studies from the different vaccine manufacturers in North America showed any evidence of an increased risk of multiple sclerosis. 

Ayres JG, Frost CD, Holmes WF, Williams DR, Ward SM. Postmarketing surveillance study of a non-chlorofluorocarbon inhaler according to the safety assessment of marketed medicines guidelines BMJ 1998 317(7I63) 926-30. 

The pharmacokinetics and safety of the 5% lidocaine patches have been studied in 20 healthy volunteers, who applied four patches to the skin either every 24 hours or every 12 hours for 3 days (67). Mean steady-state plasma concentrations were 186 and 225 ng/ml respectively, well below those required for an antidysrhythmic effect (1500 ng/ml) or a risk of toxicity (5000 ng/ml). The patches were well tolerated, with no major cutaneous adverse effects. This is in line with data from postmarketing surveillance studies, which have shown that since the availability of lidocaine patches in 1999, no adverse cardiac or other serious adverse events have been reported (68). 

A postmarketing surveillance study in 10 800 patients with osteoarthritis and rheumatoid arthritis, who were followed up at 12 months, reported that 12% of patients discontinued the drug because of adverse events 11 serious events may have been related to nabumetone and seven of these were gastrointestinal hemorrhage (2). In 6148 patients treated with nabumetone in long-term trials, the 3-month cumulative incidence of chnically detected perforations, ulcers, and bleeding was 0.1% and the 6-month incidence was 0.2% (3). 

Jenner PN. A 12-month postmarketing surveillance study of nabumetone. A preliminary report. Drugs 1990 40(Suppl 5) 80-6. 

Cinnoxicam is the cinnamate ester of piroxicam its adverse effects are similar. Gastrointestinal effects (81%), nervous system effects (4%), and cutaneous effects (4%) were most common in a multicenter postmarketing surveillance study of 2969 patients 12% had adverse effects (SEDA-16, 113). Cinnoxicam cream can cause itchy erythema, edema, vesicles, and exudation (SEDA-20, 94). 

Pharmaceutical companies must report suspected adverse drug reactions noted during postmarketing surveillance studies. 

That postmarketing surveillance studies be established involving large numbers of family physicians and others. 

IV Determination of long-term efficacy and toxicity of marketed dmgs. Postmarketing surveillance studies. These studies are often conducted in private practice for postmarketing with a per-capita fee paid to assess side effects and patient acceptance. Such payments can create bias. REBs must assess the science and ethics of these studies as much as with the other phases. 

Clinical trials in which it would be unethical to use a double-blind design Some large, multicentre postmarketing 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 postmarketing surveillance study be conducted. The drug may be withdrawn from further clinical development. 

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

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