FDA report on Searle's submission for NutraSweet approval 1977 - Part 18

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(57)

 

All other organs examined grossly were unremarkable.

 

Original Pathology Sheet:

 

Pituitary - Missing

Lung - Left, mid-portion adheres to the medial area of

the rib cage by a "fibrous" type of tissue. (Sub-

mitted together with relevant portion of the rib cage).

 

Right, post-caval lobe has undergone consolidation. Contains

grayish-yellowish nodules measuring 2 x 2 mm. (Entire lung

submitted in toto)

 

Lymph NOdes, Pancreatic - Slightly enlarged

 

Adrenal - Left, moderately enlarged. Right and left, covered

with tiny yellow spots measuring 1.0 x 1.0 mm.

 

Lymph Nodes, Mesenteric - moderately enlarged.

Mass - previously described on 8/20/73 has since then regressed.

Prostate - Marked atrophy, all lobes

Seminal Vesicles - Marked atrophy, bilaterally

 

All other organs examined were grossly normal and unremarkable.

 

M15CF

 

Submission:

 

Mammary gland - subcutaneous mass located in mid-thoracic

region measuring 7 x 6 x 2.5 cm.

 

Urinary bladder - papillary growth in the lumen.

 

All other organs examined grossly were unremarkable.

 

Original:

 

Mass #1 - Previously described in the left inguinal region

on 2/9/73 has since then regressed.

 

(58)

 

Masses #2 and # - Located in the mid-axillary-cervical regions

are all on mass now measuring 7.0 x 6.0 x 2.5 cm

and may be described as irregular in shape, multi-

nodular, smooth-surfaced, non-glistening,

No Spinal Cord yellowish-purpulish in color, non-adherent to the

VL underlying muscle and containing a whitish-yellowish

firm tissue within. (Submitted in toto together with

remainder of tissue).

 

Heart - Left Ventricle - dilitation and walls thin.

Spleen - Slightly enlarged

Liver - Prominent lobular architecture.

Adrenal - Left, slightly enlarged. Right, unremarkable.

Ovary - Right, small cyst measuring 4.0 x 4.0 mm and

distended with a clear yellow fluid.

 

All other organs examined were grossly normal and unremarkable.

 

G10LM

 

Submission:

 

Testis - Marked atrophy, unilaterally.

Kidney - Moderate enlargement, mottled appearance, bilaterally.

Small and large intestine exhibited moderate autolysis, no sections

submitted.

 

All other organs examined were grossly normal and unremarkable.

 

Original:

 

Mass which was initially palpated on 2/9/72 (86 days Rx)

in the left inguinal area was actually the left testis which

ascended and went thru weakened left inguinal ring into the

subcutaneous area.

 

Testis - Left (ascended) appears atrophied (submitted in toto).

Kidney - MOderate, diffuse and uniform enlargement, mottled,

bilaterally (submitted in toto).

Small and large intestines are moderately autolyzed (no sections

submitted).

Thyroid - Moderately enlarged, bilaterally. A 2 mm in dia., dis-

crete, sl raised, moderately firm yellowish-grey lesion

is located in the posterior tip, bilaterally. (Thyroid

submitted in toto wrapped in a lens paper).

 

All other organs examined were grossly normal and unremarkable.

 

(59)

 

L11LM

 

Submission:

 

Kidney - Mottled appearance

Testes - Marked atrophy, bilaterally

Prostate - Marked atrophy

 

All other organs examined grossly exhibited marked autolysis.

 

Original:

 

Adrenal - Pale yellow, bilaterally

Kidney - Pale yellow, bilaterally, rough-surfaced, bilaterally,

moderately autolyzed, bilaterally, tiny spaces in the

cortex region measuring about 1 mm in diameter,

bilaterally.

Testes - Marked atrophy, bilaterally, marked autolysis,

bilaterally.

Prostate - Marked atrophy, all lobes

Seminal Vesicles - Marked atrophy, bilaterally

Spleen - Marked autolysis

Pancreas - Marked autolysis

Stomach - Marked autolysis. A glandular portion - numerous, tiny,

pitted ulcerations measuring 1 -4 mm in diameter.

Lymph Nodes, Mesenteric - Marked autolysis

Heart - Wall of left ventricle thin

Brain - Marked autolysis

Pituitary - Marked autolysis

Liver - Marked autolysis

 

All other organs examined were grossly normal and unremarkable.

 

M17LF

 

Submission:

 

Pituitary - Marked enlargement.

Adrenal - Markedly enlarged and hyperemic, bilaterally.

Mammary Gland - Mass 1, located subcutaneously in left axillary

region, measuring 3 X 3 X 2.5 cm; mass 2, located

subcutaneously adjacent to mass 1, measuring 3 X 2

X 1 cm; mass 3, located subcutaneously in the right

axillary region, measuring 2.5 X 2 X 1 cm; mass 4,

 

(60)

 

located subcutaneously in the left inguinal region,

measuring 3 X 1 X 1 cm; mass 5, located subcutane-

ously in the right inguinal region, measuring 2 X

1.5 X 1 cm.

 

All other organs examined grossly were unremarkable.

 

Original

 

Pit - appears markedly hyperemic

Adrenal - Exhibits numerous minute greyish spots on the serosal

surface bilaterally. It appears markedly enlarged.

 

Mass (1) - A 3 X 3 X 2.5 cm. spheroidal, multinodular, yellowish

white, slightly firm mass located subcutaneously in

the left axillary area. Mass non-adherent to the

surrounding muscles or tissue (submitted in toto).

 

Mass (2) - A 2.5 X 2 X 1 cm spheroidal, smooth, yellowish white

firm mass located subcutaneously and adjacent to the

above described mass (submitted in toto) mass non-

adherent to the surrounding muscles or tissues.

 

Mass (3) - A 2.3 X 2 X 1 cm. irregularly shaped, multinodular,

yellowish white, firm mass located subcutaneously on

the rt. axillary area. Mass non-adherent to the

surrounding muscles or tissues (submitted in toto).

 

Mass (4) - A 3 X 1 X 1 cm. elongated, multinodular, yellowish

white, firm mass located subcutaneously on the left

inguinal area. Mass non-adherent to the surrounding

muscles or tissues (submitted in toto).

 

Mass (5) - A 2 X 1.5 X 1 cm. flat, multinodular, yellowish white,

firm mass located subcutaneously on the rt. inguinal

area. Mass non-adherent to the surrounding muscles

or tissues (submitted in toto).

 

All other organs examined were grossly normal and unremarkable.

 

C1MM

 

Submission

 

Kidney Marked enlargement with yellowish discoloration.

Testis Marked atrophy, bilaterally.

 

Continue to Part 19

 

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