PMID- 9385494
OWN - NLM
STAT- MEDLINE
DCOM- 19971230
LR  - 20190920
IS  - 0149-2918 (Print)
IS  - 0149-2918 (Linking)
VI  - 19
IP  - 5
DP  - 1997 Sep-Oct
TI  - Safety surveillance of esterified estrogens-methyltestosterone (Estratest and 
      Estratest HS) replacement therapy in the United States.
PG  - 1070-84
AB  - This paper summarizes all postmarketing safety surveillance data collected by 
      Solvay Pharmaceuticals, Inc. (Marietta, Georgia), between 1989 and 1996 for 
      Estratest and Estratest HS (half-strength). These oral esterified 
      estrogens--methyltestosterone combination products have been marketed in the 
      United States since 1964 for the treatment of moderate-to-severe vasomotor 
      symptoms associated with menopause in patients whose symptoms have not been 
      relieved by estrogens alone. Between 1989 and 1996, more than 1 million 
      woman-years of exposure occurred. The safety profile contained in this paper is 
      based on a cumulative total of 568 individual cases comprising 863 adverse events 
      (AEs). The proportions of AEs associated with the use of Estratest (575 events; 
      66.6%) and Estratest HS (288 events; 33.4%) were commensurate with the 
      proportions of individual reports of adverse experiences for the two formulations 
      (369 reports [65.0%] and 199 reports [35.0%], respectively). The rank order and 
      percentage of types of AEs reported were also similar. The cumulative volume of 
      reports was relatively low given the extent of exposure. Despite the limitations 
      inherent in spontaneous postmarketing surveillance, the safety profile derived 
      from this assessment does not indicate a significant safety concern with 
      Estratest or Estratest HS. No deaths were reported, and no adverse findings 
      indicative of the need for more comprehensive surveillance or concern on the part 
      of the medical community or consumers were observed. Reports of cancer, 
      cardiovascular disease, thromboembolic phenomena, and hepatic dysfunction were 
      few and were assessed as not related to treatment with Estratest or Estratest HS; 
      reports of drug overdose, drug-drug interaction, and birth defects were rare (4 
      of 863 events; 0.5%). The most commonly reported AEs were those known to be 
      associated with estrogen therapy (weight gain, headache, nausea, and 
      vasodilatation) and androgen treatment (alopecia, acne, and hirsutism). 
      Twenty-three (4.0%) of the 568 cases reported had at least one event that was 
      regarded as serious, and 53 (6.1%) of the total 863 AEs were regarded as serious. 
      The findings indicate that Estratest and Estratest HS are safe when used as 
      directed and that the marginal increase in risk associated with androgen 
      coadministration can be managed with appropriate patient selection and 
      monitoring, as stated in the package insert for these compounds.
FAU - Phillips, E
AU  - Phillips E
AD  - Drug Safety Unit, Solvay Pharmaceuticals, Inc., Marietta, Georgia, USA.
FAU - Bauman, C
AU  - Bauman C
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PL  - United States
TA  - Clin Ther
JT  - Clinical therapeutics
JID - 7706726
RN  - 0 (Drug Combinations)
RN  - 0 (Estratest-HS)
RN  - 0 (Estrogens)
RN  - 0 (Estrogens, Esterified (USP))
RN  - V9EFU16ZIF (Methyltestosterone)
SB  - IM
MH  - Acne Vulgaris/chemically induced
MH  - Adult
MH  - Adverse Drug Reaction Reporting Systems
MH  - Aged
MH  - Alopecia/chemically induced
MH  - Drug Combinations
MH  - Estrogen Replacement Therapy/*adverse effects
MH  - Estrogens/*adverse effects
MH  - Estrogens, Esterified (USP)
MH  - Female
MH  - Hirsutism/chemically induced
MH  - Humans
MH  - Methyltestosterone/*adverse effects
MH  - Middle Aged
MH  - *Product Surveillance, Postmarketing
MH  - United States
EDAT- 1998/01/07 00:00
MHDA- 1998/01/07 00:01
CRDT- 1998/01/07 00:00
PHST- 1998/01/07 00:00 [pubmed]
PHST- 1998/01/07 00:01 [medline]
PHST- 1998/01/07 00:00 [entrez]
AID - S0149291897800604 [pii]
AID - 10.1016/s0149-2918(97)80060-4 [doi]
PST - ppublish
SO  - Clin Ther. 1997 Sep-Oct;19(5):1070-84. doi: 10.1016/s0149-2918(97)80060-4.