Reyes, Karren T.

BSP3C

M3: CHECK-IN ACTIVITY 1

A. Misbranded Product

risperidone (Risperdal)

“In a criminal information filed today in the Eastern District of Pennsylvania, the
government charged that, from March 3, 2002, through Dec. 31, 2003, Janssen
Pharmaceuticals Inc., a J&J subsidiary, introduced the antipsychotic drug Risperdal into
interstate commerce for an unapproved use, rendering the product misbranded. For most of
this time period, Risperdal was approved only to treat schizophrenia. The information alleges
that Janssen’s sales representatives promoted Risperdal to physicians and other prescribers
who treated elderly dementia patients by urging the prescribers to use Risperdal to treat
symptoms such as anxiety, agitation, depression, hostility and confusion. The information
alleges that the company created written sales aids for use by Janssen’s ElderCare sales force
that emphasized symptoms and minimized any mention of the FDA-approved use, treatment of
schizophrenia. The company also provided incentives for off-label promotion and intended use
by basing sales representatives’ bonuses on total sales of Risperdal in their sales areas, not
just sales for FDA-approved uses”. – a press release from the United States Department of
Justice PR# Number: 13-1170 (2013)
According to Chapter 7, Section 19 of Republic Act No. 3720, a drug or device shall be
deemed to be misbranded (a) if its labeling is false or misleading in any particular; (c) if any
work, statement, or other information required by or under authority of this Act to appear on the
label or labeling is not prominently placed thereon with such conspicuousness (as compared
with other words, statements, designs, or devices, in the labeling) and in such terms as to
render it likely to be read and understood by the ordinary individual under customary conditions
of purchase and use; (h) if it has been found by the Secretary to be a drug liable to
deterioration, unless it is packaged in such form and manner, and its label bears a statement of
such precautions, as the Secretary shall by regulations require as necessary for the protection
of the public health; and (j) if it is dangerous to health when used in the dosage, or with the
frequency of duration prescribed, recommended or suggested in the labeling thereof.
Henceforth, the drug risperidone (Risperdal) by Janssen Pharmaceuticals is subject to
all these clauses because (1) its labeling is misleading as it did not include a black box warning
and was used freely in elderly patients with dementia-induced psychosis even though it was
never approved for that use; (2) it did not include established scientific data on its adverse
effects and its impact to different subpopulations, and purposely withheld findings that showed
that Risperdal increases the risk of stroke in elderly patients; (3) Risperdal side effects were
identified as life-threatening for people of different age groups but special precautions were not
indicated in the label; (4) it was marketed as a remedy to agitation associated with dementia in
the elderly and psychiatric disorders in children, indicating to physicians and other prescribers
that Risperdal was safe and effective for these unapproved indications and populations.

B. Adulterated Product
 Tati 5 in 1 Skincare New & Improved Glow of Lasting Beauty – Ultra Night Cream

“The aforementioned product has been tested by the Department of Pharmaceutical

Services, Ministry of Health, Brunei Darussalam as part of their post-marketing surveillance
activities and results of the laboratory analyses show that this product is not compliant with the
technical standards set forth by the ASEAN Cosmetic Directive (ACD). Tati 5 in 1 Skincare New
& Improved Glow of Lasting Beauty – Ultra Night Cream has been verified to contain mercury
beyond the maximum allowed limit of 1 part per million (ppm)”. – Food and Drug Administration
(FDA) Philippines Advisory No. 2018-232
According to Chapter 10, Section 23 of Republic Act No. 3720, a cosmetic shall be
deemed to be adulterated if it bears or contains any poisonous or deleterious substances which
may render it injurious to users under the conditions of use prescribed in the labeling thereof or
under the conditions of use as are customary or usual. In this case, the product contains
mercury which is a naturally occurring heavy metal known to be severely hazardous to health
even in small amounts. Potential harmful effects of mercury contained in this adulterated
product include symptoms but not limited to pink discoloration of the hands of feet (especially in
children), numbness, tremors, tingling in hands and feet, irritability, gingivitis, and sensitivity to
light. Moreover, mercury can also be passed on to nursing newborns through breast milk,
posing a risk to the baby's development.

References:
https://www.justice.gov/opa/pr/johnson-johnson-pay-more-22-billion-resolve-criminal-and-civil-
investigations
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/020272Orig1s036,s041,020588Orig
1s024,s028,s029,21444Orig1s008,s015.pdf
https://www.fda.gov.ph/wp-content/uploads/2018/08/FDA-Advisory-No.-2018-232.pdf